[House Report 110-225]
[From the U.S. Government Publishing Office]





110th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    110-225

======================================================================



 
          FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007

                                _______
                                

 July 11, 2007.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Dingell, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 2900]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 2900) to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and for medical devices, to enhance the 
postmarket authorities of the Food and Drug Administration with 
respect to the safety of drugs, and for other purposes, having 
considered the same, report favorably thereon without amendment 
and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     5
Hearings.........................................................    13
Subcommittee Consideration.......................................    14
Committee Consideration..........................................    15
Committee Votes..................................................    15
Committee Oversight Findings.....................................    18
Statement of General Performance Goals and Objectives............    18
New Budget Authority, Entitlement Authority, and Tax Expenditures    18
Earmarks and Tax and Tariff Benefits.............................    18
Committee Cost Estimate..........................................    18
Congressional Budget Office Estimate.............................    18
Federal Mandates Statement.......................................    25
Advisory Committee Statement.....................................    25
Constitutional Authority Statement...............................    25
Applicability to Legislative Branch..............................    25
Section-by-Section Analysis of the Legislation...................    25
Changes in Existing Law Made by the Bill, as Reported............    64
Additional Views.................................................   196

                          Purpose and Summary

    The bill, H.R. 2900, consists of nine titles.

         TITLE I. PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

    Title I reauthorizes the prescription drug user fee program 
through fiscal year 2012. Changes to the prescription drug user 
fee program fall into three major categories: enhancements to 
ensure sound financial footing for the human drug review 
program, enhancements for premarket review of human drug 
applications, and enhancements to modernize and transform the 
postmarket safety system.
    Title I includes the Administration's request for an 
increase in the total annual user fees collected to $392.8 
million for FY2008, an $87.4 million increase over the current 
base. The increases in fees take into account inflation and 
increased resources needed to conduct certain activities, known 
as a workload adjustment. Title I also expands the amount and 
scope of fees devoted to postmarket safety. H.R. 2900 contains 
an additional $225 million in user fees that will be collected 
over five years. These additional funds are intended to be used 
for drug safety activities and are intended to supplement and 
not supplant any other drug safety resources. There will be a 
dollar-for-dollar decrease in user fees collected for these 
additional drug safety activities for every dollar appropriated 
for the same purpose.
    Title I establishes a new program to assess, collect, and 
use fees for the voluntary review of prescription drug direct-
to-consumer (DTC) television advertisements. This title also 
requires the Food and Drug Administration (FDA), and the drug 
companies and biotechnology firms that pay fees to FDA, to 
allow other stakeholders such as consumer and patient advocates 
to participate in the negotiations for PDUFA V.

          TITLE II. MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

    Title II reauthorizes medical device user fees through 
FY2012. Changes to the medical device program fall into two 
major categories: enhancements to ensure sound financial 
footing for the device review program, and enhancements to the 
process for premarket review of device applications. Medical 
device companies will pay 31 percent more in fees in 2008 and 
8.5 percent more in each subsequent fiscal year through 2012. 
This will ensure fee increases over the next five years to 
cover anticipated costs related to rent, security, and 
statutorily mandated payroll and benefit increases.
    In an effort to add stability to this fee program, Title II 
includes two new types of fees that are intended to generate 
about 50 percent of the total fee revenue. The new fees are an 
annual establishment registration fee and an annual fee for 
filing periodic reports, for devices approved under a Premarket 
Approval Application (PMA), to FDA that provides, at least on 
an annual basis, a variety of information, including 
manufacturing and design changes, and new studies involving 
their products. This title authorizes $7,100,000 in 
appropriations for additional postmarket safety activities. 
Title II also includes provisions to streamline the third-party 
inspection program.
    Title II requires FDA, and the manufacturers of medical 
devices that pay fees to FDA, to allow other stakeholders such 
as consumer and patient advocates to participate in the 
negotiations for MDUFMA III.

     TITLE III. PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT

    Title III provides incentives to device manufacturers to 
create medical devices specifically designed to meet the needs 
of pediatric patients. It also gives FDA the authority to 
review these devices in a manner distinct from devices in 
general, and to require postmarket studies to ensure the 
continued safety and effectiveness of these devices. The 
provisions of Title III only apply to devices that are used in 
4,000 or fewer individuals.
    Title III modifies the existing humanitarian device 
exemption (HDE) for medical devices to allow manufacturers of 
HDE-approved devices specifically designed to meet a pediatric 
need to make a profit from the sale of such devices. This HDE 
modification will sunset in 2013.
    Title III authorizes FDA to establish a mechanism to track 
the number and types of devices approved specifically for 
children or for conditions that occur in children. Title III 
also grants explicit authority to FDA's Pediatric Advisory 
Committee to monitor the use of pediatric devices and to make 
recommendations for improving their availability and safety.

            TITLE IV. PEDIATRIC RESEARCH EQUITY ACT OF 2007

    Title IV reauthorizes FDA's authority to require a 
manufacturer of a drug or biologic who submits an application 
to market a new active ingredient, new indication, new dosage 
form, new dosing regimen, or new route of administration to 
also submit a pediatric assessment.
    Title IV grants the Secretary of the Department of Health 
and Human Services (HHS) permanent authority to require 
pediatric tests in appropriate circumstances. The title 
strengthens provisions of current law that allow a deferral of 
pediatric tests for new products. The standard requiring tests 
for drugs currently being marketed is also strengthened. 
Requirements with respect to labeling drugs are strengthened to 
ensure that they reflect in a timely way the results of 
studies.

         TITLE V. BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

    Title V reauthorizes for five years FDA's authority to 
grant an additional six months of marketing exclusivity to a 
manufacturer of a drug in return for FDA-requested pediatric 
use studies and reports. Title V also includes provisions to 
encourage pediatric research for products that are off-patent 
or for products whose manufacturer declines to conduct FDA-
related studies.
    Title V increases to 180 days the time limit that the 
Secretary has for deciding whether or not to grant exclusivity. 
This title also strengthens labeling requirements to ensure 
that labels reflect study results in a timely and consistent 
fashion.

                   TITLE VI. REAGAN-UDALL FOUNDATION

    Title VI creates the Reagan-Udall Foundation for the Food 
and Drug Administration. The purpose of the Foundation is to 
establish a private-public partnership to advance FDA's 
Critical Path Initiative to modernize medical product 
development, accelerate innovation, and enhance product safety. 
Title VI sets forth the duties of the Foundation to include 
identifying unmet needs in the sciences of developing, 
manufacturing, and evaluating the safety and effectiveness of 
diagnostics, devices, biologics, and drugs. Other duties 
include establishing goals and priorities to meet the 
identified unmet needs, and awarding grants to advance the 
goals and priorities identified.

                    TITLE VII. CONFLICTS OF INTEREST

    Title VII requires all individuals under consideration for 
appointment to serve on an advisory committee to disclose to 
the HHS Secretary all financial interests that would be 
affected by the advisory committee's actions. The Secretary may 
grant no more than one conflict of interest waiver per 
committee meeting for an individual if the individual's 
expertise is necessary for the work of the advisory committee. 
Disclosure of the waiver must be made public 15 or more days 
prior to the meeting of the advisory committee and must be 
posted on the Internet. Title VII spells out a process to allow 
experts with a financial conflict of interest to present 
information to the committee.
    Title VII enhances FDA's outreach activities for 
identifying non-conflicted experts to participate on advisory 
committees and directs the Secretary to review guidance on 
conflict of interest waiver determinations with respect to 
advisory committees at least once every five years and update 
this guidance as necessary.

                  TITLE VIII. CLINICAL TRIAL DATABASES

    Title VIII establishes two separate databases: one for a 
clinical trials registry and the other for clinical trials 
results. All clinical trials that are conducted to test the 
safety and efficacy of either drugs or devices would be subject 
to the database reporting requirements. The databases would 
apply to both privately and publicly-funded clinical trials. 
Title VIII requires the clinical trials registry and clinical 
trials results database to be made publicly available through 
the Internet. Title VIII provides civil monetary penalties 
(CMPs) for noncompliance.

          TITLE IX. RISK EVALUATION AND MITIGATION STRATEGIES

    Title IX strengthens FDA's postmarket drug safety authority 
and provides greater FDA transparency. Specifically, Title IX 
provides FDA with the authority to require labeling changes 
under appropriate circumstances and provides for an increased 
level of civil monetary penalties for violations of the Federal 
Food, Drug, and Cosmetic Act. Title IX provides FDA with a 
process to prereview television pharmaceutical advertisements. 
Specifically, this title strengthens FDA's ability to monitor 
and remedy false and misleading television advertising and 
provides an administrative procedure and CMPs for violations.
    Title IX provides FDA with enhanced tools to ensure 
postmarket drug safety through a ``Risk Evaluation and 
Mitigation Strategy'' (REMS) process. This title grants the 
Secretary the authority to require a REMS, if the Secretary 
determines it is necessary to ensure that the benefits of the 
drug involved outweigh the risks of the drug, for new drug and 
biologic license applications, for drugs and biologics that 
have already been approved, and for supplemental applications 
seeking approval of a new indication for use of the drug. Title 
IX requires FDA to review data on the use of drug products 
after they have been on the market for at least seven years. It 
also directs the Secretary to establish an active postmarket 
drug surveillance infrastructure.

                  Background and Need for Legislation

    The mission statement of the U.S. Food and Drug 
Administration asserts its responsibility to protect the public 
health by assuring the safety, efficacy, and security of human 
and veterinary drugs, biological products, medical devices, our 
Nation's food supply, cosmetics, and products that emit 
radiation. FDA is also responsible for advancing the public 
health by helping to speed innovations that make medicines and 
foods more effective, safer, and more affordable; and helping 
the public get the accurate, science-based information they 
need to use medicines and foods to improve their health. FDA 
regulates $1 trillion worth of products a year, representing 25 
cents out of every consumer dollar. FDA's budget amounts to 
only about $6 a year for each citizen. There are a number of 
programs that provide FDA with resources and authority to carry 
out its mission. The primary focus of H.R. 2900 is FDA's 
programs and resources devoted to human drugs and medical 
devices.

Title I. Prescription Drug User Fee Amendments of 2007

    The Prescription Drug User Fee Act (PDUFA), originally 
enacted in 1992, provides an additional revenue source for the 
Food and Drug Administration to supplement appropriations from 
Congress. These resources are used to expedite review of drug 
and biologic product approval applications and subsequent drug 
safety monitoring. PDUFA requires pharmaceutical companies to 
pay application fees for each new product and supplements to 
existing products, annual manufacturing establishment fees, and 
annual product fees. PDUFA expires on September 30, 2007, 
prompting congressional action for its third reauthorization.
    Impetus for PDUFA peaked during the late 1980s, as 
frustration grew among industry, consumers, and Government over 
the length of time between submission of a product application 
to FDA and the agency's final approval decision. Prior to 
PDUFA, FDA review of a new drug or a new biologic for sale in 
the United States took a median time of 29 months. Industry 
pressed for shorter review times in order to bring their drugs 
and biologics to market sooner and consumers argued for faster 
access to potentially life-saving products. FDA, citing a lack 
of sufficient appropriations from Congress, concluded that they 
needed extra resources to hire additional scientists to 
expedite the review process.
    Manufacturers agreed to the establishment of user fees that 
would be used to supplement, not replace, direct appropriations 
from Congress for FDA. Under the original PDUFA, user fees 
could only be assessed if Congressional appropriations for FDA 
exceeded FY1992 levels and the new drug review budget exceeded 
1992 levels. These fees were used to meet performance goals, 
mutually agreed upon by FDA and manufacturers. The Commissioner 
of Food and Drugs is required to send these goals to the 
Chairman of the Committee on Energy and Commerce of the U.S. 
House of Representatives and the Chairman of the Committee on 
Health, Education, Labor and Pensions of the U.S. Senate for 
inclusion in the Congressional Record.
    The original 1992 law establishing user fees, PL 102-571, 
commonly referred to as PDUFA I, was reauthorized in 1997 
(PDUFA II) and 2002 (PDUFA III). Each reauthorization has built 
upon the foundation of PDUFA I by adding components for 
decreased review times and increased consumer safety. PDUFA I 
required FDA to review and act on a progressively increasing 
proportion of original new drug applications (NDAs), biologic 
license applications (BLAs), and efficacy supplements within 12 
months and resubmissions and manufacturing supplements within 6 
months. FDA was also required to review and act on 90 percent 
of priority NDAs, BLAs, and efficacy supplements submitted in 
FY1997 within 6 months. PDUFA II shortened review time 
expectations and expanded the scope of PDUFA work by including 
new goals intended to improve communication between FDA and 
application sponsors during the drug development process. PDUFA 
III, for the first time, required FDA to meet with interested 
public and private stakeholders when considering the 
reauthorization of the program. PDUFA III also gave FDA the 
authority to use fees to support postmarketing surveillance and 
risk management activities for up to three years.
    User fees are a substantial part of FDA's budget. The 
FY2006 program level for FDA's human drugs program was 
approximately $517.5 million, of which 42.5 percent was from 
user fees. The median time between an application for a new 
drug or biologic license has decreased from 29 months in 1987 
to less than 14 months in fiscal year 2003. HHS has concluded 
that user fees have resulted in significant increases in 
patient access to new drugs and biologics. From fiscal year 
1993 through October 31, 2006, FDA has approved 1,103 NDAs and 
117 BLAs, including 76 new cancer drugs; 111 drugs for 
metabolic and endocrine disorders; 178 anti-infective drugs 
(including 56 for treatment of HIV or hepatitis); 115 drugs for 
neurologic and psychiatric disorders; and 80 drugs for 
cardiovascular and renal disease. Over time, the proportion of 
user fees for FDA's drug programs has increased relative to 
appropriations. This is due to limited increases in 
appropriations for FDA. One concern heard by the Committee from 
almost every witness who testified at hearings this year was 
the need to provide more resources for FDA, and the best source 
of those resources would be appropriated funds. This 
legislation cannot address that concern, but it is noted for 
the record.

Title II. Medical Device User Fee Amendments of 2007

    The Medical Device User Fee and Modernization Act (MDUFMA), 
originally enacted in 2002, provides an additional revenue 
source for the Food and Drug Administration to supplement 
appropriations from Congress. These user fees provide FDA with 
additional resources to review medical devices. MDUFMA amended 
the Federal Food, Drug, and Cosmetic Act in three significant 
ways: (1) it established user fees for premarket review of 
devices; (2) it allowed establishment inspections to be 
conducted by accredited persons (third parties); and (3) it 
instituted new regulatory requirements for reprocessed single-
use devices.
    FDA's authority to collect medical device user fees expires 
on October 1, 2007, prompting congressional action for 
reauthorization. Without a timely reauthorization, FDA would be 
forced to carry out a reduction-in-force (RIF) that could 
result in the loss of a number of employees who currently 
review medical device applications.
    Unsafe medical devices can have serious consequences for 
consumers that are deadly or far reaching. Problems with the 
procedures and equipment for HIV and hepatitis C laboratory 
tests led to hundreds of incorrect test results in 2004. 
Defects in other types of medical devices, such as pacemakers, 
defibrillators, and coronary stents, have caused patient 
deaths. Consequences such as these have raised questions as to 
whether adequate enforcement tools, resources, and processes 
are in place to ensure that marketed devices are safe.
    In the years preceding enactment of MDUFMA, FDA's medical 
device program suffered a long-term, significant loss of 
resources that undermined the program's capacity and 
performance. Many reviews of premarket approval applications 
were delayed because necessary expertise was stretched thin or 
unavailable, and many guidance documents were out-of-date. In 
response, leaders of the device industry, FDA, and Congress 
initiated discussions about linking new user fees to increased 
appropriations to augment the resources available for device 
review. MDUFMA was influenced by those discussions.
    FDA collects user fees that fund the device review process 
under the authority of MDUFMA. Over the period of FY2003 to 
FY2008, MDUFMA funding has increased at a much faster rate 
(220.1 percent) than FDA's program-level device review budget 
(31.3 percent). MDUFMA fees comprised less than 7 percent of 
FDA's program-level device review budget in FY2003, and 
estimates are that they will comprise more than 16 percent in 
FY2008.
    A number of technical corrections were made to MDUFMA in 
2004 when Congress enacted the Medical Devices Technical 
Corrections Act (MDTCA). MDTCA clarified some potentially 
confusing language in MDUFMA; modified important features of 
the provisions for third-party inspections; expanded the 
provision for electronic labeling, delayed the effective date 
of section 502(u) of the Food, Drug and Cosmetic Act (FDCA), 
which required a device to ``prominently and conspicuously'' 
bear the name of its manufacturer; and required FDA to prepare 
and submit to Congress a report on barriers to the availability 
of devices intended for children.
    FDA and the medical device industry supported MDUFMA. It 
did not take long, however, before they realized that progress 
would be limited by financial shortfalls and uncertainties. 
MDUFMA outlined both the amount Congress was expected to 
appropriate to the program and the amount expected to be 
collected in user fees for each fiscal year. In practice, 
however, the user fee framework under MDUFMA created 
uncertainty for industry and FDA regarding the annual increase 
in fees and the amount of funds that would be collected by the 
Agency in any given year. The amount of fees collected in a 
given year was unpredictable because of fluctuations in the 
number of applications FDA received and the number of 
applications received for which fees may be reduced because of 
a small business exemption. MDUFMA granted FDA the power to 
apply a ``compensating judgment'' that could lead to escalating 
fee rates if fee revenue expectations were not met. This led to 
substantial increases in fees and uncertainty for industry.
    By May 2005, uncertainty as to whether corrective 
legislation would be enacted before the October 1, 2005 
appropriations ``trigger'' date required FDA to impose a hiring 
freeze in its Center for Devices and Radiological Health. FDA 
was also faced with the difficult task of developing a workable 
approach to implement section 502(u) of the FDCA.
    In response to the growing problems with the user fee 
program, Congress enacted the Medical Device User Fee 
Stabilization Act of 2005 (the Stabilization Act). This Act 
repealed the appropriations trigger for FY2003 and FY2004 and 
allowed for tolerances of up to 1 percent of the appropriations 
trigger for FYs2005-2007; provided for predictable application 
fees by establishing fixed annual fees for FY2006 and FY2007, 
although at a lower rate of increase than under the original 
legislation; and expanded the definition of ``small business'' 
for FY2006 and FY2007. The new law also limited section 502(u) 
to reprocessed single-use devices and eliminated the granting 
by FDA of device-specific waivers.

Title III. Pediatric Medical Device Safety and Improvement Act

    Pediatric medical devices are used to treat or diagnose 
diseases and conditions in patients from birth through age 21. 
Some products are designed specifically for children, while 
others are borrowed from adult applications or produced for 
more general use.
    Children have specific medical needs that must be 
considered when medical and surgical devices are prescribed. 
Devices that have not been studied for use in children may not 
accommodate the unique needs of children, such as allowing for 
expandable growth, and accommodating their active lifestyles 
and differing metabolism.
    FDA addressed premarket review of medical devices intended 
for pediatric patients by issuing a guidance in May 2004 
entitled, Premarket Assessment of Pediatric Medical Devices. 
The guidance was published pursuant to the Medical Device User 
Fee and Modernization Act, which contained several provisions 
intended to promote the development of safe and effective 
pediatric devices. In this guidance, FDA defined the age ranges 
for pediatric subpopulations, identified the types of 
information needed to provide reasonable assurance of the 
safety and effectiveness of medical devices intended for use in 
the pediatric population, and described the protections that 
sponsors should consider for pediatric subjects involved in 
device clinical trials.
    MDUFMA also called for the Institute of Medicine (IOM) to 
evaluate FDA's postmarket surveillance of pediatric medical 
devices. The subsequent report found that FDA lacked effective 
procedures to monitor the status of safety studies of medical 
devices and recommended that Congress ensure that the agency 
establish a reliable system to track these postmarket studies. 
Additionally, the report found that it was difficult to 
reliably identify postmarket studies that considered pediatric 
issues or that more generally focused on children. The report 
also recommended that FDA, NIH, Agency for Healthcare Research 
and Quality, and other research funding agencies and interested 
parties set priorities for research on unanswered questions 
about the safe use of devices for children.
    The Medical Devices Technical Corrections Act of 2004, 
required the Secretary of HHS to submit a ``report on the 
barriers to the availability of devices intended for the 
treatment or diagnosis of diseases and conditions that affect 
children.'' This report was completed in October 2004. To 
prepare the report, FDA sought comment from interested parties 
through participation in a stakeholder meeting and by 
publishing a notice in the Federal Register requesting comment. 
HHS concluded that it was premature to recommend any 
substantive policy changes, including administrative and 
legislative changes.

Titles IV-V. Pediatric Research Equity Act of 2007; Best 
        Pharmaceuticals for Children Act of 2007

    Approximately 75 percent of drugs and a large majority of 
devices used in pediatric medicine have not been appropriately 
tested for use in children. Clinicians, however, often 
prescribe them for children believing that the safety and 
effectiveness demonstrated with adults will apply to younger 
patients. Unfortunately, this off-label prescribing can result 
in children receiving ineffective drugs or too much or too 
little of a potentially useful drug. Some side effects are 
unique to children or children of specific ages, including 
effects on growth and development. Studies show that drugs vary 
in bioavailability in children, which depends on the maturation 
and development of organs and other factors.
    The market for any individual drug's pediatric indications 
is generally small, providing an economic disincentive for 
manufacturers to commit resources to pediatric testing. The 
result is that few marketed drugs have been tested for safety 
and effectiveness in children. In some tragic cases, children 
have died or suffered serious injury as a result of either 
taking drugs that are shown safe for use in adults or from a 
medical device that worked properly in adults, but had 
different results when used in children. A March 2007 study, 
``Off-label Drug Use in Hospitalized Children,'' published in 
the Archives of Pediatric Adolescent Medicine, found that 78.7 
percent of pediatric patients discharged from the hospital 
during the time period of the study used at least one drug off-
label.
    Prior to the enactment of the Best Pharmaceuticals for 
Children Act (BPCA) and the Pediatric Research Equity Act 
(PREA), most therapies commonly used by children failed to 
provide instructions for pediatric use. Historically, 
approximately 80 percent of medication labels in the 
Physician's Reference Directory did not have pediatric use 
information. At least 62 percent of drugs on the market were 
unstudied and labeled for pediatric use. Only 38 percent of new 
drugs potentially useful in pediatrics were labeled for 
children when initially approved.
    Pediatric exclusivity was intended to provide a substantial 
incentive for sponsors to conduct some pediatric studies. The 
pediatric rule was intended to increase the number of drug and 
biological products that have adequate labeling by granting FDA 
authority to require pediatric studies. Because of the 
voluntary nature of the incentive provided by the Food and Drug 
Administration Modernization Act of 1997 (FDAMA) and BPCA, the 
possibility arose that many drugs might never have been studied 
for pediatric uses.
    On December 2, 1998, FDA published in the Federal Register 
a final regulation known as the `Pediatric Rule,' asserting the 
authority to require all manufacturers to submit pediatric 
testing data upon submittal of all new drug and biologic 
applications. On October 17, 2002, a Federal court held that 
FDA lacked the statutory authority to promulgate the Pediatric 
Rule, and declared the rule invalid.
    In response to the court decision, Congress enacted PREA, 
which essentially codified the Pediatric Rule by adding a new 
section 505B to the FFDCA. With PREA, a manufacturer submitting 
an application to market a new active ingredient, new 
indication, new dosage form, new dosing regimen, or new route 
of administration must at the same time submit a pediatric 
assessment. If the disease course and drug effects are 
sufficiently similar for adults and children, the HHS Secretary 
may allow extrapolation from adult study data as evidence of 
pediatric effectiveness, usually supplemented with other data 
from children, such as pharmacokinetic studies. PREA specifies 
situations in which the HHS Secretary may defer or waive the 
pediatric assessment requirement.
    For products already on the market, PREA grants the HHS 
Secretary the authority to require the manufacturer of an 
approved drug or licensed biologic to submit a pediatric 
assessment in situations in which the absence of pediatric use 
information on the label could pose significant risks. Before 
requiring the assessment, the Secretary must have issued a 
written request under FFDCA Section 505A or Public Health 
Service Act (PHSA) Section 409I. Further, the manufacturer must 
not have agreed to conduct the assessment, and the Secretary 
must have stated that the NIH funding programs either have or 
do not have sufficient funds to conduct that study. If the 
manufacturer does not comply with the Secretary's notice of a 
required study, the Secretary may consider the product 
misbranded. Because Congress wanted to protect adult access to 
a product under these circumstances, the law sets limits on 
FDA's enforcement options, precluding, for example, the 
withdrawal of approval or license to market.
    In January of 2002, Congress passed the Best 
Pharmaceuticals for Children Act as part of its second major 
attempt to increase the number of clinical tests performed on 
pediatric populations. Congress's earlier effort to promote 
pediatric clinical testing was the pediatric exclusivity 
provision of FDAMA. With FDAMA, Congress provided an incentive: 
in exchange for a manufacturer's completion of pediatric 
studies, performed voluntarily or in response to an FDA written 
request, FDA would extend its market exclusivity for that 
product for six months. Enacted in 2002, BPCA reauthorized this 
program for five years.
    BPCA renewed FDA's authority to give an additional six 
month period of marketing exclusivity to a manufacturer in 
return for FDA-requested pediatric use studies and reports. 
Since pediatric exclusivity, as originally defined in FDAMA, 
did not apply to products no longer covered by patent (off-
patent) or other marketing exclusivity agreements, and since 
patent holding manufacturers could decline to conduct FDA-
requested studies, BPCA added provisions to encourage pediatric 
research in those products. For off-patent products, BPCA added 
a new section, 409I, to the Public Health Service Act, which 
established an off-patent NIH research fund for these studies 
and authorized appropriations of $200 million for FY2002 and 
such sums as are necessary for each of the five years until the 
provisions sunset on October 1, 2007. For on-patent drugs whose 
manufacturers declined FDA's written requests for studies, BPCA 
amended the Federal Food, Drug, and Cosmetic Act Section 505A 
to allow their referral by FDA to the NIH Foundation for 
pediatric studies.
    BPCA also granted pediatric supplemental applications 
priority status to address the concern that pediatric 
exclusivity did not lead to quick changes in drug labels. 
Further, the legislation provided for a dispute resolution 
mechanism for labeling changes that have not been resolved 
within 180 days of supplement submission. At the end of this 
process, should the manufacturer not agree to comply with the 
Secretary's proposed label, the Secretary may `deem' the drug 
misbranded.
    Pediatric exclusivity has resulted in more than 132 
completed studies leading to over 114 label changes 
incorporating new pediatric information. In a March 2007 report 
to Congress entitled Pediatric Drug Research: Studies Conducted 
Under Best Pharmaceuticals for Children Act, the U.S. 
Government Accountability Office (GAO) noted that these 
labeling changes were often made as a result of findings by the 
pediatric drug studies that children may have been exposed to 
ineffective drugs, ineffective dosing, overdosing, or 
previously unknown side effects. These studies underscore the 
danger of assuming that because a drug that is safe and 
effective in adults, it is also safe and effective in children.

Titles VI-IX. Reagan-Udall Foundation; Conflicts of Interest; Clinical 
        Trials Databases; Risk Evaluation and Mitigation Strategies

    Following several high-profile drug safety cases in 2004, 
the GAO wrote a report in March 2006 entitled, Drug Safety: 
Improvement Needed in FDA's Postmarket Decision-Making and 
Oversight Process. In its report, the GAO found that FDA lacked 
clear and effective processes for making decisions about, and 
providing management oversight of, postmarket drugs safety 
issues. Specific problems cited included: a lack of criteria 
for determining what safety action to take and when to take 
them; insufficient communication between the Office of New 
Drugs (OND) and the Office of Drug Safety (ODS); FDA's access 
to data being constrained by its limited authority to require 
drug sponsors to conduct postmarket studies; and FDA's limited 
resources for acquiring data from other external sources.
    FDA then commissioned the Institute of Medicine to write a 
report on drug safety. In its report, The Future of Drug 
Safety: Promoting and Protecting the Health of the Public, IOM 
raised several concerns: FDA and the pharmaceutical industry do 
not consistently demonstrate accountability and transparency to 
the public about safety concerns in a timely and effective 
fashion; the drug safety system is impaired by serious resource 
constraints that weaken the quality and quantity of the 
science; and an organizational structure in the Center for Drug 
Evaluation and Research (CDER) is not functioning properly and 
being hindered by unclear, insufficient regulatory authority.
    Four titles in this bill address the concerns raised by the 
GAO and IOM reports: Reagan-Udall Foundation, Conflicts of 
Interest for FDA Advisory Committees, Clinical Trials Registry 
Database and Clinical Trials Results Database, and Risk 
Evaluation and Mitigation Strategies (REMS).
    Title VI, the Regan-Udall Foundation, addresses the concern 
that, over the last decade, fewer new medical products have 
been submitted to the FDA for approval because the use of 
outmoded testing methods is resulting in a rising product 
failure rate during development. Newer technologies need new 
methods for their assessment. Allowing FDA to collaborate with 
other researchers will contribute greatly to filling this void.
    Title VII addresses concerns that advisory panels play an 
important role in FDA's work, and therefore, the advice 
provided by these panels should not be influenced by conflicts 
of interest. FDA relies heavily on the recommendations of its 
30 advisory committees in its assessment of product safety and 
benefit. There has been concern that members of these 
committees may not be operating in the most judicious manner 
due to industry funding or other financial interests. It is 
important that more safeguards are put into place to ensure 
that advisory committee members are serving with integrity and 
with the best interest of the consumer in mind.
    Title VIII establishes a comprehensive, mandatory clinical 
trials registry database and clinical trials results database. 
This addresses concerns raised by the IOM's report on drug 
safety in regard to the need for FDA to increase the 
availability of information to the public and to researchers 
for recruitment purposes and to communicate the risks and 
benefits of drugs. Currently, the NIH database, 
ClinicalTrials.gov, hosts information only on trials for 
serious or life-threatening conditions. The Committee believes 
that information about trial results is important to providers 
and patients. Presently, negative results may or may not be 
released by sponsors. A uniform, centralized database and 
registry will help patients, providers, and researchers learn 
new information and make more informed healthcare decisions.
    Title IX is the centerpiece of this bill's attempt to 
enhance postmarket drug safety. A central aspect of this 
program is to authorize FDA to require a risk evaluation and 
mitigation strategy (REMS) in all appropriate cases. The IOM 
report highlights the need to extend drug safety consideration 
from premarket through postmarket approval. A number of other 
reports suggest that cultural issues within FDA and gaps in the 
agency's authorities hamper the ability to take swift and 
effective action when problems arise. The REMS program will be 
enhanced by the establishment of a robust active surveillance 
program designed to see how drugs work in real world postmarket 
circumstances, which are often quite different than what is 
learned about a drug in the carefully controlled clinical trial 
setting.

                                Hearings

    There were four oversight hearings and one legislative 
hearing held by the Committee's Subcommittee on Health in 
connection to the bill reported by the Committee.
    The Subcommittee on Health held a hearing on 
``Reauthorization of the Prescription Drug User Fee Act'' on 
Tuesday, April 17, 2007. The Subcommittee received testimony 
from the following: Theresa M. Mullin, Ph.D., Assistant 
Commissioner for Planning, Food and Drug Administration (FDA); 
Alan Goldhammer, Ph.D., Deputy Vice President for Regulatory 
Affairs, Pharmaceutical Research and Manufacturers of America 
(PhRMA); Mr. James Thew, Patient Advocate, Amyotrophic Lateral 
Sclerosis (ALS) Association; Ms. Kay Holcombe, Senior Policy 
Advisor, Genzyme Corporation; Mr. William K. Vaughan, Senior 
Policy Advocate, Consumers Union; and Mr. William Hubbard, 
Senior Advisor, Coalition for a Stronger FDA.
    The Subcommittee on Health held a hearing on ``Assessing 
the Safety of our Nation's Drug Supply'' on Wednesday, May 9, 
2007. The Subcommittee received testimony from the following: 
Steven K. Galson, M.D., M.P.H., Director, Center for Drug 
Evaluation and Research, Food and Drug Administration; Marcia 
Crosse, Ph.D., Director, Health Care Issues, U.S. Government 
Accountability Office; Susan S. Ellenberg, Ph.D., Associate 
Dean for Clinical Research, University of Pennsylvania School 
of Medicine; Sharon Levine, M.D., Associate Executive Director, 
The Permanente Medical Group; Caroline Loew, Ph.D., Senior Vice 
President, Science and Regulatory Affairs, PhRMA; John H. 
Powers, III, M.D., F.A.C.P., F.I.D.S.A. (formerly of FDA); 
Ellen V. Sigal, Ph.D., Friends of Cancer Research; Ms. Lisa Van 
Syckel; Mr. R. John Theriault, Chief Security Officer and Vice 
President, Global Security, Pfizer, Inc.; and Ms. Diane 
Thompson, Vice President, Public Policy and Communications, 
Elizabeth Glaser Pediatric AIDS Foundation (on behalf of the 
Alliance for Drug Safety and Access).
    The Subcommittee on Health held a hearing on 
``Reauthorization of the Medical Device User Fee and 
Modernization Act'' on Wednesday, May 16, 2007. The 
Subcommittee received testimony from the following: Jeffrey 
Shuren, M.D., J.D., Assistant Commissioner for Policy, FDA; 
Paul LaViolette, M.B.A., Chief Operating Officer, Boston 
Scientific Corporation; Diana Zuckerman, Ph.D., President, 
National Research Center for Women and Families; Mr. Kelvyn 
Cullimore, Jr., President and CEO, Dynatronics Corporation, and 
Secretary, Medical Device Manufacturers Association; Mr. Steven 
A. Grossman, Executive Director, The FDA Alliance; and Ms. 
Diane E. Dorman, Vice President for Public Policy, National 
Organization for Rare Disorders (NORD).
    The Subcommittee on Health held a hearing on ``Programs 
Affecting Safety and Innovation in Pediatric Therapies'' on 
Tuesday, May 22, 2007. The Subcommittee received testimony from 
the following: RADM Sandra L. Kweder, M.D., Deputy Director, 
Office of New Drugs, Center for Drug Evaluation and Research, 
FDA; Donald Mattison, M.D., Chief, Obstetric and Pediatric 
Pharmacology Branch, National Institute of Child Health and 
Human Development, NIH; Ms. Lori Reilly, Vice President for 
Policy and Research, PhRMA; Marcia Crosse, Ph.D., Director, 
Health Care Issues, U.S. Government Accountability Office; 
Richard L. Gorman, M.D., F.A.A.P., Chair, AAP Section on 
Clinical Pharmacology and Therapeutics, American Academy of 
Pediatrics (AAP); Peter Lurie, M.D., M.P.H., Deputy Director, 
Public Citizen's Health Research Group; Mr. Donald P. Lombardi, 
President and CEO, Institute for Pediatric Innovation; Ed 
Rozynski, Vice President, Global Government Affairs, Stryker 
Corporation; and Ms. Susan Belfiore, testifying on behalf of 
the Elizabeth Glaser Pediatric AIDS Foundation.
    The Subcommittee on Health held a legislative hearing on 
``Discussion Drafts Concerning Prescription Drug User Fee Act 
Reauthorization, Medical Device User Fee and Modernization Act 
Reauthorization, Drug Safety, and Certain Pediatric 
Pharmaceutical and Device Legislation'' on Tuesday, June 12, 
2007. The Subcommittee received testimony from the following: 
Randall L. Lutter, Ph.D., Associate Commissioner for Policy and 
Planning, FDA; Richard L. Gorman, M.D., F.A.A.P., Chair, AAP 
Section on Clinical Pharmacology and Therapeutics, American 
Academy of Pediatrics; Diana Zuckerman, Ph.D. President, 
National Research Center for Women and Families; Caroline Loew, 
Ph.D., Senior Vice President, Science and Regulatory Affairs, 
PhRMA; Mr. Steve Walker, Co-Founder and Chief Advisor, Abigail 
Alliance for Better Access to Developmental Drugs; Mr. James 
Guest, President and CEO, Consumers Union; and Mr. Steven J. 
Ubl, President and CEO, Advanced Medical Technology 
Association.

                       Subcommittee Consideration

    Prior to the introduction of H.R. 2900, its text was 
considered in the Committee as nine separate Committee Prints, 
each of which became one of the titles of the bill.
    On Tuesday, June 19, 2007, the Subcommittee on Health met 
in open markup session and took the following actions on the 
nine Committee Prints:
          The Committee Print on the Prescription Drug User Fee 
        Amendments of 2007 (PDUFA) was favorably forwarded to 
        the full Committee, amended, by a voice vote.
          The Committee Print on the Medical Device User Fee 
        Amendments of 2007 (MDUFA) was favorably forwarded to 
        the full Committee, amended, by a voice vote.
          The Committee Print on the Pediatric Medical Device 
        Safety and Improvement Act of 2007 was favorably 
        forwarded to the full Committee, without amendment, by 
        a voice vote.
          The Committee Print on the Pediatric Research Equity 
        Act of 2007 was favorably forwarded to the full 
        Committee, amended, by a voice vote.
          The Committee Print on the Best Pharmaceuticals for 
        Children Act of 2007 was favorably forwarded to the 
        full Committee, amended, by a voice vote.
          The Committee Print to amend the Federal Food, Drug, 
        and Cosmetic Act to provide for the establishment of 
        the Reagan-Udall Institute for Applied Biomedical 
        Research, and for other purposes, was favorably 
        forwarded to the full Committee, amended, by a voice 
        vote.
          The Committee Print to amend the Federal Food, Drug, 
        and Cosmetic Act with respect to conflicts of interest, 
        and for other purposes, was favorably forwarded to the 
        full Committee, without amendment, by a voice vote.
          The Committee Print to amend the Public Health 
        Service Act to provide for the establishment of a 
        clinical trial registry database and a clinical trial 
        results database, and for other purposes, was favorably 
        forwarded to the full Committee, amended, by a voice 
        vote.
          The Committee Print to amend the Federal Food, Drug, 
        and Cosmetic Act to improve drug safety, and for other 
        purposes, was favorably forwarded to the full 
        Committee, amended, by a voice vote.

                        Committee Consideration

    On Thursday, June 21, 2007, the full Committee met in open 
markup session and considered the nine Committee Prints, each 
of which was ordered favorably reported to the House, amended, 
by a voice vote, except that the Committee Print to amend the 
Federal Food, Drug, and Cosmetic Act with respect to conflicts 
of interest, and for other purposes, was ordered favorably 
reported to the House, without amendment, by a voice vote.
    By unanimous consent, the full Committee then agreed that 
the nine Committee Prints, as ordered reported, be combined and 
introduced as a single bill and reported favorably to the House 
without further consideration by the Committee. Pursuant to 
that agreement, the Committee ordered the single bill favorably 
reported, by a recorded vote of 43-0.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. Mr. 
Pallone moved that, pursuant to the agreement to introduce a 
single bill consisting of the nine approved Committee Prints, a 
recorded vote be held to report the single bill favorably to 
the House. The motion to report the single bill favorably to 
the House was agreed to by a recorded vote of 43 yeas and 0 
nays. The following are the recorded votes taken on the motion 
and on amendments, including the names of those Members voting 
for and against.


                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Subcommittee on Health has held 
legislative and oversight hearings on this legislation and made 
findings that are reflected in this report.

         Statement of General Performance Goals And Objectives

    The objectives of H.R. 2900 are to reauthorize prescription 
drug and medical device user fee programs; ensure that drugs 
and devices used in children are properly studied and labeled 
for pediatric use; and improve prescription drug and medical 
device safety and oversight.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee finds 
that H.R. 2900 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures. As 
described in the cost estimate included below (from the 
Director of the Congressional Budget Office), new receipts 
would result under section 901(d)(4) of the bill, which amends 
section 303 of the Federal Food, Drug, and Cosmetic Act to add 
a subsection (g) that provides for civil money penalties.

                  Earmarks and Tax And Tariff Benefits

    In compliance with clause 9 of rule XXI of the Rules of the 
House of Representatives, H.R. 2900 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

H.R. 2900--Food and Drug Administration Amendments of 2007

    Summary: H.R. 2900 would authorize the collection and 
spending of user fees by the Food and Drug Administration (FDA) 
for certain activities to expedite the marketing approval of 
prescription drugs and medical devices and to regulate 
prescription drugs after they enter the market. Such fees would 
be collected and made available for obligation only to the 
extent and in the amounts provided in advance in appropriation 
acts.
    The bill also would establish a surveillance system to 
monitor and assess the safety profile of drugs on the market, 
enhance FDA's authority to regulate marketed drugs, expand 
federal databases that track information on certain clinical 
trials, and reauthorize and modify programs that evaluate the 
use of drugs and devices by children. The legislation would 
authorize funds to extend FDA's grant program for orphan 
products, conduct post-marketing surveillance of medical 
devices, establish programs to accelerate innovation and 
improve the evaluation of medical products, and promote the 
security of drugs distributed in the United States.
    On balance, CBO estimates that implementing H.R. 2900 would 
have net discretionary costs of $728 million over the 2008-2012 
period. Enacting the bill would increase direct spending by $7 
million over the 2009-2012 period and by $200 million over the 
2009-2017 period. Finally, we estimate that enacting H.R. 2900 
would decrease net federal revenues by $1 million over the next 
five years and by $41 million over the 10 years through 2017.
    H.R. 2900 contains both intergovernmental and private-
sector mandates as defined in the Unfunded Mandates Reform Act 
(UMRA). The bill would preempt any state or local law that 
requires manufacturers of medical devices or drugs to register 
clinical trails and related information in a database, but the 
net costs of that mandate would be minimal and far below the 
threshold established in UMRA ($66 million in 2007, adjusted 
annually for inflation). The most costly of the bill's private-
sector mandates would be the requirement that manufacturers of 
prescription drugs and medical devices pay fees to the FDA. The 
direct cost of the fees would exceed the annual threshold 
specified in UMRA ($131 million in 2007, adjusted annually for 
inflation).
    Estimated Cost to the Federal Government: H.R. 2900 would 
affect discretionary and direct spending, as well as revenues. 
(See Tables 1 and 2 at the end of this estimate). The costs of 
this legislation fall primarily within budget functions 550 
(health) and 570 (Medicare). It would also affect budget 
functions 370 (commerce and housing credit), 700 (veterans 
benefits and services), and 750 (administration of justice).

Spending subject to appropriation

    Assuming appropriation action consistent with the bill, CBO 
estimates that implementing H.R. 2900 would reduce net 
discretionary outlays by $100 million in 2008, primarily 
because the spending of fees lags somewhat behind their 
collection. CBO estimates that gross spending in subsequent 
years would exceed the amounts collected from user fees 
(because some of that spending under the bill would not be 
offset by fees), and that the net cost of implementing the bill 
would amount to $728 million over the 2008-2012 period, 
assuming the appropriation of the necessary amounts (see Table 
1).
    Because a significant portion of the cost of FDA activities 
would be offset by user fees, the largest component of the net 
discretionary cost of implementing H.R. 2900 would be an 
estimated $432 million in spending over the 2008-2012 period 
mostly for pediatric research conducted by the National 
Institutes of Health. It is unclear how a provision in the bill 
(in section 103) would be implemented. The provision would 
require FDA to reduce annual assessments for user fees 
dedicated to drug safety activities based, in part, on certain 
levels of funds appropriated for the ``process of human drug 
review.'' Given that uncertainty, our estimate reflects the 
full (unadjusted) collections of user fees authorized under the 
bill plus any funding provided by additional authorizations of 
appropriations.

Direct spending

    H.R. 2900 also would extend the authority for FDA to 
administer an incentive program that grants market exclusivity 
to manufacturers that voluntarily conduct studies on the use of 
drugs in certain pediatric populations, the so-called 
``pediatric exclusivity program.'' The bill would require that 
affected periods of existing market exclusivity be extended by 
an additional six months if the manufacturer meets specified 
requirements. (During such period of pediatric exclusivity, FDA 
could not permit another manufacturer to market a version of 
the drug.)
    Extending market exclusivity for certain prescription drugs 
by six months would delay the entry of lower-priced generic 
versions of those drugs, which would affect both direct 
spending and federal revenues. Because delaying the 
availability of lower-priced generic drugs would increase 
spending on pharmaceutical benefits by federal health programs, 
CBO estimates that direct spending for Medicare, Medicaid, the 
Federal Employees Health Benefits (FEHB) program, and the 
TRICARE for Life program would increase by an estimated $7 
million over the 2009-2012 period and $200 million over the 
2009-2017 period (see Table 2). (CBO estimates that the market 
exclusivity provisions would increase discretionary spending by 
the FEHB program, Department of Veterans Affairs, Department of 
Defense, and other federal health benefits programs by about $2 
million over the 2009-2012 period. Those effects are included 
under ``Provisions Affecting Pediatric Populations'' in Table 
1.)

Revenues

    H.R. 2900 would affect revenues in two ways. First, it 
would make certain violations of new requirements under the 
bill subject to civil money penalties; collections of such 
penalties are classified as federal revenues. Second, higher 
spending for prescription drugs would increase the cost of 
premiums for private health insurance. Higher premiums, in 
turn, would result in more of an employee's compensation being 
received in the form of nontaxable employer-paid premiums, and 
less in the form of taxable wages. As a result of this shift, 
federal income and payroll tax revenues would decline. CBO 
estimates that the proposal would reduce net federal revenues 
by $1 million over the 2009-2012 period and $41 million over 
the 2009-2017 period (see Table 2). Social Security payroll 
taxes, which are off-budget, would account for $13 million of 
that total.
    Estimated impact on State, Local, and tribal governments: 
H.R. 2900 would preempt any state or local law that requires 
manufacturers of medical devices or drugs to register clinical 
trials and related information in a database. That preemption 
would be an intergovernmental mandate as defined in the 
Unfunded Mandates Reform Act because it would limit the 
application of state and local law. While a number of states 
have considered legislation in recent years to establish such 
requirements, only a few have enacted them. In some cases, 
states have established fees that are tied to the registration 
requirements. While those states would lose a small amount of 
fee revenues as a result of the preemption, costs of state 
regulatory responsibilities also would decline. Consequently, 
CBO estimates that the net costs to comply with the mandate 
would be minimal and far below the threshold established in 
UMRA ($66 million in 2007, as adjusted for inflation).
    Spending by states for Medicaid would increase by an 
additional $35 million over the 2009-2017 period because of the 
provision in the bill that would delay entrance into the market 
of some generic drugs. Because states have flexibility in that 
program to adjust their financial and programmatic 
responsibilities, such additional spending would not result 
from an intergovernmental mandate.
    Estimated impact on the private sector: The bill would 
place a number of requirements on the manufacturers of 
prescription drugs and medical devices that would be private-
sector mandates as defined in UMRA. The most costly of those 
mandates would be the requirement that those entities pay fees 
to the FDA. CBO estimates that the direct cost of those fees 
alone would exceed the annual threshold specified in UMRA ($131 
million in 2007, adjusted annually for inflation) in each of 
the five years that the mandates would be effective.
    In addition to the fees on manufacturers of prescription 
drugs and medical devices under titles I and II, the bill 
contains other private-sector mandates that would impose 
additional but smaller costs. Title IV would renew FDA's 
authority to require that manufacturers undertake certain 
studies of the safety and efficacy of their drugs in pediatric 
populations. Title V would renew the Secretary's ability to 
award brand-name drug manufacturers six months of market 
exclusivity for the completion of FDA-requested pediatric 
studies. (The exclusivity period would effectively be a mandate 
on generic drug manufacturers because they would not be allowed 
to enter the market during that period.) Title VIII would 
require that manufacturers submit information about clinical 
trials to FDA. Title IX would enhance FDA's authority to 
regulate drugs by requiring that drug manufacturers submit a 
risk evaluation and mitigation strategy if the Secretary 
determines that such a strategy is necessary to protect the 
public's health.
    Previous CBO estimate: On April 27, 2007, CBO transmitted a 
cost estimate for S. 1082, the Prescription Drug User Fee 
Amendments of 2007, as reported by the Senate Committee on 
Health, Education, Labor, and Pensions. Many of the provisions 
contained in H.R. 2900 as ordered reported by the House 
Committee on Energy and Commerce are contained in S. 1082. The 
differences between the two bills are reflected in CBO's two 
estimates.
    H.R. 2900 differs from S. 1082 in a number of ways. For 
example, H.R. 2900 would provide six months of exclusivity to 
all drugs granted pediatric exclusivity under the program; S. 
1082 would limit the pediatric exclusivity period to three 
months for certain ``blockbuster'' drugs. H.R. 2900 would also 
allow FDA to require that firms submit television 
advertisements to FDA for review prior to distribution and to 
make certain violations related to direct-to-consumer 
advertising subject to civil monetary penalties. S. 1082 does 
not contain a similar provision.
    In addition, the bills would authorize different levels of 
additional user fee collections for activities related to drug 
safety while specifying different adjustment mechanisms for 
assessing such fees in a given year. H.R. 2900 would authorize 
$25 million a year through 2012 to establish a surveillance 
system for marketed drugs compared with annual authorizations 
of $30 million under S. 1082.
    H.R. 2900 also would authorize $25 million annually through 
2012 to carry out activities related to risk evaluation and 
management strategies and for initiatives by several federal 
agencies to improve the security of drugs distributed in the 
United States. The bill would authorize $30 million annually 
over the 2008-2012 period to extend FDA's grant program for 
orphan products and additional funding for other activities.
    In total, CBO's estimate of net discretionary spending for 
H.R. 2900 is $181 million higher than for S. 1082 over the 
2008-2012 period. Estimates of direct spending and revenues are 
also different for the two bills. Over the 2009-2017 period, 
CBO estimates that direct spending under H.R. 2900 would be $50 
million higher and total net revenue losses would be $9 million 
higher than for S. 1082 as reported by the Senate Committee on 
Health, Education, Labor, and Pensions.
    Estimate prepared by: Federal Costs: Julia Christensen and 
Sarah Evans. Impact on State, Local, and Tribal Governments: 
Lisa Ramirez-Branum. Impact on the Private Sector: Anna Cook 
and Stuart Hagen.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                        TABLE 1. ESTIMATED IMPACT OF H.R. 2900 ON DISCRETIONARY SPENDING
----------------------------------------------------------------------------------------------------------------
                                                                    By fiscal year, in millions of dollars--
                                                               -------------------------------------------------
                                                                  2008      2009      2010      2011      2012
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Collections from User Fees:
  Prescription Drug Fees......................................      -463      -541      -626      -717      -886
  Advertising Fees............................................       -13        -8       -10       -10       -11
  Medical Device Fees.........................................       -48       -53       -57       -62       -67
      Total, Estimated Authorization Level....................      -524      -602      -693      -789      -964
      Total, Estimated Outlays................................      -524      -602      -693      -789      -964
Spending of User Fees:
  Prescription Drug Fees......................................       463       541       626       717       886
  Advertising Fees............................................        13         8        10        10        11
  Medical Device Fees.........................................        48        53        57        62        67
      Total, Estimated Authorization Level....................       524       602       693       789       964
      Total, Estimated Outlays................................       345       594       682       776       878
        Net Changes in User Fees:
          Estimated Authorization Level.......................         0         0         0         0         0
          Estimated Outlays...................................      -179        -8       -11       -13       -86
Other Proposed Changes:
  Risk Evaluation and Mitigation Strategies:
      Authorization Level.....................................        80        80        80        80        80
      Estimated Outlays.......................................        56        79        84        81        81
  Provisions Affecting Pediatric Populations:
      Program for Pediatric Research:
        Estimated Authorization Level.........................         0        75       150       200       225
        Estimated Outlays.....................................         0        19        79       144       190
      Other Provisions:
        Estimated Authorization Level.........................        14        19        24        25        26
        Estimated Outlays.....................................        11        19        23        25        26
  Other Provisions1:
      Estimated Authorization Level...........................        15        21        25        27        28
      Estimated Outlays.......................................        12        20        22        26        28
          Total Changes:
            Estimated Authorization Level.....................       109       195       279       332       359
            Estimated Outlays.................................      -100       129       197       263       239
----------------------------------------------------------------------------------------------------------------
1Amounts primarily reflect costs for the Food and Drug Administration and the National Institutes of Health of
  expanding federal efforts to collect information on clinical trials, establishing partnerships with private
  entities to foster the innovation and safety of medical products, and enhancing federal oversight of medical
  devices to assess their safety after market entry.


                                            TABLE 2. CHANGES IN DIRECT SPENDING AND REVENUES UNDER H.R. 2900
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  By fiscal year, in millions of dollars--
                                                   -----------------------------------------------------------------------------------------------------
                                                     2008    2009    2010    2011    2012    2013    2014    2015    2016    2017   2008-2012  2008-2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               CHANGES IN DIRECT SPENDING

Estimated Budget Authority........................       0       *       *       1       5      11      19      29      53      83         7        200
Estimated Outlays.................................       0       *       *       1       5      11      19      29      53      83         7        200

                                                                   CHANGES IN REVENUES

Estimated Revenues:
    On-budget.....................................       0       *       *       *      -1      -2      -3      -4      -7     -11        -1        -28
    Off-budget....................................       0       *       *       *       *      -l      -l      -2      -4      -5         *        -13
                                                   -----------------------------------------------------------------------------------------------------
        Total.....................................       0       *       *       *      -1      -3      -4      -6     -11     -16        -1       -41
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: * = less than $500,000; components may not sum to totals because of rounding.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    Regarding section 5(b) of the Federal Advisory Committee 
Act, section 901(d)(4) of the bill amends section 303 of the 
Federal Food, Drug, and Cosmetic Act to add a subsection (g) 
(relating to civil money penalties) that, in paragraph (7), 
requires the establishment of an advisory committee to provide 
certain advice to the Secretary of Health and Human Services 
regarding direct-to-consumer advertising. The Committee finds 
that establishing the advisory committee is the most efficient 
way of carrying out the policies involved.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes, and in the provisions of 
Article I, section 8, clause 1, that relate to expending funds 
to provide for the general welfare of the United States.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


               SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

Sec. 1. Short title.
Sec. 2. Table of contents.

         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Sec. 101. Short title; references in title.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Fees relating to advisory review of prescription-drug 
          television advertising.
Sec. 105. Reauthorization; reporting requirements.
Sec. 106. Sunset dates.

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

Sec. 201. Short title; references in title.

               Subtitle A--Fees Related to Medical Devices

Sec. 211. Definitions.
Sec. 212. Authority to assess and use device fees.
Sec. 213. Annual reports.
Sec. 214. Consultation.
Sec. 215. Additional authorization of appropriations for postmarket 
          safety information.
Sec. 216. Effective date.
Sec. 217. Sunset clause.

     Subtitle B--Amendments Regarding Regulation of Medical Devices

Sec. 221. Extension of authority for third party review of premarket 
          notification.
Sec. 222. Registration.
Sec. 223. Filing of lists of drugs and devices manufactured, prepared, 
          propagated, and compounded by registrants; statements; 
          accompanying disclosures.
Sec. 224. Electronic registration and listing.
Sec. 225. Report by Government Accountability Office.
Sec. 226. Unique device identification system.
Sec. 227. Frequency of reporting for certain devices.
Sec. 228. Inspections by accredited persons.
Sec. 229. Study of nosocomial infections relating to medical devices.

     TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT

Sec. 301. Short title.
Sec. 302. Tracking pediatric device approvals.
Sec. 303. Modification to humanitarian device exemption.
Sec. 304. Encouraging pediatric medical device research.
Sec. 305. Demonstration grants for improving pediatric device 
          availability.
Sec. 306. Amendments to office of pediatric therapeutics and pediatric 
          advisory committee.
Sec. 307. Postmarket Studies.

             TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

Sec. 401. Short title.
Sec. 402. Reauthorization of Pediatric Research Equity Act.
Sec. 403. Government Accountability Office report.

         TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

Sec. 501. Short title.
Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act.

                    TITLE VI--REAGAN-UDALL FOUNDATION

Sec. 601. The Reagan-Udall Foundation for the Food and Drug 
          Administration.
Sec. 602. Office of the Chief Scientist.
Sec. 603. Critical path public-private partnerships.

                    TITLE VII--CONFLICTS OF INTEREST

Sec. 701. Conflicts of interest.

                  TITLE VIII--CLINICAL TRIAL DATABASES

Sec. 801. Clinical trial registry database and clinical trial results 
          database.
Sec. 802. Study by Government Accountability Office.

           TITLE IX--RISK EVALUATION AND MITIGATION STRATEGIES

Sec. 901. Postmarket studies and clinical trials regarding human drugs; 
          risk evaluation and mitigation strategies.
Sec. 902. Enforcement.
Sec. 903. No effect on withdrawal or suspension of approval.
Sec. 904. Benefit-risk assessments.
Sec. 905. Postmarket risk identification and analysis system for active 
          surveillance and assessment.
Sec. 907. Statement for inclusion in direct-to-consumer advertisements 
          of drugs.
Sec. 908. Clinical trial guidance for antibiotic drugs.
Sec. 909. Prohibition against food to which drugs or biological products 
          have been added.
Sec. 910. Assuring pharmaceutical safety.
Sec. 911. Orphan antibiotic drugs.
Sec. 912. Authorization of appropriations.
Sec. 913. Effective date and applicability.

         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Section 101. Short title; references in act

    Section 101 establishes the short title as the 
``Prescription Drug User Fee Amendments of 2007''. This section 
also establishes that references in the Act are to the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

Section 102. Definitions

    Section 102 amends Section 735 of the Federal Food, Drug, 
and Cosmetic Act to eliminate the distinction between approvals 
under 505(b)(1) and 505(b)(2) for requirements of this section. 
This section also expands the definition of postmarket safety 
activities beyond ``collecting, developing, and reviewing 
safety information on the drugs, including adverse event 
reports. . .'' The new definition includes the development and 
use of improved adverse-event data-collection systems, 
including information technology systems and analytical tools 
to assess potential safety problems, including access to 
external data bases. The definition also includes a summary 
analysis of adverse drug reaction reports received for recently 
approved drugs, regular bi-weekly screening of the Adverse 
Event Reporting System, updating Adverse Event Reporting System 
reports every six months, and reporting to Congress on the 
recommendations received on postmarket safety activities.
    Section 102 amends Section 735 of the FFDCA to eliminate 
the three-year limit on use of fees for postmarket safety 
activities, substitute appropriate year references, and expand 
the definition of the term ``person'' to include ``an affiliate 
thereof.''

Section 103. Authority to assess and use drug fees

    Types of Fees. Section 103 amends Section 736 ``Authority 
to Assess and Use Drug Fees'' of the FFDCA. Subsection 736(a) 
``Types of Fees'' is amended to clarify that the Secretary of 
Health and Human Services will retain 25 percent of the 
application fees for applications that are withdrawn before 
filing; and that applications or supplements previously refused 
for filing or that were withdrawn before filing will be subject 
to the full user fee upon being resubmitted or filed over 
protest, unless otherwise exempted or waived.
    Special Rules for Positron Emission Tomography Drugs. 
Section 103 provides special rules for positron emission 
tomography (PET) drugs to be exempt from the annual 
establishment fee. An applicant that is a not-for-profit 
medical center that has only one establishment for the 
production of PET drugs, and at least 95 percent of the doses 
produced by such establishment will be used within the medical 
center may be exempt from the annual establishment fee. Any 
other person named as an applicant would pay one-sixth of the 
annual establishment fee.
    Fee Revenue Amounts. Section 103 amends subsection 736(b) 
``Fee Revenue Amounts'' to establish fees that, for each of 
FY2008 through FY2012, generate total annual revenue of 
$392,783,000, plus an adjustment for FY2007 workload. The 
workload adjustment factor is modified for FY2007 to apply to 
the FY2008 total. Each subsequent fiscal year will be 
determined based on the adjusted FY2008 total increased by the 
specified amount for each year, adjusted according to changes 
in the total annual appropriation for FDA relative to the 
appropriation for FY2007. Total revenue will continue to be 
equally divided among application fees, establishment fees, and 
product fees. An additional $225,000,000 in fee revenue is 
provided for drug safety activities. This amount will be 
triggered by appropriations amounts. There will be a dollar-
for-dollar decrease in user fees collected for postmarket 
safety for every dollar appropriated for the same purpose.
    Adjustments to Fees. Section 103 amends subsection 736(c) 
``Adjustments to Fees'' to modify the inflation adjustment for 
the annual statutory revenue target to account for changes in 
personnel compensation and benefits costs. The workload 
adjustment regarding commercial investigational new drug 
applications (INDs) is modified to use the number of active, 
rather than new, commercial INDs submitted each year. A 2 
percent ceiling is set on total workload adjustment due to 
changes in review activities, and the Secretary is required to 
contract with an independent accounting firm to study the 
FY2009 adjustments and make recommendations for changing the 
adjustment methodology.
    The rent and rent-related cost adjustment is modified 
beginning in FY2010 to decrease the total fee revenue amount up 
to $11,721,000 for a fiscal year if actual costs paid for rent 
and rent-related expenses in the preceding fiscal year were 
less than had been estimated.
    Fee Waiver or Reduction. Section 103 amends subsection 
736(d) ``Fee Waiver or Reduction'' to add to the definition of 
a small business (500-mployee maximum) that the business have 
no approved drug product already in interstate commerce. The 
Secretary is also required to consider only the circumstances 
and assets of the applicant (and affiliates of the applicant) 
in determining whether to grant a waiver or fee reduction.
    Crediting and Availability of Fees. Section 103 amends 
subsection 736(e) ``Crediting and Availability of Fees'' to 
authorize appropriations for each of fiscal years 2008 through 
2012 an amount equal to the total revenue amount. If the fees 
to be collected exceed the cumulative amount appropriated for 
fees, the excess will be credited to the appropriation account 
of FDA and subtracted from the amount of fees authorized.
    Exemption for Orphan Drugs. Section 103 further amends 
section 736 to exempt orphan drugs from product and facility 
fees. The orphan drug must have had sales in the United States 
in the previous year of less than $25,000,000, meet public 
health requirements, and must be owned or licensed and marketed 
by a company that had less than $100,000,000 in gross worldwide 
revenue.

Section 104. Fees relating to advisory review of prescription-drug 
        television advertising

    Section 104 amends part 2 of subchapter C of chapter VII by 
adding after section 736 the following:
            ``Section 736A. Fees Relating to Advisory Review of 
                    Prescription-Drug Television Advertising.''
    New section 736A establishes a new user fee program to 
authorize FDA to assess, collect, and use fees for the advisory 
review of proposed direct-to-consumer (DTC) television 
advertisements prior to their initial release. To the extent 
there are additional staff resources available under this 
program that are not necessary for advisory reviews of DTC 
television advertisements, the fees may be used for advisory 
comments on other proposed ads and promotional material prior 
to public dissemination.
    New section 736A establishes an advisory review fee for 
each advertisement a company submits to FDA with a request for 
an advisory review and a one-time operating reserve fee the 
first time a company pays an advisory review fee.
    New section 736A specifies requirements for notices and 
late payments on submissions; allows for no waivers, 
exemptions, or reductions; and allows for no refunds, unless 
the Secretary has received less than $11,250,000 during the 
first 120 days after enactment, in which case the program shall 
terminate and all fees be refunded.
    New section 736A specifies revenue at $6,250,000 per year 
(FY2008 through FY2012), with inflation, personnel cost, and 
workload adjustments. Methodologies and ceilings are provided 
for setting fees. Additional provisions restrict the use of fee 
revenue, provide for the termination of the program if 
inadequate fees have been collected, and outline procedures in 
the event of a company's failure to pay or the inadequate 
funding of the program.
    New section 736A authorizes to be appropriated for fees, 
for each of FY2008 through FY2012, the total revenue amount 
plus adjustments, and any amount necessary for ending the 
program at the end of FY2012, or earlier, if funding of the 
program is inadequate.

Section 105. Reauthorization; reporting requirements

    The fees authorized by this Title will be dedicated towards 
expediting the drug development process and review process as 
set forth in the goals identified for purposes of part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on Energy and 
Commerce of the House of Representatives and the Chairman of 
the Committee on Health, Education, Labor and Pensions of the 
Senate, as set forth in the Congressional Record.
    Section 105 requires that the Secretary submit to Congress 
annually a performance report to cover FDA's progress in 
achieving the goals identified in letters from the Secretary to 
the authorizing committees. The Secretary is also required to 
submit to Congress an annual fiscal report describing the 
implementation of authority for advertising fees and FDA's use 
of such fees.
    Section 105 outlines the process the Secretary must follow 
in developing recommendations to Congress regarding goals for 
the next reauthorization. The Secretary is required to: (1) 
consult with the authorizing committees, scientific and 
academic experts, health care professionals, representatives of 
patient and consumer advocacy groups, and the regulated 
industry; (2) publish recommendations in the Federal Register 
after negotiations with regulated industry and patient and 
consumer advocacy groups; (3) provide a comment period 
regarding these recommendations, hold a public meeting, and 
revise the recommendations as necessary; and (4) transmit the 
revised recommendations to Congress by January 15, 2012, along 
with a summary of the public views and comments and any changes 
made to the recommendations in response.

Section 106. Sunset dates

    Section 106 sets October 1, 2012, for the sunset of 
sections 102 (definitions), 103 (the authority to assess and 
use drug fees), and 104 (the authority to assess and use 
prescription drug advertising fees).

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

Section 201. Short title; references

    Section 201 establishes the short title as the ``Medical 
Device User Fee Amendments of 2007''. This section also 
establishes that references in the Act are to the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

Subtitle A--Fees Related to Medical Devices

Section 211. Definitions

    Section 211 adds or amends several definitions in section 
737 of the FFDCA applicable to medical device fees. Newly added 
definitions for 30-day notice, request for classification 
information, annual fee, and establishment subject to 
regulation (and under the last of these, descriptions of 
manufacturer, single-use device reprocessor, and specification 
developer), reflect the addition of new types of fees. The 
addition of a definition for person specifies that the term 
includes an affiliate thereof. A change in the definition of 
adjustment factor shifts from April to October the Consumer 
Price Index numbers used as the basis for calculating the 
amount of direct medical device related appropriations 
necessary to enable FDA to collect medical device user fees.

Section 212. Authority to assess and use device fees

    Types of Fees, Fee Amounts, and Exceptions. Section 212 
adds three new types of fees including: (1) an annual 
establishment registration fee (paid once each year by each 
manufacturer), (2) an annual fee for filing periodic reports 
(generally applicable to Class III devices--those requiring 
FDA's highest level of safety controls), and (3) a fee for 30-
Day Notices (submitted for modifications to manufacturing 
processes or methods--typically only required for Class III 
devices). Other types of fees required by the FFDCA would 
remain in place.
    Section 212 decreases fee amounts. This section also 
strikes a provision that enables the Secretary of the 
Department of Health and Human Services to adjust the premarket 
notification fee amount annually so that, in aggregate, these 
fees comprise a target amount. No other fee amounts are set by 
this method.
    Section 212 contains an exception to new annual 
establishment registration fees for State and Federal 
governmental entities, and Indian Tribes (as defined in the 
Indian Self Determination and Educational Assistance Act).
    Section 212 provides that, once the new fees are set for 
2008, they will generally increase each year by 8.5 percent. 
For the newly created establishment fee, the Secretary could 
increase the fee amount in FY2010, up to 8.5 percent over the 
annual rate of increase, if fewer than 12,250 establishments 
paid the fee in FY2009.
    Payment and Refunds. Section 212 updates the payment 
information section to reflect new fee types and dates. It also 
adds a provision to current law, which enables the Secretary to 
refund portions of fees for modular applications withdrawn 
before FDA takes its first action, or before other subsequent 
submissions are made. For all types of applications, current 
law allows for partial refunds for applications refused for 
filing or withdrawn before filing, and for partial or full 
refunds for applications withdrawn before FDA takes its first 
action.
    Fees for Small Businesses. Section 212 makes it easier to 
qualify as a small business, removing a requirement that the 
assets of partners and parent firms be considered. This section 
also enables foreign businesses to qualify as small businesses 
by allowing evidence of income from sources other than the 
Federal income tax return submitted to the Internal Revenue 
Service. In addition, section 212 would further reduce the 
application fees paid by small business.
    Effect of Failure to Pay Fees. Section 212 expands the 
provision in current law that specifies that the Secretary 
shall deem incomplete an application from a person with a 
missing fee and shall not accept it until all fees owed by the 
person are paid to encompass the new application fees. This 
section also prevents the Secretary from considering complete 
and accepting registration information submitted under FFDCA 
Sec. 510 (Registration of Producers of Drugs and Devices) until 
the registration fee is paid.
    Conditions and Authority. Section 212 extends, for each 
subsequent year, the provision in current law that specifies 
that fees may not be assessed and the Secretary is not expected 
to meet any performance goals if the amount of medical device-
related direct appropriations falls below a specified threshold 
($205,720,000 multiplied by an annual adjustment factor).
    Section 212 extends the provision that states if the 
Secretary is prevented from collecting fees during any portion 
of a fiscal year because of insufficient direct appropriations, 
he may collect them later during that fiscal year without any 
modification in the rate to include the newly added fees as 
well.
    Crediting and Availability of Fees. Section 212 authorizes 
appropriations for FY2008--FY2012 in the following amounts: 
$48,431,000 for FY2008; $52,547,000 for FY2009; $57,014,000 for 
FY2010; $61,860,000 for FY2011; and $67,118,000 for FY2012.
    Section 212 allows FDA to aggregate all fees collected 
between FY2008 and FY2011 and compare that amount to the 
aggregate amount authorized for the same period. A reduction 
would be made in fees in the final year only if the amount 
collected in the four-year period exceeded the amount 
authorized for the same period.

Section 213. Annual reports

    Section 213 requires the Secretary to submit annual 
progress reports to relevant congressional committees regarding 
FDA's progress in achieving fee-related performance goals 
specified in a letter from the Secretary, and regarding the 
implementation of the authority to collect such fees. This 
section also specifies that the implementation report should 
include a description of the use of such fees for postmarket 
safety activities.

Section 214. Consultation

    Section 214 outlines the process the Secretary must follow 
in developing recommendations to Congress regarding goals for 
the next reauthorization. The Secretary is required to: (1) 
consult with the authorizing committees, scientific and 
academic experts, healthcare professionals, representatives of 
patient and consumer advocacy groups, and the regulated 
industry; (2) publish those developed recommendations in the 
Federal Register; and (3) provide a comment period.

Section 215. Additional authorization of appropriations for postmarket 
        safety information

    Section 215 authorizes additional appropriations for 
FY2008-FY2012 of $7,100,000 for the purpose of collecting, 
developing, reviewing, and evaluating postmarket safety 
information on medical devices.

Section 216. Effective date

    Section 216 states that the amendments made by this Act 
shall take effect on the date of enactment of the Act, except 
fees shall be assessed for all premarket submissions received 
on or after October 1, 2007, regardless of the date of 
enactment.

Section 217. Sunset clause

    Section 217 states that user fee amendments would cease to 
be effective on October 1, 2012, except that the section 
regarding annual reports would cease to be effective on January 
31, 2013.

Subtitle B--Amendments Regarding Regulation of Medical Devices

Section 221. Extension of authority for third-party review of premarket 
        notifications

    Section 221 extends the authority of the third-party review 
of premarket notifications through October 1, 2012.

Section 222. Registration

    Section 222 restricts the registration period for producers 
of devices to the period of October 1-December 31 of each year.

Section 223. Section filing lists of drugs, and devices manufactured, 
        prepared, propagated, and compounded by registrants; statements 
        and accompanying disclosures

    Section 223 changes the timing for those involved with 
devices, to provide a list of drugs and devices on which they 
perform specific functions, such as manufacturing and 
compounding to once per year between October 1 and December 31, 
thus eliminating the requirement to file a second list each 
year.

Section 224. Electronic registration and listing

    Current law requires registrations to be submitted to the 
Secretary by electronic means, upon a finding by the Secretary 
that the electronic receipt of such registrations is feasible, 
unless the Secretary grants a request for waiver of such 
requirement because use of electronic means is not reasonable 
for the person requesting such waiver (FFDCA Sec. 510(p)). 
Section 224 adds the requirement that information required by 
the section be submitted electronically unless the Secretary 
grants a waiver because electronic registration is not 
reasonable for the person requesting such a waiver.

Section 225. Report by Government Accountability Office

    Section 225 requires the Comptroller General to conduct a 
study to determine the safety and effectiveness of a new device 
based on the criteria set forth by the Secretary's evaluation 
of the device and submit a report to Congress on his findings 
within one year of the study.

Section 226. Unique device identification system

    Section 226 requires the Secretary to establish a unique 
identification system for medical devices.

Section 227. Frequency of reporting for unique devices

    Section 227 allows device manufacturer to submit reports on 
a quarterly basis in a summary form, except for devices that 
are life supporting or life sustaining, which can be submitted 
according to part 803 of Code 21.

Section 228. Inspections by accredited persons

    Section 228 requires the device inspector to notify the 
Secretary of any withdrawal, suspension, restriction, or 
expiration of certificate of conformance within 30 days of such 
change.
    Before the inspection, the owner of the device must submit 
to the Secretary a notice providing the date of the last 
inspection, a statement declaring the intention of having an 
accredited inspector, a statement identifying the intended 
inspector, and a certification that at least one device is 
marketed in the United States and is intended to be marketed in 
at least one foreign country where the accredited inspector is 
certified.
    The Secretary may deny clearance or ask for additional 
information such as compliance data or disclosure of the 
relationship between the manufacturer and the inspector. The 
manufacturer must respond within 60 days of the Secretary's 
request for additional information. If the Secretary denies 
clearance of an accredited inspector, the owner may make a new 
selection. At the Secretary's discretion, the manufacturer may 
submit audits assessing conformance with appropriate quality 
system standards.

Section 229. Study of nosocomial infections related to medical devices

    Section 229 requires the Comptroller General to submit a 
report on nosocomial infections attributed to medical devices 
and the causes of such infections and report to Congress on his 
findings no later than one year after enactment of this law. 
Nosocomial infection is defined as an infection that is 
acquired while a person is a patient of a hospital and was not 
present or incubating before the patient received treatment at 
that hospital.

 TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

Section 301. Short title

    Section 301 establishes the short title as the ``Pediatric 
Medical Device Safety and Improvement Act of 2007''.

Section 302. Tracking Pediatric Device Approvals

    Section 302 amends chapter V of the Federal Food, Drug, and 
Cosmetic Act (FFDCA) by inserting a new section 515A 
``Pediatric Uses of Devices''.
            ``Section 515A. Pediatric Uses of Devices.''
    New section 515A requires that an application or protocol 
submitted to the Secretary for a device must include a 
description of any pediatric subpopulations that suffer from 
the disease or condition that the device is intended to treat, 
diagnose, or cure, and the number of affected pediatric 
patients.
    New section 515A creates a mechanism to allow FDA to track 
the number and types of devices approved specifically for 
children or for conditions that occur in children, as well as 
the approval times for premarket approvals and humanitarian 
device exemptions. The Secretary shall submit a report to 
Congress on the results 18 months after enactment. FDA is 
granted specific authority to allow the extrapolation of adult 
data to support a pediatric indication, as appropriate.

Section 303. Modification to humanitarian device exemption (HDE)

    Section 303 amends section 520(m) of the FFDCA to modify 
the existing HDE provision to allow profit for devices 
specifically designed to meet a pediatric need. This provision 
applies from the date of enactment of this section. To prevent 
abuse, this section reverts to current law (no profit) on sales 
that exceed the number estimated to be needed for the approved 
condition (modeled after existing Orphan Products Division 
designation process). Under no circumstances can there be a 
profit on sales if the device is used to treat or diagnose 
diseases or conditions affecting more than 4,000 individuals in 
the U.S. per year (same as current law). Upon the date of 
enactment of this section, already approved adult HDEs shall be 
eligible for the HDE profit modification if they meet the 
conditions of the section.
    Section 303 defines pediatric patients as patients who are 
21 years of age or younger at the time of diagnosis or 
treatment and defines pediatric subpopulation as neonates, 
infants, children, and adolescents. As a check on postmarket 
safety, this section requires adverse events for pediatric HDE 
devices to be reported to the Office of Pediatric Therapeutics 
and requires the Pediatric Advisory Committee to conduct an 
annual review to determine whether the exemption is still 
appropriate.
    Section 303 requires a Comptroller General report no later 
than January 1, 2012, to assess whether the HDE profit 
exemption has increased the availability of pediatric devices, 
what its impact is on premarket approvals, conditions or 
diseases the pediatric devices were intended to treat or 
diagnose, costs of the pediatric devices and the extent to 
which those costs are covered by insurance, profits made by 
manufacturers for each device that receives an exemption, 
existing obstacles to pediatric device development, and an 
evaluation of the demonstration grants under Section 305.
    Section 303 directs FDA to issue guidance to institutional 
review committees for responding to HDEs.

Section 304. Encouraging pediatric medical device research

    Section 304 requires the National Institutes of Health 
(NIH) to designate a ``contact point'' to help innovators 
access existing funding for pediatric medical device 
development. NIH, FDA, and the Agency for Healthcare Research 
and Quality (AHRQ) shall submit a plan, within 180 days of 
enactment, for pediatric medical device research that 
identifies gaps and proposes a research agenda for addressing 
them. As needed, the plan can include a survey of pediatric 
medical providers to identify unmet pediatric medical device 
needs.

Section 305. Demonstration grants for improving pediatric device 
        availability

    Section 305 establishes demonstration grants for non-profit 
consortia to promote pediatric device development, including 
``matchmaking'' between inventors and manufacturers and federal 
resources and mentoring and project management throughout the 
development process. The consortia must coordinate with NIH to 
identify research issues that require further study and with 
the FDA to facilitate approval of pediatric indications. H.R. 
2900 authorizes an appropriation of $6,000,000 for each of 
FY2007-FY2011 for these grants.

Section 306. Amendments to Office of Pediatric Therapeutics and 
        Pediatric Advisory Committee

    Section 306 amends section 14 of the Best Pharmaceuticals 
for Children Act to grant explicit authority to FDA's Pediatric 
Advisory Committee to monitor pediatric devices and make 
recommendations for improving their availability and safety.

Section 307. Postmarket studies

    Section 307 amends section 522 of the FFDCA to allow FDA to 
require postmarket studies as a condition of clearance for the 
categories of devices found in this section. This includes ``a 
class II or class III device the failure of which would be 
reasonably likely to have serious adverse health consequences 
or is intended to be (1) implanted in the human body for more 
than one year, or (2) a life sustaining or life supporting 
device used outside a device user facility.'' This also 
includes devices intended for use in pediatric patients, or 
intended for use generally, but expected to have significant 
use by pediatric patients. This provision ensures that the 
Secretary can require postmarket surveillance not only for 
those devices specifically intended for pediatric uses, but 
also for devices that are cleared without specifying a specific 
patient group, yet are expected to be used to a significant 
degree in pediatric patients. Requiring postmarket surveillance 
for this latter group of devices reflects the Committee's 
understanding that most devices that FDA reviews do not specify 
whether a device is for an adult or child; they are reviewed 
for indications for use in all populations for whom the use is 
applicable. Postmarket surveillance for these devices in 
pediatric patients utilizes collection of data in a 
subpopulation of a larger population for whom the device is 
intended.
    Section 307 grants FDA the ability to require studies 
longer than three years with respect to a device that is to 
have significant use in pediatric populations, if such studies 
would be necessary to address longer-term pediatric questions, 
such as the impact on growth and development.
    Section 307 establishes a dispute resolution process for 
any order or condition requiring postmarket surveillance under 
this section. During this process, the device may not be deemed 
misbranded unless it is necessary to protect the public health.
    While children and adults suffer from many of the same 
diseases and conditions, their device needs can vary 
considerably due to differences in size, rates of growth, 
critical development periods, anatomy (e.g., organ size), 
physiological differences (e.g., breathing and heart rates), 
physical activity levels, etc. In addition, since there are 
many pediatric diseases for which no adult parallel exists, in 
some cases devices exclusively designed for children are 
needed.
    The Committee believes that, like adults, children deserve 
medical devices that are safe, effective, and designed for 
their particular needs. Yet, to date, because the pediatric 
market is so small and pediatric diseases are relatively rare, 
there has been little incentive for the development of devices 
specifically designed for children. Typically, pediatric 
providers must resort to ``jury-rigging'' or fashioning 
makeshift device solutions for pediatric use. When that is not 
an option, providers may be forced to use more invasive 
treatment or less effective therapies.
    In an effort to gain more information about pediatric uses 
of devices, the legislation amends section 522 to give the 
Secretary new authority to require postmarket surveillance as a 
condition of approval or clearance. This change is consistent 
with recommendations of the Institute of Medicine. This new 
authority applies to class II and class III devices whether 
approved under section 515 or cleared under section 510(k). In 
addition, this authority applies to devices either intended for 
use in pediatric patients or not labeled for pediatric use, but 
nonetheless expected to have significant use in pediatric 
populations. The provision of authority to require postmarket 
surveillance for this latter group of devices reflects the 
Committee's understanding that most devices are for general use 
and some devices may be labeled only for adult use--but both of 
these types of devices may still be expected to have 
significant use in children. The Committee intends this new 
authority to be available to the Secretary when appropriate, as 
discussed below.
    This provision will ensure that FDA has authority to gather 
information about physicians' uses of devices in pediatric 
populations in the post-market setting whether or not the 
device is labeled for pediatric use. Safety and effectiveness 
data to support a pediatric use is most appropriately collected 
in the premarket setting in accordance with the Agency's 
investigational device exemption and human subject protection 
regulations. The authority to require collection of postmarket 
safety data on device use in pediatric populations is not 
intended to replace this important premarket process. The 
Committee does not intend to encourage or legitimize any 
promotion of an unapproved and unproven use of a device in 
pediatric patients.
    An order under section 522 directing post-market 
surveillance on pediatric use of a device shall not be 
construed to permit any promotion, sale, or distribution that 
is otherwise prohibited by law. This provision should not be 
seen to encourage any promotion of off-label pediatric uses of 
devices that have been cleared or approved for adult use but 
for which there is no or limited safety and effectiveness data 
concerning uses in children.
    The Committee encourages the Secretary to require 
postmarket surveillance, where appropriate. The Committee 
understands that legitimate circumstances may arise that result 
in questions about a postmarket surveillance order, requiring a 
means of appealing the order. Because of the types of questions 
that likely will result in appeals, the Committee believes that 
the already established dispute resolution process for 
addressing scientific controversies under Section 562 provides 
the best means of determining the appropriateness of a post-
market surveillance order. Importantly, to avoid adverse impact 
to the public health through a product's withdrawal, the 
Committee provides that during the pendency of an appeal of a 
postmarket surveillance order, the Secretary shall not consider 
a device to be misbranded or otherwise in violation of such 
order or a related requirement of this Act, unless the 
Secretary determines it is necessary to protect the public 
health. While the exercise of this authority likely will be 
rare, it is essential that the Secretary retain the discretion 
to act in the event that such action is necessary to protect 
the public health.

            TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

Section 402. Reauthorization of the Pediatric Research Equity Act

    Section 402 amends subsection 505B of the FFDCA in the 
following ways:
            ``Section 505B. Research into Pediatric Uses for Drugs and 
                    Biological Products.''
    New Drugs and Biological Products. New section 505B 
provides that the Secretary may require the sponsor of an 
application for a drug or a license for a biological product to 
submit an assessment of the effect of their product in 
pediatric populations. The assessment must include the safety 
and effectiveness of the drug or biological product for the 
claimed indications in all relevant pediatric subpopulations 
and must support dosing and administration for each pediatric 
subpopulation.
    If the course of disease and the effects of the drug are 
similar in adult and child patients, the Secretary may conclude 
that effectiveness in pediatric populations can be extrapolated 
from studies of adults. Extrapolation may also be used between 
age groups. Scientific data supporting extrapolation must be 
included in any pertinent reviews for the application for drugs 
and biologics.
    New section 505B states that the Secretary may defer 
submission of some or all pediatric assessments until after 
approval of a drug or issuance of a license for a biological 
product. If submission is deferred, the applicant must submit 
an annual report to the Secretary including information 
detailing the progress made in conducting pediatric studies, 
and if no progress is made, evidence that such studies will be 
conducted with due diligence. These reports shall be made 
available to the public in an easily accessible manner.
    New section 505B states that the Secretary may grant a full 
waiver of pediatric assessments if the necessary studies are 
impossible or highly impracticable, there is evidence that the 
product would be ineffective or unsafe in pediatric 
populations, or the product does not represent a meaningful 
therapeutic benefit and will not be used in a substantial 
number of pediatric patients. The Secretary may also issue a 
partial waiver. Companies seeking waivers on the grounds that a 
pediatric formulation cannot be developed must submit 
documentation detailing why a pediatric formulation cannot be 
developed. If a full or partial waiver is granted, the reason 
for the waiver must be included in the product labeling.
    Marketed Drugs and Biological Products. New section 505B 
states that the Secretary may require the sponsor or the holder 
of an approved application for a drug or a license for a 
biological product to submit by a specified date an assessment 
of the effect of their product in pediatric populations.
    New section 505B states that the Secretary may grant a full 
waiver if the necessary studies are impossible or highly 
impracticable, there is evidence that the product would be 
ineffective or unsafe in pediatric populations, or the product 
does not represent a meaningful therapeutic benefit and will 
not be used in a substantial number of pediatric patients. The 
Secretary may also issue a partial waiver. Companies seeking 
waivers on the grounds that a pediatric formulation cannot be 
developed must submit documentation detailing why a pediatric 
formulation cannot be developed. If a full or partial waiver is 
granted, the reason for the waiver must be included in the 
product labeling.
    Meaningful Therapeutic Benefit. New section 505B outlines 
the criteria used to determine if a product provides a 
meaningful therapeutic benefit.
    Submission of Assessments. New section 505B states that if 
a person fails to submit an assessment or a request for 
approval of a pediatric formulation, the drug or biological 
product may be deemed misbranded. Failure to submit the 
assessment or request, however, cannot be the basis for 
withdrawing approval of the product or revoking the license of 
the product.
    Meetings. New section 505B states that the Secretary shall 
meet with the sponsor of a new drug or biological product 
before and during the investigational process to discuss the 
sponsor's plans and timelines for pediatric studies and any 
planned request by the sponsor for waiver or deferral of 
pediatric studies.
    Review of Pediatric Plans, Deferrals, and Waivers. New 
section 505B states that the Secretary shall establish an 
internal review committee, composed of employees with expertise 
in pediatrics and other subspecialties, to review all pediatric 
plans, deferrals, and waivers made under this section. The 
Secretary is required to track the number and types of 
assessments, deferrals, waivers, and labeling changes conducted 
under this section, as well as the number of pediatric 
formulations developed or not developed and an annual summary 
of information submitted for deferrals.
    Labeling Changes. New section 505B considers applications 
or supplements proposing a labeling change as a result of 
pediatric studies under PREA a priority application or 
supplement.
    If label changes are not made within 180 days of submission 
of the application, a dispute resolution process is outlined. 
If an application sponsor does not agree with the 
Commissioner's request for label change within 30 days, the 
matter is referred to the Pediatric Advisory Committee. The 
Committee shall consider the matter within 90 days and make 
recommendations to the Commissioner. The Commissioner then has 
30 days to make a request to the sponsor of the application to 
make any labeling changes. If the sponsor still does not agree 
with the recommendations, the Commissioner may deem the drug 
misbranded.
    New section 505B grants the Secretary the authority to 
order the label of a product to include information from 
studies indicating that a drug is or is not safe and effective 
in pediatric populations or subpopulations, including whether 
the study results are inconclusive.
    Dissemination of Pediatric Information. New section 505B 
requires the Secretary to make medical, statistical, and 
clinical pharmacology reviews of pediatric studies available to 
the public not later than 180 days after the date of submission 
of a report. The Secretary will also require the sponsors of 
studies that result in labeling changes reflected in the annual 
summary to distribute this information to physicians and other 
healthcare providers.
    Adverse Event Reporting. New section 505B requires the 
Secretary, during the one-year period beginning on the date a 
labeling change is made, to ensure that all adverse event 
reports that have been received for a drug are referred to the 
Office of Pediatric Therapeutics and provided for review by the 
Pediatric Advisory Committee.
    Following the one year period, the Secretary is required to 
provide the Office of Pediatric Therapeutics a report of any 
information regarding pediatric adverse events for a drug for 
which a pediatric study was conducted. When considering the 
report, the director of the Office of Pediatric Therapeutics 
may provide for the review of the report by the Pediatric 
Advisory Committee including obtaining any committee 
recommendations regarding whether the Secretary should take 
action.
    Scope of Authority. New section 505B states that the 
Secretary may not require pediatric assessment of a drug or 
biological product outside of what is described in this 
section.
    Orphan Drugs. New section 505B does not apply to orphan 
drugs unless required otherwise by the Secretary.
    Institute of Medicine Study. New section 505B requires the 
Secretary to ask IOM to conduct a study of the implementation 
of PREA and report to Congress not later than three years after 
enactment of this section. The study shall review and assess 
pediatric studies conducted since 1997 and the use of 
extrapolation for pediatric subpopulations, the use of 
alternative endpoints, neonatal assessment tools, the number 
and type of pediatric adverse events, and ethical issues in 
pediatric clinical trials.

Section 403. Government Accountability Office Report

    Section 403 provides that no later than September 1, 2011, 
the Comptroller General of the U.S., in consultation with the 
Secretary, shall submit to Congress a report that addresses the 
effectiveness of sections 505A and 505B of the FFDCA and 
section 409I of the PHSA in ensuring that medicines used by 
children are tested and properly labeled.

             TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT

Section 501. Short title

    Section 501 establishes the short title as the ``Best 
Pharmaceuticals for Children Act of 2007''.

Section 502. Reauthorization of the Best Pharmaceuticals for Children 
        Act

    Section 502 amends section 505A of the Federal Food, Drug, 
and Cosmetic Act to read as follows:
            ``Section 505A. Pediatric Studies of Drugs.''
    Definitions. New section 505A amends the definition of 
pediatric studies to include preclinical studies.
    Market Exclusivity for New Drugs. New section 505A states 
that if, prior to the approval of a new drug application, the 
Secretary determines that the new drug may produce health 
benefits in the pediatric population, the Secretary may make a 
written request to the holder of an approved drug application 
to conduct pediatric studies. Should the holder agree to the 
request, complete the appropriate studies in the designated 
timeframe, provide reports, and comply with labeling changes 
requested by the Secretary, the Secretary may grant six months 
of additional market exclusivity. The Secretary shall not grant 
additional market exclusivity for a new drug if the 
determination is made within one year before either the last 
listed patent for that product has expired or all other 
exclusivities have expired, whichever is later.
    Market Exclusivity for Already Marketed Drugs. New section 
505A states that if the Secretary discovers that an already 
marketed drug may produce health benefits in the pediatric 
population, the Secretary may make a written request to the 
holder of an approved drug application to conduct pediatric 
studies. Should the holder agree to the request, completes the 
appropriate studies in the designated timeframe, provide 
reports, and comply with labeling changes requested by the 
Secretary, the Secretary may grant six months of additional 
market exclusivity. The Secretary shall not grant additional 
market exclusivity if the determination is made within the 
final year of the patent life.
    Conduct of Pediatric Studies. New section 505A grants the 
Secretary the authority to issue a written request for conduct 
of pediatric studies. In issuing a request, the Secretary must 
take into account adequate representation of children of ethnic 
and racial minorities. The request must be in writing, include 
a timeframe for the study requested, and request that the 
sponsor propose pediatric labeling resulting from the study. 
The Secretary may issue a single written request that may 
relate to more than one use of a drug, including approved and 
unapproved uses.
    The sponsor has 180 days to accept or decline a written 
request for pediatric studies. If the sponsor does not agree to 
the request the sponsor shall state its reasons for declining 
the study. If the reason the sponsor declined the written 
request is because a pediatric formulation is not possible, the 
sponsor must state why a formulation cannot be developed. 
Sponsors agreeing to complete studies are required to submit 
all postmarket adverse event reports regarding the drug when 
the sponsor submits its report. The Secretary is required to 
accept or reject the study reports within 180 days after the 
sponsor's submission.
    Notice of Determinations on Studies Requirement. New 
section 505A requires the Secretary to publish a notice of 
determination within 30 days after the date of the Secretary's 
determination regarding market exclusivity. The Secretary is 
also required to publish a notice identifying any drug for 
which a pediatric formulation was developed, studied, and found 
to be safe and effective in the pediatric population if the 
pediatric formulation is not introduced to the market within 
one year of the date that the notice is published. The 
Secretary must publish this no later than 30 days after the 
expiration of the 1 year period.
    Internal Review of Written Requests and Pediatric Studies. 
New section 505A requires the Secretary to establish an 
internal review committee to review all written requests. 
Members of the committee shall have expertise in pediatrics, 
biopharmacology, statistics, drugs and drug formulations, legal 
issues, pediatric ethics, the appropriate expertise pertaining 
to the pediatric product under review, one or more experts from 
the Office of Pediatric Therapeutics, and other individuals the 
Secretary designates.
    New section 505A requires the Secretary to track and make 
available to the public the number of studies conducted, the 
specific drugs and biological products and their studied uses, 
types of studies conducted, number of pediatric formulations 
developed and not developed, labeling changes made due to the 
studies, annual summary of labeling changes made as a result of 
the studies conducted, and information regarding reports 
submitted on or after the date of enactment of the Act.
    Relationship to Pediatric Research Requirements. New 
section 505A states that if a pediatric study is required by 
law or regulation other than BPCA, and it meets the 
completeness, timeliness, and other requirements of BPCA, it 
shall be deemed to satisfy the requirement for additional 
market exclusivity pursuant to BPCA.
    Labeling Changes. New section 505A states that applications 
or supplements proposing a labeling change as a result of 
pediatric studies under BPCA shall be considered a priority 
application or supplement, and subject to the performance goals 
established by the Commissioner for priority drugs.
    Within 180 days after the submission of the application, if 
the Commissioner determines that the sponsor and the 
Commissioner have been unable to reach agreement on appropriate 
changes to a drug label, then the Commissioner must request 
that the sponsor make any labeling change the Commissioner 
deems appropriate. If an application sponsor does not agree 
with the Commissioner's request for label change within 30 
days, the matter is referred to the Pediatric Advisory 
Committee. The Committee shall consider the matter within 90 
days and make recommendations to the Commissioner. The 
Commissioner then has 30 days to make a request to the sponsor 
of the application to make any labeling changes. If the sponsor 
still does not agree with the recommendations and fails to make 
a requested label change, the Commissioner may deem the drug 
misbranded.
    Other Labeling Changes. New section 505A grants the 
Secretary the authority to order the label of a drug to include 
information from studies demonstrating that a drug is or is not 
safe and effective in the pediatric population.
    Dissemination of Pediatric Information. New section 505A 
requires the Secretary to make medical, statistical, and 
clinical pharmacology reviews of pediatric studies available to 
the public not later than 180 days after the date of submission 
of a report. The Secretary will also require the sponsors of 
studies that result in labeling changes to distribute this 
information to physicians and other healthcare providers.
    Adverse Event Reporting. New section 505A requires the 
Secretary, during the one year period beginning on the date a 
labeling change is made, to ensure that all adverse event 
reports that have been received for a drug are referred to the 
Office of Pediatric Therapeutics established under BPCA and 
provided for review by the Pediatric Advisory Committee. The 
Pediatric Advisory Committee may choose to offer recommended 
actions in response to such reports to the Secretary.
    Following the one year period, the Secretary must refer to 
the Office of Pediatric Therapeutics a report of all 
information regarding pediatric adverse events for a drug for 
which a pediatric study was conducted. When considering the 
report, the director of the Office of Pediatric Therapeutics 
may provide for the review of the report by the Pediatric 
Advisory Committee, including obtaining any committee 
recommendations regarding whether the Secretary should take 
action. The requirements of this subsection shall supplement, 
and not supplant, other reviews of such adverse event reports 
by the Secretary.
    Clarification of Interaction of Market Exclusivity Under 
This Section and Market Exclusivity Awarded to an Applicant for 
Approval of a Drug Under 505(j). New section 505A states that 
if an abbreviated new drug application that is eligible for a 
180 day period of market exclusivity under 505(j), and any or 
all of that period overlaps with the pediatric exclusivity 
period under this section, then the 180-day period shall be 
extended by the number of days of the overlapping period.
    The granting of exclusivity under section 505A should not 
limit exclusivity under section 527, relating to orphan drugs, 
of this Act.
    Referral if Pediatric Studies are not Completed. New 
section 505A states that if pediatric studies have not been 
completed and if the Secretary determines that there is a 
continuing need for information relating to the use of the drug 
in the pediatric population the Secretary shall: 1) for on-
patent drugs, make a determination regarding whether an 
assessment shall be required to be submitted under the 
Pediatric Research Equity Act; and 2) for drugs that have no 
listed patents or have listed patents that have expired, 
determine whether there are Prescription Drug User Fee Act 
funds available to fund the requested studies. If the funds are 
not available, the Commissioner shall refer the drug for 
inclusion on the list established under section 409I of the 
Public Health Service Act for the conduct of studies.
    New section 505A requires the Secretary to provide public 
notice of the decision not to require an assessment under 
section 505B and the basis of the decisions, name of any drug, 
its manufacturer, the indications to be studied pursuant to a 
grant made, and any decision to refer a drug for inclusion on 
the list established under 409I of the Public Health Service 
Act.
    Prompt Approval of Drugs Under Section 505(j) When 
Pediatric Information is Added to Labeling. New section 505A 
states that an abbreviated new drug application shall be not be 
considered ineligible for approval under 505(j) or misbranded 
under section 502 on the basis that the labeling of the drug 
omits a pediatric indication or any other aspect of labeling 
pertaining to pediatric use when the omitted indication or 
other aspect is protected by patent or by exclusivity. The 
Secretary may require that the labeling of a drug approved 
under section 505(j) include a statement that, because of 
marketing exclusivity for a manufacturer, the drug is not 
labeled for pediatric use and must include any appropriate 
pediatric contraindications, warnings, or precautions the 
Secretary deems necessary. This subsection does not affect the 
availability or scope of exclusivity.
    Institute of Medicine Study. New section 505A requires the 
Secretary to request an IOM study of the written requests made 
and the studies conducted under BPCA, and report to Congress 
within three years of enactment of BPCA of 2007.
    Sunset. New section 505A states that the authority to award 
exclusivity takes effect on the date of enactment and sunsets 
on October 1, 2012.
    Section 502 amends section 409I of the Public Health 
Service Act to read as follows:
            ``Section 409I. Program for Pediatric Studies of Drugs.''
    List of Priority Issues in Pediatric Therapeutics. New 
section 409I requires the Secretary in conjunction with the 
Director of NIH, the FDA Commissioner, and experts in pediatric 
research to provide a list of priority issues in pediatric 
therapeutics that need studies (including drugs) within one 
year of enacting BPCA of 2007. The list shall be revised every 
three years, and will consider therapeutic gaps, specific 
pediatric diseases, and the adequacy of the pediatric research 
infrastructure.
    Pediatric Studies and Research. New section 409I authorizes 
the Secretary, through NIH, to award funds to entities that 
have the expertise to conduct pediatric clinical trials or 
other research to enable the entities to conduct the drug 
studies or other research on the issues described via 
contracts, grants, or other appropriate funding mechanisms.
    Process for Proposed Pediatric Study Requests and Labeling 
Changes. New section 409I allows the NIH Director to submit 
proposed pediatric study requests for consideration by the FDA 
Commissioner. The FDA Commissioner, in consultation with the 
NIH Director, may issue a written request based on a proposed 
pediatric study request from NIH to all holders of an approved 
application for the drug. If the FDA Commissioner does not 
receive a response to this written request, the Secretary shall 
publish a request for proposals to conduct the pediatric 
studies.
    Once the award is granted and the study is completed, a 
report concerning the study shall be submitted to the NIH 
Director and the FDA Commissioner. The report will be made 
public and open for public comment. The FDA Commissioner then 
has 180 days to review the report and negotiate any labeling 
changes with the holders of the approved applications. The 
Commissioner shall place the report and labeling change 
requests in the Federal Register.
    New section 409I outlines a dispute resolution process if 
label changes are not made within 180 days of submission of the 
application. If an application sponsor does not agree with the 
Commissioner's request for label change within 30 days, the 
matter is referred to the Pediatric Advisory Committee. The 
Committee shall consider the matter within 90 days and make 
recommendations to the Commissioner. The Commissioner then has 
30 days to make a request to the sponsor of the application to 
make any labeling changes. If the sponsor still does not agree 
with the recommendations, the Commissioner may deem the drug 
misbranded.
    Dissemination of Pediatric Information. New section 409I 
requires the Secretary, through NIH, within a year of passage, 
to conduct a study on the feasibility of establishing a 
compilation of information on pediatric drug use and to report 
the findings to Congress.
    Authorization of Appropriations. New section 409I 
authorizes $200 million in FY2008 and such sums as necessary 
for the following 4 fiscal years to conduct pediatric studies. 
PDUFA is amended to include activities relating to the support 
of off-patent studies of drugs on pediatric populations.
    Continuation of Operation of Committee. New section 409I 
allows the pediatric subcommittee of the Oncologic Drugs 
Advisory Committee to continue to operate for five years 
beginning on the date of enactment of BPCA 2007.
    Pediatric Subcommittee of the Oncologic Drugs Advisory 
Committee. New section 409I allows the pediatric subcommittee 
of the Oncologic Drugs Advisory Committee to continue to 
operate for five years beginning on the date of enactment of 
BPCA 2007. This committee is allowed to provide recommendations 
to the internal review committee on the implementation of PREA 
and BPCA with respect to treating pediatric cancers.
    Effective Date and Limitation for Rule Relating to Toll-
Free Number for Reporting Adverse Events on Labeling for Human 
Drug Products. New section 409I mandates the proposed FDA rule 
entitled ``Toll-Free Number for Reporting Adverse Events on 
Labeling for Human Drug Products'' to take effect on January 1, 
2008, unless the Commissioner issues the final rule earlier.

 TITLE VI. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

Section 601. The Reagan-Udall Foundation for the Food and Drug 
        Administration

    Chapter VII of the Federal Food, Drug, and Cosmetic Act is 
amended by adding at the end the following:
            ``Subchapter I--Reagan-Udall Foundation for the Food and 
                    Drug Administration''
            ``Section 770. Establishment and Functions of the 
                    Foundation.''
    In General. New section 770 provides for the establishment 
of a non-profit corporation, independent of the U.S. 
Government, to be known as the Reagan-Udall Foundation for the 
Food and Drug Administration.
    Purpose of Foundation. New section 770 states the purpose 
of the Foundation is to advance the mission of FDA to 
``modernize medical, veterinary, food, food ingredient, and 
cosmetic product development, accelerate innovation, and 
enhance product safety.''
    Duties of the Foundation. New section 770 states that the 
Foundation shall advance the Critical Path Initiative to 
identify unmet needs in the sciences of developing, 
manufacturing, and evaluating the safety and effectiveness of 
diagnostics, devices, biologics, and drugs; establish goals and 
priorities to meet such unmet needs; assess Federal intramural 
and extramural research and development programs, and 
facilitate interagency coordination of such programs; release, 
publish, license, and distribute material, reagents, and 
techniques to meet such goals and priorities; take the 
necessary actions to patent and license inventions developed 
through the Institute; and provide objective clinical and 
scientific information to FDA and other Federal agencies.
    Board of Directors. New section 770 states the Foundation 
shall have a Board of Directors composed of both appointed and 
ex-officio members. Ex-officio members of the Board include the 
Commissioner of Food and Drugs, the Director of NIH, the 
Director of the Centers for Disease Control and Prevention, and 
the Director of AHRQ. The ex-officio members shall appoint 12 
Board members as outlined in the bill.
    New section 770 requires the Secretary to convene a meeting 
of the ex-officio members of the Board within 30 days of 
enactment of this Act to incorporate the Foundation and appoint 
the members of the Board and its Chair. The terms of service of 
the ex-officio members shall then terminate.
    New section 770 states that the Board shall establish by-
laws and polices for the selection of officers, employees, 
agents, and contractors of the Foundation; acceptance of 
donations; conflicts of interest; licensure and publication; 
review of proposals and awarding of grants; specification of a 
cap for administrative expenses; execution of memoranda of 
understanding; funding of training fellowships; annual Board 
review; and duties of the Executive Director. The Board shall 
also prioritize and provide overall direction to the activities 
of the Foundation, evaluate the performance of the Executive 
Director, and carry out any other necessary activities 
regarding the functioning of the Foundation.
    Members of the Board shall serve a four-year term and may 
not receive compensation for service on the Board.
    Incorporation. New section 770 requires the ex-officio 
members of the Board to serve as incorporators.
    Nonprofit Status. New section 770 states that the 
Foundation shall be considered a non-profit corporation.
    Executive Director. New section 770 states that an 
Executive Director shall be appointed by the Board and shall be 
responsible for the day-to-day operations of the Foundation. 
The compensation of the Executive Director shall not exceed the 
compensation of the Commissioner.
    Administrative Powers. New section 770 states that the 
Executive Director may use a corporate seal; hire, promote, and 
discharge officers and employees; oversee personal property, 
general operations, and privileges granted to the Board of the 
Foundation; enter into and modify contracts; oversee 
financials; and exercise other powers granted.
    Acceptance of Funds from Other Sources. New section 770 
allows the Executive Director to solicit and accept any funds 
and property on behalf of the Foundation to carry out the 
duties of the Foundation.
    Service of Federal Employees. New section 770 allows 
Federal employees to serve on advisory committees to the 
Foundation and ``otherwise cooperate with and assist the 
Foundation'' or be detailed to the Foundation.
    Detail of Government Employees. New section 770 allows 
Federal Government employees to be detailed from Federal 
agencies to the Foundation with or without reimbursement to 
those agencies at any time.
    Annual Reports. New section 770 requires any recipient of a 
grant, contract, fellowship, memorandum of understanding, or 
cooperative agreement from the Foundation to provide annual 
reports on their activities. The Executive Director shall 
provide annual reports to FDA and to Congress describing the 
activities of the Foundation, recommendations for incorporating 
outcomes into FDA ``regulatory and product review activities,'' 
and financial accounting of its funds beginning with FY 2009.
    Separation of Funds. New section 770 requires funds 
received from the Treasury to be held in separate accounts from 
funds received from private entities.
    Funding. New section 770 prohibits the FDA Commissioner 
from transferring less than $500,000 and no more than 
$1,250,000 to the Foundation from FDA appropriated funds.
    Section 601 further amends Chapter VII of the Federal Food, 
Drug, and Cosmetic Act by adding at the end the following:
            ``Section 771. Location of Foundation.''
    New section 771 requires the Foundation to be located ``not 
more than 20 miles from the District of Columbia.''
            ``Section 772. Activities of the Food and Drug 
                    Administration.''
    In General. New section 772 requires the Commissioner to 
receive and assess the report submitted to the Commissioner by 
the Executive Director of the Foundation.
    Report to Congress. New section 772 requires the 
Commissioner, beginning with FY2009, to submit an annual report 
to Congress summarizing the Executive Director's report to FDA 
and Congress.
    Extramural Grants. New section 772 states this subchapter 
shall have no effect on any grant, contract, memorandum of 
understanding, or cooperative agreement between the Food and 
Drug Administration and any other entity entered into before, 
on, or after the date of enactment of this Act.

Section 602. Office of the Chief Scientist

    Section 602 amends chapter IX of the Federal Food, Drug, 
and Cosmetic Act by adding at the end the following:
            ``Section 910. Office of the Chief Scientist.''
    Establishment; Appointment. New section 910 states the 
Secretary shall establish an office of the Chief Scientist 
within the Office of the Commissioner, and shall appoint a 
Chief Scientist to lead the office.
    Duties of the Office. New section 910 states the Office of 
the Chief Scientist shall oversee and coordinate intramural 
research of FDA; track intramural research awards made by the 
Food and Drug Administration to avoid research duplication; 
develop and advocate for a budget for intramural research; 
develop a peer-review evaluation process for intramural 
research; and identify and solicit research proposals from 
across FDA through an advisory board.

Section 603. Critical path public-private partnerships

    Section 603 amends subchapter E of chapter V of the Federal 
Food, Drug, and Cosmetic Act by adding at the end the 
following:
            ``Section 566. Critical Path Public-Private Partnerships.''
    Establishment. New section 566 states that the Secretary, 
acting through the Commissioner, shall enter into collaborative 
agreements to implement the Critical Path Initiative of FDA. 
This shall be done by developing innovative, collaborative 
projects in research, education, and outreach for the purpose 
of fostering medical product innovation, enabling the 
acceleration of medical product development, and enhancing 
medical product safety.
    Eligible Entity. New section 566 outlines criteria to be 
considered an `eligible entity.'
    Funding. New section 566 states eligible entities may not 
accept funding for a Critical Path Public-Private Partnership 
project from any organization that manufactures or distributes 
products regulated by FDA unless funding comes from two or more 
of such organizations and the entity assures FDA that the 
results of the Partnership will not be influenced by any source 
of funding.
    Annual Report. New section 566 requires the Secretary, 
beginning not later than 18 months after enactment of this 
section, to submit annual reports to Congress reviewing the 
operations and activities of the Partnerships in the previous 
year.
    Definition. New section 566 defines the term `medical 
product' to include drugs, biological products, devices, or 
combinations of these products.
    Authorization of Appropriations. New section 566 authorizes 
$5,000,000 for fiscal year 2008 and such sums as may be 
necessary for each of fiscal years 2009 through 2012 to carry 
out this section.

                    TITLE VII--CONFLICTS OF INTEREST

Section 701. Conflicts of interest

    Section 701 amends subchapter A of chapter VII of the 
Federal Food, Drug, and Cosmetic Act by inserting at the end 
the following:
            ``Section 712. Conflicts of Interest.''
    Definitions. New section 712 defines the terms ``advisory 
committee'' and ``financial interest.
    Appointments to Advisory Committees. New section 712 
directs the Secretary to recruit advisory committee members 
through various offices of FDA and with direction from 
professional societies. The Secretary shall consider the 
advisory committees with the largest number of vacancies. The 
Secretary may advertise the process for becoming an advisory 
committee member, and set forth guidelines for such 
advertising. Recruitment may also take place through entities 
receiving funding from various Federal health agencies.
    New section 712 requires the Secretary, in appointing 
advisory committee members, to take into account the expertise 
of the individual, as well as the financial disclosure report 
the candidate has filed, so as to reduce the likelihood that 
the individual will require written waivers when serving on the 
advisory committee.
    Individuals with financial interest in a matter before an 
advisory committee may, at the discretion of the Secretary, be 
allowed to participate in an advisory committee meeting as a 
guest expert, but may not participate in the committee's 
discussion or voting.
    Granting and Disclosure of Waivers. New section 712 
requires each member of an advisory committee to disclose to 
the Secretary all relevant financial interests before an 
advisory committee meeting. An advisory committee member shall 
be prohibited from voting with respect to any matter considered 
by the committee if the member (or immediate family member of 
such member) has a financial interest that could affect the 
member's decision.
    New section 712 allows the Secretary to grant a waiver if 
necessary to afford the committee the benefit of the member's 
expertise. The Secretary may not grant more than one waiver per 
committee member, and no waiver may be granted if the member's 
own scientific work is under review. The Secretary must 
disclose on the FDA website, 15 or more days in advance of the 
advisory committee meeting, any waivers, determinations, or 
certifications the Secretary has granted, the reasons for such 
waivers, determinations, or certifications, and the type, 
nature, and magnitude of the financial interests of the 
committee member to which the waiver, determination, or 
certification applies.
    Public Record. New section 712 requires the Secretary to 
ensure that the public record and transcript of each meeting of 
an advisory committee includes the disclosure of waivers, 
determinations, or certifications pertaining to that meeting.
    Annual Report. New section 712 requires the Secretary to 
submit to various congressional committees an annual report on 
advisory committee vacancies and the number of disclosures 
required by this act.
    Periodic Review of Guidance. New section 712 states that 
the Secretary shall review FDA guidance documents on conflicts 
of interest waiver determinations with respect to advisory 
committees at least once every five years.
    Additionally, the Committee strongly encourages FDA to 
reconsider its decision to terminate the Medical Imaging Drugs 
Advisory Committee (MIDAC). Accordingly, the Committee directs 
FDA to either re-establish this advisory committee, or provide 
a detailed explanation of why it is not re-establishing this 
advisory committee. This should be done not later than six 
months after enactment of this act.

                  TITLE VIII--CLINICAL TRIAL DATABASES

Section 801. Clinical trial registry database and clinical trial 
        results database

    Section 801 amends title IV of the Public Health Service 
Act by striking subsection (i) of section 402 and inserting the 
following after section 492B:
            ``Section 492C. Clinical Trial Registry Database; Clinical 
                    Trial Results Database.''
    Definitions. New section 492C defines the terms applicable 
clinical trial, clinical trial information, completion date, 
device, drug, and responsible party. Current law requires the 
registration of certain drug trials; this section extends its 
requirements to certain trials conducted on drugs, devices, and 
biologics. Current law generally pertains to clinical trials 
testing treatments of serious or life-threatening diseases or 
conditions. This section expands this aspect as well, as it 
generally pertains to phase II--IV studies--(whether Federally 
or privately funded, and whether on an approved or unapproved 
product)--that test a product's safety or effectiveness. This 
section's requirements would also apply to trials conducted 
outside of the United States on products with or seeking FDA 
approval. Current law specifies that required clinical trial 
information is to be forwarded to the data bank by the sponsor 
of the trial. This section requires action by the trial 
sponsor, or alternately, in certain circumstances, by the 
principal investigator.
    The definition of completion date deems a trial complete 
after the final collection of data from subjects for the 
primary and secondary outcomes to be examined in the trial. The 
default responsible party (RP) is the trial sponsor. This 
section enables the principle investigator to act as the RP, 
only if he or she was responsible for conducting the trial, had 
access to and control over the data, had the right to publish 
results of the trial, and had the responsibility to meet all of 
the bill's requirements.
    Clinical Trials Registry Database. New section 492C 
categorizes clinical trials registry database provisions into 
those addressing registry establishment, contents format, data 
submission, truthful clinical information, timing of 
submission, and updates.
    Establishment. New section 492C requires the Secretary of 
Health and Human Services, acting through the Director of the 
National Institutes of Health (Director), to establish and 
maintain a clinical trials registry. The information in the 
registry shall be made public via a Web site on the Internet.
    Contents. New section 492C significantly expands the 
contents of the registry. Current law specifies that the 
registry should contain eligibility criteria, trial locations, 
an enrollment point of contact, and a description of whether 
and how requests for single-patient and expanded protocol use 
of the new drug would be addressed. The requirements are 
expanded to include the elements of the World Health 
Organization's (WHO's) International Clinical Trials Registry 
Platform registration data set: city, State, and zip code for 
each trial location; estimated completion date; RP contact 
information; restrictions on non-RP employee's ability to 
discuss or publish trial results; and other data, as 
appropriate.
    Format and Structure. New section 492C requires that 
database entries be easily compared, and that the registry be 
searchable by indication being studied, safety issue, 
enrollment status, and sponsor.
    Data Submission and Truthful Clinical Information. New 
section 492C requires the RP to submit required registry 
information to the Director, and the information may not be 
false or misleading. The clinical trial information will not be 
required to include information from any source other than the 
trial.
    Timing of Submission and Updates. New section 492C states 
the timing of submission will be linked to patient enrollment 
(within 14 days). Notice of trial completion and changes in 
enrollment status must be submitted within 30 days of the 
respective events. Updates, reflecting the dates of any 
changes, must be submitted once every six months until 
information on the results of the trial are submitted to the 
results database.
    Clinical Trials Results Database. New section 492C requires 
the Secretary, acting through the Director, to establish and 
administer a clinical trial results database, made publicly 
available via the Internet. Details of the results publication 
requirements are presented below.
    Searchable Categories. New section 492C requires the 
Director to ensure that the database is searchable by the 
indication being studied, safety issue, FDA application status, 
trial phase, product name, and the trial's primary sponsor and 
other financial sponsors.
    Contents. New section 492C requires the RP to submit to the 
Director for inclusion in the results database two summaries 
and several pieces of information. One summary will be in non-
technical language understandable to patients, and will include 
the trial purpose, sponsor, point of contact for information 
about the clinical trial, patient population, and a general 
description of the clinical trial results including changes in 
trial design and any significant safety information. The second 
summary will be technical, and will include the same elements 
as the non-technical summary as well as each financial sponsor 
(not just the primary sponsor), and a summary of results 
describing primary and secondary endpoints, as well as 
significant safety information. The additional pieces of 
information will include information regarding any subjects who 
ceased participation in the trial, agreements that would 
prevent non-employees of the RP from discussing or publishing 
trial results, links to peer-reviewed publications of trial 
results, trial completion date, and links to any relevant FDA 
adverse regulatory actions.
    Timing. New section 492C requires, in general, the RP to 
submit information to the Director within one year after the 
earlier of the actual or estimated trial completion date, or 
trial termination date. The Director could grant one or more 
extensions for good cause. The RP will be required to submit 
biannual updates reflecting changes in previously submitted 
data for a decade following the initial submission, except that 
changes in FDA regulatory status would be required to be 
submitted within 30 days after the change.
    Truthful Clinical Trial Information. New section 492C 
states, as was the case for the registry, for the results 
database, information submitted by an RP may not be false or 
misleading, and information will not be required from any 
source other than the clinical trial involved.
    Public Availability of Results. New section 492C requires 
the Director to make results information publicly available at 
different times, depending on the type of information. For pre-
approval studies, the publication date will occur within a 
certain period following either: (1) FDA product approval or 
clearance, or (2) FDA issuance of a not approvable or not 
substantially equivalent letter. Trial results will be required 
to be made public within 30 days of such actions, and FDA 
medical and clinical pharmacology reviews of the pre-approval 
studies will be made public within 90 days.
    For post-approval studies, results will be required to be 
made public within 30 days of submission, unless the RP 
certified that he or she filed, or will file within one year, 
an FDA application for a new use of the product. In that case, 
the results will be required to be made public within 30 days 
after: (1) FDA new use approval or clearance, (2) FDA issuance 
of a not approvable or not substantially equivalent letter, (3) 
withdrawal of the application, or (4) two years following the 
certification. FDA medical and clinical pharmacology reviews 
will be required to be made public within 90 days of 
requirements 1 through 3.
    The date trial results are required to be made public in 
the results database could be postponed for up to two years if 
the RP is seeking publication in a peer-reviewed journal. In 
this case, clinical trial information will not be required to 
be made public under the Freedom of Information Act (5 U.S.C. 
522; FOIA). In a period during which the Director has received, 
but not made public clinical trial information in accordance 
with the provisions of the bill, the Director will be required 
to respond to requests from other Federal agencies and peer-
reviewed journals that clinical trial information has been 
submitted, but has not yet been made public.
    Updates; Tracking of Changes in Submitted Information. New 
section 492 requires the Director to ensure that updates made 
by the RP to the registry and results database do not result in 
the removal of original submissions or previous updates, and 
that the public shall have access to previous submissions and 
be able to track changes.
    Coordination and Compliance. The Secretary will be required 
to consult with heads of other agencies that conduct human 
studies to determine if such studies are applicable clinical 
trials and to develop with such agencies appropriate procedures 
to ensure that clinical trial information for such applicable 
trials is submitted to the registry and databases established 
under this title.
    New section 492C requires the Director to link 
corresponding entries in the registry and results database. If 
the Director locates a missing results database entry, the RP 
will be given notice and an opportunity for correction. If the 
correction is not made, the Director will report the 
noncompliance to the relevant Federal agency's scientific peer 
review committee and to the Office of Human Research 
Protections, and post notice of the failure in the registry.
    New section 492C requires the Secretary, acting through the 
FDA Commissioner, to verify that required clinical trial 
information has been submitted when considering a product 
application. After notice to the RP and an opportunity to 
correct noncompliance, the Secretary will be required to refuse 
to file, approve, or clear the application or premarket 
notification.
    New section 492C requires the Secretary to take certain 
steps to ensure that results database summary documents are not 
false or misleading, and to give RPs notice and an opportunity 
to correct noncompliance.
    Penalties for Noncompliance. New section 492C states it 
shall be unlawful to fail to submit required clinical 
information, or to submit false, or misleading information. The 
Secretary could, after considering specific factors, such as 
whether the RP had engaged in a pattern of noncompliance, apply 
penalties. In addition to the penalties under Sec. 303(a) of 
the FFDCA, this bill includes additional new penalties 
including a fine of not more than a total of $15,000 for all 
violations adjudicated in a single proceeding in the case of an 
individual, and not more than $10,000 per day until the 
violation is corrected in the case of any other person. If the 
case, however, is against an individual or a non-profit entity, 
the penalty may not exceed $15,000 for all violations 
adjudicated in a single proceeding.
    Authorization of Appropriations. New section 492C 
authorizes $10 million to be appropriated for any fiscal year.
    Conforming Amendments. New section 492C includes conforming 
provisions that amend relevant sections of the FFDCA and Public 
Health Service Act.
    Guidance. New section 492C requires the FDA Commissioner, 
in consultation with the Director of the National Institutes of 
Health, to issue guidance to clarify which clinical trials are 
required to be submitted for inclusion in the registry.
    Preemption. New section 492C provides that States are 
prohibited from requiring the registration of clinical trials 
or the posting of their results. Submissions that are in 
compliance with new section 492C are prohibited from being 
considered either (1) by the Secretary as evidence of a new 
intended use different from labeling, or (2) as labeling, 
adulteration, or misbranding under the FFDCA.
    Effective Dates. New section 492C requires the Secretary to 
establish the registry and results database within one year of 
the Act's date of enactment. Trials initiated after the date of 
enactment and before the date the registry is established will 
have 120 days from establishment to submit information. Trials 
completed after the Act's date of enactment and before the 
results database is established will have 180 days after 
establishment to submit information, except that such trials 
involving a drug to treat a serious or life-threatening 
condition will have 90 days after establishment to submit 
results.
    New section 492C states that information about trials 
initiated or concluded before the date of enactment may be 
voluntarily submitted to the registry or results database. The 
Secretary may require such information to be submitted if it is 
in the interest of public health.
    New section 492C states that the Secretary shall consult 
with other agencies to determine if their human studies are 
applicable clinical trials and to develop procedures to ensure 
that clinical trial data is submitted 210 days after the date 
that the registry and results database were established. After 
receiving public comment and within 90 days of enactment, the 
Secretary will be required to publish a notice determining 
whether to build upon or supplant the current Federal registry 
(clinicaltrials.gov). If supplanted, the current registry will 
be required to be maintained as an archive.

Section 802. Study by Government Accountability Office

    Section 802 states, not later than one year after enactment 
of this section, the Comptroller General of the United States 
shall report to Congress on whether information on the trials 
registry and database is considered promotional and to evaluate 
the implementation of this database.

          TITLE IX--RISK EVALUATION AND MITIGATION STRATEGIES

Section 901. Postmarket studies and clinical trials regarding human 
        drugs; risk evaluation and mitigation strategies

    Section 901 amends section 505 of the Federal Food, Drug, 
and Cosmetic Act by adding at the end the following 
subsections:
            ``(o). Postmarket Studies and Clinical Trials; Labeling.''
    In General. New subsection (o) states that a responsible 
person may not introduce or deliver into interstate commerce 
the new drug involved if the person is in violation of 
postmarket studies or clinical trials required by the Secretary 
or by safety labeling changes requested by the Secretary.
    Definitions. New subsection (o) defines the terms 
responsible person, and covered application.
    Studies and Clinical Trials. New subsection (o) states that 
the Secretary may require a responsible person (a product 
sponsor) to conduct a post-approval study of the drug, or a 
post-approval clinical trial of the drug, on the basis of 
scientific information, including information regarding 
chemically-related or pharmacologically-related drugs. The 
purpose of such study or trial is to assess a known serious 
risk related to the use of the drug involved, assess signals of 
a serious risk related to the use of the drug, or to identify a 
serious risk.
    New subsection (o) states after approval of a covered 
application, the Secretary may require a post-approval study or 
trial only if the Secretary becomes aware of new safety 
information. For such a study, the applicant must submit a 
timetable for completion of the study and shall periodically 
report on the status of the study to the Secretary.
    The applicant shall be deemed in violation of this 
subsection unless the applicant demonstrates good cause for 
failure to comply with such a timeline. Good cause is to be 
defined by the Secretary.
    The Committee expresses its concern with the historical 
under-representation of medically underserved populations in 
clinical trials and post-market drug research. The Committee 
urges FDA to identify and retain an employee who will study and 
report on ways in which to increase diversity in clinical 
trials and post-market drug research. The individual should 
consider how studies of drugs, medical devices, vaccines, and 
other medical devices regulated by the FDA should include the 
collection, statistical analysis and interpretation of data on 
medically underserved populations. The Committee urges the FDA 
to encourage diverse populations to participate in clinical 
trials and post-market drug research. Furthermore, the FDA 
should provide a report to Congress annually on the FDA's 
progress in increasing diversity in clinical trials and post-
market drug research.
    Safety Labeling Changes Requested by Secretary. New 
subsection (o) requires the Secretary to promptly notify the 
responsible person should the Secretary become aware of new 
safety information that the Secretary believes should be 
included in the labeling of the drug.
    New subsection (o) requires the responsible person, within 
30 days of notification, to either submit a supplement 
proposing changes to the approved labeling to reflect the new 
safety information or notify the Secretary that the responsible 
person does not believe a labeling change is warranted and 
submit a statement detailing the reasons why such a change is 
not warranted.
    Upon receipt of such supplement, the Secretary will review 
the supplement. If the Secretary disagrees with the proposed 
changes by the responsible person, the Secretary shall initiate 
discussions with the responsible person to reach agreement on 
whether the labeling changes for the drug should be modified to 
reflect the new safety information and, if so, the contents of 
such labeling changes. Discussions will not last more than 30 
days after the response to the notification unless the 
Secretary determines an extension is necessary. Within 15 days 
of the conclusion of the discussions, the Secretary may issue 
an order directing the responsible person to make such a 
labeling change as the Secretary deems appropriate to address 
the new safety information. Within 15 days of such an order, 
the responsible person shall submit a supplement containing the 
labeling change.
    New subsection (o) allows the responsible person, within 
five days of receiving an order, to appeal using the Food and 
Drug Administration's normal dispute resolution procedures 
established by the Secretary in regulation and guidance.
    If the required label change is not made by the date 
specified, the responsible person shall be deemed in violation 
of this section.
    If the Secretary concludes that a labeling change is 
necessary to protect against a serious public health threat, 
the Secretary may accelerate the timelines set forth above.
            ``(p). Risk Evaluation and Mitigation Strategy (REMS).''
    In General. New subsection (p) states a person may not 
introduce or deliver for introduction into interstate commerce 
a new drug if a risk evaluation and mitigation strategy is 
required with respect to the drug and the person fails to 
maintain compliance with the requirements of the approved 
strategy, or a postmarket strategy is required and the 
Secretary, after notice and opportunity for a hearing, 
publishes in the Federal Register a statement that the person 
is not cooperating with the Secretary in developing such a 
strategy for the drug.
    The Secretary may not approve an application for a new drug 
or biological product or supplement unless the product sponsor 
has submitted to the Secretary a statement that states whether 
a REMS strategy or a postmarket study or clinical trial is 
necessary. The statement must take into account the following 
five factors: size of the population likely to use the drug 
involved; seriousness of the disease or condition that the drug 
shall treat; expected benefit of the drug with respect to such 
disease or condition; expected or actual duration of treatment 
with the drug; and the seriousness of any known or potential 
adverse events that may be related to the drug.
    Section 901 amends chapter V of the Federal Food, Drug, and 
Cosmetic Act by inserting after section 505 the following 
section:
            ``Section 505-1. Risk Evaluation and Mitigation 
                    Strategies.''
    Submission of Proposed Strategy. New section 505-1 states 
for new drug and biologic license applications, if the 
Secretary determines a risk evaluation and mitigation strategy 
is necessary to ensure that the benefits of the drug involved 
outweigh the risks of the drug, a person must submit, as part 
of the application, a proposed risk evaluation and mitigation 
strategy. The Secretary must consider the statement along with 
the following factors:
          a. The estimated size of the population likely to use 
        the drug involved;
          b. The seriousness of the disease or condition that 
        is to be treated;
          c. The expected benefit of the drug with respect to 
        such disease or condition;
          d. The expected or actual treatment with the drug;
          e. The seriousness of any known or potential adverse 
        events that may be related to the drug and the 
        background incidence of such events in the population 
        likely to use the drug;
          f. The availability and safety of a drug or other 
        treatment, if any, for such disease or condition to 
        which the safety of the drug may be compared; and
          g. Whether the drug is a new molecular entity;
    New section 505-1 states that for those drugs or biologics 
that have been approved, the Secretary may subsequently require 
a risk evaluation and mitigation strategy if the Secretary 
becomes aware of new safety information and makes a 
determination that such a strategy is necessary to ensure that 
the benefits of the drug outweigh the risks of the drug. Within 
120 days after the Secretary notifies the holder of an approved 
covered application, the holder must submit to the Secretary a 
proposed risk evaluation and mitigation strategy. The authority 
of the Secretary to require a risk evaluation and mitigation 
strategy also applies to supplemental applications seeking 
approval of a new indication for use of the drug. Abbreviated 
new drug applications may also be subject to REMS requirements 
for medication guides or patient package inserts and 
restrictions on distribution or use.
    Definitions. New section 505-1 defines adverse drug 
experience, covered application, new safety information, 
serious adverse drug experience, serious risk, signal of a 
serious risk, responsible person, and unexpected serious risk.
    Contents. New section 505-1 requires a proposed risk 
evaluation and mitigation strategy to include a timetable and 
may include additional elements, including medication guides or 
patient package inserts, communication plans, and restrictions 
on distribution or use.
    Minimal Strategy. New section 505-1 requires that a risk 
evaluation and mitigation strategy be assessed at least once 
annually for the first three years after the strategy is 
initially approved, an assessment in the seventh year after 
approval of the REMS, and for subsequent years, assessments are 
increased or reduced in frequency as necessary. After the 
initial three year period, the Secretary may eliminate a REMS 
if the Secretary determines that the serious risks of the drug 
have been adequately identified and assessed and are adequately 
being managed.
    Additional Potential Elements of Strategy. The Secretary 
may require that the REMS for a drug include one or more of the 
additional elements listed in the bill. These include 
medication guides or patient package inserts, and a 
communication plan to health care providers, if the Secretary 
determines such plan may support implementation of the 
strategy.
    The Committee is aware that pharmacies may not be able to 
obtain Medication Guides in an efficient manner so that they 
can be distributed to patients with their prescriptions. The 
Committee is also aware that FDA held a public meeting in June 
to solicit input from stakeholders on how the agency might 
address some of the implementation issues in the Medication 
Guide program. We urge that the agency take expeditious action 
in making changes to the program so that the program is more 
effective in providing patients with Medication Guide 
information and pharmacies can provide these important 
information sheets to patients. Among the changes we urge FDA 
to make as soon as possible relate to the ability of pharmacies 
to print these Medication Guides electronically as part of the 
``single pass'' information that they print as part of filling 
the prescription (i.e., labels, receipts, warning labels, etc.) 
The Committee believes that the electronic printing of 
Medication Guides by pharmacies through this method would 
increase the distribution of Medication Guides. The Committee 
urges that FDA work with pharmacies and information vendors to 
assure that Medication Guides are properly formatted for 
electronic distribution and are electronically printed in such 
a way that the ability of patients to read and understand the 
information in the Medication Guide is not compromised. This 
may include FDA issuing guidance on electronic distribution and 
printing of Medication Guides. The Committee also urges that 
FDA explore the option of allowing pharmacies to distribute 
these Medication Guides to patients (upon request) through 
electronic mail.
    Additionally, the Committee is also concerned that 
pharmacies are having difficulty in obtaining these Medication 
Guides because of the number of such leaflets that are now 
required to be distributed. The Committee asks that FDA report 
to the Committee on specific steps that are being taken to 
streamline the process by which these Medication Guides are 
obtained by pharmacies and distributed by manufacturers. This 
would include evaluating the feasibility of a single access 
point for pharmacies in obtaining these Medication Guides.
    The Committee urges the FDA Commissioner to expand the 
functions of the Risk Communication Advisory Committee to 
advise that the dissemination and communication of the risks 
and benefits of drugs, biologics, and devices to health 
disparity populations, individuals with disabilities or 
cognitive impairments, and senior citizens be done in a manner 
and formats that are appropriate and accessible and which take 
into account relevant factors that limit access to information, 
including language barriers; to healthcare providers, 
accounting for the diversity among providers in terms of 
practice, affinity for technology, and focus; and advising on 
the dissemination of risk and benefit information through 
multiple media platforms.
    Restrictions on Distribution or Use. If the Secretary 
determines that a drug shown to be effective can be safely used 
only if distribution or use of such drug is restricted, the 
Secretary may require, as elements of the risk evaluation and 
mitigation strategy, such restrictions on distribution or use 
as are needed to ensure safe use of the drug. Such restrictions 
on distribution or use must be commensurate with a specific 
serious risk listed in the labeling of the drug, not be unduly 
burdensome on patient access to the drug, and, to the extent 
practicable, minimize the burden on the healthcare delivery 
system. Within 30 days of requiring a restriction on 
distribution or use, the Secretary must publicly post an 
explanation of how such elements will mitigate the observed 
safety risk.
    New section 505-1 states that restrictions on distribution 
or use may require one or more of the following: healthcare 
providers that prescribe the drug have special training or 
experience; pharmacies, practitioners, or healthcare settings 
that dispense the drug are specially certified; the drug be 
dispensed to patients only in certain healthcare settings; the 
drug be dispensed to patients with evidence or other 
documentation of safe-use conditions; each patient using the 
drug be subject to certain monitoring; or each patient using 
the drug be enrolled in a registry.
    New section 505-1 states that the restrictions on 
distribution of use may require a system through which the 
responsible person is able to monitor and evaluate the 
implementation of the restrictions; work to improve 
implementation of the restrictions by parties in the healthcare 
system who are responsible for implementing the restrictions; 
and notify those drug wholesalers who have failed to meet their 
responsibilities for implementing the restrictions.
    New section 505-1 requires the holder of an approved 
application that is subject to distribution restrictions under 
this subsection to provide the sponsor seeking approval of an 
abbreviated new drug application a sufficient quantity of the 
drug to conduct bioequivalence testing if the sponsor meets two 
requirements. First, the sponsor must agree to such 
restrictions on distribution as the Secretary finds necessary 
to assure safe use of the drug during bioequivalence testing. 
When the sponsor seeking the abbreviated new drug application 
has agreed to the restrictions necessary to assure safe use of 
the drug during bioequivalence testing, the Secretary shall 
issue to the sponsor a letter that describes the Secretary's 
finding and serves as proof that the sponsor has satisfied the 
requirements. Next, the sponsor must pay the holder of the 
approved application the fair market value of the drug 
purchased for bioequivalence testing.
    New section 505-1 requires the Secretary, acting through 
the Drug Safety and Risk Management Advisory Committee of the 
Food and Drug Administration, to seek input from patients, 
physicians, pharmacists, and other healthcare providers about 
how elements to assure safe use of one or more drugs may be 
standardized so as not to be unduly burdensome on patient 
access to the drug and minimize the burden on the healthcare 
delivery system. At least once a year, the Drug Safety and Risk 
Management Advisory Committee shall evaluate for one or more 
drugs the elements to assure safe use. Considering such input 
and evaluations, the Secretary shall issue or modify agency 
guidance about how to implement the requirements and may modify 
elements under this subsection for one or more drugs where 
appropriate.
    New section 505-1 allows the Secretary, in public health 
emergencies, to waive any restriction on distribution or use.
    Assessment and Modification of Approved Strategy. New 
section 505-1 states that, for voluntary assessments, the 
responsible person involved may submit to the Secretary an 
assessment of, and proposed modification to, the approved 
strategy for the drug at any time.
    For required assessments, a responsible person must submit 
an assessment of, and may propose a modification to, the 
approved risk evaluation and mitigation strategy for a drug 
under one of four situations:
          1. when submitting a supplemental application for a 
        new indication for use;
          2. when required by the strategy;
          3. within a time period to be determined by the 
        Secretary, if the Secretary determines that new safety 
        or effectiveness information indicates that either a 
        timetable, medication guide, or communication plan 
        should be modified or included in the strategy, or an 
        element regarding restricted distribution or use should 
        be modified or included in the strategy; or
          4. within 15 days when ordered by the Secretary, if 
        the Secretary determines that there may be a cause of 
        for action by the Secretary under section 505(e).
    Label changes that do not require submission to the 
Secretary or for which distribution of the drug involved may 
commence upon the receipt by the Secretary of a supplemental 
application for the change do not require a REMS assessment.
    Review of Proposed Strategies; Review of Assessments of 
Approved Strategies. New section 505-1, in general, requires 
the Secretary to promptly review each proposed risk evaluation 
and mitigation strategy for a submitted drug and promptly 
review each assessment of an approved risk evaluation and 
mitigation strategy.
    New section 505-1 states the Secretary may require the 
applicant to submit information regarding its marketing plan 
and practices for the drug, so as to allow the Secretary to 
determine whether any of the proposed or ongoing marketing 
activities undermine any of the requirements of the risk 
evaluation and mitigation strategy.
    New section 505-1 states that unless the responsible person 
requests the dispute resolution process, the Secretary must 
approve and describe the REMS for a drug, or any modification 
to the strategy, as part of the action letter on the 
application or in an order issued within 50 days after the date 
discussions of such modification begin. An approved REMS shall 
remain in effect until the Secretary acts. Any action letter or 
order shall be made publicly available.
    New section 505-1 states not earlier than 15 days, and not 
later than 35 days, a responsible person may request in writing 
that a dispute about the strategy be reviewed by the Drug 
Safety Oversight Board. The Board may look at the elements of 
the REMS, but may not determine whether a REMS is necessary.
    New section 505-1 allows the Secretary to convene a meeting 
of one or more advisory committees of the Food and Drug 
Administration to review a concern about the safety of a drug 
or class of drugs; review the REM strategy or strategies of a 
drug or group of drugs; or to review a dispute between the 
Secretary and a responsible person.
    When a concern about a serious risk of a drug may be 
related to the pharmacological class of the drug, the Secretary 
may defer assessments of the approved REMS for such drugs until 
the Secretary has convened one or more public meetings to 
consider possible responses to such concern. If the Secretary 
defers such an assessment, the Secretary must give public 
notice of such action within five days. After considering the 
discussions from any public meeting under this subparagraph, 
the Secretary may announce in the Federal Register a planned 
regulatory action, seek public comment about such action, and, 
after seeking such comment, issue an order addressing such 
regulatory action.
    Abbreviated New Drug Applications. New section 505-1 
states, in general, a drug that is the subject of an 
abbreviated new drug application under section 505(j) is 
subject only to two elements of a REMS strategy if the listed 
drug is subject to a REMS that also contains those elements. 
The two elements are a medication guide or patient package 
insert and restrictions on distribution or use. A listed drug 
and its abbreviated new drug application shall use a single, 
shared system with regard to restrictions in distribution or 
use. The Secretary, however, may waive such a requirement if 
the Secretary determines that it is either not practical or the 
burden of using the single, shared system outweighs the benefit 
of not using this system.
    New section 505-1, for an applicable listed drug for which 
a drug is approved under section 505(j), requires the Secretary 
to undertake any communication plan to healthcare providers and 
to inform the responsible person of any modification to the 
REMS of the applicable listed drug.
    Drug Safety Oversight Board. New section 505-1 establishes 
a Drug Safety Oversight Board. The Board shall be composed of 
Federal employees who are scientists and healthcare providers; 
representatives from offices throughout the Food and Drug 
Administration, include at least one representative from each 
of the National Institutes of Health and the Department of 
Health and Human Services, and other representatives from 
appropriate Federal agencies the Secretary designates. The 
Board will meet at least monthly to provide oversight and 
advice to the Secretary on the management of important drug 
safety issues.
    Section 901 amends section 301 of the Federal Food, Drug, 
and Cosmetic Act by adding at the end the following:
    ``(jj) The dissemination of a television advertisement 
without complying with section 503B.''; and by inserting after 
section 503A the following:
            ``Section 503B. Prereview of Television Advertisements.''
    New section 503B, in general, allows the Secretary to 
require the submission of any television advertisement for a 
drug (including any script, story board, rough, or a completed 
video production of the television advertisement) for review 
not later than 45 days before dissemination of the television 
advertisement.
    New section 503B allows the Secretary, in conducting a 
review of a television advertisement, to make recommendations 
on changes that are necessary to protect the consumer or 
consistent with prescribing information for the product under 
review. If appropriate and if information exists, the Secretary 
may make recommendations on statements for inclusion in the 
advertisement to address the specific efficacy of the drug as 
it relates to a specific population group. The Secretary is not 
authorized to make or direct changes in any submitted material.
    New section 503B states in cases where the Secretary 
determines that the advertisement would be false or misleading 
without a specific disclosure about a serious risk listed in 
the labeling of the drug involved, the Secretary may require 
inclusion of such disclosure in the advertisement. The 
Secretary may require the advertisements to include, within the 
first two years from the date of the approval of the drug under 
section 505, a specific disclosure of such date of approval if 
the Secretary determines that the advertisement would otherwise 
be false or misleading.
    Direct-to-Consumer Advertisements. New section 503B states, 
in general, in the case of an advertisement for a prescription 
drug presented directly to consumers in television or radio 
format and stating the name of the drug and its conditions of 
use, the major statement relating to side effects and 
contraindications shall be presented in a clear and conspicuous 
manner. The Secretary of Health and Human Services shall issue 
a regulation establishing standards for determining whether a 
major statement relating to side effects and contraindications 
of a drug is presented in a clear and conspicuous manner.
    Civil Penalties. New section 503B states any person who 
disseminates a direct-to-consumer advertisement that is false 
or misleading shall be liable to the United States for a civil 
penalty in an amount not to exceed $250,000 for the first such 
violation in any 3-year period, and not to exceed $500,000 for 
each subsequent violation in any 3-year period. Prior to 
written notice by the Secretary of an order to assess a 
penalty, repeated dissemination of the same or similar 
advertisement shall be considered one violation. On and after 
the date of the receipt of a written notice, all violations 
that occur in a single day shall be considered one violation.
    With respect to advertisements that appear in magazines or 
other publications that are published less frequently than 
daily, each issue date (e.g., week, month) should be treated as 
a single day for purposes of calculating the number of 
violations.
    New section 503B allows the Secretary, after providing 
written notice to the person to be assessed a civil penalty and 
an opportunity for a hearing, to assess a civil penalty by an 
order made on the record. Upon request of the person to be 
assessed a civil penalty, the Secretary shall take into account 
the nature, circumstances, extent, and gravity of the violation 
or violations.
    New section 503B states no person shall be required to pay 
a civil penalty if the person submitted the advertisement for 
review and after incorporating any comment received from the 
Secretary in the advertisement. The Secretary may retract or 
modify any prior comments the Secretary has provided with 
respect to the submitted advertisement based on new information 
or changed circumstances. The Secretary must provide written 
notice to the person of the new views and provide a reasonable 
time for modification or correction of an advertisement. The 
Secretary may compromise, modify, or remit, with or without 
conditions, any civil penalty.
    New section 503B allows any person who requested a hearing 
and was ordered to pay a civil penalty to file a petition for 
de novo judicial review of such order with the United States 
Court of Appeals for the District of Columbia, or any other 
circuit in which such person resides or conducts business. A 
petition may only be filed within 60 days from the date the 
order making such assessments was issued.
    New section 503B requires the Secretary to report to 
Congress on direct-to-consumer advertising and its ability to 
communicate to subsets of the general population, including 
elderly populations, children, and racial and ethnic 
minorities. The Secretary must establish a permanent advisory 
committee to advise the Secretary with respect to such report.

Section 902. Enforcement

    Section 902 amends section 502 of the FFDCA to deem a drug 
misbranded if the sponsor fails to comply with a requirement of 
a REMS. This section amends section 303 of the FFDCA to 
establish civil penalties for violations of REMS requirements. 
Penalties would be not more than $250,000 for each violation, 
not to exceed $1 million for all violations adjudicated in one 
proceeding. If the violation continues after the applicant has 
been notified by the Secretary, penalties will not be more than 
$10 million per violation, not to exceed $50 million for all 
violations adjudicated in a single proceeding. If a violation 
continues and poses a threat to the public health, the 
Secretary may impose a penalty not to exceed $1 million per 
day.

Section 903. No effect on withdrawal or suspension of approval

    Section 903 amends Section 505(e) of the FFDCA to make it 
clear that the Secretary is authorized to withdraw or suspend 
approval of an application without first ordering a REMS 
assessment.

Section 904. Benefit-risk assessments

    Section 904 requires the FDA Commissioner to submit a 
report to Congress, within one year of enactment, on how best 
to communicate to the public the risks and benefits of new 
drugs, and the role of the REMS in assessing such risks and 
benefits.

Section 905. Postmarket risk identification and analysis system for 
        active surveillance and assessment

    Section 905 amends subsection 505(k) of the FFDCA to 
require the Secretary to establish public-private partnerships 
to develop tools and methods to enable the Secretary and others 
to use available electronic databases to create a robust 
surveillance system that will support active surveillance on 
important drug safety questions.
    Section 905 requires the Secretary, in consultation with 
experts, to develop methods for integrating and analyzing 
safety data from multiple sources and mechanisms for obtaining 
access to that data within one year of enactment.
    Section 905 requires the Secretary to have entered into 
partnerships that will allow the analysis of available data 
from the various data sources using developed standards and 
methods to identify drug safety signals and trends within two 
years of enactment.
    Section 905 requires the Secretary to report to Congress on 
the ways in which the Secretary has used the surveillance 
system to identify specific drug safety signals and to better 
understand the outcomes associated with drugs marketed in the 
United States within four years of enactment.
    Section 905 states disclosure of individually identifiable 
information, unless done lawfully, is prohibited in the 
surveillance system described in this subsection.
    Proposed subparagraph 505(k)(7) indicates that entities may 
have other purposes for the use of databases other than the use 
described in this section, such as patient safety efforts or 
quality control. Nothing in this section prohibits lawful use 
or disclosure for such purposes. The Secretary has authority to 
interpret this paragraph and the term ``disclosure'' to allow 
entities that own a database to enter into contracts that allow 
contractors to access individually identifiable information in 
the database for the purpose of searches for the surveillance 
system, as long as the contract prohibits the contractor from 
disclosing individually identifiable information to which they 
have access through such activity.
    Section 905 authorizes the use of PDUFA fees for the 
activities described in this section; and, in addition, 
authorizes appropriations of $25 million for each of FY2008 
through FY2012 to carry out this section.
    Section 905 requires that not later than 18 months after 
enactment, a GAO report shall evaluate data confidentiality and 
security issues relating to collection, transmission, and 
maintenance of data for the surveillance system established by 
this section. GAO shall also make recommendations to the 
Committees of jurisdiction regarding the need for any 
additional legislative or regulatory actions to ensure 
confidentiality and security of these data.

Section 907. Statement for inclusion in direct-to-consumer 
        advertisements of drugs

    Section 907 requires that direct-to-consumer advertisements 
include a statement encouraging individuals to report adverse 
effects of prescription drugs to FDA via the Internet 
(www.fda.gov/medwatch) or phone (1-800-FDA-1088).

Section 908. Clinical trial guidance for antibiotic drugs

    Section 908 amends chapter V of the Federal Food, Drug, and 
Cosmetic Act by inserting after section 510 the following:
            ``Section 511. Clinical Trial Guidance for Antibiotic 
                    Drugs.''
    New section 511 states not later than one year after 
enactment of this section, the Secretary, acting through the 
Commissioner, shall issue guidance for the conduct of clinical 
trials with respect to antibiotic drugs. The guidelines shall 
indicate the appropriate animal models of infection, in vitro 
techniques, and valid microbiologic surrogate markers.
    New section 511 requires, not later than five years after 
enactment, the Secretary, acting through the Commissioner, to 
review and update the guidance to reflect developments in 
scientific and medical information and technology.

Section 909. Prohibition against food to which drugs or biological 
        products have been added

    Section 909 amends section 301 of the Federal Food, Drug, 
and Cosmetic Act to prohibit the introduction or delivery for 
introduction into interstate commerce of any food to which a 
drug or biologic product is added unless the drug or biologic 
product was marketed in food before approval under section 505 
of the FFDCA or section 351 of the PHSA.

Section 910. Assuring pharmaceutical safety

    Section 910 amends Chapter V of the Federal Food, Drug, and 
Cosmetic Act by inserting after section 505B the following:
            ``Section 505C. Pharmaceutical Security.''
    New section 505C states the Secretary shall develop 
standards and identify and validate effective technologies for 
the purpose of securing the prescription drug distribution 
system against counterfeit, diverted, subpotent, substandard, 
adulterated, misbranded, or expired drugs. In developing these 
standards, the Secretary shall consult with Federal health and 
security agencies, and address promising technologies.
    The Committee urges the Secretary to take additional steps 
to further secure the pharmaceutical supply chain against the 
threat of counterfeit drugs. While there is no single solution 
to this growing threat, technology can enhance pharmaceutical 
security and frustrate the introduction of counterfeit 
products. As such, the Secretary should work to develop, 
recommend, and promote standards, in consultation with 
specified agencies and with industry stakeholders, including 
manufacturers, distributors, pharmacies, and third party 
standard-setting organizations, to encourage the development 
and adoption of anti-counterfeiting technologies.
    New section 505C requires the Secretary to expand and 
enhance the resources and facilities of the Office of 
Regulatory Affairs of the Food and Drug Administration to 
protect the prescription drug distribution system, and 
establish regional capacities for the validation of 
prescription drugs and the inspection of the prescription drug 
distribution system.
    Moreover, inspection and enforcement is essential to 
identify and punish criminals who seek to infiltrate the 
pharmaceutical supply chain. The Committee has therefore 
authorized additional appropriations to enhance joint 
enforcement activities and to coordinate inspections and 
enforcement wherever counterfeit products may be introduced. 
The Committee believes an inspection and enforcement effort is 
necessary to properly confront this increasingly sophisticated 
threat to patient health and safety.
    New section 505C defines the term prescription drug.

Section 911. Orphan antibiotic drugs

    Section 911 states the Commissioner shall convene a public 
meeting regarding which serious and life threatening infectious 
diseases potentially qualify for available grants and contracts 
under section 5(a) of the Orphan Drug Act, regarding 
development of drugs for rare diseases.
    Section 911 authorizes to be appropriated $30 million for 
each of fiscal years 2008 through 2012 for these purposes.

Section 912. Authorization of appropriations

    Section 912 authorizes appropriations of $25 million for 
each of FY2008 through FY2012 for carrying out this title and 
amendments made by this title. This authorization of 
appropriations is in addition to other funds available for 
these activities.

Section 913. Effective date and applicability

    Section 913 takes effect 180 days after enactment. A 
product with an approved application before the effective date 
of this Act is considered to have an approved REMS if there is: 
(1) a restriction on distribution or use under regulations for 
accelerated approval; or (2) an agreement between the Secretary 
and the applicant. Section 913 requires the sponsor to submit a 
proposed REMS to the Secretary within 180 days of enactment.
    Section 913 grants the Secretary additional authorities for 
a product with an approved application before the effective 
date of this Act that does not have a restriction under 
accelerated approval regulations. The Secretary is authorized 
to require, on a case-by-case basis, that a sponsor submit a 
proposed REMS, in a specified timeframe, if the Secretary 
determines that its labeling may need modification, or another 
element of a REMS added. Section 913 authorizes the Secretary, 
in making such a requirement, to convene one or more FDA 
advisory committees to review a safety concern or dispute.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *


               CHAPTER III--PROHIBITED ACTS AND PENALTIES

                            PROHIBITED ACTS

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) * * *

           *       *       *       *       *       *       *

  (jj) The dissemination of a television advertisement without 
complying with section 503B.
  (kk) The introduction or delivery for introduction into 
interstate commerce of any food to which has been added--
          (1) a drug approved under section 505,
          (2) a biological product licensed under section 351 
        of the Public Health Service Act, or
          (3) a drug or biological product for which 
        substantial clinical investigations have been 
        instituted and for which the existence of such 
        investigations has been made public,
unless such drug or biological product was marketed in food 
before any approval of the drug under section 505 of this Act, 
before licensure of the biological product under section 351 of 
the Public Health Service Act, and before any substantial 
clinical investigations involving the drug or biological 
product have been instituted, or unless the Secretary, in the 
Secretary's discretion, has issued a regulation, after notice 
and comment, approving the addition of such drug or biological 
product to the food.

           *       *       *       *       *       *       *


                               PENALTIES

  Sec. 303. (a) * * *

           *       *       *       *       *       *       *

  [(g)] (f)(1) * * *

           *       *       *       *       *       *       *

  (2)(A)  * * *

           *       *       *       *       *       *       *

  (C) In a hearing to assess a civil penalty under this 
paragraph, the presiding officer shall have the same authority 
with regard to compelling testimony or production of documents 
as a presiding officer has under section 408(g)(2)(B). The 
third sentence of paragraph [(3)(A)] (4)(A) shall not apply to 
any investigation under this paragraph.
  (3) Any applicant (as such term is used in section 505-1) who 
violates a requirement of section 505(o), section 505(p), or 
section 505-1 shall be subject to a civil monetary penalty of--
          (A) not more than $250,000 per violation, and not to 
        exceed $1,000,000 for all such violations adjudicated 
        in a single proceeding; or
          (B) in the case of a violation that continues after 
        the Secretary provides notice of such violation to the 
        applicant, not more than $10,000,000 per violation, and 
        not to exceed $50,000,000 for all such violations 
        adjudicated in a single proceeding.
If a violation referred to in subparagraph (A) or (B) is 
continuing in nature and poses a substantial threat to the 
public health, the Secretary may impose a civil penalty not to 
exceed $1,000,000 per day during such time period such person 
is in violation.
  [(3)] (4)(A) A civil penalty under [paragraph (1) or (2)] 
paragraph (1), (2), or (3)shall be assessed by the Secretary by 
an order made on the record after opportunity for a hearing 
provided in accordance with this subparagraph and section 554 
of title 5, United States Code. Before issuing such an order, 
the Secretary shall give written notice to the person to be 
assessed a civil penalty under such order of the Secretary's 
proposal to issue such order and provide such person an 
opportunity for a hearing on the order. In the course of any 
investigation, the Secretary may issue subpoenas requiring the 
attendance and testimony of witnesses and the production of 
evidence that relates to the matter under investigation.

           *       *       *       *       *       *       *

  (C) The Secretary may compromise, modify, or remit, with or 
without conditions, any civil penalty which may be assessed 
under [paragraph (1) or (2)] paragraph (1), (2), or (3). The 
amount of such penalty, when finally determined, or the amount 
agreed upon in compromise, may be deducted from any sums owing 
by the United States to the person charged.
  [(4)] (5) Any person who requested, in accordance with 
paragraph (3)(A), a hearing respecting the assessment of a 
civil penalty and who is aggrieved by an order assessing a 
civil penalty may file a petition for judicial review of such 
order with the United States Court of Appeals for the District 
of Columbia Circuit or for any other circuit in which such 
person resides or transacts business. Such a petition may only 
be filed within the 60-day period beginning on the date the 
order making such assessment was issued.
  [(5)] (6) If any person fails to pay an assessment of a civil 
penalty--
          (A) after the order making the assessment becomes 
        final, and if such person does not file a petition for 
        judicial review of the order in accordance with 
        paragraph [(4)] (5), or
          (B) after a court in an action brought under 
        paragraph [(4)] (5) has entered a final judgment in 
        favor of the Secretary,
        the Attorney General shall recover the amount assessed 
        (plus interest at currently prevailing rates from the 
        date of the expiration of the 60-day period referred to 
        in paragraph [(4)] (5) or the date of such final 
        judgment, as the case may be) in an action brought in 
        any appropriate district court of the United States. In 
        such an action, the validity, amount, and 
        appropriateness of such penalty shall not be subject to 
        review.
  (g)(1) With respect to a person who is a holder of an 
approved application under section 505 for a drug subject to 
section 503(b) or under section 351 of the Public Health 
Service Act, any such person who disseminates a direct-to-
consumer advertisement that is false or misleading shall be 
liable to the United States for a civil penalty in an amount 
not to exceed $250,000 for the first such violation in any 3-
year period, and not to exceed $500,000 for each subsequent 
violation in any 3-year period. No other civil monetary 
penalties in this Act (including the civil penalty in section 
303(f)(3)) shall apply to a violation regarding direct-to-
consumer advertising. For purposes of this paragraph: (A) 
Repeated dissemination of the same or similar advertisement 
prior to the receipt of the written notice referred to in 
paragraph (2) for such advertisements shall be considered one 
violation. (B) On and after the date of the receipt of such a 
notice, all violations under this paragraph occurring in a 
single day shall be considered one violation
  (2) A civil penalty under paragraph (1) shall be assessed by 
the Secretary by an order made on the record after providing 
written notice to the person to be assessed a civil penalty and 
an opportunity for a hearing in accordance with this paragraph 
and section 554 of title 5, United States Code. If upon receipt 
of the written notice, the person to be assessed a civil 
penalty objects and requests a hearing, then in the course of 
any investigation related to such hearing, the Secretary may 
issue subpoenas requiring the attendance and testimony of 
witnesses and the production of evidence that relates to the 
matter under investigation, including information pertaining to 
the factors described in paragraph (3).
  (3) Upon the request of the person to be assessed a civil 
penalty under paragraph (1), the Secretary, in determining the 
amount of the civil penalty, shall take into account the 
nature, circumstances, extent, and gravity of the violation or 
violations, including the following factors:
          (A) Whether the person submitted the advertisement or 
        a similar advertisement for review under section 736A.
          (B) Whether the person submitted the advertisement 
        for review if required under section 503B.
          (C) Whether, after submission of the advertisement as 
        described in subparagraph (A) or (B), the person 
        disseminated the advertisement before the end of the 
        45-day comment period.
          (D) Whether the person incorporated any comments made 
        by the Secretary with regard to the advertisement into 
        the advertisement prior to its dissemination.
          (E) Whether the person ceased distribution of the 
        advertisement upon receipt of the written notice 
        referred to in paragraph (2) for such advertisement.
          (F) Whether the person had the advertisement reviewed 
        by qualified medical, regulatory, and legal reviewers 
        prior to its dissemination.
          (G) Whether the violations were material.
          (H) Whether the person who created the advertisement 
        acted in good faith.
          (I) Whether the person who created the advertisement 
        has been assessed a civil penalty under this provision 
        within the previous 1-year period.
          (J) The scope and extent of any voluntary, subsequent 
        remedial action by the person.
          (K) Such other matters, as justice may require.
  (4)(A) Subject to subparagraph (B), no person shall be 
required to pay a civil penalty under paragraph (1) if the 
person submitted the advertisement to the Secretary and 
disseminated such advertisement after incorporating any comment 
received from the Secretary other than a recommendation subject 
to subsection 503B(c).
  (B) The Secretary may retract or modify any prior comments 
the Secretary has provided to an advertisement submitted to the 
Secretary based on new information or changed circumstances, so 
long as the Secretary provides written notice to the person of 
the new views of the Secretary on the advertisement and 
provides a reasonable time for modification or correction of 
the advertisement prior to seeking any civil penalty under 
paragraph (1).
  (5) The Secretary may compromise, modify, or remit, with or 
without conditions, any civil penalty which may be assessed 
under paragraph (1). The amount of such penalty, when finally 
determined, or the amount charged upon in compromise, may be 
deducted from any sums owed by the United States to the person 
charged.
  (6) Any person who requested, in accordance with paragraph 
(2), a hearing with respect to the assessment of a civil 
penalty and who is aggrieved by an order assessing a civil 
penalty, may file a petition for de novo judicial review of 
such order with the United States Court of Appeals for the 
District of Columbia Circuit or for any other circuit in which 
such person resides or transacts business. Such a petition may 
only be filed within the 60-day period beginning on the date 
the order making such assessments was issued.
  (7) On an annual basis, the Secretary shall report to the 
Congress on direct-to-consumer advertising and its ability to 
communicate to subsets of the general population, including 
elderly populations, children, and racial and ethnic minority 
communities. The Secretary shall establish a permanent advisory 
committee to advise the Secretary with respect to such report. 
The membership of the advisory committee shall consist of 
nationally recognized medical, advertising, and communications 
experts, including experts representing subsets of the general 
population. The members of the advisory committee shall serve 
without pay, but may receive travel expenses, including per 
diem in lieu of subsistence in accordance with applicable 
provisions under subchapter I of chapter 57 of title 5, United 
States Code. The advisory committee shall study direct-to-
consumer advertising as it relates to increased access to 
health information and decreased health disparities for these 
populations. The annual report required by this paragraph shall 
recommend effective ways to present and disseminate information 
to these populations. Such report shall also make 
recommendations regarding impediments to the participation of 
elderly populations, children, racially and ethnically diverse 
communities, and medically underserved populations in clinical 
drug trials and shall recommend best practice approaches for 
increasing the inclusion of such subsets of the general 
population. The Secretary shall submit the first annual report 
under this paragraph to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives not later than 18 
months after the advisory committee has been convened by the 
Secretary.
  (8) If any person fails to pay an assessment of a civil 
penalty under paragraph (1)--
          (A) after the order making the assessment becomes 
        final, and if such person does not file a petition for 
        judicial review of the order in accordance with 
        paragraph (6), or
          (B) after a court in an action brought under 
        paragraph (6) has entered a final judgment in favor of 
        the Secretary,
        the Attorney General of the United States shall recover 
        the amount assessed (plus interest at currently 
        prevailing rates from the date of the expiration of the 
        60-day period referred to in paragraph (6) or the date 
        of such final judgment, as the case may be) in an 
        action brought in any appropriate district court of the 
        United States. In such an action, the validity, amount, 
        and appropriateness of such penalty shall not be 
        subject to review.

           *       *       *       *       *       *       *


                      CHAPTER V--DRUGS AND DEVICES

SUBCHAPTER A--Drugs and Devices

           *       *       *       *       *       *       *


                      MISBRANDED DRUGS AND DEVICES

  Sec. 502. A drug or device shall be deemed to be misbranded--
  (a) * * *

           *       *       *       *       *       *       *

  (n) In the case of any prescription drug distributed or 
offered for sale in any State, unless the manufacturer, packer, 
or distributor thereof includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to that drug 
a true statement of (1) the established name as defined in 
section 502(e), printed prominently and in type at least half 
as large as that used for any trade or brand name thereof, (2) 
the formula showing quantitatively each ingredient of such drug 
to the extent required for labels under section 502(e), and (3) 
such other information in brief summary relating to side 
effects, contraindications, and effectiveness as shall be 
required in regulations which shall be issued by the Secretary 
in accordance with the procedure specified in section 701(e) 
[of this Act, except that] of this Act, and in the case of any 
direct-to-consumer advertisement the following statement: ``You 
are encouraged to report adverse effects of prescription drug 
medication to the FDA. Log onto www.fda.gov/medwatch or call 1-
800-FDA-1088.'', except that (A) except in extraordinary 
circumstances, no regulation issued under this paragraph shall 
require prior approval by the Secretary of the content of any 
advertisement, and (B) no advertisement of a prescription drug, 
published after the effective date of regulations issued under 
this paragraph applicable to advertisements of prescription 
drugs, shall, with respect to the matters specified in this 
paragraph or covered by such regulations, be subject to the 
provisions of sections 12 through 17 of the Federal Trade 
Commission Act, as amended (15 U.S.C. 52-57). This paragraph 
(n) shall not be applicable to any printed matter which the 
Secretary determines to be labeling as defined in section 
201(m) of this Act. Nothing in the Convention on Psychotropic 
Substances, signed at Vienna, Austria, on February 21, 1971, 
shall be construed to prevent drug price communications to 
consumers. In the case of an advertisement for a drug subject 
to section 503(b)(1) presented directly to consumers in 
television or radio format and stating the name of the drug and 
its conditions of use, the major statement relating to side 
effects and contraindications shall be presented in a clear and 
conspicuous manner.

           *       *       *       *       *       *       *

  (y) If it is a drug subject to an approved risk evaluation 
and mitigation strategy pursuant to section 505(p) and the 
person responsible for complying with the strategy fails to 
comply with a requirement of such strategy provided for under 
subsection (d), (e), or (f) of section 505-1.
  (z) If it is a drug, and the responsible person (as such term 
is used in section 505(o)) is in violation of a requirement 
established under paragraph (3) (relating to postmarket studies 
and clinical trials) or paragraph (4) (relating to labeling) of 
section 505(o) with respect to such drug.

           *       *       *       *       *       *       *


SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.

  (a) In General.--The Secretary may require the submission of 
any television advertisement for a drug (including any script, 
story board, rough, or a completed video production of the 
television advertisement) to the Secretary for review under 
this section not later than 45 days before dissemination of the 
television advertisement.
  (b) Review.--In conducting a review of a television 
advertisement under this section, the Secretary may make 
recommendations--
          (1) on changes that are--
                  (A) necessary to protect the consumer good 
                and well-being; or
                  (B) consistent with prescribing information 
                for the product under review; and
          (2) if appropriate and if information exists, on 
        statements for inclusion in the advertisement to 
        address the specific efficacy of the drug as it relates 
        to a specific population group, including elderly 
        populations, children, and racially and ethnically 
        diverse populations.
  (c) No Authority to Require Changes.--This section does not 
authorize the Secretary to make or direct changes in any 
material submitted pursuant to subsection (a).
  (d) Elderly Populations, Children, Racially and Ethnically 
Diverse Communities.--In formulating recommendations under 
subsection (b), the Secretary shall take into consideration the 
impact of the advertised drug on elderly populations, children, 
and racially and ethnically diverse communities.
  (e) Specific Disclosures.--
          (1) Serious risk; safety protocol.--In conducting a 
        review of a television advertisement under this 
        section, if the Secretary determines that the 
        advertisement would be false or misleading without a 
        specific disclosure about a serious risk listed in the 
        labeling of the drug involved, the Secretary may 
        require inclusion of such disclosure in the 
        advertisement.
          (2) Date of approval.--In conducting a review of a 
        television advertisement under this section, the 
        Secretary may require the advertisement to include, for 
        a period not to exceed 2 years from the date of the 
        approval of the drug under section 505, a specific 
        disclosure of such date of approval if the Secretary 
        determines that the advertisement would otherwise be 
        false or misleading.
  (f) Rule of Construction.--Nothing in this section may be 
construed as having any effect on the authority of the 
Secretary under section 314.550, 314.640, 601.45, or 601.94 of 
title 21, Code of Federal Regulations (or successor 
regulations).

           *       *       *       *       *       *       *


                               NEW DRUGS

  Sec. 505. (a) * * *

           *       *       *       *       *       *       *

  (d) If the Secretary finds, after due notice to the applicant 
in accordance with subsection (c) and giving him an opportunity 
for a hearing, in accordance with said subsection, that (1) the 
investigations, reports of which are required to be submitted 
to the Secretary pursuant to subsection (b), do not include 
adequate tests by all methods reasonably applicable to show 
whether or not such drug is safe for use under the conditions 
prescribed, recommended, or suggested in the proposed labeling 
thereof; (2) the results of such tests show that such drug is 
unsafe for use under such conditions or do not show that such 
drug is safe for use under such conditions; (3) the methods 
used in, and the facilities and controls used for, the 
manufacture, processing, and packing of such drug are 
inadequate to preserve its identity, strength, quality, and 
purity; (4) upon the basis of the information submitted to him 
as part of the application, or upon the basis of any other 
information before him with respect to such drug, he has 
insufficient information to determine whether such drug is safe 
for use under such conditions; or (5) evaluated on the basis of 
the information submitted to him as part of the application and 
any other information before him with respect to such drug, 
there is a lack of substantial evidence that the drug will have 
the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
proposed labeling thereof; or (6) the application failed to 
contain the patent information prescribed by subsection (b); or 
(7) based on a fair evaluation of all material facts, such 
labeling is false or misleading in any particular; or (8) the 
applicant failed to submit the clinical trial information for 
any applicable clinical trial as required by section 492C of 
the Public Health Service Act; he shall issue an order refusing 
to approve the application. If, after such notice and 
opportunity for hearing, the Secretary finds that [clauses (1) 
through (6)] paragraphs (1) through (8) do not apply, he shall 
issue an order approving the application. As used in this 
subsection and subsection (e), the term ``substantial 
evidence'' means evidence consisting of adequate and well-
controlled investigations, including clinical investigations, 
by experts qualified by scientific training and experience to 
evaluate the effectiveness of the drug involved, on the basis 
of which it could fairly and responsibly be concluded by such 
experts that the drug will have the effect it purports or is 
represented to have under the conditions of use prescribed, 
recommended, or suggested in the labeling or proposed labeling 
thereof. If the Secretary determines, based on relevant 
science, that data from one adequate and well-controlled 
clinical investigation and confirmatory evidence (obtained 
prior to or after such investigation) are sufficient to 
establish effectiveness, the Secretary may consider such data 
and evidence to constitute substantial evidence for purposes of 
the preceding sentence.
  (e) The Secretary shall, after due notice and opportunity for 
hearing to the applicant, withdraw approval of an application 
with respect to any drug under this section if the Secretary 
finds (1) that clinical or other experience, tests, or other 
scientific data show that such drug is unsafe for use under the 
conditions of use upon the basis of which the application was 
approved; (2) that new evidence of clinical experience, not 
contained in such application or not available to the Secretary 
until after such application was approved, or tests by new 
methods, or tests by methods not deemed reasonably applicable 
when such application was approved, evaluated together with the 
evidence available to the Secretary when the application was 
approved, shows that such drug is not shown to be safe for use 
under the conditions of use upon the basis of which the 
application was approved; or (3) on the basis of new 
information before him with respect to such drug, evaluated 
together with the evidence available to him when the 
application was approved, that there is a lack of substantial 
evidence that the drug will have the effect it purports or is 
represented to have under the conditions of use prescribed, 
recommended, or suggested in the labeling thereof; or (4) the 
patent information prescribed by subsection (c) was not filed 
within thirty days after the receipt of written notice from the 
Secretary specifying the failure to file such information; or 
(5) that the application contains any untrue statement of a 
material fact: Provided, That if the Secretary (or in his 
absence the officer acting as Secretary) finds that there is an 
imminent hazard to the public health, he may suspend the 
approval of such application immediately, and give the 
applicant prompt notice of his action and afford the applicant 
the opportunity for an expedited hearing under this subsection; 
but the authority conferred by this proviso to suspend the 
approval of an application shall not be delegated. The 
Secretary may also, after due notice and opportunity for 
hearing to the applicant, withdraw the approval of an 
application submitted under subsection (b) or (j) with respect 
to any drug under this section if the Secretary finds (1) that 
the applicant has failed to establish a system for maintaining 
required records, or has repeatedly or deliberately failed to 
maintain such records or to make required reports, in 
accordance with a regulation or order under subsection (k) or 
to comply with the notice requirements of section 510(k)(2), or 
the applicant has refused to permit access to, or copying or 
verification of, such records as required by paragraph (2) of 
such subsection; or (2) that on the basis of new information 
before him, evaluated together with the evidence before him 
when the application was approved, the methods used in, or the 
facilities and controls used for, the manufacture, processing, 
and packing of such drug are inadequate to assure and preserve 
its identity, strength, quality, and purity and were not made 
adequate within a reasonable time after receipt of written 
notice from the Secretary specifying the matter complained of; 
or (3) that on the basis of new information before him, 
evaluated together with the evidence before him when the 
application was approved, the labeling of such drug, based on a 
fair evaluation of all material facts, is false or misleading 
in any particular and was not corrected within a reasonable 
time after receipt of written notice from the Secretary 
specifying the matter complained of. Any order under this 
subsection shall state the findings upon which it is based. The 
Secretary may withdraw the approval of an application submitted 
under this section, or suspend the approval of such an 
application, as provided under this subsection, without first 
ordering the applicant to submit an assessment of the approved 
risk evaluation and mitigation strategy for the drug under 
section 505-1(g)(2)(D).

           *       *       *       *       *       *       *

  (i)(1) The Secretary shall promulgate regulations for 
exempting from the operation of the foregoing subsections of 
this section drugs intended solely for investigational use by 
experts qualified by scientific training and experience to 
investigate the safety and effectiveness of drugs. Such 
regulations may, within the discretion of the Secretary, among 
other conditions relating to the protection of the public 
health, provide for conditioning such exemption upon--
          (A) * * *

           *       *       *       *       *       *       *

          (C) the establishment and maintenance of such 
        records, and the making of such reports to the 
        Secretary, by the manufacturer or the sponsor of the 
        investigation of such drug, of data (including but not 
        limited to analytical reports by investigators) 
        obtained as the result of such investigational use of 
        such drug, as the Secretary finds will enable him to 
        evaluate the safety and effectiveness of such drug in 
        the event of the filing of an application pursuant to 
        subsection (b); [and]
          (D) the submission to the Secretary by the 
        manufacturer or the sponsor of the investigation of a 
        new drug of a statement of intent regarding whether the 
        manufacturer or sponsor has plans for assessing 
        pediatric safety and efficacy[.]; and
          (E) the submission to the Director of NIH of clinical 
        trial information for the clinical investigation at 
        issue required under section 492C of the Public Health 
        Service Act for inclusion in the registry database and 
        the results database described in such section.

           *       *       *       *       *       *       *

  (3)(A) * * *
  (B) For purposes of subparagraph (A), a determination 
described in this subparagraph with respect to a clinical hold 
is that--
          (i) the drug involved represents an unreasonable risk 
        to the safety of the persons who are the subjects of 
        the clinical investigation, taking into account the 
        qualifications of the clinical investigators, 
        information about the drug, the design of the clinical 
        investigation, the condition for which the drug is to 
        be investigated, and the health status of the subjects 
        involved; [or]
          (ii) the clinical hold should be issued for such 
        other reasons as the Secretary may by regulation 
        establish (including reasons established by regulation 
        before the date of the enactment of the Food and Drug 
        Administration Modernization Act of 1997)[.]; or
          (iii) clinical trial information for the clinical 
        investigation at issue was not submitted in compliance 
        with section 492C of the Public Health Service Act.

           *       *       *       *       *       *       *

  (4) Regulations under paragraph (1) shall provide that such 
exemption shall be conditioned upon the manufacturer, or the 
sponsor of the investigation, requiring that experts using such 
drugs for investigational purposes certify to such manufacturer 
or sponsor that they will inform any human beings to whom such 
drugs, or any controls used in connection therewith, are being 
administered, or their representatives, that such drugs are 
being used for investigational purposes and will obtain the 
consent of such human beings or their representatives, except 
where it is not feasible or it is contrary to the best 
interests of such human beings. Nothing in this subsection 
shall be construed to require any clinical investigator to 
submit directly to the Secretary reports on the investigational 
use of drugs. The Secretary shall update such regulations to 
require inclusion in the informed consent form a statement that 
clinical trial information for such clinical investigation will 
be submitted for inclusion in the registry database and results 
database, as applicable, described in section 492C of the 
Public Health Service Act.

           *       *       *       *       *       *       *

  (k)(1) * * *

           *       *       *       *       *       *       *

  (3) The Secretary shall establish public private partnerships 
to develop tools and methods to enable the Secretary and others 
to use available electronic databases to create a robust 
surveillance system that will support active surveillance on 
important drug safety questions including detecting and 
assessing drug safety signals; monitoring the frequency of 
known adverse events; and evaluating the outcomes of off label 
uses. Such surveillance shall provide for adverse event 
surveillance using the following data sources:
          (A) Federal health-related electronic data (such as 
        data from the Medicare program and the health systems 
        of the Department of Veterans Affairs).
          (B) Private sector health-related electronic data 
        (such as pharmaceutical purchase data and health 
        insurance claims data).
          (C) Other information as the Secretary deems useful 
        to create a robust system to identify and assess 
        adverse events and potential drug safety signals and to 
        evaluate the extent and outcomes of off label uses of 
        drugs.
  (4) Not later than 1 year after the date of the enactment of 
this paragraph, the Secretary, in consultation with experts 
including individuals who are recognized in the field of data 
privacy and security, shall develop methods for integrating and 
analyzing safety data from multiple sources and mechanisms for 
obtaining access to such data. Such methods and mechanisms 
shall not compromise the protection of individually 
identifiable health information.
  (5) Not later than 2 years after the date of the enactment of 
this paragraph, the Secretary shall have entered into 
partnerships that will allow the analysis of available data 
from the various data sources using the standards and methods 
to identify drug safety signals and trends. Such analysis shall 
not disclose individually identifiable health information when 
presenting such drug safety signals and trends or when 
responding to inquiries regarding such drug safety signals and 
trends.
  (6) Not later than 4 years after the date of the enactment of 
this paragraph, the Secretary shall report to the Congress on 
the ways in which the Secretary has used the surveillance 
system described in this subsection to identify specific drug 
safety signals and to better understand the outcomes associated 
with drugs marketed in the United States.
  (7) Disclosure of individually identifiable information is 
prohibited in the surveillance system described in this 
subsection. Nothing in this subsection prohibits lawful 
disclosure of such information for other purposes.
  (8) Nothing in this subsection shall be construed as limiting 
public health activities authorized under law.

           *       *       *       *       *       *       *

  (n)(1) * * *

           *       *       *       *       *       *       *

  [(4) Each member of a panel shall publicly disclose all 
conflicts of interest that member may have with the work to be 
undertaken by the panel. No member of a panel may vote on any 
matter where the member or the immediate family of such member 
could gain financially from the advice given to the Secretary. 
The Secretary may grant a waiver of any conflict of interest 
requirement upon public disclosure of such conflict of interest 
if such waiver is necessary to afford the panel essential 
expertise, except that the Secretary may not grant a waiver for 
a member of a panel when the member's own scientific work is 
involved.]
  [(5)] (4) The Secretary shall, as appropriate, provide 
education and training to each new panel member before such 
member participates in a panel's activities, including 
education regarding requirements under this Act and related 
regulations of the Secretary, and the administrative processes 
and procedures related to panel meetings.
  [(6)] (5) Panel members (other than officers or employees of 
the United States), while attending meetings or conferences of 
a panel or otherwise engaged in its business, shall be entitled 
to receive compensation for each day so engaged, including 
traveltime, at rates to be fixed by the Secretary, but not to 
exceed the daily equivalent of the rate in effect for positions 
classified above grade GS-15 of the General Schedule. While 
serving away from their homes or regular places of business, 
panel members may be allowed travel expenses (including per 
diem in lieu of subsistence) as authorized by section 5703 of 
title 5, United States Code, for persons in the Government 
service employed intermittently.
  [(7)] (6) The Secretary shall ensure that scientific advisory 
panels meet regularly and at appropriate intervals so that any 
matter to be reviewed by such a panel can be presented to the 
panel not more than 60 days after the matter is ready for such 
review. Meetings of the panel may be held using electronic 
communication to convene the meetings.
  [(8)] (7) Within 90 days after a scientific advisory panel 
makes recommendations on any matter under its review, the Food 
and Drug Administration official responsible for the matter 
shall review the conclusions and recommendations of the panel, 
and notify the affected persons of the final decision on the 
matter, or of the reasons that no such decision has been 
reached. Each such final decision shall be documented including 
the rationale for the decision.
  (o) Postmarket Studies and Clinical Trials; Labeling.--
          (1) In general.--A responsible person may not 
        introduce or deliver for introduction into interstate 
        commerce the new drug involved if the person is in 
        violation of a requirement established under paragraph 
        (3) or (4) with respect to the drug.
          (2) Definitions.--For purposes of this subsection:
                  (A) Responsible person.--The term 
                ``responsible person'' means a person who--
                          (i) has submitted to the Secretary a 
                        covered application that is pending; or
                          (ii) is the holder of an approved 
                        covered application.
                  (B) Covered application.--The term ``covered 
                application'' means--
                          (i) an application under subsection 
                        (b) for a drug that is subject to 
                        section 503(b); and
                          (ii) an application under section 351 
                        of the Public Health Service Act.
                  (C) New safety information; serious risk.--
                The terms ``new safety information'', ``serious 
                risk'', and ``signal of a serious risk'' have 
                the meanings given such terms in section 505-
                1(b).
          (3) Studies and clinical trials.--
                  (A) In general.--For any or all of the 
                purposes specified in subparagraph (B), the 
                Secretary may, subject to subparagraph (C), 
                require a responsible person for a drug to 
                conduct a postapproval study or studies of the 
                drug, or a postapproval clinical trial or 
                trials of the drug, on the basis of scientific 
                information, including information regarding 
                chemically-related or pharmacologically-related 
                drugs.
                  (B) Purposes of study or trial.--The purposes 
                referred to in this subparagraph with respect 
                to a postapproval study or postapproval 
                clinical trial are the following:
                          (i) To assess a known serious risk 
                        related to the use of the drug 
                        involved.
                          (ii) To assess signals of serious 
                        risk related to the use of the drug.
                          (iii) To identify a serious risk.
                  (C) Establishment of requirement after 
                approval of covered application.--The Secretary 
                may require a postapproval study or studies or 
                postapproval trial or trials for a drug for 
                which an approved covered application is in 
                effect as of the date on which the Secretary 
                seeks to establish such requirement only if the 
                Secretary becomes aware of new safety 
                information. For each study required to be 
                conducted under this subparagraph, the 
                Secretary shall require that the applicant 
                submit a timetable for completion of the study 
                and shall require the applicant to periodically 
                report to the Secretary on the status of the 
                study. Unless the applicant demonstrates good 
                cause for failure to comply with such timeline, 
                the applicant shall be in violation of this 
                subsection. The Secretary shall determine what 
                constitutes good cause under the preceding 
                sentence.
          (4) Safety labeling changes requested by secretary.--
                  (A) New safety information.--The Secretary 
                shall promptly notify the responsible person if 
                the Secretary becomes aware of new safety 
                information that the Secretary believes should 
                be included in the labeling of the drug.
                  (B) Response to notification.--Following 
                notification pursuant to subparagraph (A), the 
                responsible person shall within 30 days--
                          (i) submit a supplement proposing 
                        changes to the approved labeling to 
                        reflect the new safety information, 
                        including changes to boxed warnings, 
                        contraindications, warnings, 
                        precautions, or adverse reactions; or
                          (ii) notify the Secretary that the 
                        responsible person does not believe a 
                        labeling change is warranted and submit 
                        a statement detailing the reasons why 
                        such a change is not warranted.
                  (C) Review.--Upon receipt of such supplement, 
                the Secretary shall promptly review and act 
                upon such supplement. If the Secretary 
                disagrees with the proposed changes in the 
                supplement or with the statement setting forth 
                the responsible person's reasons why no 
                labeling change is necessary, the Secretary 
                shall initiate discussions with the responsible 
                person to reach agreement on whether the 
                labeling for the drug should be modified to 
                reflect the new safety information, and if so, 
                the contents of such labeling changes.
                  (D) Discussions.--Such discussions shall not 
                extend for more than 30 days after the response 
                to the notification under subparagraph (B), 
                unless the Secretary determines an extension of 
                such discussion period is warranted.
                  (E) Order.--Within 15 days of the conclusion 
                of the discussions under subparagraph (D), the 
                Secretary may issue an order directing the 
                responsible person to make such a labeling 
                change as the Secretary deems appropriate to 
                address the new safety information. Within 15 
                days of such an order, the responsible person 
                shall submit a supplement containing the 
                labeling change.
                  (F) Dispute resolution.--Within 5 days of 
                receiving an order under subparagraph (E), the 
                responsible person may appeal using the Food 
                and Drug Administration's normal dispute 
                resolution procedures established by the 
                Secretary in regulation and guidance.
                  (G) Violation.--If the change required by an 
                order under subparagraph (E) is not made by the 
                date so specified, the responsible person shall 
                be considered to be in violation of this 
                section.
                  (H) Serious public health threat.--
                Notwithstanding subparagraphs (A) through (F), 
                if the Secretary concludes that failure to make 
                such a labeling change is necessary to protect 
                against a serious public health threat, the 
                Secretary may accelerate the timelines in such 
                subparagraphs.
                  (I) Rule of construction.--This paragraph 
                shall not be construed to affect the 
                responsibility of the responsible person to 
                maintain its label in accordance with existing 
                requirements, including subpart B and section 
                314.70 of title 21, Code of Federal Regulations 
                (or any successor regulations).
  (p) Risk Evaluation and Mitigation Strategy.--
          (1) In general.--A person may not introduce or 
        deliver for introduction into interstate commerce a new 
        drug if--
                  (A)(i) the application for such drug is 
                approved under subsection (b) or (j) and is 
                subject to section 503(b); or
          (ii) the application for such drug is approved under 
        section 351 of the Public Health Service Act; and
                  (B) a risk evaluation and mitigation strategy 
                is required under section 505-1 with respect to 
                the drug and--
                          (i) the person fails to maintain 
                        compliance with the requirements of the 
                        approved strategy or with other 
                        requirements under section 505-1, 
                        including requirements regarding 
                        assessments of approved strategies; or
                          (ii) in the case of a requirement for 
                        such a strategy that is first 
                        established after the applicable 
                        application referred to in subparagraph 
                        (A) was approved with respect to the 
                        drug, the Secretary, after notice and 
                        opportunity for a hearing, publishes in 
                        the Federal Register a statement that 
                        the person is not cooperating with the 
                        Secretary in developing such a strategy 
                        for the drug.
          (2) Required statement during approval process.--In 
        the case of an application approved under subsection 
        (b) or (j) for a new drug that is subject to section 
        503(b), or an application approved under section 351 of 
        the Public Health Service Act, or a supplement to such 
        an application that requires substantive data, the 
        Secretary may not approve the application or supplement 
        unless the person involved has complied with the 
        following:
                  (A) The person has submitted to the Secretary 
                a statement that provides the following 
                information:
                          (i) Whether the person believes that 
                        a risk evaluation and mitigation 
                        strategy should be required under 
                        section 505-1.
                          (ii) Whether a postmarket study or 
                        clinical trial should be required under 
                        subsection (o)(3).
                  (B) In making the statement under 
                subparagraph (A), the person took into account 
                each of the following factors:
                          (i) The estimated size of the 
                        population likely to use the drug 
                        involved.
                          (ii) The seriousness of the disease 
                        or condition that is to be treated with 
                        the drug.
                          (iii) The expected benefit of the 
                        drug with respect to such disease or 
                        condition.
                          (iv) The expected or actual duration 
                        of treatment with the drug.
                          (v) The seriousness of any known or 
                        potential adverse events that may be 
                        related to the drug and the background 
                        incidence of such events in the 
                        population likely to use the drug.
          (3) Certain postmarket studies.--The failure to 
        conduct a postmarket study under subpart H of part 314 
        of title 21, Code of Federal Regulations (or any 
        successor regulation), is deemed to be a violation of 
        paragraph (1).

SEC. 505-1. RISK EVALUATION AND MITIGATION STRATEGIES.

  (a) Submission of Proposed Strategy.--
          (1) Initial approval.--A person who submits an 
        application referred to in section 505(p)(1)(A) 
        (referred to in this section as a ``covered 
        application'') shall submit to the Secretary as part of 
        the application a proposed risk evaluation and 
        mitigation strategy if the Secretary determines such a 
        strategy is necessary to ensure that the benefits of 
        the drug involved outweigh the risks of the drug. In 
        making such a determination, the Secretary shall 
        consider the statement submitted by the person under 
        section 505(p)(2) with respect to the drug and shall 
        consider the following factors:
                  (A) The estimated size of the population 
                likely to use the drug involved.
                  (B) The seriousness of the disease or 
                condition that is to be treated with the drug.
                  (C) The expected benefit of the drug with 
                respect to such disease or condition.
                  (D) The expected or actual duration of 
                treatment with the drug.
                  (E) The seriousness of any known or potential 
                adverse events that may be related to the drug 
                and the background incidence of such events in 
                the population likely to use the drug.
                  (F) The availability and safety of a drug or 
                other treatment, if any, for such disease or 
                condition to which the safety of the drug may 
                be compared.
                  (G) Whether the drug is a new molecular 
                entity.
          (2) Postapproval requirement.--
                  (A) In general.--If the Secretary approves a 
                covered application and does not when approving 
                the application require a risk evaluation and 
                mitigation strategy under paragraph (1), the 
                Secretary may subsequently require such a 
                strategy for the drug involved if the Secretary 
                becomes aware of new safety information and 
                makes a determination that such a strategy is 
                necessary to ensure that the benefits of the 
                drug outweigh the risks of the drug.
                  (B) Submission of proposed strategy.--Not 
                later than 120 days after the Secretary 
                notifies the holder of an approved covered 
                application that the Secretary has made a 
                determination under subparagraph (A) with 
                respect to the drug involved, or within such 
                other time as the Secretary requires to protect 
                the public health, the holder shall submit to 
                the Secretary a proposed risk evaluation and 
                mitigation strategy.
          (3) Approval of new indication for use.--The 
        applicability of paragraph (2) includes applicability 
        to a drug for which an approved covered application was 
        in effect on the day before the effective date of this 
        section and for which, on or after such effective date, 
        the holder of the approved application submits to the 
        Secretary a supplemental application seeking approval 
        of a new indication for use of the drug.
          (4) Abbreviated new drug applications.--The 
        applicability of this section to an application under 
        section 505(j) is subject to subsection (i).
  (b) Definitions.--For purposes of this section:
          (1) Adverse drug experience.--The term ``adverse drug 
        experience'' means any adverse event associated with 
        the use of a drug in humans, whether or not considered 
        drug related, including--
                  (A) an adverse event occurring in the course 
                of the use of the drug in professional 
                practice;
                  (B) an adverse event occurring from an 
                overdose of the drug, whether accidental or 
                intentional;
                  (C) an adverse event occurring from abuse of 
                the drug;
                  (D) an adverse event occurring from 
                withdrawal of the drug; and
                  (E) any failure of expected pharmacological 
                action of the drug.
          (2) Covered application.--The term ``covered 
        application'' has the meaning indicated for such term 
        in subsection (a)(1).
          (3) New safety information.--The term ``new safety 
        information'' with respect to a drug means information 
        about--
                  (A) a serious risk or an unexpected serious 
                risk associated with use of the drug that the 
                Secretary has become aware of since the drug 
                was approved, since the risk evaluation and 
                mitigation strategy was required, or since the 
                last assessment of the approved risk evaluation 
                and mitigation strategy for the drug; or
                  (B) the effectiveness of the approved risk 
                evaluation and mitigation strategy for the drug 
                obtained since the last assessment of such 
                strategy.
          (4) Serious adverse drug experience.--The term 
        ``serious adverse drug experience'' is an adverse event 
        that--
                  (A) results in--
                          (i) death;
                          (ii) an adverse drug experience that 
                        places the patient at immediate risk of 
                        death from the adverse drug experience 
                        as it occurred (not including an 
                        adverse drug experience that might have 
                        caused death had it occurred in a more 
                        severe form);
                          (iii) inpatient hospitalization or 
                        prolongation of existing 
                        hospitalization;
                          (iv) a persistent or significant 
                        incapacity or substantial disruption of 
                        the ability to conduct normal life 
                        functions; or
                          (v) a congenital anomaly or birth 
                        defect; or
                  (B) based on appropriate medical judgment, 
                may jeopardize the patient and may require a 
                medical or surgical intervention to prevent an 
                outcome described under subparagraph (A).
          (5) Serious risk.--The term ``serious risk'' means a 
        risk of a serious adverse drug experience.
          (6) Signal of a serious risk.--The term ``signal of a 
        serious risk'' means information related to a serious 
        adverse drug experience associated with use of a drug 
        and derived from--
                  (A) a clinical trial;
                  (B) adverse event reports;
                  (C) a postapproval study, including a study 
                under section 505(o)(3);
                  (D) peer-reviewed biomedical literature; or
                  (E) data derived from a postmarket risk 
                identification and analysis system under 
                section 505(k)(3).
          (7) Responsible person.--The term ``responsible 
        person'' has the meaning indicated for such term in 
        subsection (e)(2).
          (8) Unexpected serious risk.--The term ``unexpected 
        serious risk'' means a serious adverse drug experience 
        that is not listed in the labeling of a drug, or that 
        may be symptomatically and pathophysiologically related 
        to an adverse drug experience identified in the 
        labeling, but differs from such adverse drug experience 
        because of greater severity, specificity, or 
        prevalence.
  (c) Contents.--A proposed risk evaluation and mitigation 
strategy under subsection (a) shall--
          (1) include the timetable required under subsection 
        (d); and
          (2) to the extent required by the Secretary, include 
        additional elements described in subsections (e) and 
        (f).
  (d) Minimal Strategy.--For purposes of subsection (c)(1), the 
risk evaluation and mitigation strategy for a drug shall 
require a timetable for submission of assessments of the 
strategy that--
          (1) is not less frequent than once annually for the 
        first 3 years after the strategy is initially approved;
          (2) includes an assessment in the seventh year after 
        the strategy is so approved; and
          (3) subject to paragraph (2), for subsequent years--
                  (A) is at a frequency specified in the 
                strategy;
                  (B) is increased or reduced in frequency as 
                necessary as provided for in subsection 
                (g)(4)(A); and
                  (C) is eliminated after the 3-year period 
                described in paragraph (1) if the Secretary 
                determines that serious risks of the drug have 
                been adequately identified and assessed and are 
                being adequately managed.
  (e) Additional Potential Elements of Strategy.--
          (1) In general.--The Secretary may under subsection 
        (c)(2) require that the risk evaluation and mitigation 
        strategy for a drug include 1 or more of the additional 
        elements described in this subsection if the Secretary 
        makes the determination required with respect to the 
        element involved.
          (2) Medguide; patient package insert.--The risk 
        evaluation and mitigation strategy for a drug may 
        require that, as applicable, the person submitting the 
        covered application or the holder of the approved such 
        application (referred to in this section as the 
        ``responsible person'') develop for distribution to 
        each patient when the drug is dispensed--
                  (A) a Medication Guide, as provided for under 
                part 208 of title 21, Code of Federal 
                Regulations (or any successor regulations); and
                  (B) a patient package insert, if the 
                Secretary determines that such insert may help 
                mitigate a serious risk of the drug.
          (3) Communication plan.--The risk evaluation and 
        mitigation strategy for a drug may require that the 
        responsible person conduct a communication plan to 
        health care providers, if, with respect to such drug, 
        the Secretary determines that such plan may support 
        implementation of an element of the strategy. Such plan 
        may include--
                  (A) sending letters to health care providers;
                  (B) disseminating information about the 
                elements of the risk evaluation and mitigation 
                strategy to encourage implementation by health 
                care providers of components that apply to such 
                health care providers, or to explain certain 
                safety protocols (such as medical monitoring by 
                periodic laboratory tests); or
                  (C) disseminating information to health care 
                providers through professional societies about 
                any serious risks of the drug and any protocol 
                to assure safe use.
  (f) Restrictions on Distribution or Use.--
          (1) In general.--If the Secretary determines that a 
        drug shown to be effective can be safely used only if 
        distribution or use of such drug is restricted, the 
        Secretary may under subsection (c)(2) require as 
        elements of the risk evaluation and mitigation strategy 
        such restrictions on distribution or use as are needed 
        to ensure safe use of the drug.
          (2) Assuring access and minimizing burden.--Elements 
        of a risk evaluation and mitigation strategy included 
        under paragraph (1) shall--
                  (A) be commensurate with a specific serious 
                risk listed in the labeling of the drug;
                  (B) be posted publicly by the Secretary with 
                an explanation of how such elements will 
                mitigate the observed safety risk, which 
                posting shall be made within 30 days after the 
                date on which the Secretary requires the 
                element involved;
                  (C) considering the risk referred to in 
                subparagraph (A), not be unduly burdensome on 
                patient access to the drug, considering in 
                particular--
                          (i) patients with serious or life-
                        threatening diseases or conditions; and
                          (ii) patients who have difficulty 
                        accessing health care (such as patients 
                        in rural or medically underserved 
                        areas); and
                  (D) to the extent practicable, so as to 
                minimize the burden on the health care delivery 
                system--
                          (i) conform with elements to assure 
                        safe use for other drugs with similar, 
                        serious risks; and
                          (ii) be designed to be compatible 
                        with established distribution, 
                        procurement, and dispensing systems for 
                        drugs.
          (3) Elements.--The restrictions on distribution or 
        use described in paragraph (1) shall include 1 or more 
        goals to evaluate or mitigate a serious risk listed in 
        the labeling of the drug, and may require that--
                  (A) health care providers that prescribe the 
                drug have special training or experience, or 
                are specially certified, which training or 
                certification with respect to the drug is 
                available to any willing provider from a 
                frontier area;
                  (B) pharmacies, practitioners, or health care 
                settings that dispense the drug are specially 
                certified, which training or certification with 
                respect to the drug is available to any willing 
                provider from a frontier area;
                  (C) the drug be dispensed to patients only in 
                certain health care settings, such as 
                hospitals;
                  (D) the drug be dispensed to patients with 
                evidence or other documentation of safe-use 
                conditions, such as laboratory test results;
                  (E) each patient using the drug be subject to 
                certain monitoring; or
                  (F) each patient using the drug be enrolled 
                in a registry.
          (4) Implementation system.--The restrictions on 
        distribution or use described in paragraph (1) may 
        require a system through which the responsible person 
        is able to--
                  (A) monitor and evaluate implementation of 
                the restrictions by health care providers, 
                pharmacists, patients, and other parties in the 
                health care system who are responsible for 
                implementing the restrictions;
                  (B) work to improve implementation of the 
                restrictions by health care providers, 
                pharmacists, patients, and other parties in the 
                health care system who are responsible for 
                implementing the restrictions; and
                  (C) notify wholesalers of the drug of those 
                health care providers--
                          (i) who are responsible for 
                        implementing the restrictions; and
                          (ii) whom the responsible person 
                        knows have failed to meet their 
                        responsibilities for implementing the 
                        restrictions, after the responsible 
                        person has informed such party of such 
                        failure and such party has not remedied 
                        such failure.
          (5) Limitation.--No holder of an approved application 
        shall use any restriction on distribution required by 
        the Secretary as necessary to assure safe use of the 
        drug to block or delay approval of an application under 
        section 505(b)(2) or (j) or to prevent application of 
        such restriction under subsection (i)(1)(B) to a drug 
        that is the subject of an abbreviated new drug 
        application.
          (6) Bioequivalence testing.--Notwithstanding any 
        other provisions in this subsection, the holder of an 
        approved application that is subject to distribution 
        restrictions required under this subsection that limit 
        the ability of a sponsor seeking approval of an 
        application under subsection 505(b)(2) or (j) to 
        purchase on the open market a sufficient quantity of 
        drug to conduct bioequivalence testing shall provide to 
        such a sponsor a sufficient amount of drug to conduct 
        bioequivalence testing if the sponsor seeking approval 
        under section 505(b)(2) or (j)--
                  (A) agrees to such restrictions on 
                distribution as the Secretary finds necessary 
                to assure safe use of the drug during 
                bioequivalence testing; and
                  (B) pays the holder of the approved 
                application the fair market value of the drug 
                purchased for bioequivalence testing.
          (7) Letter by secretary.--Upon a showing by the 
        sponsor seeking approval under section 505(b)(2) or (j) 
        that the sponsor has agreed to such restrictions 
        necessary to assure safe use of the drug during 
        bioequivalence testing, the Secretary shall issue to 
        the sponsor seeking to conduct bioequivalence testing a 
        letter that describes the Secretary's finding which 
        shall serve as proof that the sponsor has satisfied the 
        requirements of subparagraph (6)(A).
          (8) Evaluation of elements to assure safe use.--The 
        Secretary, acting through the Drug Safety and Risk 
        Management Advisory Committee (or any successor 
        committee) of the Food and Drug Administration, shall--
                  (A) seek input from patients, physicians, 
                pharmacists, and other health care providers 
                about how elements to assure safe use under 
                this subsection for 1 or more drugs may be 
                standardized so as not to be--
                          (i) unduly burdensome on patient 
                        access to the drug; and
                          (ii) to the extent practicable, 
                        minimize the burden on the health care 
                        delivery system;
                  (B) at least annually, evaluate, for 1 or 
                more drugs, the elements to assure safe use of 
                such drug to assess whether the elements--
                          (i) assure safe use of the drug;
                          (ii) are not unduly burdensome on 
                        patient access to the drug; and
                          (iii) to the extent practicable, 
                        minimize the burden on the health care 
                        delivery system; and
                  (C) considering such input and evaluations--
                          (i) issue or modify agency guidance 
                        about how to implement the requirements 
                        of this subsection; and
                          (ii) modify elements under this 
                        subsection for 1 or more drugs as 
                        appropriate.
          (9) Waiver in public health emergencies.--The 
        Secretary may waive any restriction on distribution or 
        use under this subsection during the period described 
        in section 319(a) of the Public Health Service Act with 
        respect to a qualified countermeasure described under 
        section 319F-1(a)(2) of such Act, to which a 
        restriction or use under this subsection has been 
        applied, if the Secretary has--
                  (A) declared a public health emergency under 
                such section 319; and
                  (B) determined that such waiver is required 
                to mitigate the effects of, or reduce the 
                severity of, such public health emergency.
  (g) Assessment and Modification of Approved Strategy.--
          (1) Voluntary assessments.--After the approval of a 
        risk evaluation and mitigation strategy under 
        subsection (a), the responsible person involved may, 
        subject to paragraph (2), submit to the Secretary an 
        assessment of, and propose a modification to, the 
        approved strategy for the drug involved at any time.
          (2) Required assessments.--A responsible person 
        shall, subject to paragraph (5), submit an assessment 
        of, and may propose a modification to, the approved 
        risk evaluation and mitigation strategy for a drug--
                  (A) when submitting a supplemental 
                application for a new indication for use under 
                section 505(b) or under section 351 of the 
                Public Health Service Act, unless the drug is 
                not subject to section 503(b) and the risk 
                evaluation and mitigation strategy for the drug 
                includes only the timetable under subsection 
                (d);
                  (B) when required by the strategy, as 
                provided for in such timetable under subsection 
                (d);
                  (C) within a time period to be determined by 
                the Secretary, if the Secretary determines that 
                new safety or effectiveness information 
                indicates that--
                          (i) an element under subsection (d) 
                        or (e) should be modified or included 
                        in the strategy; or
                          (ii) an element under subsection (f) 
                        should be modified or included in the 
                        strategy; or
                  (D) within 15 days when ordered by the 
                Secretary, if the Secretary determines that 
                there may be a cause for action by the 
                Secretary under section 505(e).
          (3) Requirements for assessments.--An assessment 
        under paragraph (1) or (2) of an approved risk 
        evaluation and mitigation strategy for a drug shall 
        include--
                  (A) with respect to any goal under subsection 
                (f), an assessment of the extent to which the 
                restrictions on distribution or use are meeting 
                the goal or whether the goal or such 
                restrictions should be modified;
                  (B) with respect to any postapproval study 
                required under section 505(o)(3), the status of 
                such study, including whether any difficulties 
                completing the study have been encountered; and
                  (C) with respect to any postapproval clinical 
                trial required under section 505(o), the status 
                of such clinical trial, including whether 
                enrollment has begun, the number of 
                participants enrolled, the expected completion 
                date, whether any difficulties completing the 
                clinical trial have been encountered, and 
                registration information with respect to 
                requirements under section 492C of the Public 
                Health Service Act.
          (4) Modification.--A modification (whether an 
        enhancement or a reduction) to the approved risk 
        evaluation and mitigation strategy for a drug may 
        include the addition or modification of any element 
        under subsection (d) or the addition, modification, or 
        removal of any element under subsection (e) or (f), 
        such as--
                  (A) modifying the timetable for assessments 
                of the strategy under subsection (d), including 
                to eliminate assessments; or
                  (B) adding, modifying, or removing a 
                restriction on distribution or use under 
                subsection (f).
          (5) No effect on labeling changes that do not require 
        preapproval.--In the case of a labeling change to which 
        section 314.70 of title 21, Code of Federal Regulations 
        (or any successor regulation), applies for which the 
        submission of a supplemental application is not 
        required or for which distribution of the drug involved 
        may commence upon the receipt by the Secretary of a 
        supplemental application for the change, the submission 
        of an assessment of the approved risk evaluation and 
        mitigation strategy for the drug under paragraph (2) is 
        not required.
  (h) Review of Proposed Strategies; Review of Assessments of 
Approved Strategies.--
          (1) In general.--The Secretary shall promptly review 
        each proposed risk evaluation and mitigation strategy 
        for a drug submitted under subsection (a) and each 
        assessment of an approved risk evaluation and 
        mitigation strategy for a drug submitted under 
        subsection (g).
          (2) Marketing plan.--As part of a review conducted 
        under this subsection, the Secretary may require the 
        applicant to submit information regarding its marketing 
        plan and practices for the drug, so as to allow the 
        Secretary to determine whether any of the proposed or 
        ongoing marketing activities undermine any of the 
        requirements of the risk evaluation and mitigation 
        strategy.
          (3) Discussion.--The Secretary shall initiate 
        discussions with a responsible person for purposes of 
        this subsection to determine a strategy--
                  (A) if the proposed strategy is submitted as 
                part of an application or supplemental 
                application under subsection (a) or subsection 
                (g)(2)(A), not less than 60 days before the 
                action deadline for the application that has 
                been agreed to by the Secretary and that has 
                been set forth in goals identified in letters 
                of the Secretary (relating to the use of fees 
                collected under section 736 to expedite the 
                drug development process and the process for 
                the review of human drug applications);
                  (B) if the assessment is submitted under 
                subparagraph (B) or (C) or subsection (g)(2), 
                not later than 20 days after such submission;
                  (C) if the assessment is submitted under 
                subsection (g)(1) or subsection (g)(2)(D) , not 
                later than 30 days after such submission; or
                  (D) if the assessment is submitted under 
                subsection (g)(2)(D), not later than 10 days 
                after such submission.
          (4) Action.--
                  (A) In general.--Unless the responsible 
                person requests the dispute resolution process 
                described under paragraph (5), the Secretary 
                shall approve and describe the risk evaluation 
                and mitigation strategy for a drug, or any 
                modification to the strategy--
                          (i) as part of the action letter on 
                        the application, when a proposed 
                        strategy is submitted under subsection 
                        (a) or an assessment of the strategy is 
                        submitted under subsection (g)(1); or
                          (ii) in an order issued not later 
                        than 50 days after the date discussions 
                        of such modification begin under 
                        paragraph (3), when an assessment of 
                        the strategy is submitted under 
                        subsection (g)(1) or under any of 
                        subparagraphs (B) through (D) of 
                        subsection (g)(2).
                  (B) Inaction.--An approved risk evaluation 
                and mitigation strategy shall remain in effect 
                until the Secretary acts, if the Secretary 
                fails to act as provided under subparagraph 
                (A).
                  (C) Public availability.--Any action letter 
                described in subparagraph (A)(i) or order 
                described in subparagraph (A)(ii) shall be made 
                publicly available.
          (5) Dispute resolution.--
                  (A) Request for review.--
                          (i) In general.--Not earlier than 15 
                        days, and not later than 35 days, after 
                        discussions under paragraph (3) have 
                        begun, the responsible person may 
                        request in writing that a dispute about 
                        the strategy be reviewed by the Drug 
                        Safety Oversight Board under subsection 
                        (j), except that the determination of 
                        the Secretary to require a risk 
                        evaluation and mitigation strategy is 
                        not subject to review under this 
                        paragraph. The preceding sentence does 
                        not prohibit review under this 
                        paragraph of the particular elements of 
                        such a strategy.
                          (ii) Scheduling.--Upon receipt of a 
                        request under clause (i), the Secretary 
                        shall schedule the dispute involved for 
                        review under subparagraph (B) and, not 
                        later than 5 business days of 
                        scheduling the dispute for review, 
                        shall publish by posting on the 
                        Internet or otherwise a notice that the 
                        dispute will be reviewed by the Drug 
                        Safety Oversight Board.
                  (B) Scheduling review.--If a responsible 
                person requests review under subparagraph (A), 
                the Secretary--
                          (i) shall schedule the dispute for 
                        review at 1 of the next 2 regular 
                        meetings of the Drug Safety Oversight 
                        Board, whichever meeting date is more 
                        practicable; or
                          (ii) may convene a special meeting of 
                        the Drug Safety Oversight Board to 
                        review the matter more promptly, 
                        including to meet an action deadline on 
                        an application (including a 
                        supplemental application).
                  (C) Agreement after discussion or 
                administrative appeals.--
                          (i) Further discussion or 
                        administrative appeals.--A request for 
                        review under subparagraph (A) shall not 
                        preclude further discussions to reach 
                        agreement on the risk evaluation and 
                        mitigation strategy, and such a request 
                        shall not preclude the use of 
                        administrative appeals within the Food 
                        and Drug Administration to reach 
                        agreement on the strategy, including 
                        appeals as described in letters of the 
                        Secretary (relating to the use of fees 
                        collected under section 736 to expedite 
                        the drug development process and the 
                        process for the review of human drug 
                        applications) for procedural or 
                        scientific matters involving the review 
                        of human drug applications and 
                        supplemental applications that cannot 
                        be resolved at the divisional level.
                          (ii) Agreement terminates dispute 
                        resolution.--At any time before a 
                        decision and order is issued under 
                        subparagraph (G) , the Secretary and 
                        the responsible person may reach an 
                        agreement on the risk evaluation and 
                        mitigation strategy through further 
                        discussion or administrative appeals, 
                        terminating the dispute resolution 
                        process, and the Secretary shall issue 
                        an action letter or order, as 
                        appropriate, that describes the 
                        strategy.
                  (D) Meeting of the board.--At a meeting of 
                the Drug Safety Oversight Board described in 
                subparagraph (B), the Board shall--
                          (i) hear from both parties; and
                          (ii) review the dispute.
                  (E) Record of proceedings.--The Secretary 
                shall ensure that the proceedings of any such 
                meeting are recorded, transcribed, and made 
                public within 30 days of the meeting. The 
                Secretary shall redact the transcript to 
                protect any trade secrets or other confidential 
                information described in section 552(b)(4) of 
                title 5, United States Code.
                  (F) Recommendation of the board.--Not later 
                than 5 days after any such meeting, the Drug 
                Safety Oversight Board shall provide a written 
                recommendation on resolving the dispute to the 
                Secretary. Not later than 5 days after the 
                Board provides such written recommendation to 
                the Secretary, the Secretary shall make the 
                recommendation available to the public.
                  (G) Action by the secretary.--
                          (i) Action letter.--With respect to a 
                        proposal or assessment referred to in 
                        paragraph (1), the Secretary shall 
                        issue an action letter that resolves 
                        the dispute not later than the later 
                        of--
                                  (I) the action deadline 
                                referred to in paragraph 
                                (3)(A); or
                                  (II) 7 days after receiving 
                                the recommendation of the Drug 
                                Safety Oversight Board.
                          (ii) Order.--With respect to an 
                        assessment of an approved risk 
                        evaluation and mitigation strategy 
                        under subsection (g)(1) or under any of 
                        subparagraphs (B) through (D) of 
                        subsection (g)(2), the Secretary shall 
                        issue an order, which shall be made 
                        public, that resolves the dispute not 
                        later than 7 days after receiving the 
                        recommendation of the Drug Safety 
                        Oversight Board.
                  (H) Inaction.--An approved risk evaluation 
                and mitigation strategy shall remain in effect 
                until the Secretary acts, if the Secretary 
                fails to act as provided for under subparagraph 
                (G).
                  (I) Effect on action deadline.--With respect 
                to a proposal or assessment referred to in 
                paragraph (1), the Secretary shall be 
                considered to have met the action deadline 
                referred to in paragraph (3)(A) with respect to 
                the application involved if the responsible 
                person requests the dispute resolution process 
                described in this paragraph and if the 
                Secretary--
                          (i) has initiated the discussions 
                        described under paragraph (3) not less 
                        than 60 days before such action 
                        deadline; and
                          (ii) has complied with the timing 
                        requirements of scheduling review by 
                        the Drug Safety Oversight Board, 
                        providing a written recommendation, and 
                        issuing an action letter under 
                        subparagraphs (B), (F), and (G), 
                        respectively.
                  (J) Disqualification.--No individual who is 
                an employee of the Food and Drug Administration 
                and who reviews a drug or who participated in 
                an administrative appeal under subparagraph 
                (C)(i) with respect to such drug may serve on 
                the Drug Safety Oversight Board at a meeting 
                under subparagraph (D) to review a dispute 
                about the risk evaluation and mitigation 
                strategy for such drug.
                  (K) Additional expertise.--The Drug Safety 
                Oversight Board may add members with relevant 
                expertise from the Food and Drug 
                Administration, including the Office of 
                Pediatrics, the Office of Women's Health, or 
                the Office of Rare Diseases, or from other 
                Federal public health or health care agencies, 
                for a meeting under subparagraph (D) of the 
                Drug Safety Oversight Board.
          (6) Use of advisory committees.--The Secretary may 
        convene a meeting of 1 or more advisory committees of 
        the Food and Drug Administration to--
                  (A) review a concern about the safety of a 
                drug or class of drugs, including before an 
                assessment of the risk evaluation and 
                mitigation strategy or strategies of such drug 
                or drugs is required to be submitted under any 
                of subparagraphs (B) through (D) of subsection 
                (g)(2);
                  (B) review the risk evaluation and mitigation 
                strategy or strategies of a drug or group of 
                drugs; or
                  (C) review a dispute under paragraph (5).
          (7) Process for addressing drug class effects.--
                  (A) In general.--When a concern about a 
                serious risk of a drug may be related to the 
                pharmacological class of the drug, the 
                Secretary may defer assessments of the approved 
                risk evaluation and mitigation strategies for 
                such drugs until the Secretary has convened 1 
                or more public meetings to consider possible 
                responses to such concern. If the Secretary 
                defers an assessment under this subparagraph, 
                the Secretary shall give notice to the public 
                of the deferral not later than 5 days of the 
                deferral.
                  (B) Public meetings.--Such public meetings 
                may include--
                          (i) 1 or more meetings of the 
                        reviewed entities for such drugs;
                          (ii) 1 or more meetings of 1 or more 
                        advisory committees of the Food and 
                        Drug Administration, as provided for 
                        under paragraph (6); or
                          (iii) 1 or more workshops of 
                        scientific experts and other 
                        stakeholders.
                  (C) Action.--After considering the 
                discussions from any meetings under 
                subparagraph (B), the Secretary may--
                          (i) announce in the Federal Register 
                        a planned regulatory action, including 
                        a modification to each risk evaluation 
                        and mitigation strategy, for drugs in 
                        the pharmacological class;
                          (ii) seek public comment about such 
                        action; and
                          (iii) after seeking such comment, 
                        issue an order addressing such 
                        regulatory action.
          (8) International coordination.--The Secretary may 
        coordinate the timetable for submission of assessments 
        under subsection (d), or a study or clinical trial 
        under section 505(o)(3), with efforts to identify and 
        assess the serious risks of such drug by the marketing 
        authorities of other countries whose drug approval and 
        risk management processes the Secretary deems 
        comparable to the drug approval and risk management 
        processes of the United States. If the Secretary takes 
        action to coordinate such timetable, the Secretary 
        shall give notice to the public of the action not later 
        than 5 days after the action.
          (9) Effect.--Use of the processes described in 
        paragraphs (7) and (8) shall not delay action on an 
        application or a supplement to an application for a 
        drug.
  (i) Abbreviated New Drug Applications.--
          (1) In general.--A drug that is the subject of an 
        abbreviated new drug application under section 505(j) 
        is subject to only the following elements of the risk 
        evaluation and mitigation strategy required under 
        subsection (a) for the applicable listed drug:
                  (A) A Medication Guide or patient package 
                insert, if required under subsection (e) for 
                the applicable listed drug.
                  (B) Restrictions on distribution or use, if 
                required under subsection (f) for the listed 
                drug. A drug that is the subject of an 
                abbreviated new drug application and the listed 
                drug shall use a single, shared system under 
                subsection (f)(4). The Secretary may waive the 
                requirement under the preceding sentence for a 
                drug that is the subject of an abbreviated new 
                drug application if the Secretary determines 
                that--
                          (i) it is not practical for the drug 
                        to use such single, shared system; or
                          (ii) the burden of using the single, 
                        shared system outweighs the benefit of 
                        using the single system.
          (2) Action by secretary.--For an applicable listed 
        drug for which a drug is approved under section 505(j), 
        the Secretary--
                  (A) shall undertake any communication plan to 
                health care providers required under subsection 
                (e)(3) for the applicable listed drug; and
                  (B) shall inform the responsible person for 
                the drug that is so approved if the risk 
                evaluation and mitigation strategy for the 
                applicable listed drug is modified.
  (j) Drug Safety Oversight Board.--
          (1) In general.--There is established a Drug Safety 
        Oversight Board.
          (2) Composition; meetings.--The Drug Safety Oversight 
        Board shall--
                  (A) be composed of scientists and health care 
                practitioners appointed by the Secretary, each 
                of whom is an employee of the Federal 
                Government;
                  (B) include representatives from offices 
                throughout the Food and Drug Administration;
                  (C) include at least 1 representative from 
                each of the National Institutes of Health and 
                the Department of Health and Human Services 
                (other than the Food and Drug Administration);
                  (D) include such representatives as the 
                Secretary shall designate from other 
                appropriate agencies that wish to provide 
                representatives; and
                  (E) meet at least monthly to provide 
                oversight and advice to the Secretary on the 
                management of important drug safety issues.

[SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

  [(a) Definitions.--As used in this section, the term 
``pediatric studies'' or ``studies'' means at least one 
clinical investigation (that, at the Secretary's discretion, 
may include pharmacokinetic studies) in pediatric age groups 
(including neonates in appropriate cases) in which a drug is 
anticipated to be used.
  [(b) Market Exclusivity for New Drugs.--If, prior to approval 
of an application that is submitted under section 505(b)(1), 
the Secretary determines that information relating to the use 
of a new drug in the pediatric population may produce health 
benefits in that population, the Secretary makes a written 
request for pediatric studies (which shall include a timeframe 
for completing such studies), and such studies are completed 
within any such timeframe and the reports thereof submitted in 
accordance with subsection (d)(2) or accepted in accordance 
with subsection (d)(3)--
          [(1)(A)(i) the period referred to in subsection 
        (c)(3)(D)(ii) of section 505, and in subsection 
        (j)(5)(F)(ii) of such section, is deemed to be five 
        years and six months rather than five years, and the 
        references in subsections (c)(3)(D)(ii) and 
        (j)(5)(F)(ii) of such section to four years, to forty-
        eight months, and to seven and one-half years are 
        deemed to be four and one-half years, fifty-four 
        months, and eight years, respectively; or
          [(ii) the period referred to in clauses (iii) and 
        (iv) of subsection (c)(3)(D) of such section, and in 
        clauses (iii) and (iv) of subsection (j)(5)(F) of such 
        section, is deemed to be three years and six months 
        rather than three years; and
          [(B) if the drug is designated under section 526 for 
        a rare disease or condition, the period referred to in 
        section 527(a) is deemed to be seven years and six 
        months rather than seven years; and
          [(2)(A) if the drug is the subject of--
                  [(i) a listed patent for which a 
                certification has been submitted under 
                subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
                of section 505 and for which pediatric studies 
                were submitted prior to the expiration of the 
                patent (including any patent extensions); or
                  [(ii) a listed patent for which a 
                certification has been submitted under 
                subsections (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be 
        approved under section 505(c)(3) or section 
        505(j)(5)(B) shall be extended by a period of six 
        months after the date the patent expires (including any 
        patent extensions); or
          [(B) if the drug is the subject of a listed patent 
        for which a certification has been submitted under 
        subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
        section 505, and in the patent infringement litigation 
        resulting from the certification the court determines 
        that the patent is valid and would be infringed, the 
        period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(5)(B) shall 
        be extended by a period of six months after the date 
        the patent expires (including any patent extensions).
  [(c) Market Exclusivity for Already-Marketed Drugs.--If the 
Secretary determines that information relating to the use of an 
approved drug in the pediatric population may produce health 
benefits in that population and makes a written request to the 
holder of an approved application under section 505(b)(1) for 
pediatric studies (which shall include a timeframe for 
completing such studies), the holder agrees to the request, the 
studies are completed within any such timeframe, and the 
reports thereof are submitted in accordance with subsection 
(d)(2) or accepted in accordance with subsection (d)(3)--
          [(1)(A)(i) the period referred to in subsection 
        (c)(3)(D)(ii) of section 505, and in subsection 
        (j)(5)(F)(ii) of such section, is deemed to be five 
        years and six months rather than five years, and the 
        references in subsections (c)(3)(D)(ii) and 
        (j)(5)(F)(ii) of such section to four years, to forty-
        eight months, and to seven and one-half years are 
        deemed to be four and one-half years, fifty-four 
        months, and eight years, respectively; or
          [(ii) the period referred to in clauses (iii) and 
        (iv) of subsection (c)(3)(D) of such section, and in 
        clauses (iii) and (iv) of subsection (j)(5)(F) of such 
        section, is deemed to be three years and six months 
        rather than three years; and
          [(B) if the drug is designated under section 526 for 
        a rare disease or condition, the period referred to in 
        section 527(a) is deemed to be seven years and six 
        months rather than seven years; and
          [(2)(A) if the drug is the subject of--
                  [(i) a listed patent for which a 
                certification has been submitted under 
                subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
                of section 505 and for which pediatric studies 
                were submitted prior to the expiration of the 
                patent (including any patent extensions); or
                  [(ii) a listed patent for which a 
                certification has been submitted under 
                subsection (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be 
        approved under section 505(c)(3) or section 
        505(j)(5)(B) shall be extended by a period of six 
        months after the date the patent expires (including any 
        patent extensions); or
          [(B) if the drug is the subject of a listed patent 
        for which a certification has been submitted under 
        subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
        section 505, and in the patent infringement litigation 
        resulting from the certification the court determines 
        that the patent is valid and would be infringed, the 
        period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(5)(B) shall 
        be extended by a period of six months after the date 
        the patent expires (including any patent extensions).
  [(d) Conduct of Pediatric Studies.--
          [(1) Agreement for studies.--The Secretary may, 
        pursuant to a written request from the Secretary under 
        subsection (b) or (c), after consultation with--
                  [(A) the sponsor of an application for an 
                investigational new drug under section 505(i);
                  [(B) the sponsor of an application for a new 
                drug under section 505(b)(1); or
                  [(C) the holder of an approved application 
                for a drug under section 505(b)(1),
        agree with the sponsor or holder for the conduct of 
        pediatric studies for such drug. Such agreement shall 
        be in writing and shall include a timeframe for such 
        studies.
          [(2) Written protocols to meet the studies 
        requirement.--If the sponsor or holder and the 
        Secretary agree upon written protocols for the studies, 
        the studies requirement of subsection (b) or (c) is 
        satisfied upon the completion of the studies and 
        submission of the reports thereof in accordance with 
        the original written request and the written agreement 
        referred to in paragraph (1). In reaching an agreement 
        regarding written protocols, the Secretary shall take 
        into account adequate representation of children of 
        ethnic and racial minorities. Not later than 60 days 
        after the submission of the report of the studies, the 
        Secretary shall determine if such studies were or were 
        not conducted in accordance with the original written 
        request and the written agreement and reported in 
        accordance with the requirements of the Secretary for 
        filing and so notify the sponsor or holder.
          [(3) Other methods to meet the studies requirement.--
        If the sponsor or holder and the Secretary have not 
        agreed in writing on the protocols for the studies, the 
        studies requirement of subsection (b) or (c) is 
        satisfied when such studies have been completed and the 
        reports accepted by the Secretary. Not later than 90 
        days after the submission of the reports of the 
        studies, the Secretary shall accept or reject such 
        reports and so notify the sponsor or holder. The 
        Secretary's only responsibility in accepting or 
        rejecting the reports shall be to determine, within the 
        90 days, whether the studies fairly respond to the 
        written request, have been conducted in accordance with 
        commonly accepted scientific principles and protocols, 
        and have been reported in accordance with the 
        requirements of the Secretary for filing.
          [(4) Written request to holders of approved 
        applications for drugs that have market exclusivity.--
                  [(A) Request and response.--If the Secretary 
                makes a written request for pediatric studies 
                (including neonates, as appropriate) under 
                subsection (c) to the holder of an application 
                approved under section 505(b)(1), the holder, 
                not later than 180 days after receiving the 
                written request, shall respond to the Secretary 
                as to the intention of the holder to act on the 
                request by--
                          [(i) indicating when the pediatric 
                        studies will be initiated, if the 
                        holder agrees to the request; or
                          [(ii) indicating that the holder does 
                        not agree to the request.
                  [(B) No agreement to request.--
                          [(i) Referral.--If the holder does 
                        not agree to a written request within 
                        the time period specified in 
                        subparagraph (A), and if the Secretary 
                        determines that there is a continuing 
                        need for information relating to the 
                        use of the drug in the pediatric 
                        population (including neonates, as 
                        appropriate), the Secretary shall refer 
                        the drug to the Foundation for the 
                        National Institutes of Health 
                        established under section 499 of the 
                        Public Health Service Act (42 U.S.C. 
                        290b) (referred to in this paragraph as 
                        the ``Foundation'') for the conduct of 
                        the pediatric studies described in the 
                        written request.
                          [(ii) Public notice.--The Secretary 
                        shall give public notice of the name of 
                        the drug, the name of the manufacturer, 
                        and the indications to be studied made 
                        in a referral under clause (i).
                  [(C) Lack of funds.--On referral of a drug 
                under subparagraph (B)(i), the Foundation shall 
                issue a proposal to award a grant to conduct 
                the requested studies unless the Foundation 
                certifies to the Secretary, within a timeframe 
                that the Secretary determines is appropriate 
                through guidance, that the Foundation does not 
                have funds available under section 
                499(j)(9)(B)(i) to conduct the requested 
                studies. If the Foundation so certifies, the 
                Secretary shall refer the drug for inclusion on 
                the list established under section 409I of the 
                Public Health Service Act for the conduct of 
                the studies.
                  [(D) Effect of subsection.--Nothing in this 
                subsection (including with respect to referrals 
                from the Secretary to the Foundation) alters or 
                amends section 301(j) of this Act or section 
                552 of title 5 or section 1905 of title 18, 
                United States Code.
                  [(E) No requirement to refer.--Nothing in 
                this subsection shall be construed to require 
                that every declined written request shall be 
                referred to the Foundation.
                  [(F) Written requests under subsection (b).--
                For drugs under subsection (b) for which 
                written requests have not been accepted, if the 
                Secretary determines that there is a continuing 
                need for information relating to the use of the 
                drug in the pediatric population (including 
                neonates, as appropriate), the Secretary shall 
                issue a written request under subsection (c) 
                after the date of approval of the drug.
  [(e) Delay of Effective Date for Certain Application.--If the 
Secretary determines that the acceptance or approval of an 
application under section 505(b)(2) or 505(j) for a new drug 
may occur after submission of reports of pediatric studies 
under this section, which were submitted prior to the 
expiration of the patent (including any patent extension) or 
the applicable period under clauses (ii) through (iv) of 
section 505(c)(3)(D) or clauses (ii) through (iv) of section 
505(j)(5)(F), but before the Secretary has determined whether 
the requirements of subsection (d) have been satisfied, the 
Secretary shall delay the acceptance or approval under section 
505(b)(2) or 505(j) until the determination under subsection 
(d) is made, but any such delay shall not exceed 90 days. In 
the event that requirements of this section are satisfied, the 
applicable six-month period under subsection (b) or (c) shall 
be deemed to have been running during the period of delay.
  [(f) Notice of Determinations on Studies Requirement.--The 
Secretary shall publish a notice of any determination that the 
requirements of subsection (d) have been met and that 
submissions and approvals under subsection (b)(2) or (j) of 
section 505 for a drug will be subject to the provisions of 
this section.
  [(g) Limitations.--A drug to which the six-month period under 
subsection (b) or (c) has already been applied--
          [(1) may receive an additional six-month period under 
        subsection (c)(1)(A)(ii) for a supplemental application 
        if all other requirements under this section are 
        satisfied, except that such a drug may not receive any 
        additional such period under subsection (c)(2); and
          [(2) may not receive any additional such period under 
        subsection (c)(1)(B).
  [(h) Relationship to Pediatric Research Requirements.--
Notwithstanding any other provision of law, if any pediatric 
study is required by a provision of law (including a 
regulation) other than this section and such study meets the 
completeness, timeliness, and other requirements of this 
section, such study shall be deemed to satisfy the requirement 
for market exclusivity pursuant to this section.
  [(i) Labeling Supplements.--
          [(1) Priority status for pediatric supplements.--Any 
        supplement to an application under section 505 
        proposing a labeling change pursuant to a report on a 
        pediatric study under this section--
                  [(A) shall be considered to be a priority 
                supplement; and
                  [(B) shall be subject to the performance 
                goals established by the Commissioner for 
                priority drugs.
          [(2) Dispute resolution.--
                  [(A) Request for labeling change and failure 
                to agree.--If the Commissioner determines that 
                an application with respect to which a 
                pediatric study is conducted under this section 
                is approvable and that the only open issue for 
                final action on the application is the reaching 
                of an agreement between the sponsor of the 
                application and the Commissioner on appropriate 
                changes to the labeling for the drug that is 
                the subject of the application, not later than 
                180 days after the date of submission of the 
                application--
                          [(i) the Commissioner shall request 
                        that the sponsor of the application 
                        make any labeling change that the 
                        Commissioner determines to be 
                        appropriate; and
                          [(ii) if the sponsor of the 
                        application does not agree to make a 
                        labeling change requested by the 
                        Commissioner, the Commissioner shall 
                        refer the matter to the Pediatric 
                        Advisory Committee.
                  [(B) Action by the pediatric advisory 
                committee.--Not later than 90 days after 
                receiving a referral under subparagraph 
                (A)(ii), the Pediatric Advisory Committee 
                shall--
                          [(i) review the pediatric study 
                        reports; and
                          [(ii) make a recommendation to the 
                        Commissioner concerning appropriate 
                        labeling changes, if any.
                  [(C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations 
                of the Pediatric Advisory Committee and, if 
                appropriate, not later than 30 days after 
                receiving the recommendation, make a request to 
                the sponsor of the application to make any 
                labeling change that the Commissioner 
                determines to be appropriate.
                  [(D) Misbranding.--If the sponsor of the 
                application, within 30 days after receiving a 
                request under subparagraph (C), does not agree 
                to make a labeling change requested by the 
                Commissioner, the Commissioner may deem the 
                drug that is the subject of the application to 
                be misbranded.
                  [(E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United 
                States to bring an enforcement action under 
                this Act when a drug lacks appropriate 
                pediatric labeling. Neither course of action 
                (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as 
                the basis to stay the other course of action.
  [(j) Dissemination of Pediatric Information.--
          [(1) In general.--Not later than 180 days after the 
        date of submission of a report on a pediatric study 
        under this section, the Commissioner shall make 
        available to the public a summary of the medical and 
        clinical pharmacology reviews of pediatric studies 
        conducted for the supplement, including by publication 
        in the Federal Register.
          [(2) Effect of subsection.--Nothing in this 
        subsection alters or amends section 301(j) of this Act 
        or section 552 of title 5 or section 1905 of title 18, 
        United States Code.
  [(k) Clarification of Interaction of Market Exclusivity Under 
This Section and Market Exclusivity Awarded to an Applicant for 
Approval of a Drug Under Section 505(j).--If a 180-day period 
under section 505(j)(5)(B)(iv) overlaps with a 6-month 
exclusivity period under this section, so that the applicant 
for approval of a drug under section 505(j) entitled to the 
180-day period under that section loses a portion of the 180-
day period to which the applicant is entitled for the drug, the 
180-day period shall be extended from--
          [(1) the date on which the 180-day period would have 
        expired by the number of days of the overlap, if the 
        180-day period would, but for the application of this 
        subsection, expire after the 6-month exclusivity 
        period; or
          [(2) the date on which the 6-month exclusivity period 
        expires, by the number of days of the overlap if the 
        180-day period would, but for the application of this 
        subsection, expire during the six-month exclusivity 
        period.
  [(l) Prompt Approval of Drugs Under Section 505(j) When 
Pediatric Information Is Added to Labeling.--
          [(1) General rule.--A drug for which an application 
        has been submitted or approved under section 505(j) 
        shall not be considered ineligible for approval under 
        that section or misbranded under section 502 on the 
        basis that the labeling of the drug omits a pediatric 
        indication or any other aspect of labeling pertaining 
        to pediatric use when the omitted indication or other 
        aspect is protected by patent or by exclusivity under 
        clause (iii) or (iv) of section 505(j)(5)(F).
          [(2) Labeling.--Notwithstanding clauses (iii) and 
        (iv) of section 505(j)(5)(F), the Secretary may require 
        that the labeling of a drug approved under section 
        505(j) that omits a pediatric indication or other 
        aspect of labeling as described in paragraph (1) 
        include--
                  [(A) a statement that, because of marketing 
                exclusivity for a manufacturer--
                          [(i) the drug is not labeled for 
                        pediatric use; or
                          [(ii) in the case of a drug for which 
                        there is an additional pediatric use 
                        not referred to in paragraph (1), the 
                        drug is not labeled for the pediatric 
                        use under paragraph (1); and
                  [(B) a statement of any appropriate pediatric 
                contraindications, warnings, or precautions 
                that the Secretary considers necessary.
          [(3) Preservation of pediatric exclusivity and other 
        provisions.--This subsection does not affect--
                  [(A) the availability or scope of exclusivity 
                under this section;
                  [(B) the availability or scope of exclusivity 
                under section 505 for pediatric formulations;
                  [(C) the question of the eligibility for 
                approval of any application under section 
                505(j) that omits any other conditions of 
                approval entitled to exclusivity under clause 
                (iii) or (iv) of section 505(j)(5)(F); or
                  [(D) except as expressly provided in 
                paragraphs (1) and (2), the operation of 
                section 505.
  [(m) Report.--The Secretary shall conduct a study and report 
to Congress not later than January 1, 2001, based on the 
experience under the program established under this section. 
The study and report shall examine all relevant issues, 
including--
          [(1) the effectiveness of the program in improving 
        information about important pediatric uses for approved 
        drugs;
          [(2) the adequacy of the incentive provided under 
        this section;
          [(3) the economic impact of the program on taxpayers 
        and consumers, including the impact of the lack of 
        lower cost generic drugs on patients, including on 
        lower income patients; and
          [(4) any suggestions for modification that the 
        Secretary determines to be appropriate.
  [(n) Sunset.--A drug may not receive any 6-month period under 
subsection (a) or (c) unless--
          [(1) on or before October 1, 2007, the Secretary 
        makes a written request for pediatric studies of the 
        drug;
          [(2) on or before October 1, 2007, an application for 
        the drug is accepted for filing under section 505(b); 
        and
          [(3) all requirements of this section are met.

[SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL 
                    PRODUCTS.

  [(a) New Drugs and Biological Products.--
          [(1) In general.--A person that submits an 
        application (or supplement to an application)--
                  [(A) under section 505 for a new active 
                ingredient, new indication, new dosage form, 
                new dosing regimen, or new route of 
                administration; or
                  [(B) under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) for a new active 
                ingredient, new indication, new dosage form, 
                new dosing regimen, or new route of 
                administration;
        shall submit with the application the assessments 
        described in paragraph (2).
          [(2) Assessments.--
                  [(A) In general.--The assessments referred to 
                in paragraph (1) shall contain data, gathered 
                using appropriate formulations for each age 
                group for which the assessment is required, 
                that are adequate--
                          [(i) to assess the safety and 
                        effectiveness of the drug or the 
                        biological product for the claimed 
                        indications in all relevant pediatric 
                        subpopulations; and
                          [(ii) to support dosing and 
                        administration for each pediatric 
                        subpopulation for which the drug or the 
                        biological product is safe and 
                        effective.
                  [(B) Similar course of disease or similar 
                effect of drug or biological product.--
                          [(i) In general.--If the course of 
                        the disease and the effects of the drug 
                        are sufficiently similar in adults and 
                        pediatric patients, the Secretary may 
                        conclude that pediatric effectiveness 
                        can be extrapolated from adequate and 
                        well-controlled studies in adults, 
                        usually supplemented with other 
                        information obtained in pediatric 
                        patients, such as pharmacokinetic 
                        studies.
                          [(ii) Extrapolation between age 
                        groups.--A study may not be needed in 
                        each pediatric age group if data from 
                        one age group can be extrapolated to 
                        another age group.
          [(3) Deferral.--On the initiative of the Secretary or 
        at the request of the applicant, the Secretary may 
        defer submission of some or all assessments required 
        under paragraph (1) until a specified date after 
        approval of the drug or issuance of the license for a 
        biological product if--
                  [(A) the Secretary finds that--
                          [(i) the drug or biological product 
                        is ready for approval for use in adults 
                        before pediatric studies are complete;
                          [(ii) pediatric studies should be 
                        delayed until additional safety or 
                        effectiveness data have been collected; 
                        or
                          [(iii) there is another appropriate 
                        reason for deferral; and
                  [(B) the applicant submits to the Secretary--
                          [(i) certification of the grounds for 
                        deferring the assessments;
                          [(ii) a description of the planned or 
                        ongoing studies; and
                          [(iii) evidence that the studies are 
                        being conducted or will be conducted 
                        with due diligence and at the earliest 
                        possible time.
          [(4) Waivers.--
                  [(A) Full waiver.--On the initiative of the 
                Secretary or at the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit 
                assessments for a drug or biological product 
                under this subsection if the applicant 
                certifies and the Secretary finds that--
                          [(i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients is so 
                        small or the patients are 
                        geographically dispersed);
                          [(ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in all pediatric age groups; or
                          [(iii) the drug or biological 
                        product--
                                  [(I) does not represent a 
                                meaningful therapeutic benefit 
                                over existing therapies for 
                                pediatric patients; and
                                  [(II) is not likely to be 
                                used in a substantial number of 
                                pediatric patients.
                  [(B) Partial waiver.--On the initiative of 
                the Secretary or at the request of an 
                applicant, the Secretary shall grant a partial 
                waiver, as appropriate, of the requirement to 
                submit assessments for a drug or biological 
                product under this subsection with respect to a 
                specific pediatric age group if the applicant 
                certifies and the Secretary finds that--
                          [(i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients in that 
                        age group is so small or patients in 
                        that age group are geographically 
                        dispersed);
                          [(ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in that age group;
                          [(iii) the drug or biological 
                        product--
                                  [(I) does not represent a 
                                meaningful therapeutic benefit 
                                over existing therapies for 
                                pediatric patients in that age 
                                group; and
                                  [(II) is not likely to be 
                                used by a substantial number of 
                                pediatric patients in that age 
                                group; or
                          [(iv) the applicant can demonstrate 
                        that reasonable attempts to produce a 
                        pediatric formulation necessary for 
                        that age group have failed.
                  [(C) Pediatric formulation not possible.--If 
                a waiver is granted on the ground that it is 
                not possible to develop a pediatric 
                formulation, the waiver shall cover only the 
                pediatric groups requiring that formulation.
                  [(D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there 
                is evidence that a drug or biological product 
                would be ineffective or unsafe in pediatric 
                populations, the information shall be included 
                in the labeling for the drug or biological 
                product.
  [(b) Marketed Drugs and Biological Products.--
          [(1) In general.--After providing notice in the form 
        of a letter and an opportunity for written response and 
        a meeting, which may include an advisory committee 
        meeting, the Secretary may (by order in the form of a 
        letter) require the holder of an approved application 
        for a drug under section 505 or the holder of a license 
        for a biological product under section 351 of the 
        Public Health Service Act (42 U.S.C. 262) to submit by 
        a specified date the assessments described in 
        subsection (a)(2) if the Secretary finds that--
                  [(A)(i) the drug or biological product is 
                used for a substantial number of pediatric 
                patients for the labeled indications; and
                  [(ii) the absence of adequate labeling could 
                pose significant risks to pediatric patients; 
                or
                  [(B)(i) there is reason to believe that the 
                drug or biological product would represent a 
                meaningful therapeutic benefit over existing 
                therapies for pediatric patients for one or 
                more of the claimed indications; and
                  [(ii) the absence of adequate labeling could 
                pose significant risks to pediatric patients.
          [(2) Waivers.--
                  [(A) Full waiver.--At the request of an 
                applicant, the Secretary shall grant a full 
                waiver, as appropriate, of the requirement to 
                submit assessments under this subsection if the 
                applicant certifies and the Secretary finds 
                that--
                          [(i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients in that 
                        age group is so small or patients in 
                        that age group are geographically 
                        dispersed); or
                          [(ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in all pediatric age groups.
                  [(B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial 
                waiver, as appropriate, of the requirement to 
                submit assessments under this subsection with 
                respect to a specific pediatric age group if 
                the applicant certifies and the Secretary finds 
                that--
                          [(i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients in that 
                        age group is so small or patients in 
                        that age group are geographically 
                        dispersed);
                          [(ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in that age group;
                          [(iii)(I) the drug or biological 
                        product--
                                  [(aa) does not represent a 
                                meaningful therapeutic benefit 
                                over existing therapies for 
                                pediatric patients in that age 
                                group; and
                                  [(bb) is not likely to be 
                                used in a substantial number of 
                                pediatric patients in that age 
                                group; and
                          [(II) the absence of adequate 
                        labeling could not pose significant 
                        risks to pediatric patients; or
                          [(iv) the applicant can demonstrate 
                        that reasonable attempts to produce a 
                        pediatric formulation necessary for 
                        that age group have failed.
                  [(C) Pediatric formulation not possible.--If 
                a waiver is granted on the ground that it is 
                not possible to develop a pediatric 
                formulation, the waiver shall cover only the 
                pediatric groups requiring that formulation.
                  [(D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there 
                is evidence that a drug or biological product 
                would be ineffective or unsafe in pediatric 
                populations, the information shall be included 
                in the labeling for the drug or biological 
                product.
          [(3) Relationship to other pediatric provisions.--
                  [(A) No assessment without written request.--
                No assessment may be required under paragraph 
                (1) for a drug subject to an approved 
                application under section 505 unless--
                          [(i) the Secretary has issued a 
                        written request for a related pediatric 
                        study under section 505A(c) of this Act 
                        or section 409I of the Public Health 
                        Service Act (42 U.S.C. 284m);
                          [(ii)(I) if the request was made 
                        under section 505A(c)--
                                  [(aa) the recipient of the 
                                written request does not agree 
                                to the request; or
                                  [(bb) the Secretary does not 
                                receive a response as specified 
                                under section 505A(d)(4)(A); or
                          [(II) if the request was made under 
                        section 409I of the Public Health 
                        Service Act (42 U.S.C. 284m)--
                                  [(aa) the recipient of the 
                                written request does not agree 
                                to the request; or
                                  [(bb) the Secretary does not 
                                receive a response as specified 
                                under section 409I(c)(2) of 
                                that Act; and
                          [(iii)(I) the Secretary certifies 
                        under subparagraph (B) that there are 
                        insufficient funds under sections 409I 
                        and 499 of the Public Health Service 
                        Act (42 U.S.C. 284m, 290b) to conduct 
                        the study; or
                          [(II) the Secretary publishes in the 
                        Federal Register a certification that 
                        certifies that--
                                  [(aa) no contract or grant 
                                has been awarded under section 
                                409I or 499 of the Public 
                                Health Service Act (42 U.S.C. 
                                284m, 290b); and
                                  [(bb) not less than 270 days 
                                have passed since the date of a 
                                certification under 
                                subparagraph (B) that there are 
                                sufficient funds to conduct the 
                                study.
                  [(B) No agreement to request.--Not later than 
                60 days after determining that no holder will 
                agree to the written request (including a 
                determination that the Secretary has not 
                received a response specified under section 
                505A(d) of this Act or section 409I of the 
                Public Health Service Act (42 U.S.C. 284m), the 
                Secretary shall certify whether the Secretary 
                has sufficient funds to conduct the study under 
                section 409I or 499 of the Public Health 
                Service Act (42 U.S.C. 284m, 290b), taking into 
                account the prioritization under section 409I.
  [(c) Meaningful Therapeutic Benefit.--For the purposes of 
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) 
and paragraphs (1)(B)(i) and (2)(B)(iii)(I)(aa) of subsection 
(b), a drug or biological product shall be considered to 
represent a meaningful therapeutic benefit over existing 
therapies if the Secretary estimates that--
          [(1) if approved, the drug or biological product 
        would represent a significant improvement in the 
        treatment, diagnosis, or prevention of a disease, 
        compared with marketed products adequately labeled for 
        that use in the relevant pediatric population; or
          [(2) the drug or biological product is in a class of 
        products or for an indication for which there is a need 
        for additional options.
  [(d) Submission of Assessments.--If a person fails to submit 
an assessment described in subsection (a)(2), or a request for 
approval of a pediatric formulation described in subsection (a) 
or (b), in accordance with applicable provisions of subsections 
(a) and (b)--
          [(1) the drug or biological product that is the 
        subject of the assessment or request may be considered 
        misbranded solely because of that failure and subject 
        to relevant enforcement action (except that the drug or 
        biological product shall not be subject to action under 
        section 303); but
          [(2) the failure to submit the assessment or request 
        shall not be the basis for a proceeding--
                  [(A) to withdraw approval for a drug under 
                section 505(e); or
                  [(B) to revoke the license for a biological 
                product under section 351 of the Public Health 
                Service Act (42 U.S.C. 262).
  [(e) Meetings.--Before and during the investigational process 
for a new drug or biological product, the Secretary shall meet 
at appropriate times with the sponsor of the new drug or 
biological product to discuss--
          [(1) information that the sponsor submits on plans 
        and timelines for pediatric studies; or
          [(2) any planned request by the sponsor for waiver or 
        deferral of pediatric studies.
  [(f) Scope of Authority.--Nothing in this section provides to 
the Secretary any authority to require a pediatric assessment 
of any drug or biological product, or any assessment regarding 
other populations or uses of a drug or biological product, 
other than the pediatric assessments described in this section.
  [(g) Orphan Drugs.--Unless the Secretary requires otherwise 
by regulation, this section does not apply to any drug for an 
indication for which orphan designation has been granted under 
section 526.
  [(h) Integration With Other Pediatric Studies.--The authority 
under this section shall remain in effect so long as an 
application subject to this section may be accepted for filing 
by the Secretary on or before the date specified in section 
505A(n).]

SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

  (a) Definitions.--As used in this section, the term 
``pediatric studies'' or ``studies'' means at least one 
clinical investigation (that, at the Secretary's discretion, 
may include pharmacokinetic studies) in pediatric age groups 
(including neonates in appropriate cases) in which a drug is 
anticipated to be used, and at the discretion of the Secretary, 
may include preclinical studies.
  (b) Market Exclusivity for New Drugs.--
          (1) In general.--Except as provided in paragraph (2), 
        if, prior to approval of an application that is 
        submitted under section 505(b)(1), the Secretary 
        determines that information relating to the use of a 
        new drug in the pediatric population may produce health 
        benefits in that population, the Secretary makes a 
        written request for pediatric studies (which shall 
        include a timeframe for completing such studies), the 
        applicant agrees to the request, such studies are 
        completed using appropriate formulations for each age 
        group for which the study is requested within any such 
        timeframe, and the reports thereof are submitted and 
        accepted in accordance with subsection (d)(3), and if 
        the Secretary has determined that labeling changes are 
        appropriate, such changes are approved within the 
        timeframe requested by the Secretary--
                  (A)(i)(I) the period referred to in 
                subsection (c)(3)(E)(ii) of section 505, and in 
                subsection (j)(5)(F)(ii) of such section, is 
                deemed to be five years and six months rather 
                than five years, and the references in 
                subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of 
                such section to four years, to forty-eight 
                months, and to seven and one-half years are 
                deemed to be four and one-half years, fifty-
                four months, and eight years, respectively; or
                  (II) the period referred to in clauses (iii) 
                and (iv) of subsection (c)(3)(E) of such 
                section, and in clauses (iii) and (iv) of 
                subsection (j)(5)(F) of such section, is deemed 
                to be three years and six months rather than 
                three years; and
                  (ii) if the drug is designated under section 
                526 for a rare disease or condition, the period 
                referred to in section 527(a) is deemed to be 
                seven years and six months rather than seven 
                years; and
                  (B)(i) if the drug is the subject of--
                          (I) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(ii) or 
                        (j)(2)(A)(vii)(II) of section 505 and 
                        for which pediatric studies were 
                        submitted prior to the expiration of 
                        the patent (including any patent 
                        extensions); or
                          (II) a listed patent for which a 
                        certification has been submitted under 
                        subsections (b)(2)(A)(iii) or 
                        (j)(2)(A)(vii)(III) of section 505,
                the period during which an application may not 
                be approved under section 505(c)(3) or section 
                505(j)(5)(B) shall be extended by a period of 
                six months after the date the patent expires 
                (including any patent extensions); or
                  (ii) if the drug is the subject of a listed 
                patent for which a certification has been 
                submitted under subsection (b)(2)(A)(iv) or 
                (j)(2)(A)(vii)(IV) of section 505, and in the 
                patent infringement litigation resulting from 
                the certification the court determines that the 
                patent is valid and would be infringed, the 
                period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B) shall be extended by a period of 
                six months after the date the patent expires 
                (including any patent extensions).
          (2) Exception.--The Secretary shall not extend the 
        period referred to in paragraph (1)(A) or (1)(B) if the 
        determination is made later than one year prior to the 
        expiration of such period.
  (c) Market Exclusivity for Already-Marketed Drugs.--
          (1) In general.--Except as provided in paragraph (2), 
        if the Secretary determines that information relating 
        to the use of an approved drug in the pediatric 
        population may produce health benefits in that 
        population and makes a written request to the holder of 
        an approved application under section 505(b)(1) for 
        pediatric studies (which shall include a timeframe for 
        completing such studies), the holder agrees to the 
        request, such studies are completed using appropriate 
        formulations for each age group for which the study is 
        requested within any such timeframe and the reports 
        thereof are submitted and accepted in accordance with 
        subsection (d)(3), and if the Secretary determines that 
        labeling changes are appropriate and such changes are 
        approved within the timeframe requested by the 
        Secretary--
                  (A)(i)(I) the period referred to in 
                subsection (c)(3)(E)(ii) of section 505, and in 
                subsection (j)(5)(F)(ii) of such section, is 
                deemed to be five years and six months rather 
                than five years, and the references in 
                subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of 
                such section to four years, to forty-eight 
                months, and to seven and one-half years are 
                deemed to be four and one-half years, fifty-
                four months, and eight years, respectively; or
                  (II) the period referred to in clauses (iii) 
                and (iv) of subsection (c)(3)(D) of such 
                section, and in clauses (iii) and (iv) of 
                subsection (j)(5)(F) of such section, is deemed 
                to be three years and six months rather than 
                three years; and
                  (ii) if the drug is designated under section 
                526 for a rare disease or condition, the period 
                referred to in section 527(a) is deemed to be 
                seven years and six months rather than seven 
                years; and
                  (B)(i) if the drug is the subject of--
                          (I) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(ii) or 
                        (j)(2)(A)(vii)(II) of section 505 and 
                        for which pediatric studies were 
                        submitted prior to the expiration of 
                        the patent (including any patent 
                        extensions); or
                          (II) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(iii) or 
                        (j)(2)(A)(vii)(III) of section 505,
                the period during which an application may not 
                be approved under section 505(c)(3) or section 
                505(j)(5)(B)(ii) shall be extended by a period 
                of six months after the date the patent expires 
                (including any patent extensions); or
                  (ii) if the drug is the subject of a listed 
                patent for which a certification has been 
                submitted under subsection (b)(2)(A)(iv) or 
                (j)(2)(A)(vii)(IV) of section 505, and in the 
                patent infringement litigation resulting from 
                the certification the court determines that the 
                patent is valid and would be infringed, the 
                period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B) shall be extended by a period of 
                six months after the date the patent expires 
                (including any patent extensions)
          (2) Exception.--The Secretary shall not extend the 
        period referred to in paragraph (1)(A) or (1)(B) if the 
        determination is made later than one year prior to the 
        expiration of such period.
  (d) Conduct of Pediatric Studies.--
          (1) Request for studies.--
                  (A) In general.--The Secretary may, after 
                consultation with the sponsor of an application 
                for an investigational new drug under section 
                505(i), the sponsor of an application for a new 
                drug under section 505(b)(1), or the holder of 
                an approved application for a drug under 
                section 505(b)(1) issue to the sponsor or 
                holder a written request for the conduct of 
                pediatric studies for such drug. In issuing 
                such request, the Secretary shall take into 
                account adequate representation of children of 
                ethnic and racial minorities. Such request to 
                conduct pediatric studies shall be in writing 
                and shall include a timeframe for such studies 
                and a request to the sponsor or holder to 
                propose pediatric labeling resulting from such 
                studies.
                  (B) Single written request.--A single written 
                request--
                          (i) may relate to more than one use 
                        of a drug; and
                          (ii) may include uses that are both 
                        approved and unapproved.
          (2) Written request for pediatric studies.--
                  (A) Request and response.--
                          (i) In general.--If the Secretary 
                        makes a written request for pediatric 
                        studies (including neonates, as 
                        appropriate) under subsection (b) or 
                        (c), the applicant or holder, not later 
                        than 180 days after receiving the 
                        written request, shall respond to the 
                        Secretary as to the intention of the 
                        applicant or holder to act on the 
                        request by--
                                  (I) indicating when the 
                                pediatric studies will be 
                                initiated, if the applicant or 
                                holder agrees to the request; 
                                or
                                  (II) indicating that the 
                                applicant or holder does not 
                                agree to the request and 
                                stating the reasons for 
                                declining the request.
                          (ii) Disagree with request.--If, on 
                        or after the date of the enactment of 
                        the Best Pharmaceuticals for Children 
                        Act of 2007, the applicant or holder 
                        does not agree to the request on the 
                        grounds that it is not possible to 
                        develop the appropriate pediatric 
                        formulation, the applicant or holder 
                        shall submit to the Secretary the 
                        reasons such pediatric formulation 
                        cannot be developed.
                  (B) Adverse event reports.--An applicant or 
                holder that, on or after the date of the 
                enactment of the Best Pharmaceuticals for 
                Children Act of 2007, agrees to the request for 
                such studies shall provide the Secretary, at 
                the same time as the submission of the reports 
                of such studies, with all postmarket adverse 
                event reports regarding the drug that is the 
                subject of such studies and are available prior 
                to submission of such reports.
          (3) Meeting the studies requirement.--Not later than 
        180 days after the submission of the reports of the 
        studies, the Secretary shall accept or reject such 
        reports and so notify the sponsor or holder. The 
        Secretary's only responsibility in accepting or 
        rejecting the reports shall be to determine, within the 
        180-day period, whether the studies fairly respond to 
        the written request, have been conducted in accordance 
        with commonly accepted scientific principles and 
        protocols, and have been reported in accordance with 
        the requirements of the Secretary for filing.
          (4) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 
        552 of title 5 or section 1905 of title 18, United 
        States Code.
  (e) Notice of Determinations on Studies Requirement.--
          (1) In general.--The Secretary shall publish a notice 
        of any determination, made on or after the date of the 
        enactment of the Best Pharmaceuticals for Children Act 
        of 2007, that the requirements of subsection (d) have 
        been met and that submissions and approvals under 
        subsection (b)(2) or (j) of section 505 for a drug will 
        be subject to the provisions of this section. Such 
        notice shall be published not later than 30 days after 
        the date of the Secretary's determination regarding 
        market exclusivity and shall include a copy of the 
        written request made under subsection (b) or (c).
          (2) Identification of certain drugs.--The Secretary 
        shall publish a notice identifying any drug for which, 
        on or after the date of the enactment of the Best 
        Pharmaceuticals for Children Act of 2007, a pediatric 
        formulation was developed, studied, and found to be 
        safe and effective in the pediatric population (or 
        specified subpopulation) if the pediatric formulation 
        for such drug is not introduced onto the market within 
        one year after the date that the Secretary publishes 
        the notice described in paragraph (1). Such notice 
        identifying such drug shall be published not later than 
        30 days after the date of the expiration of such one 
        year period.
  (f) Internal Review of Written Requests and Pediatric 
Studies.--
          (1) Internal review.--
                  (A) In general.--The Secretary shall 
                establish an internal review committee to 
                review all written requests issued on or after 
                the date of the enactment of the Best 
                Pharmaceuticals for Children Act of 2007, in 
                accordance with paragraph (2).
                  (B) Members.--The committee established under 
                subparagraph (A) shall include individuals with 
                expertise in pediatrics, biopharmacology, 
                statistics, drugs and drug formulations, legal 
                issues, pediatric ethics, the appropriate 
                expertise, such as expertise in child and 
                adolescent psychiatry, pertaining to the 
                pediatric product under review, one or more 
                experts from the Office of Pediatric 
                Therapeutics, and other individuals designated 
                by the Secretary.
          (2) Review of written requests.--The committee 
        established under paragraph (1) shall review all 
        written requests issued pursuant to this section prior 
        to being issued.
          (3) Tracking pediatric studies and labeling 
        changes.--The Secretary shall track and make available 
        to the public, in an easily accessible manner, 
        including through posting on the website of the Food 
        and Drug Administration--
                  (A) the number of studies conducted under 
                this section and under section 409I of the 
                Public Health Service Act;
                  (B) the specific drugs and biological 
                products and their uses, including labeled and 
                off-labeled indications, studied under such 
                sections;
                  (C) the types of studies conducted under such 
                sections, including trial design, the number of 
                pediatric patients studied, and the number of 
                centers and countries involved;
                  (D) the number of pediatric formulations 
                developed and the number of pediatric 
                formulations not developed and the reasons such 
                formulations were not developed;
                  (E) the labeling changes made as a result of 
                studies conducted under such sections;
                  (F) an annual summary of labeling changes 
                made as a result of studies conducted under 
                such sections for distribution pursuant to 
                subsection (k)(2); and
                  (G) information regarding reports submitted 
                on or after the date of the enactment of the 
                Best Pharmaceuticals for Children Act of 2007.
          (4) Committee.--The committee established under 
        paragraph (1) shall be the committee utilized under 
        section 505B(f)(1).
  (g) Limitations.--Notwithstanding subsection (c)(2), a drug 
to which the six-month period under subsection (b) or (c) has 
already been applied--
          (1) may receive an additional six-month period under 
        subsection (c)(1)(A)(i)(II) for a supplemental 
        application if all other requirements under this 
        section are satisfied; and
          (2) may not receive any additional such period under 
        subsection (c)(1)(A)(ii).
  (h) Relationship to Pediatric Research Requirements.--
Notwithstanding any other provision of law, if any pediatric 
study is required by a provision of law (including a 
regulation) other than this section and such study meets the 
completeness, timeliness, and other requirements of this 
section, such study shall be deemed to satisfy the requirement 
for market exclusivity pursuant to this section.
  (i) Labeling Changes.--
          (1) Priority status for pediatric applications and 
        supplements.--Any application or supplement to an 
        application under section 505 proposing a labeling 
        change as a result of any pediatric study conducted 
        pursuant to this section--
                  (A) shall be considered to be a priority 
                application or supplement; and
                  (B) shall be subject to the performance goals 
                established by the Commissioner for priority 
                drugs.
          (2) Dispute resolution.--
                  (A) Request for labeling change and failure 
                to agree.--If, on or after the date of the 
                enactment of the Best Pharmaceuticals for 
                Children Act of 2007, the Commissioner 
                determines that the sponsor and the 
                Commissioner have been unable to reach 
                agreement on appropriate changes to the 
                labeling for the drug that is the subject of 
                the application, not later than 180 days after 
                the date of submission of the application--
                          (i) the Commissioner shall request 
                        that the sponsor of the application 
                        make any labeling change that the 
                        Commissioner determines to be 
                        appropriate; and
                          (ii) if the sponsor of the 
                        application does not agree within 30 
                        days after the Commissioner's request 
                        to make a labeling change requested by 
                        the Commissioner, the Commissioner 
                        shall refer the matter to the Pediatric 
                        Advisory Committee.
                  (B) Action by the pediatric advisory 
                committee.--Not later than 90 days after 
                receiving a referral under subparagraph 
                (A)(ii), the Pediatric Advisory Committee 
                shall--
                          (i) review the pediatric study 
                        reports; and
                          (ii) make a recommendation to the 
                        Commissioner concerning appropriate 
                        labeling changes, if any.
                  (C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations 
                of the Pediatric Advisory Committee and, if 
                appropriate, not later than 30 days after 
                receiving the recommendation, make a request to 
                the sponsor of the application to make any 
                labeling change that the Commissioner 
                determines to be appropriate.
                  (D) Misbranding.--If the sponsor of the 
                application, within 30 days after receiving a 
                request under subparagraph (C), does not agree 
                to make a labeling change requested by the 
                Commissioner, the Commissioner may deem the 
                drug that is the subject of the application to 
                be misbranded.
                  (E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United 
                States to bring an enforcement action under 
                this Act when a drug lacks appropriate 
                pediatric labeling. Neither course of action 
                (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as 
                the basis to stay the other course of action.
  (j) Other Labeling Changes.--If, on or after the date of the 
enactment of the Best Pharmaceuticals for Children Act of 2007, 
the Secretary determines that a pediatric study conducted under 
this section does or does not demonstrate that the drug that is 
the subject of the study is safe and effective in pediatric 
populations or subpopulations, including whether such study 
results are inconclusive, the Secretary shall order the 
labeling of such product to include information about the 
results of the study and a statement of the Secretary's 
determination.
  (k) Dissemination of Pediatric Information.--
          (1) In general.--Not later than 180 days after the 
        date of submission of a report on a pediatric study 
        under this section, the Secretary shall make available 
        to the public the medical, statistical, and clinical 
        pharmacology reviews of pediatric studies conducted 
        under subsection (b) or (c).
          (2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of the enactment of the 
        Best Pharmaceuticals for Children Act of 2007, the 
        Secretary shall include as a requirement of a written 
        request that the sponsors of the studies that result in 
        labeling changes that are reflected in the annual 
        summary developed pursuant to subsection (f)(3)(F) 
        distribute, at least annually (or more frequently if 
        the Secretary determines that it would be beneficial to 
        the public health), such information to physicians and 
        other health care providers.
          (3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 
        552 of title 5 or section 1905 of title 18, United 
        States Code.
  (l) Adverse Event Reporting.--
          (1) Reporting in year one.--Beginning on the date of 
        the enactment of the Best Pharmaceuticals for Children 
        Act of 2007, during the one-year period beginning on 
        the date a labeling change is approved pursuant to 
        subsection (i), the Secretary shall ensure that all 
        adverse event reports that have been received for such 
        drug (regardless of when such report was received) are 
        referred to the Office of Pediatric Therapeutics 
        established under section 6 of the Best Pharmaceuticals 
        for Children Act (Public Law 107-109). In considering 
        the reports, the Director of such Office shall provide 
        for the review of the reports by the Pediatric Advisory 
        Committee, including obtaining any recommendations of 
        such Committee regarding whether the Secretary should 
        take action under this Act in response to such reports.
          (2) Reporting in subsequent years.--Following the 
        one-year period described in paragraph (1), the 
        Secretary shall, as appropriate, refer to the Office of 
        Pediatric Therapeutics all pediatric adverse event 
        reports for a drug for which a pediatric study was 
        conducted under this section. In considering such 
        reports, the Director of such Office may provide for 
        the review of such reports by the Pediatric Advisory 
        Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should 
        take action in response to such reports.
          (3) Effect.--The requirements of this subsection 
        shall supplement, not supplant, other review of such 
        adverse event reports by the Secretary.
  (m) Clarification of Interaction of Market Exclusivity Under 
This Section and Market Exclusivity Awarded to An Applicant for 
Approval of A Drug Under Section 505(j).--If a 180-day period 
under section 505(j)(5)(B)(iv) overlaps with a 6-month 
exclusivity period under this section, so that the applicant 
for approval of a drug under section 505(j) entitled to the 
180-day period under that section loses a portion of the 180-
day period to which the applicant is entitled for the drug, the 
180-day period shall be extended from--
          (1) the date on which the 180-day period would have 
        expired by the number of days of the overlap, if the 
        180-day period would, but for the application of this 
        subsection, expire after the 6-month exclusivity 
        period; or
          (2) the date on which the 6-month exclusivity period 
        expires, by the number of days of the overlap if the 
        180-day period would, but for the application of this 
        subsection, expire during the six-month exclusivity 
        period.
  (n) Referral if Pediatric Studies Not Completed.--
          (1) In general.--Beginning on the date of the 
        enactment of the Best Pharmaceuticals for Children Act 
        of 2007, if pediatric studies have not been completed 
        under subsection (d) and if the Secretary, through the 
        committee established under subsection (f), determines 
        that there is a continuing need for information 
        relating to the use of the drug in the pediatric 
        population (including neonates, as appropriate), the 
        Secretary shall--
                  (A) for a drug for which listed patents have 
                not expired, make a determination regarding 
                whether an assessment shall be required to be 
                submitted under section 505B; or
                  (B) for a drug that has no listed patents or 
                has 1 or more listed patents that have expired, 
                determine whether there are funds available 
                under section 736 to award a grant to conduct 
                the requested studies pursuant to paragraph 
                (2).
          (2) Funding of studies.--If, pursuant to paragraph 
        (1), the Secretary determines that there are funds 
        available under section 736 to award a grant to conduct 
        the requested pediatric studies, then the Secretary 
        shall issue a proposal to award a grant to conduct the 
        requested studies. If the Secretary determines that 
        funds are not available under section 736, the 
        Secretary shall refer the drug for inclusion on the 
        list established under section 409I of the Public 
        Health Service Act or the conduct of studies.
          (3) Public notice.--The Secretary shall give the 
        public notice of--
                  (A) a decision under paragraph (1)(A) not to 
                require an assessment under section 505B and 
                the basis for such decision;
                  (B) the name of any drug, its manufacturer, 
                and the indications to be studied pursuant to a 
                grant made under paragraph (2); and
                  (C) any decision under paragraph (2) to 
                include a drug on the list established under 
                section 409I of the Public Health Service Act.
          (4) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 
        552 of title 5 or section 1905 of title 18, United 
        States Code.
  (o) Prompt Approval of Drugs under Section 505(j) When 
Pediatric Information is Added to Labeling.--
          (1) General rule.--A drug for which an application 
        has been submitted or approved under section 505(j) 
        shall not be considered ineligible for approval under 
        that section or misbranded under section 502 on the 
        basis that the labeling of the drug omits a pediatric 
        indication or any other aspect of labeling pertaining 
        to pediatric use when the omitted indication or other 
        aspect is protected by patent or by exclusivity under 
        clause (iii) or (iv) of section 505(j)(5)(F).
          (2) Labeling.--Notwithstanding clauses (iii) and (iv) 
        of section 505(j)(5)(F), the Secretary may require that 
        the labeling of a drug approved under section 505(j) 
        that omits a pediatric indication or other aspect of 
        labeling as described in paragraph (1) include--
                  (A) a statement that, because of marketing 
                exclusivity for a manufacturer--
                          (i) the drug is not labeled for 
                        pediatric use; or
                          (ii) in the case of a drug for which 
                        there is an additional pediatric use 
                        not referred to in paragraph (1), the 
                        drug is not labeled for the pediatric 
                        use under paragraph (1); and
                  (B) a statement of any appropriate pediatric 
                contraindications, warnings, or precautions 
                that the Secretary considers necessary.
          (3) Preservation of pediatric exclusivity and other 
        provisions.--This subsection does not affect--
                  (A) the availability or scope of exclusivity 
                under this section;
                  (B) the availability or scope of exclusivity 
                under section 505 for pediatric formulations;
                  (C) the question of the eligibility for 
                approval of any application under section 
                505(j) that omits any other conditions of 
                approval entitled to exclusivity under clause 
                (iii) or (iv) of section 505(j)(5)(F); or
                  (D) except as expressly provided in 
                paragraphs (1) and (2), the operation of 
                section 505.
  (p) Institute of Medicine Study.--Not later than 3 years 
after the date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007, the Secretary shall enter into a contract 
with the Institute of Medicine to conduct a study and report to 
Congress regarding the written requests made and the studies 
conducted pursuant to this section. The Institute of Medicine 
may devise an appropriate mechanism to review a representative 
sample of requests made and studies conducted pursuant to this 
section in order to conduct such study. Such study shall--
          (1) review such representative written requests 
        issued by the Secretary since 1997 under subsections 
        (b) and (c);
          (2) review and assess such representative pediatric 
        studies conducted under subsections (b) and (c) since 
        1997 and labeling changes made as a result of such 
        studies;
          (3) review the use of extrapolation for pediatric 
        subpopulations, the use of alternative endpoints for 
        pediatric populations, neonatal assessment tools, and 
        ethical issues in pediatric clinical trials; and
          (4) make recommendations regarding appropriate 
        incentives for encouraging pediatric studies of 
        biologics.
  (q) Sunset.--A drug may not receive any 6-month period under 
subsection (b) or (c) unless--
          (1) on or before October 1, 2012, the Secretary makes 
        a written request for pediatric studies of the drug;
          (2) on or before October 1, 2012, an application for 
        the drug is accepted for filing under section 505(b); 
        and
          (3) all requirements of this section are met.

SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL 
                    PRODUCTS.

  (a) New Drugs and Biological Products.--
          (1) In general.--A person that submits, on or after 
        the date of enactment of the Pediatric Research Equity 
        Act of 2007, an application (or supplement to an 
        application)--
                  (A) under section 505 for a new active 
                ingredient, new indication, new dosage form, 
                new dosing regimen, or new route of 
                administration, or
                  (B) under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) for a new active 
                ingredient, new indication, new dosage form, 
                new dosing regimen, or new route of 
                administration,
        shall submit with the application the assessments 
        described in paragraph (2).
          (2) Assessments.--
                  (A) In general.--The assessments referred to 
                in paragraph (1) shall contain data, gathered 
                using appropriate formulations for each age 
                group for which the assessment is required, 
                that are adequate--
                          (i) to assess the safety and 
                        effectiveness of the drug or the 
                        biological product for the claimed 
                        indications in all relevant pediatric 
                        subpopulations; and
                          (ii) to support dosing and 
                        administration for each pediatric 
                        subpopulation for which the drug or the 
                        biological product is safe and 
                        effective.
                  (B) Similar course of disease or similar 
                effect of drug or biological product.--
                          (i) In general.--If the course of the 
                        disease and the effects of the drug are 
                        sufficiently similar in adults and 
                        pediatric patients, the Secretary may 
                        conclude that pediatric effectiveness 
                        can be extrapolated from adequate and 
                        well-controlled studies in adults, 
                        usually supplemented with other 
                        information obtained in pediatric 
                        patients, such as pharmacokinetic 
                        studies.
                          (ii) Extrapolation between age 
                        groups.--A study may not be needed in 
                        each pediatric age group if data from 
                        one age group can be extrapolated to 
                        another age group.
                          (iii) Information on extrapolation.--
                        A brief documentation of the scientific 
                        data supporting the conclusion under 
                        clauses (i) and (ii) shall be included 
                        in the medical review that is collected 
                        as part of the application under 
                        section 505 of this Act or section 351 
                        of the Public Health Service Act (42 
                        U.S.C. 262).
          (3) Deferral.--
                  (A) In general.--On the initiative of the 
                Secretary or at the request of the applicant, 
                the Secretary may defer submission of some or 
                all assessments required under paragraph (1) 
                until a specified date after approval of the 
                drug or issuance of the license for a 
                biological product if--
                          (i) the Secretary finds that--
                                  (I) the drug or biological 
                                product is ready for approval 
                                for use in adults before 
                                pediatric studies are complete;
                                  (II) pediatric studies should 
                                be delayed until additional 
                                safety or effectiveness data 
                                have been collected; or
                                  (III) there is another 
                                appropriate reason for 
                                deferral; and
                          (ii) the applicant submits to the 
                        Secretary--
                                  (I) certification of the 
                                grounds for deferring the 
                                assessments;
                                  (II) a description of the 
                                planned or ongoing studies;
                                  (III) evidence that the 
                                studies are being conducted or 
                                will be conducted with due 
                                diligence and at the earliest 
                                possible time; and
                                  (IV) a timeline for the 
                                completion of such studies.
                  (B) Annual review.--
                          (i) In general.--On an annual basis 
                        following the approval of a deferral 
                        under subparagraph (A), the applicant 
                        shall submit to the Secretary the 
                        following information:
                                  (I) Information detailing the 
                                progress made in conducting 
                                pediatric studies.
                                  (II) If no progress has been 
                                made in conducting such 
                                studies, evidence and 
                                documentation that such studies 
                                will be conducted with due 
                                diligence and at the earliest 
                                possible time.
                          (ii) Public availability.--The 
                        information submitted through the 
                        annual review under clause (i) shall 
                        promptly be made available to the 
                        public in an easily accessible manner, 
                        including through the website of the 
                        Food and Drug Administration.
          (4) Waivers.--
                  (A) Full waiver.--On the initiative of the 
                Secretary or at the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit 
                assessments for a drug or biological product 
                under this subsection if the applicant 
                certifies and the Secretary finds that--
                          (i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients is so 
                        small or the patients are 
                        geographically dispersed);
                          (ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in all pediatric age groups; or
                          (iii) The drug or biological 
                        product--
                                  (I) does not represent a 
                                meaningful therapeutic benefit 
                                over existing therapies for 
                                pediatric patients; and
                                  (II) is not likely to be used 
                                in a substantial number of 
                                pediatric patients.
                  (B) Partial waiver.--On the initiative of the 
                Secretary or at the request of an applicant, 
                the Secretary shall grant a partial waiver, as 
                appropriate, of the requirement to submit 
                assessments for a drug or biological product 
                under this subsection with respect to a 
                specific pediatric age group if the applicant 
                certifies and the Secretary finds that--
                          (i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients in that 
                        age group is so small or patients in 
                        that age group are geographically 
                        dispersed);
                          (ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in that age group;
                          (iii) the drug or biological 
                        product--
                                  (I) does not represent a 
                                meaningful therapeutic benefit 
                                over existing therapies for 
                                pediatric patients in that age 
                                group; and
                                  (II) is not likely to be used 
                                by a substantial number of 
                                pediatric patients in that age 
                                group; or
                          (iv) the applicant can demonstrate 
                        that reasonable attempts to produce a 
                        pediatric formulation necessary for 
                        that age group have failed.
                  (C) Pediatric formulation not possible.--If a 
                waiver is granted on the ground that it is not 
                possible to develop a pediatric formulation, 
                the waiver shall cover only the pediatric 
                groups requiring that formulation. An applicant 
                seeking either a full or partial waiver shall 
                submit to the Secretary documentation detailing 
                why a pediatric formulation cannot be developed 
                and, if the waiver is granted, the applicant's 
                submission shall promptly be made available to 
                the public in an easily accessible manner, 
                including through posting on the website of the 
                Food and Drug Administration.
                  (D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there 
                is evidence that a drug or biological product 
                would be ineffective or unsafe in pediatric 
                populations, the information shall be included 
                in the labeling for the drug or biological 
                product.
  (b) Marketed Drugs and Biological Products.--
          (1) In general.--Beginning on the date of enactment 
        of the Pediatric Research Equity Act of 2007, after 
        providing notice in the form of a letter and an 
        opportunity for written response and a meeting, which 
        may include an advisory committee meeting, the 
        Secretary may (by order in the form of a letter) 
        require the sponsor or holder of an approved 
        application for a drug under section 505 or the holder 
        of a license for a biological product under section 351 
        of the Public Health Service Act to submit by a 
        specified date the assessments described in subsection 
        (a)(2), if the Secretary finds that--
                  (A)(i) the drug or biological product is used 
                for a substantial number of pediatric patients 
                for the labeled indications; and
                  (ii) adequate pediatric labeling could confer 
                a benefit on pediatric patients;
                  (B) there is reason to believe that the drug 
                or biological product would represent a 
                meaningful therapeutic benefit over existing 
                therapies for pediatric patients for 1 or more 
                of the claimed indications; or
                  (C) the absence of adequate pediatric 
                labeling could pose a risk to pediatric 
                patients.
          (2) Waivers.--
                  (A) Full waiver.--At the request of an 
                applicant, the Secretary shall grant a full 
                waiver, as appropriate, of the requirement to 
                submit assessments under this subsection if the 
                applicant certifies and the Secretary finds 
                that--
                          (i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients in that 
                        age group is so small or patients in 
                        that age group are geographically 
                        dispersed); or
                          (ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in all pediatric age groups.
                  (B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial 
                waiver, as appropriate, of the requirement to 
                submit assessments under this subsection with 
                respect to a specific pediatric age group if 
                the applicant certifies and the Secretary finds 
                that--
                          (i) necessary studies are impossible 
                        or highly impracticable (because, for 
                        example, the number of patients in that 
                        age group is so small or patients in 
                        that age group are geographically 
                        dispersed);
                          (ii) there is evidence strongly 
                        suggesting that the drug or biological 
                        product would be ineffective or unsafe 
                        in that age group;
                          (iii)(I) the drug or biological 
                        product--
                                  (aa) does not represent a 
                                meaningful therapeutic benefit 
                                over existing therapies for 
                                pediatric patients in that age 
                                group; and
                                  (bb) is not likely to be used 
                                in a substantial number of 
                                pediatric patients in that age 
                                group; and
                          (II) the absence of adequate labeling 
                        could not pose significant risks to 
                        pediatric patients; or
                          (iv) the applicant can demonstrate 
                        that reasonable attempts to produce a 
                        pediatric formulation necessary for 
                        that age group have failed.
                  (C) Pediatric formulation not possible.--If a 
                waiver is granted on the ground that it is not 
                possible to develop a pediatric formulation, 
                the waiver shall cover only the pediatric 
                groups requiring that formulation. An applicant 
                seeking either a full or partial waiver shall 
                submit to the Secretary documentation detailing 
                why a pediatric formulation cannot be developed 
                and, if the waiver is granted, the applicant's 
                submission shall promptly be made available to 
                the public in an easily accessible manner, 
                including through posting on the website of the 
                Food and Drug Administration.
                  (D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there 
                is evidence that a drug or biological product 
                would be ineffective or unsafe in pediatric 
                populations, the information shall be included 
                in the labeling for the drug or biological 
                product.
  (c) Meaningful Therapeutic Benefit.--For the purposes of 
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) 
and paragraphs (1)(B)(I) and (2)(B)(iii)(I)(aa) of subsection 
(b), a drug or biological product shall be considered to 
represent a meaningful therapeutic benefit over existing 
therapies if the Secretary determines that--
          (1) if approved, the drug or biological product could 
        represent an improvement in the treatment, diagnosis, 
        or prevention of a disease, compared with marketed 
        products adequately labeled for that use in the 
        relevant pediatric population; or
          (2) the drug or biological product is in a class of 
        products or for an indication for which there is a need 
        for additional options.
  (d) Submission of Assessments.--If a person fails to submit 
an assessment described in subsection (a)(2), or a request for 
approval of a pediatric formulation described in subsection (a) 
or (b), in accordance with applicable provisions of subsections 
(a) and (b)--
          (1) the drug or biological product that is the 
        subject of the assessment or request may be considered 
        misbranded solely because of that failure and subject 
        to relevant enforcement action (except that the drug or 
        biological product shall not be subject to action under 
        section 303); but
          (2) the failure to submit the assessment or request 
        shall not be the basis for a proceeding--
                  (A) to withdraw approval for a drug under 
                section 505(e); or
                  (B) to revoke the license for a biological 
                product under section 351 of the Public Health 
                Service Act.
  (e) Meetings.--Before and during the investigational process 
for a new drug or biological product, the Secretary shall meet 
at appropriate times with the sponsor of the new drug or 
biological product to discuss--
          (1) information that the sponsor submits on plans and 
        timelines for pediatric studies; or
          (2) any planned request by the sponsor for waiver or 
        deferral of pediatric studies.
  (f) Review of Pediatric Plans, Deferrals, and Waivers.--
          (1) Review.--Beginning not later than 30 days after 
        the date of enactment of the Pediatric Research Equity 
        Act of 2007, the Secretary shall utilize an internal 
        committee to provide consultation to reviewing 
        divisions on all pediatric plans and assessments prior 
        to approval of an application or supplement for which a 
        pediatric assessment is required under this section and 
        all deferral and waiver requests granted pursuant to 
        this section. Such internal committee shall include 
        employees of the Food and Drug Administration, with 
        expertise in pediatrics (including representation from 
        the Office of Pediatric Therapeutics), biopharmacology, 
        statistics, chemistry, legal issues, pediatric ethics, 
        and the appropriate expertise pertaining to the 
        pediatric product under review, and other individuals 
        designated by the Secretary.
          (2) Activity by committee.--The committee referred to 
        in paragraph (1) may operate using appropriate members 
        of such committee and need not convene all members of 
        the committee.
          (3) Documentation of committee action.--For each drug 
        or biological product, the committee referred to in 
        paragraph (1) shall document, for each activity 
        described in paragraph (4), which members of the 
        committee participated in such activity.
          (4) Review of pediatric plans, deferrals and 
        waivers.--Consultation on pediatric plans and 
        assessments by the internal committee pursuant to this 
        section shall occur prior to approval of an application 
        or supplement for which a pediatric assessment is 
        required under this section. The internal committee 
        shall review all requests for deferrals and waivers 
        from the requirement to submit a pediatric assessment 
        granted under this section and shall provide 
        recommendations as needed to reviewing divisions.
          (5) Retrospective review of pediatric plans, 
        deferrals and waivers.--Within one year after enactment 
        of the Pediatric Research Equity Act of 2007, the 
        committee shall conduct a retrospective review and 
        analysis of a representative sample of assessments 
        submitted and deferrals and waivers approved under this 
        section since enactment of the Pediatric Research 
        Equity Act of 2003. Such review shall include an 
        analysis of the quality and consistency of pediatric 
        information in pediatric assessments and the 
        appropriateness of waivers and deferrals granted. Based 
        on such review, the Secretary shall issue 
        recommendations to the review divisions for 
        improvements and initiate guidance to industry related 
        to the scope of pediatric studies required under this 
        section.
          (6) Tracking of assessments and labeling changes.--
        Beginning on the date of enactment of the Pediatric 
        Research Equity Act of 2007, the Secretary shall track 
        and make available to the public in an easily 
        accessible manner, including through posting on the 
        website of the Food and Drug Administration--
                  (A) the number of assessments conducted under 
                this section;
                  (B) the specific drugs and biological 
                products and their uses assessed under this 
                section;
                  (C) the types of assessments conducted under 
                this section, including trial design, the 
                number of pediatric patients studied, and the 
                number of centers and countries involved;
                  (D) the total number of deferrals requested 
                and granted under this section and, if granted, 
                the reasons for such deferrals, the timeline 
                for completion, and the number completed and 
                pending by the specified date, as outlined in 
                subsection (a)(3);
                  (E) the number of waivers requested and 
                granted under this section and, if granted, the 
                reasons for the waivers;
                  (F) the number of pediatric formulations 
                developed and the number of pediatric 
                formulations not developed and the reasons any 
                such formulation was not developed;
                  (G) the labeling changes made as a result of 
                assessments conducted under this section;
                  (H) an annual summary of labeling changes 
                made as a result of assessments conducted under 
                this section for distribution pursuant to 
                subsection (h)(2); and
                  (I) an annual summary of information 
                submitted pursuant to subsection (a)(3)(B).
          (7) Committee.--The committee utilized under 
        paragraph (1) shall be the committee established under 
        section 505A(f)(1).
  (g) Labeling Changes.--
          (1) Priority status for pediatric applications.--Any 
        supplement to an application under section 505 and 
        section 351 of the Public Health Service Act proposing 
        a labeling change as a result of any pediatric 
        assessments conducted pursuant to this section--
                  (A) shall be considered a priority 
                application or supplement; and
                  (B) shall be subject to the performance goals 
                established by the Commissioner for priority 
                drugs.
          (2) Dispute resolution.--
                  (A) Request for labeling change and failure 
                to agree.--If, on or after the date of 
                enactment of the Pediatric Research Equity Act 
                of 2007, the Commissioner determines that a 
                sponsor and the Commissioner have been unable 
                to reach agreement on appropriate changes to 
                the labeling for the drug that is the subject 
                of the application or supplement, not later 
                than 180 days after the date of the submission 
                of the application or supplement--
                          (i) the Commissioner shall request 
                        that the sponsor of the application 
                        make any labeling change that the 
                        Commissioner determines to be 
                        appropriate; and
                          (ii) if the sponsor does not agree 
                        within 30 days after the Commissioner's 
                        request to make a labeling change 
                        requested by the Commissioner, the 
                        Commissioner shall refer the matter to 
                        the Pediatric Advisory Committee.
                  (B) Action by the pediatric advisory 
                committee.--Not later than 90 days after 
                receiving a referral under subparagraph 
                (A)(ii), the Pediatric Advisory Committee 
                shall--
                          (i) review the pediatric study 
                        reports; and
                          (ii) make a recommendation to the 
                        Commissioner concerning appropriate 
                        labeling changes, if any.
                  (C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations 
                of the Pediatric Advisory Committee and, if 
                appropriate, not later than 30 days after 
                receiving the recommendation, make a request to 
                the sponsor of the application to make any 
                labeling changes that the Commissioner 
                determines to be appropriate.
                  (D) Misbranding.--If the sponsor of the 
                application, within 30 days after receiving a 
                request under subparagraph (C), does not agree 
                to make a labeling change requested by the 
                Commissioner, the Commissioner may deem the 
                drug that is the subject of the application to 
                be misbranded.
                  (E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United 
                States to bring an enforcement action under 
                this Act when a drug lacks appropriate 
                pediatric labeling. Neither course of action 
                (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as 
                the basis to stay the other course of action.
          (3) Other labeling changes.--If, on or after the date 
        of enactment of the Pediatric Research Equity Act of 
        2007, the Secretary makes a determination that a 
        pediatric assessment conducted under this section does 
        or does not demonstrate that the drug that is the 
        subject of such assessment is safe and effective in 
        pediatric populations or subpopulations, including 
        whether such assessment results are inconclusive, the 
        Secretary shall order the label of such product to 
        include information about the results of the assessment 
        and a statement of the Secretary's determination.
  (h) Dissemination of Pediatric Information.--
          (1) In general.--Not later than 180 days after the 
        date of submission of a pediatric assessment under this 
        section, the Secretary shall make available to the 
        public in an easily accessible manner the medical, 
        statistical, and clinical pharmacology reviews of such 
        pediatric assessments, and shall post such assessments 
        on the website of the Food and Drug Administration.
          (2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of enactment of the 
        Pediatric Research Equity Act of 2007, the Secretary 
        shall require that the sponsors of the assessments that 
        result in labeling changes that are reflected in the 
        annual summary developed pursuant to subsection 
        (f)(6)(H) distribute such information to physicians and 
        other health care providers.
          (3) Effect of subsection.--Nothing in this subsection 
        shall alter or amend Section 301(j) of this Act or 
        section 552 of title 5 or section 1905 of title 18, 
        United States Code.
  (i) Adverse Event Reporting.--
          (1) Reporting in year one.--Beginning on the date of 
        enactment of the Pediatric Research Equity Act of 2007, 
        during the one-year period beginning on the date a 
        labeling change is made pursuant to subsection (g), the 
        Secretary shall ensure that all adverse event reports 
        that have been received for such drug (regardless of 
        when such report was received) are referred to the 
        Office of Pediatric Therapeutics. In considering the 
        report, the Director of such Office shall provide for 
        the review of the report by the Pediatric Advisory 
        Committee, including obtaining any recommendations of 
        such committee regarding whether the Secretary should 
        take action under this Act in response to such report.
          (2) Reporting in subsequent years.--Following the 
        one-year period described in paragraph (1), the 
        Secretary shall, as appropriate, refer to the Office of 
        Pediatric Therapeutics all pediatric adverse event 
        reports for a drug for which a pediatric study was 
        conducted under this section. In considering the 
        report, the Director of such Office may provide for the 
        review of the report by the Pediatric Advisory 
        Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should 
        take action in response to such report.
          (3) Effect.--The requirements of this subsection 
        shall supplement, not supplant, other review of such 
        adverse event reports by the Secretary.
  (j) Scope of Authority.--Nothing in this section provides to 
the Secretary any authority to require a pediatric assessment 
of any drug or biological product, or any assessment regarding 
other populations or uses of a drug or biological product, 
other than the pediatric assessments described in this section.
  (k) Orphan Drugs.--Unless the Secretary requires otherwise by 
regulation, this section does not apply to any drug for an 
indication for which orphan designation has been granted under 
section 526.
  (l) Institute of Medicine Study.--
          (1) In general.--Not later than three years after the 
        date of the enactment of the Pediatric Research Equity 
        Act of 2007, the Secretary shall contract with the 
        Institute of Medicine to conduct a study and report to 
        Congress regarding the pediatric studies conducted 
        pursuant to this section since 1997 and labeling 
        changes made as a result of such studies.
          (2) Content of study.--The study under paragraph (1) 
        shall review and assess the use of extrapolation for 
        pediatric subpopulations, the use of alternative 
        endpoints for pediatric populations, neonatal 
        assessment tools, the number and type of pediatric 
        adverse events, and ethical issues in pediatric 
        clinical trials.
          (3) Representative sample.--The Institute of Medicine 
        may devise an appropriate mechanism to review a 
        representative sample of studies conducted pursuant to 
        this section from each review division within the 
        Center for Drug Evaluation and Research in order to 
        make the requested assessment.

SEC. 505C. PHARMACEUTICAL SECURITY.

  (a) In General.--The Secretary shall develop standards and 
identify and validate effective technologies for the purpose of 
securing the prescription drug distribution system against 
counterfeit, diverted, subpotent, substandard, adulterated, 
misbranded, or expired drugs.
  (b) Standards Development.--
          (1) In general.--The Secretary shall, in consultation 
        with the agencies specified in paragraph (3), 
        prioritize and develop standards for the 
        identification, validation, authentication, and 
        tracking of prescription drugs.
          (2) Promising technologies.--The standards developed 
        under this subsection shall address promising 
        technologies, including--
                  (A) radio frequency identification 
                technology;
                  (B) nanotechnology;
                  (C) encryption technologies; and
                  (D) other track-and-trace technologies.
          (3) Interagency collaboration.--In carrying out this 
        subsection, the Secretary shall consult with Federal 
        health and security agencies, including--
                  (A) the Administrator of the Drug Enforcement 
                Administration;
                  (B) the Secretary of the Department of 
                Homeland Security
                  (C) the Secretary of Commerce; and
                  (D) other appropriate Federal and State 
                agencies.
  (c) Inspection and Enforcement.--
          (1) In general.--The Secretary shall expand and 
        enhance the resources and facilities of the Office of 
        Regulatory Affairs of the Food and Drug Administration 
        to protect the prescription drug distribution system 
        against counterfeit, diverted, subpotent, substandard, 
        adulterated, misbranded, or expired drugs.
          (2) Activities.--The Secretary shall undertake 
        enhanced and joint enforcement activities with other 
        Federal agencies and State officials, and establish 
        regional capacities for the validation of prescription 
        drugs and the inspection of the prescription drug 
        distribution system.
  (d) Definition.--In this section, the term ``prescription 
drug'' means a drug subject to section 503(b)(1).

           *       *       *       *       *       *       *


             REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES

  Sec. 510. (a)  * * *
  (b) [On or before] (1) On or before December 31 of each year 
every person who owns or operates any establishment in any 
State engaged in the manufacture, preparation, propagation, 
compounding, or processing of a drug or drugs [or a device or 
devices] shall register with the Secretary his name, places of 
business, and all such establishments.
  (2) During the period beginning on October 1 and ending on 
December 31 of each year, every person who owns or operates any 
establishment in any State engaged in the manufacture, 
preparation, propagation, compounding, or processing of a 
device or devices shall register with the Secretary his name, 
places of business, and all such establishments.

           *       *       *       *       *       *       *

  (i)(1) [On or before December 31 of each year, any 
establishment within any foreign country engaged in the 
manufacture, preparation, propagation, compounding, or 
processing of a drug or a device that is imported or offered 
for import into the United States shall, through electronic 
means in accordance with the criteria of the Secretary, 
register with the Secretary the name and place of business of 
the establishment, the name of the United States agent for the 
establishment, the name of each importer of such drug or device 
in the United States that is known to the establishment, and 
the name of each person who imports or offers for import such 
drug or device to the United States for purposes of 
importation.] Any establishment within any foreign country 
engaged in the manufacture, preparation, propagation, 
compounding, or processing of a drug or device that is imported 
or offered for import into the United States shall, through 
electronic means in accordance with the criteria of the 
Secretary--
          (A) upon first engaging in any such activity, 
        immediately register with the Secretary the name and 
        place of business of the establishment, the name of the 
        United States agent for the establishment, the name of 
        each importer of such drug or device in the United 
        States that is known to the establishment, and the name 
        of each person who imports or offers for import such 
        drug or device to the United States for purposes of 
        importation; and
          (B) each establishment subject to the requirements of 
        subparagraph (A) shall thereafter--
                  (i) with respect to drugs, register with the 
                Secretary on or before December 31 of each 
                year; and
                  (ii) with respect to devices, register with 
                the Secretary during the period beginning on 
                October 1 and ending on December 31 of each 
                year.

           *       *       *       *       *       *       *

  (j)(1)  * * *
  (2) [Each person who registers with the Secretary under this 
section shall report to the Secretary once during the month of 
June of each year and once during the month of December of each 
year the following information:] Each person who registers with 
the Secretary under this section shall report to the Secretary, 
with regard to drugs once during the month of June of each year 
and once during the month of December of each year, and with 
regard to devices once each year during the period beginning on 
October 1 and ending on December 31, the following information:
          (A)  * * *

           *       *       *       *       *       *       *

  (k) Each person who is required to register under this 
section and who proposes to begin the introduction or delivery 
for introduction into interstate commerce for commercial 
distribution of a device intended for human use shall, at least 
ninety days before making such introduction or delivery, report 
to the Secretary or person who is accredited under section 
523(a) (in such form and manner as the Secretary shall by 
regulation prescribe)--
          (1) the class in which the device is classified under 
        section 513 or if such person determines that the 
        device is not classified under such section, a 
        statement of that determination and the basis for such 
        person's determination that the device is or is not so 
        classified, [and]
          (2) action taken by such person to comply with 
        requirements under section 514 or 515 which are 
        applicable to the device[.], and
          (3) action taken by such person to comply with 
        requirements under section 492C of the Public Health 
        Service Act for the submission of clinical trial 
        information for inclusion in the registry database and 
        the results database described in such section.

           *       *       *       *       *       *       *

  [(p) Registrations under subsections (b), (c), (d), and (i) 
(including the submission of updated information) shall be 
submitted to the Secretary by electronic means, upon a finding 
by the Secretary that the electronic receipt of such 
registrations is feasible, unless the Secretary grants a 
request for waiver of such requirement because use of 
electronic means is not reasonable for the person requesting 
such waiver.]
  (p)(1) Registrations and listings under this section 
(including the submission of updated information) shall be 
submitted to the Secretary by electronic means unless the 
Secretary grants a request for waiver of such requirement 
because use of electronic means is not reasonable for the 
person requesting such waiver.
  (2) With regard to any establishment engaged in the 
manufacture, preparation, propagation, compounding, or 
processing of a device, the registration and listing 
information required by this section shall be submitted to the 
Secretary by electronic means, unless the Secretary grants a 
waiver because electronic registration and listing is not 
reasonable for the person requesting such waiver.

SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.

  (a) In General.--Not later than 1 year after the date of 
enactment of this section, the Secretary, acting through the 
Commissioner of Food and Drugs, shall issue guidance for the 
conduct of clinical trials with respect to antibiotic drugs, 
including antimicrobials to treat acute bacterial sinusitis, 
acute bacterial otitis media, and acute bacterial exacerbation 
of chronic bronchitis. Such guidelines shall indicate the 
appropriate animal models of infection, in vitro techniques, 
and valid microbiologic surrogate markers.
  (b) Review.--Not later than 5 years after the date of 
enactment of this section, the Secretary, acting through the 
Commissioner of Food and Drugs, shall review and update the 
guidance described under subsection (a) to reflect developments 
in scientific and medical information and technology.

           *       *       *       *       *       *       *


                           premarket approval

                          General Requirement

  Sec. 515. (a) * * *

           *       *       *       *       *       *       *


            Action on an Application for Premarket Approval

  (d)(1) * * *
  (2) The Secretary shall deny approval of an application for a 
device if, upon the basis of the information submitted to the 
Secretary as part of the application and any other information 
before him with respect to such device, the Secretary finds 
that--
          (A) * * *

           *       *       *       *       *       *       *

          (D) based on a fair evaluation of all material facts, 
        the proposed labeling is false or misleading in any 
        particular; [or]
          (E) such device is not shown to conform in all 
        respects to a performance standard in effect under 
        section 514 compliance with which is a condition to 
        approval of the application and there is a lack of 
        adequate information to justify the deviation from such 
        standard[.]; or
          (F) the applicant is in violation of the requirements 
        under section 492C of the Public Health Service Act for 
        the submission of clinical trial information for 
        inclusion in the registry database or the results 
        database described in such section.

           *       *       *       *       *       *       *


SEC. 515A. PEDIATRIC USES OF DEVICES.

  (a) New Devices.--
          (1) In general.--A person that submits to the 
        Secretary an application under section 520(m), or an 
        application (or supplement to an application) or a 
        product development protocol under section 515, shall 
        include in the application or protocol the information 
        described in paragraph (2).
          (2) Required information.--The application or 
        protocol described in paragraph (1) shall include, with 
        respect to the device for which approval is sought and 
        if readily available--
                  (A) a description of any pediatric 
                subpopulations that suffer from the disease or 
                condition that the device is intended to treat, 
                diagnose, or cure; and
                  (B) the number of affected pediatric 
                patients.
          (3) Annual report.--Not later than 18 months after 
        the date of enactment of this section, and annually 
        thereafter, the Secretary shall submit to the Committee 
        on Health, Education, Labor, and Pensions of the Senate 
        and the Committee on Energy and Commerce of the House 
        of Representatives a report that includes--
                  (A) the number of devices approved in the 
                year preceding the year in which the report is 
                submitted, for which there is a pediatric 
                subpopulation that suffers from the disease or 
                condition that the device is intended to treat, 
                diagnose, or cure;
                  (B) the number of devices approved in the 
                year preceding the year in which the report is 
                submitted, labeled for use in pediatric 
                patients;
                  (C) the number of pediatric devices approved 
                in the year preceding the year in which the 
                report is submitted, exempted from a fee 
                pursuant to section 738(a)(2)(B)(v); and
                  (D) the review time for each device described 
                in subparagraphs (A), (B), and (C).
  (b) Determination of Pediatric Effectiveness Based on Similar 
Course of Disease or Condition or Similar Effect of Device on 
Adults.--
          (1) In general.--If the course of the disease or 
        condition and the effects of the device are 
        sufficiently similar in adults and pediatric patients, 
        the Secretary may conclude that adult data may be used 
        to support a determination of a reasonable assurance of 
        effectiveness in pediatric populations, as appropriate.
          (2) Extrapolation between subpopulations.--A study 
        may not be needed in each pediatric subpopulation if 
        data from one subpopulation can be extrapolated to 
        another subpopulation.
  (c) Pediatric Subpopulation.--For purposes of this section, 
the term ``pediatric subpopulation'' has the meaning given the 
term in section 520(m)(6)(E)(ii).

           *       *       *       *       *       *       *


                     RECORDS AND REPORTS ON DEVICES

                              General Rule

  Sec. 519. (a) Every person who is a manufacturer or importer 
of a device intended for human use shall establish and maintain 
such records, make such reports, and provide such information, 
as the Secretary may by regulation reasonably require to assure 
that such device is not adulterated or misbranded and to 
otherwise assure its safety and effectiveness. Regulations 
prescribed under the preceding sentence--
          (1) * * *
                  (A) may have caused or contributed to a death 
                or serious injury, or
                  (B) has malfunctioned and that such device or 
                a similar device marketed by the manufacturer 
                or importer would be likely to cause or 
                contribute to a death or serious injury if the 
                malfunction [were to recur;] were to recur, 
                which report under this subparagraph--
                          (i) shall be submitted in accordance 
                        with part 803 of title 21, Code of 
                        Federal Regulations (or successor 
                        regulations), if the device involved 
                        is--
                                  (I) a class III device;
                                  (II) a class II device that 
                                is permanently implantable, is 
                                life supporting, or is life 
                                sustaining; or
                                  (III) a type of device that 
                                the Secretary has by regulation 
                                determined should be subject to 
                                such part 803 in order to 
                                protect the public health; or
                          (ii) shall, if the device is not 
                        subject to clause (i), be submitted in 
                        accordance with criteria established by 
                        the Secretary for reports made pursuant 
                        to this clause, which criteria shall 
                        require the reports to be in summary 
                        form and made on a quarterly basis;

           *       *       *       *       *       *       *


                  Unique Device Identification System

  (f) The Secretary shall promulgate regulations establishing a 
unique device identification system for medical devices 
requiring the labeling of devices to bear a unique identifier.

                  Reports of Removals and Corrections

  [(f)] (g)(1)  * * *

           *       *       *       *       *       *       *


GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED FOR HUMAN USE

                              General Rule

  Sec. 520. (a) * * *

           *       *       *       *       *       *       *


             Exemption for Devices for Investigational Use

  (g)(1) * * *
  (2)(A) * * *
  (B) The conditions prescribed pursuant to subparagraph (A) 
shall include the following:
          (i) * * *

           *       *       *       *       *       *       *

          (iii) A requirement that the person applying for an 
        exemption for a device assure that such person is in 
        compliance with the requirements of section 492C of the 
        Public Health Service Act for the submission of 
        clinical trial information for inclusion in the 
        registry database and the results database described in 
        such section.
          [(iii)] (iv) Such other requirements as the Secretary 
        may determine to be necessary for the protection of the 
        public health and safety.

           *       *       *       *       *       *       *


                     Humanitarian Device Exemption

  (m)(1) * * *

           *       *       *       *       *       *       *

  (3) [No] Except as provided in paragraph (6), no person 
granted an exemption under paragraph (2) with respect to a 
device may sell the device for an amount that exceeds the costs 
of research and development, fabrication, and distribution of 
the device.

           *       *       *       *       *       *       *

  (5) The Secretary may require a person granted an exemption 
under paragraph (2) to demonstrate continued compliance with 
the requirements of this subsection if the Secretary believes 
such demonstration to be necessary to protect the public 
health, if the Secretary has reason to believe that the 
requirements of paragraph (6) are no longer met, or if the 
Secretary has reason to believe that the criteria for the 
exemption are no longer met. If the person granted an exemption 
under paragraph (2) fails to demonstrate continued compliance 
with the requirements of this subsection, the Secretary may 
suspend or withdraw the exemption from the effectiveness 
requirements of sections 514 and 515 for a humanitarian device 
only after providing notice and an opportunity for an informal 
hearing.
  [(6) The Secretary may suspend or withdraw an exemption from 
the effectiveness requirements of sections 514 and 515 for a 
humanitarian device only after providing notice and an 
opportunity for an informal hearing.]
  (6)(A) Except as provided in subparagraph (D), the 
prohibition in paragraph (3) shall not apply with respect to a 
person granted an exemption under paragraph (2) if each of the 
following conditions apply:
          (i)(I) The device with respect to which the exemption 
        is granted is intended for the treatment or diagnosis 
        of a disease or condition that occurs in pediatric 
        patients or in a pediatric subpopulation, and such 
        device is labeled for use in pediatric patients or in a 
        pediatric subpopulation in which the disease or 
        condition occurs.
          (II) The device was not previously approved under 
        this subsection for the pediatric patients or the 
        pediatric subpopulation described in subclause (I) 
        prior to the date of enactment of the Pediatric Medical 
        Device Safety and Improvement Act of 2007.
          (ii) During any calendar year, the number of such 
        devices distributed during that year does not exceed 
        the annual distribution number specified by the 
        Secretary when the Secretary grants such exemption. The 
        annual distribution number shall be based on the number 
        of individuals affected by the disease or condition 
        that such device is intended to treat, diagnose, or 
        cure, and of that number, the number of individuals 
        likely to use the device, and the number of devices 
        reasonably necessary to treat such individuals. In no 
        case shall the annual distribution number exceed the 
        number identified in paragraph (2)(A).
          (iii) Such person immediately notifies the Secretary 
        if the number of such devices distributed during any 
        calendar year exceeds the annual distribution number 
        referred to in clause (ii).
          (iv) The request for such exemption is submitted on 
        or before October 1, 2013.
  (B) The Secretary may inspect the records relating to the 
number of devices distributed during any calendar year of a 
person granted an exemption under paragraph (2) for which the 
prohibition in paragraph (3) does not apply.
  (C) A person may petition the Secretary to modify the annual 
distribution number specified by the Secretary under 
subparagraph (A)(ii) with respect to a device if additional 
information on the number of individuals affected by the 
disease or condition arises, and the Secretary may modify such 
number but in no case shall the annual distribution number 
exceed the number identified in paragraph (2)(A).
  (D) If a person notifies the Secretary, or the Secretary 
determines through an inspection under subparagraph (B), that 
the number of devices distributed during any calendar year 
exceeds the annual distribution number, as required under 
subparagraph (A)(iii), and modified under subparagraph (C), if 
applicable, then the prohibition in paragraph (3) shall apply 
with respect to such person for such device for any sales of 
such device after such notification.
  (E)(i) In this subsection, the term ``pediatric patients'' 
means patients who are 21 years of age or younger at the time 
of the diagnosis or treatment.
          (ii) In this subsection, the term ``pediatric 
        subpopulation'' means 1 of the following populations:
                  (I) Neonates.
                  (II) Infants.
                  (III) Children.
                  (IV) Adolescents.
  (7) The Secretary shall refer any report of an adverse event 
regarding a device for which the prohibition under paragraph 
(3) does not apply pursuant to paragraph (6)(A) that the 
Secretary receives to the Office of Pediatric Therapeutics, 
established under section 6 of the Best Pharmaceuticals for 
Children Act (Public Law 107-109. In considering the report, 
the Director of the Office of Pediatric Therapeutics, in 
consultation with experts in the Center for Devices and 
Radiological Health, shall provide for periodic review of the 
report by the Pediatric Advisory Committee, including obtaining 
any recommendations of such committee regarding whether the 
Secretary should take action under this Act in response to the 
report.
  (8) In consultation with the Office of Pediatric Therapeutics 
and the Center for Devices and Radiological Health, the 
Secretary shall provide for an annual review by the Pediatric 
Advisory Committee of all devices described in paragraph (6) to 
ensure that the exemption under paragraph (2) remains 
appropriate for the pediatric populations for which it is 
granted.

           *       *       *       *       *       *       *


                        POSTMARKET SURVEILLANCE

  Sec. 522. (a) In General.--The Secretary may by order, or as 
a condition to approval of an application (or a supplement to 
an application) or a product development protocol under section 
515 or as a condition to clearance of a premarket notification 
under section 510(k), for a pediatric population or pediatric 
subpopulation, require a manufacturer to conduct postmarket 
surveillance for any device of the manufacturer which is a 
class II or class III device the failure of which would be 
reasonably likely to have serious adverse health consequences, 
or that is indicated for pediatric populations or 
subpopulations or is expected to have significant use in 
pediatric populations, or which is intended to be--
  (1) * * *

           *       *       *       *       *       *       *

  [(b) Surveillance Approval.--Each]
  (b) Surveillance approval.--
          (1) In general.--Each manufacturer required to 
        conduct a surveillance of a device shall, within 30 
        days of receiving an order from the Secretary 
        prescribing that the manufacturer is required under 
        this section to conduct such surveillance, submit, for 
        the approval of the Secretary, a plan for the required 
        surveillance. The Secretary, within 60 days of the 
        receipt of such plan, shall determine if the person 
        designated to conduct the surveillance has appropriate 
        qualifications and experience to undertake such 
        surveillance and if the plan will result in the 
        collection of useful data that can reveal unforeseen 
        adverse events or other information necessary to 
        protect the public health. [The Secretary, in 
        consultation] Except as provided in paragraph (2), the 
        Secretary, in consultation with the manufacturer, may 
        by order require a prospective surveillance period of 
        up to 36 months. [Any determination] Except as provided 
        in paragraph (2), any determination by the Secretary 
        that a longer period is necessary shall be made by 
        mutual agreement between the Secretary and the 
        manufacturer or, if no agreement can be reached, after 
        the completion of a dispute resolution process as 
        described in section 562.
          (2) Longer studies for pediatric devices.--The 
        Secretary may by order require a prospective 
        surveillance period of more than 36 months with respect 
        to a device that is expected to have significant use in 
        pediatric populations if such period of more than 36 
        months is necessary in order to assess the impact of 
        the device on growth and development, or the effects of 
        growth, development, activity level, or other factors 
        on the safety or efficacy of the device.
  (c) Dispute Resolution.--A manufacturer may request review 
under section 562 of any order or condition requiring 
postmarket surveillance under this section. During the pendency 
of such review, the device subject to such a postmarket 
surveillance order or condition shall not be deemed misbranded 
under section 502(t) or otherwise in violation of such order or 
condition or a related requirement of this Act unless deemed 
necessary to protect the public health.

SEC. 523. ACCREDITED PERSONS.

  (a) * * *

           *       *       *       *       *       *       *

  (c) Duration.--The authority provided by this section 
terminates October 1, [2007] 2012.

           *       *       *       *       *       *       *


Subchapter E--General Provisions Relating to Drugs and Devices

           *       *       *       *       *       *       *


SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

  (a) Establishment.--The Secretary, acting through the 
Commissioner of Food and Drugs, shall enter into collaborative 
agreements, to be known as Critical Path Public-Private 
Partnerships, with one or more eligible entities to implement 
the Critical Path Initiative of the Food and Drug 
Administration by developing innovative, collaborative projects 
in research, education, and outreach for the purpose of 
fostering medical product innovation, enabling the acceleration 
of medical product development, and enhancing medical product 
safety.
  (b) Eligible Entity.--In this section, the term ``eligible 
entity'' means an entity that meets each of the following:
          (1) The entity is--
                  (A) an institution of higher education (as 
                such term is defined in section 101 of the 
                Higher Education Act of 1965); or
                  (B) an organization described in section 
                501(c)(3) of the Internal Revenue Code of 1986 
                and exempt from tax under section 501(a) of 
                such Code.
          (2) The entity has experienced personnel and clinical 
        and other technical expertise in the biomedical 
        sciences.
          (3) The entity demonstrates to the Secretary's 
        satisfaction that the entity is capable of--
                  (A) developing and critically evaluating 
                tools, methods, and processes--
                          (i) to increase efficiency, 
                        predictability, and productivity of 
                        medical product development; and
                          (ii) to more accurately identify the 
                        benefits and risks of new and existing 
                        medical products;
                  (B) establishing partnerships, consortia, and 
                collaborations with health care practitioners 
                and other providers of health care goods or 
                services; pharmacists; pharmacy benefit 
                managers and purchasers; health maintenance 
                organizations and other managed health care 
                organizations; health care insurers; government 
                agencies; patients and consumers; manufacturers 
                of prescription drugs, biological products, 
                diagnostic technologies, and devices; and 
                academic scientists; and
                  (C) securing funding for the projects of a 
                Critical Path Public-Private Partnership from 
                Federal and nonfederal governmental sources, 
                foundations, and private individuals.
  (c) Funding.--The Secretary may not enter into a 
collaborative agreement under subsection (a) unless the 
eligible entity involved provides an assurance that the entity 
will not accept funding for a Critical Path Public-Private 
Partnership project from any organization that manufactures or 
distributes products regulated by the Food and Drug 
Administration unless--
          (1) the entity accepts such funding for such project 
        from 2 or more such organizations; and
          (2) the entity provides assurances in its agreement 
        with the Food and Drug Administration that the results 
        of the Critical Path Public-Private Partnership project 
        will not be influenced by any source of funding.
  (d) Annual Report.--Not later than 18 months after the date 
of the enactment of this section, and annually thereafter, the 
Secretary, in collaboration with the parties to each Critical 
Path Public-Private Partnership, shall submit a report to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives--
          (1) reviewing the operations and activities of the 
        Partnerships in the previous year; and
          (2) addressing such other issues relating to this 
        section as the Secretary determines to be appropriate.
  (e) Definition.--In this section, the term ``medical 
product'' includes a drug, a biological product, a device, and 
any combination of such products.
  (f) Authorization of Appropriations.--To carry out this 
section, there are authorized to be appropriated $5,000,000 for 
fiscal year 2008 and such sums as may be necessary for each of 
fiscal years 2009 through 2012.

           *       *       *       *       *       *       *


                     CHAPTER VII--GENERAL AUTHORITY

SUBCHAPTER A--General Administrative Provisions

           *       *       *       *       *       *       *


                           FACTORY INSPECTION

  Sec. 704. (a) * * *

           *       *       *       *       *       *       *

  (g)(1) [Not later than one year after the date of the 
enactment of this subsection, the Secretary] The Secretary 
shall, subject to the provisions of this subsection, accredit 
persons for the purpose of conducting inspections of 
establishments that manufacture, prepare, propagate, compound, 
or process class II or class III devices, which inspections are 
required under section 510(h) or are inspections of such 
establishments required to register under section 510(i). The 
owner or operator of such an establishment that is eligible 
under paragraph (6) may, from the list published under 
paragraph (4), select an accredited person to conduct such 
inspections.
  (2) [Not later than 180 days after the date of enactment of 
this subsection, the Secretary] The Secretary shall publish in 
the Federal Register criteria to accredit or deny accreditation 
to persons who request to perform the duties specified in 
paragraph (1). Thereafter, the Secretary shall inform those 
requesting accreditation, within 60 days after the receipt of 
such request, whether the request for accreditation is adequate 
for review, and the Secretary shall promptly act on the request 
for accreditation. Any resulting accreditation shall state that 
such person is accredited to conduct inspections at device 
establishments identified in paragraph (1). The accreditation 
of such person shall specify the particular activities under 
this subsection for which such person is accredited. [In the 
first year following the publication in the Federal Register of 
criteria to accredit or deny accreditation to persons who 
request to perform the duties specified in paragraph (1), the 
Secretary shall accredit no more than 15 persons who request to 
perform duties specified in paragraph (1).]
  (3) An accredited person shall, at a minimum, meet the 
following requirements:
          (A) * * *

           *       *       *       *       *       *       *

          (F) Such person shall notify the Secretary of any 
        withdrawal, suspension, restriction, or expiration of 
        certificate of conformance with the quality systems 
        standard referred to in paragraph (7) for any device 
        establishment that such person inspects under this 
        subsection not later than 30 days after such 
        withdrawal, suspension, restriction, or expiration.
          (G) Such person may conduct audits to establish 
        conformance with the quality systems standard referred 
        to in paragraph (7).

           *       *       *       *       *       *       *

  [(6)(A) Subject to subparagraphs (B) and (C), a device 
establishment is eligible for inspections by persons accredited 
under paragraph (2) if the following conditions are met:
          [(i) The Secretary classified the results of the most 
        recent inspection described in paragraph (1) as ``no 
        action indicated'' or ``voluntary action indicated''.
          [(ii) With respect to inspections to be conducted by 
        an accredited person during a 2-year period--
                  [(I) the owner or operator of the 
                establishment submits to the Secretary a notice 
                requesting clearance to use an accredited 
                person to conduct the inspection, and the 
                Secretary provides such clearance; and
                  [(II) such notice identifies the accredited 
                person whom the establishment has selected to 
                conduct the inspection, and the Secretary 
                agrees to the selected accredited person.
          [(iii) With respect to the devices that are 
        manufactured, prepared, propagated, compounded, or 
        processed by the establishment, at least one of such 
        devices is marketed in the United States, and 1 or both 
        of the following additional conditions are met:
                  [(I) At least one of such devices is 
                marketed, or is intended to be marketed, in one 
                or more foreign countries, one of which 
                countries certifies, accredits, or otherwise 
                recognizes the person (accredited under 
                paragraph (2) and identified under clause 
                (ii)(II)) as a person authorized to conduct 
                such inspections of device establishments.
                  [(II) The owner or operator of the 
                establishment submits to the Secretary a 
                statement that the law of a country in which 
                such a device is marketed, or is intended to be 
                marketed, recognizes an inspection of the 
                establishment by the Secretary or by a person 
                accredited under paragraph (2), and not later 
                than 30 days after receiving such statement, 
                the Secretary informs the owner or operator of 
                the establishment that the owner or operator 
                may submit a notice requesting clearance under 
                clause (ii).
          [(iv)(I) In the case of an inspection to be conducted 
        pursuant to section 510(h), persons accredited under 
        paragraph (2) did not conduct inspections of the 
        establishment during the previous 4 years, except that 
        the establishment may petition the Secretary for a 
        waiver of such condition. Such a waiver may be granted 
        only if the petition states a commercial reason for the 
        waiver; the Secretary determines that the public health 
        would be served by granting the waiver; and the 
        Secretary has conducted an inspection of the 
        establishment during the four-year period preceding the 
        date on which the notice under clause (ii) is submitted 
        to the Secretary. Such a waiver is deemed to be granted 
        only if the Secretary has not determined that the 
        public health would not be served by granting the 
        waiver; and the owner or operator of the device 
        establishment has requested in writing, not later than 
        18 months following the most recent inspection of such 
        establishment by a person accredited under paragraph 
        (2), that the Secretary inspect the establishment and 
        the Secretary has not conducted an inspection within 30 
        months after the most recent inspection. With respect 
        to such a waiver that is granted or deemed to be 
        granted, no additional such waiver may be granted or 
        deemed to be granted until after the Secretary has 
        conducted an inspection of the establishment.
          [(II) In the case of an inspection to be conducted of 
        a device establishment required to register pursuant to 
        section 510(i), the Secretary periodically conducts 
        inspections of the establishment.
  [(B)(i) The Secretary shall respond to a notice under 
subparagraph (A) from a device establishment not later than 30 
days after the Secretary receives the notice. Through such 
response, the Secretary shall (I) provide clearance under such 
subparagraph, and agree to the selection of an accredited 
person, or (II) make a request under clause (ii). If the 
Secretary fails to respond to the notice within such 30-day 
period, the establishment is deemed to have such clearance, and 
to have the agreement of the Secretary for such selection.
  [(ii) The request referred to in clause (i)(II) is--
          [(I) a request to the device establishment involved 
        to submit to the Secretary compliance data in 
        accordance with clause (iii); or
          [(II) a request to the establishment, or to the 
        accredited person identified in the notice under 
        subparagraph (A), for information concerning the 
        relationship between the establishment and such 
        accredited person, including information about the 
        number of inspections of the establishment, or other 
        establishments owned or operated by the owner or 
        operator of the establishment, that have been conducted 
        by the accredited person.
The Secretary may make both such requests.
  [(iii) The compliance data to be submitted by a device 
establishment under clause (ii) are data describing whether the 
quality controls of the establishment have been sufficient for 
ensuring consistent compliance with current good manufacturing 
practice within the meaning of section 501(h) and with other 
applicable provisions of this Act. Such data shall include 
complete reports of inspectional findings regarding good 
manufacturing practice or other quality control audits that, 
during the preceding two-year period, were conducted at the 
establishment by persons other than the owner or operator of 
the establishment, together with all other relevant compliance 
data the Secretary deems necessary. Data under the preceding 
sentence shall demonstrate to the Secretary whether the 
establishment has facilitated consistent compliance by promptly 
correcting any compliance problems identified in such 
inspections.
  [(iv)(I) Not later than 60 days after receiving compliance 
data under clause (iii) from a device establishment, the 
Secretary shall provide or deny clearance under subparagraph 
(A). The Secretary may deny clearance if the Secretary 
determines that the establishment has failed to demonstrate 
consistent compliance for purposes of clause (iii). The 
Secretary shall provide to the establishment a statement of 
such reasons for such determination. If the Secretary fails to 
provide such statement to the establishment within such 60-day 
period, the establishment is deemed to have such clearance.
  [(II) If, during the two-year period following clearance 
under subparagraph (A), the Secretary determines that the 
device establishment is substantially not in compliance with 
this Act, the Secretary may, after notice and a written 
response, notify the establishment that the eligibility of the 
establishment for the inspections by accredited persons has 
been suspended.
  [(v)(I) A request to an accredited person under clause 
(ii)(II) may not seek any information that is not required to 
be maintained by such person in records under subsection 
(f)(1). Not later than 60 days after receiving the information 
sought by the request, the Secretary shall agree to, or reject, 
the selection of such person by the device establishment 
involved. The Secretary may reject the selection if the 
Secretary provides to the establishment a statement of the 
reasons for such rejection. Reasons for the rejection may 
include that the establishment or the accredited person, as the 
case may be, has failed to fully respond to the request, or 
that the Secretary has concerns regarding the relationship 
between the establishment and such accredited person. If within 
such 60-day period the Secretary fails to agree to or reject 
the selection in accordance with this subclause, the Secretary 
is deemed to have agreed to the selection.
  [(II) If the Secretary rejects the selection of an accredited 
person by a device establishment, the establishment may make an 
additional selection of an accredited person by submitting to 
the Secretary a notice that identifies the additional 
selection. Clauses (i) and (ii), and subclause (I) of this 
clause, apply to the selection of an accredited person through 
a notice under the preceding sentence in the same manner and to 
the same extent as such provisions apply to a selection of an 
accredited person through a notice under subparagraph (A).
  [(vi) In the case of a device establishment that under clause 
(iv) is denied clearance under subparagraph (A), or whose 
selection of an accredited person is rejected under clause (v), 
the Secretary shall designate a person to review the findings 
of the Secretary under such clause if, during the 30-day period 
beginning on the date on which the establishment receives the 
findings, the establishment requests the review. The review 
shall commence not later than 30 days after the establishment 
requests the review, unless the Secretary and the establishment 
otherwise agree.
  [(C)(i) In the case of a device establishment for which the 
Secretary classified the results of the most recent inspection 
of the establishment by a person accredited under paragraph (2) 
as ``official action indicated'', the establishment, if 
otherwise eligible under subparagraph (A), is eligible for 
further inspections by persons accredited under such paragraph 
if (I) the Secretary issues a written statement to the owner or 
operator of the establishment that the violations leading to 
such classification have been resolved, and (II) the Secretary, 
either upon the Secretary's own initiative or a petition of the 
owner or operator of the establishment, notifies the 
establishment that it has clearance to use an accredited person 
for the inspections. The Secretary shall respond to such 
petition within 30 days after the receipt of the petition.
  [(ii) If the Secretary denies a petition under clause (i), 
the device establishment involved may, after the expiration of 
one year after such denial, again petition the Secretary for a 
determination of eligibility for inspection by persons 
accredited by the Secretary under paragraph (2). If the 
Secretary denies such petition, the Secretary shall provide the 
establishment with such reasons for such denial within 60 days 
after the denial. If, as of the expiration of 48 months after 
the receipt of the first petition, the establishment has not 
been inspected by the Secretary, the establishment is eligible 
for further inspections by accredited persons.]
  (6)(A) Subject to subparagraphs (B) and (C), a device 
establishment is eligible for inspection by persons accredited 
under paragraph (2) if the following conditions are met:
          (i) The Secretary classified the results of the most 
        recent inspection of the establishment as ``no action 
        indicated'' or ``voluntary action indicated''.
          (ii) With respect to inspections of the establishment 
        to be conducted by an accredited person, the owner or 
        operator of the establishment submits to the Secretary 
        a notice that--
                  (I) provides the date of the last inspection 
                of the establishment by the Secretary and the 
                classification of that inspection;
                  (II) states the intention of the owner or 
                operator to use an accredited person to conduct 
                inspections of the establishment;
                  (III) identifies the particular accredited 
                person the owner or operator intends to select 
                to conduct such inspections; and
                  (IV) includes a certification that, with 
                respect to the devices that are manufactured, 
                prepared, propagated, compounded, or processed 
                in the establishment--
                          (aa) at least 1 of such devices is 
                        marketed in the United States; and
                          (bb) at least 1 of such devices is 
                        marketed, or is intended to be 
                        marketed, in 1 or more foreign 
                        countries, 1 of which countries 
                        certifies, accredits, or otherwise 
                        recognizes the person accredited under 
                        paragraph (2) and identified under 
                        subclause (III) as a person authorized 
                        to conduct inspections of device 
                        establishments.
  (B)(i) Except with respect to the requirement of subparagraph 
(A)(i), a device establishment is deemed to have clearance to 
participate in the program and to use the accredited person 
identified in the notice under subparagraph (A)(ii) for 
inspections of the establishment unless the Secretary, not 
later than 30 days after receiving such notice, issues a 
response that--
                  (I) denies clearance to participate as 
                provided under subparagraph (C); or
                  (II) makes a request under clause (ii).
          (ii) The Secretary may request from the owner or 
        operator of a device establishment in response to the 
        notice under subparagraph (a)(ii) with respect to the 
        establishment, or from the particular accredited person 
        identified in such notice--
                          (I) compliance data for the 
                        establishment in accordance with clause 
                        (iii)(I); or
                          (II) information concerning the 
                        relationship between the owner or 
                        operator of the establishment and the 
                        accredited person identified in such 
                        notice in accordance with clause 
                        (iii)(II).
                        The owner or operator of the 
                        establishment, or such accredited 
                        person, as the case may be, shall 
                        respond to such a request not later 
                        than 60 days after receiving such 
                        request.
          (iii)(I) The compliance data to be submitted by the 
        owner or operation of a device establishment in 
        response to a request under clause (ii)(I) are data 
        describing whether the quality controls of the 
        establishment have been sufficient for ensuring 
        consistent compliance with current good manufacturing 
        practice within the meaning of section 501(h) and with 
        other applicable provisions of this Act. Such data 
        shall include complete reports of inspectional findings 
        regarding good manufacturing practice or other quality 
        control audits that, during the preceding 2-year 
        period, were conducted at the establishment by persons 
        other than the owner or operator of the establishment, 
        together with all other compliance data the Secretary 
        deems necessary. Data under the preceding sentence 
        shall demonstrate to the Secretary whether the 
        establishment has facilitated consistent compliance by 
        promptly correcting any compliance problems identified 
        in such inspections.
                  (II) A request to an accredited person under 
                clause (ii)(II) may not seek any information 
                that is not required to be maintained by such 
                person in records under subsection (f)(1).
          (iv) A device establishment is deemed to have 
        clearance to participate in the program and to use the 
        accredited person identified in the notice under 
        subparagraph (A)(ii) for inspections of the 
        establishment unless the Secretary, not later than 60 
        days after receiving the information requested under 
        clause (ii), issues a response that denies clearance to 
        participate as provided under subparagraph (C).
  (C)(i) The Secretary may deny clearance to a device 
establishment if the Secretary has evidence that the 
certification under subparagraph (A)(ii)(IV) is untrue and the 
Secretary provides to the owner or operator of the 
establishment a statement summarizing such evidence.
          (ii) The Secretary may deny clearance to a device 
        establishment if the Secretary determines that the 
        establishment has failed to demonstrate consistent 
        compliance for purposes of subparagraph (B)(iii)(I) and 
        the Secretary provides to the owner or operator of the 
        establishment a statement of the reasons for such 
        determination.
          (iii)(I) The Secretary may reject the selection of 
        the accredited person identified in the notice under 
        subparagraph (A)(ii) if the Secretary provides to the 
        owner or operator of the establishment a statement of 
        the reasons for such rejection. Reasons for the 
        rejection may include that the establishment or the 
        accredited person, as the case may be, has failed to 
        fully respond to the request, or that the Secretary has 
        concerns regarding the relationship between the 
        establishment and such accredited person.
                  (II) If the Secretary rejects the selection 
                of an accredited person by the owner or 
                operator of a device establishment, the owner 
                or operator may make an additional selection of 
                an accredited person by submitting to the 
                Secretary a notice that identifies the 
                additional selection. Clauses (i) and (ii) of 
                subparagraph (B), and subclause (I) of this 
                clause, apply to the selection of an accredited 
                person through a notice under the preceding 
                sentence in the same manner and to the same 
                extent as such provisions apply to a selection 
                of an accredited person through a notice under 
                subparagraph (A)(ii).
          (iv) In the case of a device establishment that is 
        denied clearance under clause (i) or (ii) or with 
        respect to which the selection of the accredited person 
        is rejected under clause (iii), the Secretary shall 
        designate a person to review the statement of reasons, 
        or statement summarizing such evidence, as the case may 
        be, of the Secretary under such clause if, during the 
        30-day period beginning on the date on which the owner 
        or operator of the establishment receives such 
        statement, the owner or operator requests the review. 
        The review shall commence not later than 30 days after 
        the owner or operator requests the review, unless the 
        Secretary and the owner or operator otherwise agree.
  (7)[(A) Persons accredited under paragraph (2) to conduct 
inspections shall record in writing their inspection 
observations and shall present the observations to the device 
establishment's designated representative and describe each 
observation. Additionally, such accredited person shall prepare 
an inspection report (including for inspections classified as 
``no action indicated'') in a form and manner consistent with 
such reports prepared by employees and officials designated by 
the Secretary to conduct inspections.] (A) Persons accredited 
under paragraph (2) to conduct inspections shall record in 
writing their inspection observations and shall present the 
observations to the device establishment's designated 
representative and describe each observation. Additionally, 
such accredited person shall prepare an inspection report in a 
form and manner designated by the Secretary to conduct 
inspections, taking into consideration the goals of 
international harmonization of quality systems standards. Any 
official classification of the inspection shall be determined 
by the Secretary.

           *       *       *       *       *       *       *

  (F) For the purpose of setting risk-based inspectional 
priorities, the Secretary shall accept voluntary submissions of 
reports of audits assessing conformance with appropriate 
quality systems standards set by the International Organization 
for Standardization (ISO) and identified by the Secretary in 
public notice. If the owner or operator of an establishment 
elects to submit audit reports under this subparagraph, the 
owner or operator shall submit all such audit reports with 
respect to the establishment during the preceding 2-year 
periods.

           *       *       *       *       *       *       *

  (10)(A) * * *

           *       *       *       *       *       *       *

  (C) For purposes of this paragraph:
          (i) * * *

           *       *       *       *       *       *       *

          (iii) The term ``adjusted base amount'', with respect 
        to applicability to fiscal year 2004 or any subsequent 
        fiscal year, means the adjusted [based] base amount 
        applicable to the preceding year increased by 5 
        percent.

           *       *       *       *       *       *       *


SEC. 712. CONFLICTS OF INTEREST.

  (a) Definitions.--For purposes of this section:
          (1) Advisory committee.--The term ``advisory 
        committee'' means an advisory committee under the 
        Federal Advisory Committee Act that provides advice or 
        recommendations to the Secretary regarding activities 
        of the Food and Drug Administration.
          (2) Financial interest.--The term ``financial 
        interest'' means a financial interest under section 
        208(a) of title 18, United States Code.
  (b) Appointments to Advisory Committees.--
          (1) Recruitment.--
                  (A) In general.--Given the importance of 
                advisory committees to the review process at 
                the Food and Drug Administration, the 
                Secretary, through the Office of Women's 
                Health, the Office of Orphan Product 
                Development, the Office of Pediatric 
                Therapeutics, and other offices within the Food 
                and Drug Administration with relevant 
                expertise, shall develop and implement 
                strategies on effective outreach to potential 
                members of advisory committees at universities, 
                colleges, other academic research centers, 
                professional and medical societies, and patient 
                and consumer groups. The Secretary shall seek 
                input from professional medical and scientific 
                societies to determine the most effective 
                informational and recruitment activities. The 
                Secretary shall also take into account the 
                advisory committees with the greatest number of 
                vacancies.
                  (B) Recruitment activities.--The recruitment 
                activities under subparagraph (A) may include--
                          (i) advertising the process for 
                        becoming an advisory committee member 
                        at medical and scientific society 
                        conferences;
                          (ii) making widely available, 
                        including by using existing electronic 
                        communications channels, the contact 
                        information for the Food and Drug 
                        Administration point of contact 
                        regarding advisory committee 
                        nominations; and
                          (iii) developing a method through 
                        which an entity receiving funding from 
                        the National Institutes of Health, the 
                        Agency for Healthcare Research and 
                        Quality, the Centers for Disease 
                        Control and Prevention, or the Veterans 
                        Health Administration can identify a 
                        person who the Food and Drug 
                        Administration can contact regarding 
                        the nomination of individuals to serve 
                        on advisory committees.
          (2) Evaluation and criteria.--When considering a term 
        appointment to an advisory committee, the Secretary 
        shall review the expertise of the individual and the 
        financial disclosure report filed by the individual 
        pursuant to the Ethics in Government Act of 1978 for 
        each individual under consideration for the 
        appointment, so as to reduce the likelihood that an 
        appointed individual will later require a written 
        determination as referred to in section 208(b)(1) of 
        title 18, United States Code, a written certification 
        as referred to in section 208(b)(3) of title 18, United 
        States Code, or a waiver as referred to in subsection 
        (c)(3) of this section for service on the committee at 
        a meeting of the committee.
          (3) Participation of guest expert with financial 
        interest.--Notwithstanding any other provision of this 
        section, an individual with a financial interest with 
        respect to any matter considered by an advisory 
        committee may be allowed to participate in a meeting of 
        an advisory committee as a guest expert if the 
        Secretary determines that the individual has particular 
        expertise required for the meeting. An individual 
        participating as a guest expert may provide information 
        and expert opinion, but shall not participate in the 
        discussion or voting by the members of the advisory 
        committee.
  (c) Granting and Disclosure of Waivers.--
          (1) In general.--Prior to a meeting of an advisory 
        committee regarding a ``particular matter'' (as that 
        term is used in section 208 of title 18, United States 
        Code), each member of the committee who is a full-time 
        Government employee or special Government employee 
        shall disclose to the Secretary financial interests in 
        accordance with subsection (b) of such section 208.
          (2) Financial interest of advisory committee member 
        or family member.--No member of an advisory committee 
        may vote with respect to any matter considered by the 
        advisory committee if such member (or an immediate 
        family member of such member) has a financial interest 
        that could be affected by the advice given to the 
        Secretary with respect to such matter, excluding 
        interests exempted in regulations issued by the 
        Director of the Office of Government Ethics as too 
        remote or inconsequential to affect the integrity of 
        the services of the Government officers or employees to 
        which such regulations apply.
          (3) Waiver.--The Secretary may grant a waiver of the 
        prohibition in paragraph (2) if such waiver is 
        necessary to afford the advisory committee essential 
        expertise.
          (4) Limitations.--
                  (A) One waiver per committee meeting.--
                Notwithstanding any other provision of this 
                section, with respect to each advisory 
                committee, the Secretary shall not grant more 
                than 1 waiver under paragraph (3) per committee 
                meeting.
                  (B) Scientific work.--The Secretary may not 
                grant a waiver under paragraph (3) for a member 
                of an advisory committee when the member's own 
                scientific work is involved.
          (5) Disclosure of waiver.--Notwithstanding section 
        107(a)(2) of the Ethics in Government Act (5 U.S.C. 
        App.), the following shall apply:
                  (A) 15 or more days in advance.--As soon as 
                practicable, but in no case later than 15 days 
                prior to a meeting of an advisory committee to 
                which a written determination as referred to in 
                section 208(b)(1) of title 18, United States 
                Code, a written certification as referred to in 
                section 208(b)(3) of title 18, United States 
                Code, or a waiver as referred to in paragraph 
                (3) applies, the Secretary shall disclose 
                (other than information exempted from 
                disclosure under section 552 of title 5, United 
                States Code, and section 552a of title 5, 
                United States Code (popularly known as the 
                Freedom of Information Act and the Privacy Act 
                of 1974, respectively)) on the Internet website 
                of the Food and Drug Administration--
                          (i) the type, nature, and magnitude 
                        of the financial interests of the 
                        advisory committee member to which such 
                        determination, certification, or waiver 
                        applies; and
                          (ii) the reasons of the Secretary for 
                        such determination, certification, or 
                        waiver.
                  (B) Less than 30 days in advance.--In the 
                case of a financial interest that becomes known 
                to the Secretary less than 30 days prior to a 
                meeting of an advisory committee to which a 
                written determination as referred to in section 
                208(b)(1) of title 18, United States Code, a 
                written certification as referred to in section 
                208(b)(3) of title 18, United States Code, or a 
                waiver as referred to in paragraph (3) applies, 
                the Secretary shall disclose (other than 
                information exempted from disclosure under 
                section 552 of title 5, United States Code, and 
                section 552a of title 5, United States Code) on 
                the Internet website of the Food and Drug 
                Administration, the information described in 
                clauses (i) and (ii) of subparagraph (A) as 
                soon as practicable after the Secretary makes 
                such determination, certification, or waiver, 
                but in no case later than the date of such 
                meeting.
  (d) Public Record.--The Secretary shall ensure that the 
public record and transcript of each meeting of an advisory 
committee includes the disclosure required under subsection 
(c)(5) (other than information exempted from disclosure under 
section 552 of title 5, United States Code, and section 552a of 
title 5, United States Code).
  (e) Annual Report.--Not later than February 1 of each year, 
the Secretary shall submit to the Committee on Appropriations 
and the Committee on Health, Education, Labor, and Pensions of 
the Senate, and the Committee on Appropriations and the 
Committee on Energy and Commerce of the House of 
Representatives a report that describes--
          (1) with respect to the fiscal year that ended on 
        September 30 of the previous year, the number of 
        vacancies on each advisory committee, the number of 
        nominees received for each committee, and the number of 
        such nominees willing to serve;
          (2) with respect to such year, the aggregate number 
        of disclosures required under subsection (c)(5) for 
        each meeting of each advisory committee and the 
        percentage of individuals to whom such disclosures did 
        not apply who served on such committee for each such 
        meeting;
          (3) with respect to such year, the number of times 
        the disclosures required under subsection (c)(5) 
        occurred under subparagraph (B) of such subsection; and
          (4) how the Secretary plans to reduce the number of 
        vacancies reported under paragraph (1) during the 
        fiscal year following such year, and mechanisms to 
        encourage the nomination of individuals for service on 
        an advisory committee, including those who are 
        classified by the Food and Drug Administration as 
        academicians or practitioners.
  (f) Periodic Review of Guidance.--Not less than once every 5 
years, the Secretary shall review guidance of the Food and Drug 
Administration regarding conflict of interest waiver 
determinations with respect to advisory committees and update 
such guidance as necessary.

           *       *       *       *       *       *       *


Subchapter C--Fees

           *       *       *       *       *       *       *


                     PART 2--FEES RELATING TO DRUGS

SEC. 735. DEFINITIONS.

  For purposes of this subchapter:
          (1) The term ``human drug application'' means an 
        application for--
                  (A) approval of a new drug submitted under 
                section [505(b)(1),] 505(b), or
                  [(B) approval of a new drug submitted under 
                section 505(b)(2) after September 30, 1992, 
                which requests approval of--
                          [(i) a molecular entity which is an 
                        active ingredient (including any salt 
                        or ester of an active ingredient), or
                          [(ii) an indication for a use,
                that had not been approved under an application 
                submitted under section 505(b), or]
                  [(C)] (B) licensure of a biological product 
                under section 351 of the Public Health Service 
                Act.

           *       *       *       *       *       *       *

          (3) The term ``prescription drug product'' means a 
        specific strength or potency of a drug in final dosage 
        form--
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) which is on the list of products 
                described in section [505(j)(7)(A)] 
                505(j)(7)(A) (not including the discontinued 
                section of such list), or is on a list created 
                and maintained by the Secretary of products 
                approved under human drug applications under 
                section 351 of the Public Health Service Act 
                (not including the discontinued section of such 
                list).

           *       *       *       *       *       *       *

          (4) The term ``final dosage form'' means, with 
        respect to a prescription drug product, a finished 
        dosage form which is approved for administration to a 
        patient without substantial further manufacturing (such 
        as capsules, tablets, or lyophilized products before 
        reconstitution).

           *       *       *       *       *       *       *

          (6) The term ``process for the review of human drug 
        applications'' means the following activities of the 
        Secretary with respect to the review of human drug 
        applications and supplements:
                  (A) * * *

           *       *       *       *       *       *       *

                  [(F) In the case of drugs approved after 
                October 1, 2002, under human drug applications 
                or supplements: collecting, developing, and 
                reviewing safety information on the drugs, 
                including adverse event reports, during a 
                period of time after approval of such 
                applications or supplements, not to exceed 
                three years.]
                  (F) Postmarket safety activities with respect 
                to drugs approved under human drug applications 
                or supplements, including the following 
                activities:
                          (i) Collecting, developing, and 
                        reviewing safety information on 
                        approved drugs, including adverse event 
                        reports.
                          (ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology 
                        systems.
                          (iii) Developing and using improved 
                        analytical tools to assess potential 
                        safety problems, including access to 
                        external data bases.
                          (iv) Preparing and making publicly 
                        available (including on the website of 
                        the Food and Drug Administration) a 
                        summary analysis of the adverse drug 
                        reaction reports received for recently 
                        approved drugs, including 
                        identification of any new risks not 
                        previously identified, potential new 
                        risks, or known risks reported in 
                        unusual number not previously 
                        identified within 18 months of the 
                        drug's initial marketing or after 
                        exposure of 10,000 individuals to the 
                        drug, whichever is later.
                          (v) Conducting regular, bi-weekly 
                        screening of the Adverse Event 
                        Reporting System database and 
                        developing a report every 15 days on 
                        any new safety concerns.
                          (vi) Ensuring that the reports 
                        available to the public under the 
                        Adverse Event Reporting System are 
                        updated at least every 6 months.
                          (vii) Reporting to the Congress on--
                                  (I) the recommendations 
                                received in consultations with, 
                                and reports from, the Office of 
                                Surveillance and Epidemiology 
                                within the Food and Drug 
                                Administration on postmarket 
                                safety activities;
                                  (II) a description of the 
                                actions taken on those 
                                recommendations; and
                                  (III) if no action is taken, 
                                or a different action is taken 
                                relative to the action 
                                recommended by the Office of 
                                Surveillance and Epidemiology, 
                                an explanation of why no action 
                                or a different action was 
                                taken.
                          (viii) On an annual basis, reviewing 
                        the entire backlog of postmarket safety 
                        commitments to determine which 
                        commitments require revision or should 
                        be eliminated, reporting to the 
                        Congress on these determinations, and 
                        assigning start dates and estimated 
                        completion dates for such commitments.
                          (ix) Developing postmarket safety 
                        performance measures, including those 
                        listed in clauses (iv) through (viii), 
                        that are as measurable and rigorous as 
                        the ones already developed for 
                        premarket review.
                  (G) Activities relating to the support of 
                studies of drugs on pediatric populations under 
                section 505A(n)(1).

           *       *       *       *       *       *       *

          (8) The term ``adjustment factor'' applicable to a 
        fiscal year is the Consumer Price Index for all urban 
        consumers (all items; United States city average) for 
        [April of the preceding fiscal year] October of the 
        preceding fiscal year divided by such Index for [April 
        1997] October 1996.
          (9) The term ``person'' includes an affiliate 
        thereof.
          (10) The term ``active'', with respect to a 
        commercial investigational new drug application, means 
        such an application to which information was submitted 
        during the relevant period.
          [(9)] (11) The term ``affiliate'' means a business 
        entity that has a relationship with a second business 
        entity if, directly or indirectly--
                  (A) * * *

           *       *       *       *       *       *       *


SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.

  (a) Types of Fees.--Beginning in fiscal year [2003] 2008, the 
Secretary shall assess and collect fees in accordance with this 
section as follows:
          (1) Human drug application and supplement fee.--
                  (A) In general.--Each person that submits, on 
                or after September 1, 1992, a human drug 
                application or a supplement shall be subject to 
                a fee as follows:
                          (i) A fee established under 
                        subsection [(c)(4)] (c)(5) for a human 
                        drug application for which clinical 
                        data (other than bioavailability or 
                        bioequivalence studies) with respect to 
                        safety or effectiveness are required 
                        for approval.
                          (ii) A fee established under 
                        subsection [(c)(4)] (c)(5) for a human 
                        drug application for which clinical 
                        data with respect to safety or 
                        effectiveness are not required or a 
                        supplement for which clinical data 
                        (other than bioavailability or 
                        bioequivalence studies) with respect to 
                        safety or effectiveness are required. 
                        Such fee shall be half of the amount of 
                        the fee established under clause (i).

           *       *       *       *       *       *       *

                  (D) Refund of fee if application refused for 
                filing or withdrawn before filing.--The 
                Secretary shall refund 75 percent of the fee 
                paid under subparagraph (B) for any application 
                or supplement which is refused for filing or 
                withdrawn without a waiver before filing.
                  (E) Fees for applications previously refused 
                for filing or withdrawn before filing.--A human 
                drug application or supplement that was 
                submitted but was refused for filing, or was 
                withdrawn before being accepted or refused for 
                filing, shall be subject to the full fee under 
                subparagraph (A) upon being resubmitted or 
                filed over protest, unless the fee is waived or 
                reduced under subsection (d).
                  [(E)] (F) Exception for designated orphan 
                drug or indication.--A human drug application 
                for a prescription drug product that has been 
                designated as a drug for a rare disease or 
                condition pursuant to section 526 shall not be 
                subject to a fee under subparagraph (A), unless 
                the human drug application includes an 
                indication for other than a rare disease or 
                condition. A supplement proposing to include a 
                new indication for a rare disease or condition 
                in a human drug application shall not be 
                subject to a fee under subparagraph (A), if the 
                drug has been designated pursuant to section 
                526 as a drug for a rare disease or condition 
                with regard to the indication proposed in such 
                supplement.
                  [(F)] (G) Refund of fee if application 
                withdrawn.--If an application or supplement is 
                withdrawn after the application or supplement 
                was filed, the Secretary may refund the fee or 
                a portion of the fee if no substantial work was 
                performed on the application or supplement 
                after the application or supplement was filed. 
                The Secretary shall have the sole discretion to 
                refund a fee or a portion of the fee under this 
                subparagraph. A determination by the Secretary 
                concerning a refund under this paragraph shall 
                not be reviewable.
          (2) Prescription drug establishment fee.--
                  (A) In general.--Except as provided in 
                [subparagraph (B)] subparagraphs (B) and (C), 
                each person that--
                          (i) * * *

           *       *       *       *       *       *       *

                shall be assessed an annual fee established 
                under subsection [(c)(4)] (c)(5) for each 
                prescription drug establishment listed in its 
                approved human drug application as an 
                establishment that manufactures the 
                prescription drug product named in the 
                application. The annual establishment fee shall 
                be assessed in each fiscal year in which the 
                prescription drug product named in the 
                application is assessed a fee under paragraph 
                (3) unless the prescription drug establishment 
                listed in the application does not engage in 
                the manufacture of the prescription drug 
                product during the fiscal year. The 
                establishment fee shall be payable on or before 
                October 1 of each year. Each such establishment 
                shall be assessed only one fee per 
                establishment, notwithstanding the number of 
                prescription drug products manufactured at the 
                establishment. In the event an establishment is 
                listed in a human drug application by more than 
                one applicant, the establishment fee for the 
                fiscal year shall be divided equally and 
                assessed among the applicants whose 
                prescription drug products are manufactured by 
                the establishment during the fiscal year and 
                assessed product fees under paragraph (3).

           *       *       *       *       *       *       *

                  (C) Special rules for positron emission 
                tomography drugs.--
                          (i) In general.--Except as provided 
                        in clause (ii), each person who is 
                        named as the applicant in an approved 
                        human drug application for a positron 
                        emission tomography drug shall be 
                        subject under subparagraph (A) to one-
                        sixth of an annual establishment fee 
                        with respect to each such establishment 
                        identified in the application as 
                        producing positron emission tomography 
                        drugs under the approved application.
                          (ii) Exception from annual 
                        establishment fee.--Each person who is 
                        named as the applicant in an 
                        application described in clause (i) 
                        shall not be assessed an annual 
                        establishment fee for a fiscal year if 
                        the person certifies to the Secretary, 
                        at a time specified by the Secretary 
                        and using procedures specified by the 
                        Secretary, that--
                                  (I) the person is a not-for-
                                profit medical center that has 
                                only 1 establishment for the 
                                production of positron emission 
                                tomography drugs; and
                                  (II) at least 95 percent of 
                                the total number of doses of 
                                each positron emission 
                                tomography drug produced by 
                                such establishment during such 
                                fiscal year will be used within 
                                the medical center.
                          (iii) Definition.--For purposes of 
                        this subparagraph, the term ``positron 
                        emission tomography drug'' has the 
                        meaning given to the term ``compounded 
                        positron emission tomography drug'' in 
                        section 201(ii), except that 
                        subparagraph (1)(B) of such section 
                        shall not apply.

           *       *       *       *       *       *       *

          (3) Prescription drug product fee.--
                  (A) In general.--Except as provided in 
                subparagraph (B), each person who is named as 
                the applicant in a human drug application, and 
                who, after September 1, 1992, had pending 
                before the Secretary a human drug application 
                or supplement, shall pay for each such 
                prescription drug product the annual fee 
                established under subsection [(c)(4)] (c)(5). 
                Such fee shall be payable on or before October 
                1 of each year. Such fee shall be paid only 
                once for each product for a fiscal year in 
                which the fee is payable.

           *       *       *       *       *       *       *

  [(b) Fee Revenue Amounts.--Except as provided in subsections 
(c), (d), (f), and (g), fees under subsection (a) shall be 
established to generate the following revenue amounts:

----------------------------------------------------------------------------------------------------------------
                                             Fiscal Year   Fiscal Year   Fiscal Year   Fiscal Year   Fiscal Year
           [Type of Fee Revenue                 2003          2004          2005          2006          2007
----------------------------------------------------------------------------------------------------------------
Application/Supplement....................   $74,300,000   $77,000,000   $84,000,000   $86,434,000   $86,434,000
Establishment.............................   $74,300,000   $77,000,000   $84,000,000   $86,433,000   $86,433,000
Product...................................   $74,300,000   $77,000,000   $84,000,000   $86,433,000   $86,433,000
Total Fee Revenue.........................  $222,900,000  $231,000,000  $252,000,000  $259,300,000  $259,300,000
----------------------------------------------------------------------------------------------------------------

If, after the date of the enactment of the Prescription Drug 
User Fee Amendments of 2002 , legislation is enacted requiring 
the Secretary to fund additional costs of the retirement of 
Federal personnel, fee revenue amounts shall be increased in 
each year by the amount necessary to fully fund the portion of 
such additional costs that are attributable to the process for 
the review of human drug applications.]
  (b) Fee Revenue Amounts.--
          (1) In general.--For each of the fiscal years 2008 
        through 2012, fees under subsection (a) shall, except 
        as provided in subsections (c), (d), (f), and (g), be 
        established to generate a total revenue amount under 
        such subsection that is equal to the sum of--
                  (A) $392,783,000; and
                  (B) an amount equal to the modified workload 
                adjustment factor for fiscal year 2007 (as 
                determined under paragraph (3)).
          (2) Types of fees.--Of the total revenue amount 
        determined for a fiscal year under paragraph (1)--
                  (A) one-third shall be derived from fees 
                under subsection (a)(1) (relating to human drug 
                applications and supplements);
                  (B) one-third shall be derived from fees 
                under subsection (a)(2) (relating to 
                prescription drug establishments); and
                  (C) one-third shall be derived from fees 
                under subsection (a)(3) (relating to 
                prescription drug products).
          (3) Modified workload adjustment factor for fiscal 
        year 2007.--For purposes of paragraph (1)(B), the 
        Secretary shall determine the modified workload 
        adjustment factor by determining the dollar amount that 
        results from applying the methodology that was in 
        effect under subsection (c)(2) for fiscal year 2007 to 
        the amount $354,893,000, except that, with respect to 
        the portion of such determination that is based on the 
        change in the total number of commercial 
        investigational new drug applications, the Secretary 
        shall count the number of such applications that were 
        active during the most recent 12-month period for which 
        data on such submissions is available.
          (4) Additional fee revenues for drug safety.--
                  (A) In general.--For each of the fiscal years 
                2008 through 2012, paragraph (1)(A) shall, 
                subject to subparagraph (C), be applied by 
                substituting the amount determined under 
                subparagraph (B) for ``$392,783,000''.
          (B) Amount determined.--For each of the fiscal years 
        2008 through 2012, the amount determined under this 
        subparagraph is the sum of--
                          (i) $392,783,000; plus
                          (ii) an amount equal to--
                                  (I)(aa) for fiscal year 2008, 
                                $25,000,000;
                                  (bb) for fiscal year 2009, 
                                $35,000,000;
                                  (cc) for fiscal year 2010, 
                                $45,000,000;
                                  (dd) for fiscal year 2011, 
                                $55,000,000; and
                                  (ee) for fiscal year 2012, 
                                $65,000,000; minus
                                  (II) the amount equal to the 
                                excess amount in item (bb), 
                                provided that--
                                          (aa) the amount of 
                                        the total appropriation 
                                        for the Food and Drug 
                                        Administration for such 
                                        fiscal year (excluding 
                                        the amount of fees 
                                        appropriated for such 
                                        fiscal year) exceeds 
                                        the amount of the total 
                                        appropriation for the 
                                        Food and Drug 
                                        Administration for 
                                        fiscal year 2007 
                                        (excluding the amount 
                                        of fees appropriated 
                                        for such fiscal year), 
                                        adjusted as provided 
                                        under subsection 
                                        (c)(1); and
                                          (bb) the amount of 
                                        the total 
                                        appropriations for the 
                                        process of human drug 
                                        review at the Food and 
                                        Drug Administration for 
                                        such fiscal year 
                                        (excluding the amount 
                                        of fees appropriated 
                                        for such fiscal year) 
                                        exceeds the amount of 
                                        appropriations for the 
                                        process of human drug 
                                        review at the Food and 
                                        Drug Administration for 
                                        fiscal year 2007 
                                        (excluding the amount 
                                        of fees appropriated 
                                        for such fiscal year), 
                                        adjusted as provided 
                                        under subsection 
                                        (c)(1).
                                In making the adjustment under 
                                subclause (II) for any of 
                                fiscal years 2008 through 2012, 
                                subsection (c)(1) shall be 
                                applied by substituting 
                                ``2007'' for ``2008''.
          (C) Limitation.--This paragraph shall not apply for 
        any fiscal year if the amount described under 
        subparagraph (B)(ii) is less than 0.
  (c) Adjustments.--
          (1) Inflation adjustment.--[The revenues established 
        in subsection (b)] For fiscal year 2009 and subsequent 
        fiscal years, the revenues established in subsection 
        (b) shall be adjusted by the Secretary by notice, 
        published in the Federal Register, for a fiscal year to 
        reflect the greater of--
                  (A) the total percentage change that occurred 
                in the Consumer Price Index for all urban 
                consumers (all items; U.S. city average) for 
                the 12 month period ending June 30 preceding 
                the fiscal year for which fees are being 
                established, [or]
                  (B) the total percentage change for the 
                previous fiscal year in basic pay under the 
                General Schedule in accordance with section 
                5332 of title 5, United States Code, as 
                adjusted by any locality-based comparability 
                payment pursuant to section 5304 of such title 
                for Federal employees stationed in the District 
                of Columbia[.], or
                  (C) the average annual change in the cost, 
                per full-time equivalent position of the Food 
                and Drug Administration, of all personnel 
                compensation and benefits paid with respect to 
                such positions for the first 5 years of the 
                preceding 6 fiscal years.
        The adjustment made each fiscal year by this subsection 
        will be added on a compounded basis to the sum of all 
        adjustments made each fiscal year after [fiscal year 
        2003] fiscal year 2008 under this subsection.
          (2) Workload adjustment.--[Beginning with fiscal year 
        2004,] For fiscal year 2009 and subsequent fiscal 
        years, after the fee revenues established in subsection 
        (b) are adjusted for a fiscal year for inflation in 
        accordance with paragraph (1), the fee revenues shall 
        be adjusted further for such fiscal year to reflect 
        changes in the workload of the Secretary for the 
        process for the review of human drug applications. With 
        respect to such adjustment:
                  (A) The adjustment shall be determined by the 
                Secretary based on a weighted average of the 
                change in the total number of [human drug 
                applications, commercial investigational new 
                drug applications,] human drug applications 
                (adjusted for changes in review activities, as 
                described in the notice that the Secretary is 
                required to publish in the Federal Register 
                under this subparagraph),efficacy supplements, 
                and manufacturing supplements submitted to the 
                Secretary, and the change in the total number 
                of active commercial investigational new drug 
                applications (adjusted for changes in review 
                activities, as so described) during the most 
                recent 12-month period for which data on such 
                submissions is available. The Secretary shall 
                publish in the Federal Register the fee 
                revenues and fees resulting from the adjustment 
                and the supporting methodologies.
                  (B) Under no circumstances shall the 
                adjustment result in fee revenues for a fiscal 
                year that are less than the fee revenues for 
                the fiscal year established in subsection (b), 
                as adjusted for inflation under paragraph (1). 
                Any adjustment for changes in review activities 
                made in setting fees and revenue amounts for 
                fiscal year 2009 may not result in the total 
                workload adjustment being more than 2 
                percentage points higher than it would have 
                been in the absence of the adjustment for 
                changes in review activities.
                  (C) The Secretary shall contract with an 
                independent accounting firm to study the 
                adjustment for changes in review activities 
                applied in setting fees and revenue amounts for 
                fiscal year 2009 and to make recommendations, 
                if warranted, for future changes in the 
                methodology for calculating the adjustment. 
                After review of the recommendations, the 
                Secretary shall, if warranted, make appropriate 
                changes to the methodology, and the changes 
                shall be effective for each of the fiscal years 
                2010 through 2012. The Secretary shall not make 
                any adjustment for changes in review activities 
                for any fiscal year after 2009 unless such 
                study has been completed.
          (3) Rent and rent-related cost adjustment.--For 
        fiscal year 2010 and each subsequent fiscal year, the 
        Secretary shall, before making adjustments under 
        paragraphs (1) and (2), decrease the fee revenue amount 
        established in subsection (b) if actual costs paid for 
        rent and rent-related expenses for the preceding fiscal 
        year are less than estimates made for such year in 
        fiscal year 2006. Any reduction made under this 
        paragraph shall not exceed the amount by which such 
        costs fall below the estimates made in fiscal year 2006 
        for such fiscal year, and shall not exceed $11,721,000 
        for any fiscal year.
          [(3)] (4) Final year adjustment.--For fiscal year 
        [2007] 2012, the Secretary may, in addition to 
        adjustments under [paragraphs (1) and (2)] paragraphs 
        (1), (2), and (3), further increase the fee revenues 
        and fees established in subsection (b) if such an 
        adjustment is necessary to provide for not more than 
        three months of operating reserves of carryover user 
        fees for the process for the review of human drug 
        applications for the first three months of fiscal year 
        [2008] 2013. If such an adjustment is necessary, the 
        rationale for the amount of the increase shall be 
        contained in the annual notice establishing fee 
        revenues and fees for fiscal year [2007] 2012. If the 
        Secretary has carryover balances for such process in 
        excess of three months of such operating reserves, the 
        adjustment under this paragraph shall not be made.
          [(4)] (5) Annual fee setting.--The Secretary shall, 
        60 days before the start of each fiscal year that 
        begins after September 30, [2002] 2007, establish, for 
        the next fiscal year, application, product, and 
        establishment fees under subsection (a), based on the 
        revenue amounts established under subsection (b) and 
        the adjustments provided under this subsection.
          [(5)] (6) Limit.--The total amount of fees charged, 
        as adjusted under this subsection, for a fiscal year 
        may not exceed the total costs for such fiscal year for 
        the resources allocated for the process for the review 
        of human drug applications.
  (d) Fee Waiver or Reduction.--
          (1) In general.--The Secretary shall grant to a 
        person who is named as the applicant in a human drug 
        application a waiver from or a reduction of one or more 
        fees assessed to that person under subsection (a) where 
        the Secretary finds that--
                  (A) * * *

           *       *       *       *       *       *       *

          (2) Considerations.--In determining whether to grant 
        a waiver or reduction of a fee under paragraph (1), the 
        Secretary shall consider only the circumstances and 
        assets of the applicant involved and any affiliate of 
        the applicant.
          [(2)] (3) Use of standard costs.--In making the 
        finding in paragraph (1)(C), the Secretary may use 
        standard costs.
          [(3)] (4) Rules relating to small businesses.--
                  (A) Definition.--In paragraph (1)(D), the 
                term ``small business'' means an entity that 
                has fewer than 500 employees, including 
                employees of affiliates, and that does not have 
                a drug product that has been approved under a 
                human drug application and introduced or 
                delivered for introduction into interstate 
                commerce.

           *       *       *       *       *       *       *

  (g) Crediting and Availability of Fees.--
          (1) * * *

           *       *       *       *       *       *       *

          [(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this 
        section--
                  [(A) $222,900,000 for fiscal year 2003;
                  [(B) $231,000,000 for fiscal year 2004;
                  [(C) $252,000,000 for fiscal year 2005;
                  [(D) $259,300,000 for fiscal year 2006; and
                  [(E) $259,300,000 for fiscal year 2007;
        as adjusted to reflect adjustments in the total fee 
        revenues made under this section and changes in the 
        total amounts collected by application, supplement, 
        establishment, and product fees.
          [(4) Offset.--Any amount of fees collected for a 
        fiscal year under this section that exceeds the amount 
        of fees specified in appropriation Acts for such fiscal 
        year shall be credited to the appropriation account of 
        the Food and Drug Administration as provided in 
        paragraph (1), and shall be subtracted from the amount 
        of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation 
        Acts for a subsequent fiscal year.]
          (3) Authorization of appropriations.--For each of the 
        fiscal years 2008 through 2012, there is authorized to 
        be appropriated for fees under this section an amount 
        equal to the total revenue amount determined under 
        subsection (b) for the fiscal year, as adjusted or 
        otherwise affected under subsection (c) and paragraph 
        (4) of this subsection.
          (4) Offset.--If the sum of the cumulative amount of 
        fees collected under this section for the fiscal years 
        2008 through 2010 and the amount of fees estimated to 
        be collected under this section for fiscal year 2011 
        exceeds the cumulative amount appropriated under 
        paragraph (3) for the fiscal years 2008 through 2011, 
        the excess shall be credited to the appropriation 
        account of the Food and Drug Administration as provided 
        in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation 
        Acts for fiscal year 2012.

           *       *       *       *       *       *       *

  (k) Orphan Drugs.--A drug designated under section 526 for a 
rare disease or condition and approved under section 505 or 
under section 351 of the Public Health Service Act shall be 
exempt from product and facility fees under this section, 
provided that the drug meets all of the following:
          (1) The drug had United States sales in the previous 
        year of less than $25,000,000 for the active moiety, 
        for all indications, dosage forms, and strengths for 
        which the drug is approved and for any off-label uses.
          (2) The drug meets the public health requirements 
        contained in this Act as such requirements are applied 
        to requests for waivers for product and facility fees.
          (3) The drug is owned or licensed and marketed by a 
        company that had less than $100,000,000 in gross 
        worldwide revenue during the previous year.

SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG 
                    TELEVISION ADVERTISING.

  (a) Types of Direct-to-Consumer Television Advertisement 
Review Fees.--Beginning in fiscal year 2008, the Secretary 
shall assess and collect fees in accordance with this section 
as follows:
          (1) Advisory review fee.--
                  (A) In general.--With respect to a proposed 
                direct-to-consumer television advertisement 
                (referred to in this section as a ``DTC 
                advertisement''), each person that on or after 
                October 1, 2007, submits such an advertisement 
                for advisory review by the Secretary prior to 
                its initial public broadcast (referred to in 
                this section as ``prebroadcast advisory 
                review'') shall, except as provided in 
                subparagraph (B), be subject to a fee 
                established under subsection (c)(3).
                  (B) Exception for required submissions.--A 
                DTC advertisement that is required under 
                section 502(n) to be submitted to the Secretary 
                prior to initial public broadcast is not 
                subject to a fee under subparagraph (A) unless 
                the sponsor designates the submission as a 
                submission for prebroadcast advisory review.
                  (C) Notice to secretary of number of 
                advertisements.--Not later than June 1 of each 
                fiscal year, the Secretary shall publish a 
                notice in the Federal Register requesting any 
                person to notify the Secretary within 30 days 
                of the number of DTC advertisements the person 
                intends to submit for prebroadcast advisory 
                review in the next fiscal year.
                  (D) Payment.--
                          (i) In general.--The fee required by 
                        subparagraph (A) (referred to in this 
                        section as ``an advisory review fee'') 
                        shall be due not later than October 1 
                        of the fiscal year in which the DTC 
                        advertisement involved is intended be 
                        submitted for prebroadcast advisory 
                        review, subject to subparagraph (F)(i).
                          (ii) Effect of submission.--
                        Notification of the Secretary under 
                        subparagraph (C) of the number of DTC 
                        advertisements a person intends to 
                        submit for prebroadcast advisory review 
                        is a legally binding commitment by that 
                        person to pay the annual advisory 
                        review fee for that number of 
                        submissions on or before October 1 of 
                        the fiscal year in which the 
                        advertisement is intended to be 
                        submitted.
                          (iii) Notice regarding carryover 
                        submissions.--In making a notification 
                        under subparagraph (C), the person 
                        involved shall in addition notify the 
                        Secretary if under subparagraph (F)(i) 
                        the person intends to submit a DTC 
                        advertisement for which the advisory 
                        review fee has already been paid. If 
                        the person does not so notify the 
                        Secretary, each DTC advertisement 
                        submitted by the person for 
                        prebroadcast advisory review in the 
                        fiscal year involved shall be subject 
                        to the advisory review fee.
                  (E) Modification of advisory review fee.--
                          (i) Late payment.--If a person has 
                        submitted a notification under 
                        subparagraph (C) with respect to a 
                        fiscal year and has not paid all 
                        advisory review fees due under 
                        subparagraph (D) on or before November 
                        1 of such fiscal year, the fees are 
                        regarded as late and a revised due date 
                        and an increase in the amount of fees 
                        applies in accordance with this clause, 
                        notwithstanding any other provision of 
                        this section. For such person, the 
                        advisory review fee for each DTC 
                        advertisement submitted in such fiscal 
                        year for prebroadcast advisory review 
                        shall be due and payable 20 days before 
                        the advertisement is submitted to the 
                        Secretary, and each such fee shall be 
                        revised to be equal to 150 percent of 
                        the fee that otherwise would have 
                        applied pursuant to subsection (c)(3).
                          (ii) Exceeding identified number of 
                        submissions.--If a person submits a 
                        number of DTC ads for prebroadcast 
                        advisory review in a fiscal year that 
                        exceeds the number identified by the 
                        person under subparagraph (C), a 
                        revised due date and an increase in the 
                        amount of fees applies under this 
                        clause for each submission in excess of 
                        such number, notwithstanding any other 
                        provision of this section. For each 
                        such DTC ad, the advisory review fee 
                        shall be due and payable 20 days before 
                        the advertisement is submitted to the 
                        Secretary, and the fee shall be revised 
                        to be equal to 150 percent of the fee 
                        that otherwise would have applied 
                        pursuant to subsection (c)(3).
                  (F) Limits.--
                          (i) Submissions.--For each advisory 
                        review fee paid by a person for a 
                        fiscal year, the person is entitled to 
                        acceptance for advisory review by the 
                        Secretary of one DTC advertisement and 
                        acceptance of one resubmission for 
                        advisory review of the same 
                        advertisement. The advertisement shall 
                        be submitted for review in the fiscal 
                        year for which the fee was assessed, 
                        except that a person may carry over not 
                        more than one paid advisory review 
                        submission to the next fiscal year. 
                        Resubmissions may be submitted without 
                        regard to the fiscal year of the 
                        initial advisory review submission.
                          (ii) No refunds.--Except as provided 
                        by subsection (f), fees paid under 
                        subparagraph (A) shall not be refunded.
                          (iii) No waivers, exemptions, or 
                        reductions.--The Secretary shall not 
                        grant a waiver, exemption, or reduction 
                        of any fees due or payable under this 
                        section.
                          (iv) Right to advisory review not 
                        transferable.--The right to an advisory 
                        review under this paragraph is not 
                        transferable, except to a successor in 
                        interest.
          (2) Operating reserve fee.--
                  (A) In general.--Each person that on or after 
                October 1, 2007, is assessed an advisory review 
                fee under paragraph (1) shall be subject to fee 
                established under subsection (d)(2) referred to 
                in this section as an ``operating reserve fee'' 
                for the first fiscal year in which an advisory 
                review fee is assessed to such person. The 
                person is not subject to an operating reserve 
                fee for any other fiscal year.
                  (B) Payment.--Except as provided in 
                subparagraph (C), the operating reserve fee 
                shall be due no later than October 1 of the 
                first fiscal year in which the person is 
                required to pay an advisory review fee under 
                paragraph (1).
                  (C) Late notice of submission.--If, in the 
                first fiscal year of a person's participation 
                in the program under this section, that person 
                submits any DTC advertisements for prebroadcast 
                advisory review that are in excess of the 
                number identified by that person in response to 
                the Federal Register notice described in 
                subsection (a)(1)(C), that person shall pay an 
                operating reserve fee for each of those 
                advisory reviews equal to the advisory review 
                fee for each submission established under 
                paragraph (1)(D)(ii). Fees required by this 
                subparagraph shall be in addition to any fees 
                required by subparagraph (A). Fees under this 
                subparagraph shall be due 20 days before any 
                DTC advertisement is submitted by such person 
                to the Secretary for prebroadcast advisory 
                review.
  (b) Advisory Review Fee Revenue Amounts.--Fees under 
subsection (a)(1) shall be established to generate revenue 
amounts of $6,250,000 for each of fiscal years 2008 through 
2012, as adjusted pursuant to subsections (c) and (g)(4).
  (c) Adjustments.--
          (1) Inflation adjustment.--Beginning with fiscal year 
        2009, the revenues established in subsection (b) shall 
        be adjusted by the Secretary by notice, published in 
        the Federal Register, for a fiscal year to reflect the 
        greater of--
                  (A) the total percentage change that occurred 
                in the Consumer Price Index for all urban 
                consumers (all items; U.S. city average), for 
                the 12-month period ending June 30 preceding 
                the fiscal year for which fees are being 
                established;
                  (B) the total percentage change for the 
                previous fiscal year in basic pay under the 
                General Schedule in accordance with section 
                5332 of title 5, United States Code, as 
                adjusted by any locality-based comparability 
                payment pursuant to section 5304 of such title 
                for Federal employees stationed in the District 
                of Columbia; or
                  (C) the average annual change in the cost, 
                per full-time equivalent position of the Food 
                and Drug Administration, of all personnel 
                compensation and benefits paid with respect to 
                such positions for the first 5 fiscal years of 
                the previous 6 fiscal years.
        The adjustment made each fiscal year by this subsection 
        will be added on a compounded basis to the sum of all 
        adjustments made each fiscal year after fiscal year 
        2008 under this subsection.
          (2) Workload adjustment.--Beginning with fiscal year 
        2009, after the fee revenues established in subsection 
        (b) are adjusted for a fiscal year for inflation in 
        accordance with paragraph (1), the fee revenues shall 
        be adjusted further for such fiscal year to reflect 
        changes in the workload of the Secretary with respect 
        to the submission of DTC advertisements for advisory 
        review prior to initial broadcast. With respect to such 
        adjustment:
                  (A) The adjustment shall be determined by the 
                Secretary based upon the number of DTC 
                advertisements identified pursuant to 
                subsection (a)(1)(C) for the upcoming fiscal 
                year, excluding allowable previously paid carry 
                over submissions. The adjustment shall be 
                determined by multiplying the number of such 
                advertisements projected for that fiscal year 
                that exceeds 150 by $27,600 (adjusted each year 
                beginning with fiscal year 2009 for inflation 
                in accordance with paragraph (1)). The 
                Secretary shall publish in the Federal Register 
                the fee revenues and fees resulting from the 
                adjustment and the supporting methodologies.
                  (B) Under no circumstances shall the 
                adjustment result in fee revenues for a fiscal 
                year that are less than the fee revenues 
                established for the prior fiscal year.
          (3) Annual fee setting for advisory review.--
                  (A) In general.--Not later than August 1 of 
                each fiscal year, the Secretary shall establish 
                for the next fiscal year the DTC advertisement 
                advisory review fee under subsection (a)(1), 
                based on the revenue amounts established under 
                subsection (b), the adjustments provided under 
                paragraphs (1) and (2), and the number of DTC 
                advertisements identified pursuant to 
                subsection (a)(1)(C), excluding allowable 
                previously-paid carry over submissions. The 
                annual advisory review fee shall be established 
                by dividing the fee revenue for a fiscal year 
                (as adjusted pursuant to this subsection) by 
                the number of DTC advertisements so identified, 
                excluding allowable previously-paid carry over 
                submissions.
                  (B) Fiscal year 2008 fee limit.--
                Notwithstanding subsection (b) and the 
                adjustments pursuant to this subsection, the 
                fee established under subparagraph (A) for 
                fiscal year 2008 may not be more than $83,000 
                per submission for advisory review.
                  (C) Annual fee limit.--Notwithstanding 
                subsection (b) and the adjustments pursuant to 
                this subsection, the fee established under 
                subparagraph (A) for a fiscal year after fiscal 
                year 2008 may not be more than 50 percent more 
                than the fee established for the prior fiscal 
                year.
                  (D) Limit.--The total amount of fees 
                obligated for a fiscal year may not exceed the 
                total costs for such fiscal year for the 
                resources allocated for the process for the 
                advisory review of prescription drug 
                advertising.
  (d) Operating Reserves.--
          (1) In general.--The Secretary shall establish in the 
        Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation a 
        Direct-to-Consumer Advisory Review Operating Reserve, 
        of at least $6,250,000 in fiscal year 2008, to continue 
        the program under this section in the event the fees 
        collected in any subsequent fiscal year pursuant to 
        subsection (a)(1) do not generate the fee revenue 
        amount established for that fiscal year.
          (2) Fee setting.--The Secretary shall establish the 
        operating reserve fee under subsection (a)(2)(A) for 
        each person required to pay the fee by multiplying the 
        number of DTC advertisements identified by that person 
        pursuant to subsection (a)(1)(C) by the advisory review 
        fee established pursuant to subsection (c)(3) for that 
        fiscal year, except that in no case shall the operating 
        reserve fee assessed be less than the operating reserve 
        fee assessed if the person had first participated in 
        the program under this section in fiscal year 2008.
          (3) Use of operating reserve.--The Secretary may use 
        funds from the reserves only to the extent necessary in 
        any fiscal year to make up the difference between the 
        fee revenue amount established for that fiscal year 
        under subsections (b) and (c) and the amount of fees 
        actually collected for that fiscal year pursuant to 
        subsection (a)(1), or to pay costs of ending the 
        program under this section if it is terminated pursuant 
        to subsection (f) or not reauthorized beyond fiscal 
        year 2012.
          (4) Refund of operating reserves.--Within 120 days of 
        the end of fiscal year 2012, or if the program under 
        this section ends early pursuant to subsection (f), the 
        Secretary, after setting aside sufficient operating 
        reserve amounts to terminate the program under this 
        section, shall refund all amounts remaining in the 
        operating reserve on a pro rata basis to each person 
        that paid an operating reserve fee assessment. In no 
        event shall the refund to any person exceed the total 
        amount of operating reserve fees paid by such person 
        pursuant to subsection (a)(2).
  (e) Effect of Failure to Pay Fees.--Notwithstanding any other 
requirement, a submission for prebroadcast advisory review of a 
DTC advertisement submitted by a person subject to fees under 
subsection (a) shall be considered incomplete and shall not be 
accepted for review by the Secretary until all fees owed by 
such person under this section have been paid.
  (f) Effect of Inadequate Funding of Program.--
          (1) Initial funding.--If on November 1, 2007, or 120 
        days after enactment of this provision, whichever is 
        later, the Secretary has not received at least 
        $11,250,000 in advisory review fees and operating 
        reserve fees combined, the program under this section 
        shall not commence and all collected fees shall be 
        refunded.
          (2) Later fiscal years.--Beginning in fiscal year 
        2009, if, on November 1 of the fiscal year, the 
        combination of the operating reserves, annual fee 
        revenues from that fiscal year, and unobligated fee 
        revenues from prior fiscal years falls below 
        $9,000,000, adjusted for inflation (as described in 
        subsection (c)(1)), the program under this section 
        shall cease to exist, and the Secretary shall notify 
        all participants, retain any money from the unused 
        advisory review fees and the operating reserves needed 
        to close down the program under this section, and 
        refund the remainder of the unused fees and operating 
        reserves. To the extent required to close down the 
        program under this section, the Secretary shall first 
        use unobligated advisory review fee revenues from prior 
        fiscal years, then the operating reserves, and finally, 
        unused advisory review fees from the relevant fiscal 
        year.
  (g) Crediting and Availability of Fees.--
          (1) In general.--Fees authorized under subsection (a) 
        of this section shall be collected and available for 
        obligation only to the extent and in the amount 
        provided in advance in appropriations Acts. Such fees 
        are authorized to remain available until expended. Such 
        sums as may be necessary may be transferred from the 
        Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for the process for the 
        advisory review of prescription drug advertising.
          (2) Collections and appropriation acts.--
                  (A) In general.--The fees authorized by this 
                section--
                          (i) shall be retained in each fiscal 
                        year in an amount not to exceed the 
                        amount specified in appropriation Acts, 
                        or otherwise made available for 
                        obligation for such fiscal year; and
                          (ii) shall be available for 
                        obligation only if the amounts 
                        appropriated as budget authority for 
                        such fiscal year are sufficient to 
                        support a number of full-time 
                        equivalent review employees that is not 
                        fewer than the number of such employees 
                        supported in fiscal year 2007.
                  (B) Review employees.--For purposes of 
                subparagraph (A)(ii), the term ``full-time 
                equivalent review employees'' means the total 
                combined number of full-time equivalent 
                employees in--
                          (i) the Center for Drug Evaluation 
                        and Research, Division of Drug 
                        Marketing, Advertising, and 
                        Communications, Food and Drug 
                        Administration; and
                          (ii) the Center for Biologics 
                        Evaluation and Research, Advertising 
                        and Promotional Labeling Branch, Food 
                        and Drug Administration.
          (3) Authorization of appropriations.--For each of the 
        fiscal years 2008 through 2012, there is authorized to 
        be appropriated for fees under this section an amount 
        equal to the total revenue amount determined under 
        subsection (b) for the fiscal year, as adjusted 
        pursuant to subsection (c) and paragraph (4) of this 
        subsection, plus amounts collected for the reserve fund 
        under subsection (d).
          (4) Offset.--Any amount of fees collected for a 
        fiscal year under this section that exceeds the amount 
        of fees specified in appropriation Acts for such fiscal 
        year shall be credited to the appropriation account of 
        the Food and Drug Administration as provided in 
        paragraph (1), and shall be subtracted from the amount 
        of fees that would otherwise be collected under this 
        section pursuant to appropriation Acts for a subsequent 
        fiscal year.
  (h) Definitions.--For purposes of this subchapter:
          (1) The term ``advisory review'' means reviewing and 
        providing advisory comments on a proposed advertisement 
        prior to its initial public broadcast.
          (2) The term ``advisory review fee'' has the meaning 
        indicated for such term in subsection (a)(1)(D).
          (3) The term ``carry over submission'' means a 
        submission for an advisory review for which a fee was 
        paid in one fiscal year that is submitted for review in 
        the following fiscal year.
          (4) The term ``direct-to-consumer television 
        advertisement'' means an advertisement for a 
        prescription drug product as defined in section 735(3) 
        intended to be displayed on any television channel for 
        less than 3 minutes.
          (5) The term ``DTC advertisement'' has the meaning 
        indicated for such term in subsection (a)(1)(A).
          (6) The term ``operating reserve fee'' has the 
        meaning indicated for such term in subsection 
        (a)(2)(A).
          (7) The term ``person'' includes an individual, 
        partnership, corporation, and association, and any 
        affiliate thereof or successor in interest.
          (8) The term ``prebroadcast advisory review'' has the 
        meaning indicated for such term in subsection 
        (a)(1)(A).
          (9) The term ``process for the advisory review of 
        prescription drug advertising'' means the activities 
        necessary to review and provide advisory comments on 
        DTC advertisements prior to public broadcast and, to 
        the extent the Secretary has additional staff resources 
        available under the program under this section that are 
        not necessary for the advisory review of DTC 
        advertisements, the activities necessary to review and 
        provide advisory comments on other proposed 
        advertisements and promotional material prior to public 
        broadcast.
          (10) The term ``resources allocated for the process 
        for the advisory review of prescription drug 
        advertising'' means the expenses incurred in connection 
        with the process for the advisory review of 
        prescription drug advertising for--
                  (A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers, employees, 
                and committees, and to contracts with such 
                contractors;
                  (B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources;
                  (C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies;
                  (D) collection of fees under this section and 
                accounting for resources allocated for the 
                advisory review of prescription drug 
                advertising; and
                  (E) closing down the program under this 
                section pursuant to subsection (f)(2) if that 
                becomes necessary.
          (11) The term ``resubmission'' means a subsequent 
        submission for advisory review of a direct-to-consumer 
        television advertisement that has been revised in 
        response to the Secretary's comments on an original 
        submission. A resubmission may not introduce 
        significant new concepts or creative themes into the 
        television advertisement.
          (12) The term ``submission for advisory review'' 
        means an original submission of a direct-to-consumer 
        television advertisement for which the sponsor 
        voluntarily requests advisory comments before the 
        advertisement is publicly disseminated.

                    PART 3--FEES RELATING TO DEVICES

SEC. 737. DEFINITIONS.

  For purposes of this subchapter:
          (1) * * *

           *       *       *       *       *       *       *

          (4)(A) The term ``supplement'', with respect to a 
        panel-track supplement, a 180-day supplement, a real-
        time supplement, [or an efficacy supplement,] an 
        efficacy supplement, or a 30-day notice, means a 
        request to the Secretary to approve a change in a 
        device for which--
                  (i) * * *

           *       *       *       *       *       *       *

          (F) The term ``30-day notice'' means a supplement to 
        an approved premarket application or premarket report 
        under section 515 that is limited to a request to make 
        modifications to manufacturing procedures or methods of 
        manufacture affecting the safety and effectiveness of 
        the device.
          (5) The term ``request for classification 
        information'' means a request made under section 513(g) 
        for information respecting the class in which a device 
        has been classified or the requirements applicable to a 
        device.
          (6) The term ``annual fee'', with respect to periodic 
        reporting concerning a class III device, means the 
        annual fee associated with periodic reports required by 
        a PMA approval order (as described in section 
        814.82(a)(7) of title 21, Code of Federal Regulations 
        (or any successor regulation)).
          [(5)] (7) The term ``process for the review of device 
        applications'' means the following activities of the 
        Secretary with respect to the review of premarket 
        applications, premarket reports, supplements, and 
        premarket notification submissions:
                  (A)  * * *

           *       *       *       *       *       *       *

          [(6)] (8) The term ``costs of resources allocated for 
        the process for the review of device applications'' 
        means the expenses incurred in connection with the 
        process for the review of device applications for--
                  (A) * * *

           *       *       *       *       *       *       *

          [(7)] (9) The term ``adjustment factor'' applicable 
        to a fiscal year is the Consumer Price Index for all 
        urban consumers (all items; United States city average) 
        for [April of the preceding fiscal year] October of the 
        preceding fiscal year divided by such Index for [April 
        2002] October 2001.
          (10) The term ``person'' includes an affiliate 
        thereof.
          [(8)] (11) The term ``affiliate'' means a business 
        entity that has a relationship with a second business 
        entity (whether domestic or international) if, directly 
        or indirectly--
                  (A)

           *       *       *       *       *       *       *

          (12) The term ``establishment subject to 
        registration'' means an establishment that is required 
        to register with the Secretary under section 510 and is 
        one of the following types of establishments:
                  (A) Manufacturer.--An establishment that 
                makes by any means any article that is a 
                device, as defined in section 201(h), including 
                an establishment that sterilizes or otherwise 
                makes such article for or on behalf of a 
                specification developer or any other person.
                  (B) Single-use device reprocessor.--An 
                establishment that performs manufacturing 
                operations on a single-use device.
                  (C) Specification developer.--An 
                establishment that develops specifications for 
                a device that is distributed under the 
                establishment's name but which performs no 
                manufacturing, including an establishment that, 
                in addition to developing specifications, also 
                arranges for the manufacturing of devices 
                labeled with another establishment's name by a 
                contract manufacturer.

SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.

  (a) Types of Fees.--
          (1) * * *
          (2) [Premarket application, premarket report, 
        supplement, and submission fee] Premarket application, 
        premarket report, supplement, and submission fee, and 
        annual fee for periodic reporting concerning a class 
        III device.--
                  (A) In general.--Except as provided in 
                subparagraph (B) and subsections (d) and (e), 
                each person who submits any of the following, 
                on or after October 1, 2002, shall be subject 
                to a fee established under subsection (c)(1) 
                for the fiscal year involved in accordance with 
                the following:
                          (i)  * * *

           *       *       *       *       *       *       *

                          (iii) For a panel track supplement, 
                        [a fee equal to the fee that applies] a 
                        fee equal to 75 percent of the fee that 
                        applies under clause (i).
                          (iv) For a 180-day supplement, a fee 
                        equal to [21.5 percent] 15 percent of 
                        the fee that applies under clause (i).
                          (v) For a real-time supplement, a fee 
                        equal to [7.2 percent] 7 percent of the 
                        fee that applies under clause (i).
                          (vi) For a 30-day notice, a fee equal 
                        to 1.6 percent of the fee that applies 
                        under clause (i).
                          [(vi)] (vii) For an efficacy 
                        supplement, a fee equal to the fee that 
                        applies under clause (i).
                          [(vii)] (viii) For a premarket 
                        notification submission, a fee equal to 
                        [1.42 percent] 1.84 percent of the fee 
                        that applies under clause (i), subject 
                        to any adjustment under subsection 
                        (e)(2)(C)(ii).
                          (ix) For a request for classification 
                        information, a fee equal to 1.35 
                        percent of the fee that applies under 
                        clause (i).
                          (x) For periodic reporting concerning 
                        a class III device, the annual fee 
                        shall be equal to 3.5 percent of the 
                        fee that applies under clause (i).

           *       *       *       *       *       *       *

                  [(C) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission 
                of the premarket application, premarket report, 
                supplement, or premarket notification 
                submission except that invoices for 
                applications submitted between October 1, 2002, 
                and the date of the enactment of the Medical 
                Device User Fee and Modernization Act of 2002 
                shall be payable on October 30, 2002. 
                Applicants submitting portions of applications 
                pursuant to section 515(c)(3) shall pay such 
                fees upon submission of the first portion of 
                such applications. The fees credited to fiscal 
                year 2003 under this section shall include all 
                fees payable from October 1, 2002, through 
                September 30, 2003.]
                  (C) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission 
                of the premarket application, premarket report, 
                supplement, premarket notification submission, 
                30-day notice, request for classification 
                information, or periodic reporting concerning a 
                class III device. Applicants submitting 
                portions of applications pursuant to section 
                515(c)(3) shall pay such fees upon submission 
                of the first portion of such applications.
                  (D) Refunds.--
                          (i) * * *

           *       *       *       *       *       *       *

                          (iv) Modular applications withdrawn 
                        before first action.--The Secretary 
                        shall refund 75 percent of the 
                        application fee paid for a modular 
                        application submitted under section 
                        515(c)(4) that is withdrawn before a 
                        second module is submitted and before a 
                        first action on the first module. If 
                        the modular application is withdrawn 
                        after a second or subsequent module is 
                        submitted but before any first action, 
                        the Secretary may return a portion of 
                        the fee. The amount of refund, if any, 
                        shall be based on the level of effort 
                        already expended on the review of the 
                        modules submitted.
          (3) Annual establishment registration fee.--
                  (A) In general.--Except as provided in 
                subparagraph (B), each establishment subject to 
                registration shall be subject to a fee for each 
                initial or annual registration under section 
                510 beginning with its registration for fiscal 
                year 2008.
                  (B) Exception.--No fee shall be required 
                under subparagraph (A) for an establishment 
                operated by a State or Federal governmental 
                entity or an Indian tribe (as defined in the 
                Indian Self Determination and Educational 
                Assistance Act), unless a device manufactured 
                by the establishment is to be distributed 
                commercially.
                  (C) Payment.--The fee required under 
                subparagraph (A) shall be due once each fiscal 
                year, upon the initial registration of the 
                establishment or upon the annual registration 
                under section 510.
  [(b) Fee Revenue Amounts.--Except as provided in subsections 
(c), (d), (e), (g), and (h), the fees under subsection (a) 
shall be established to generate the following revenue amounts: 
$25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 
2004; and $29,785,000 in fiscal year 2005. If legislation is 
enacted after the date of the enactment of the Medical Device 
User Fee and Modernization Act of 2002 requiring the Secretary 
to fund additional costs of the retirement of Federal 
personnel, fee revenue amounts under this subsection shall be 
increased in each year by the amount necessary to fully fund 
the portion of such additional costs that are attributable to 
the process for the review of device applications.]
          (b) Fee amounts.--Except as provided in subsections 
        (c), (d), and (e), the fees under subsection (a) shall 
        be based on the following fee amounts:


----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                         Fee Type                          Year 2008  Year 2009  Year 2010  Year 2011  Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $185,000   $200,725   $217,787   $236,298   $256,384
Establishment Registration...............................     $1,706     $1,851     $2,008     $2,179    $2,364.
----------------------------------------------------------------------------------------------------------------

  (c) [Annual Fee Setting] Annual fee setting.--
          (1) In general.--The Secretary shall, 60 days before 
        the start of each fiscal year after September 30, 2002, 
        publish in the Federal Register fees under subsection 
        (a). [The fees established for fiscal year 2006 shall 
        be based on a premarket application fee of $259,600, 
        and the fees established for fiscal year 2007 shall be 
        based on a premarket application fee of $281,600.]
          (2) Adjustment.--
                  (A) In general.--When setting fees for fiscal 
                year 2010, the Secretary may increase the fee 
                under subsection (a)(3)(A) (applicable to 
                establishments subject to registration) only if 
                the Secretary estimates that the number of 
                establishments submitting fees for fiscal year 
                2009 is less than 12,250. The percentage 
                increase shall be the percentage by which the 
                estimate of establishments submitting fees in 
                fiscal year 2009 is less than 12,750, but in no 
                case may the percentage increase be more than 
                8.5 percent over that specified in subsection 
                (b) for fiscal year 2010. If the Secretary 
                makes any adjustment to the fee under 
                subsection (a)(3)(A) for fiscal year 2010, then 
                such fee for fiscal years 2011 and 2012 shall 
                be adjusted so that such fee for fiscal year 
                2011 is equal to the adjusted fee for fiscal 
                year 2010 increased by 8.5 percent, and such 
                fee for fiscal year 2012 is equal to the 
                adjusted fee for fiscal year 2011 increased by 
                8.5 percent.
                  (B) Publication.--For any adjustment made 
                under subparagraph (A), the Secretary shall 
                publish in the Federal Register the Secretary's 
                determination to make the adjustment and the 
                rationale for the determination.
          [(2)] (3) Limit.--The total amount of fees charged, 
        as adjusted under this subsection, for a fiscal year 
        may not exceed the total costs for such fiscal year for 
        the resources allocated for the process for the review 
        of device applications.
          [(3)] (4) Supplement.--
                  (A) In general.--[For fiscal years 2006 and 
                2007, the Secretary] The Secretary may use 
                unobligated carryover balances from fees 
                collected in previous fiscal years to ensure 
                that sufficient fee revenues are available in 
                that fiscal year, so long as the Secretary 
                maintains unobligated carryover balances of not 
                less than 1 month of operating reserves [for 
                the first month of fiscal year 2008]  for the 
                first month of the next fiscal year.

           *       *       *       *       *       *       *

  (d) Small Businesses; Fee Waiver and Fee Reduction Regarding 
Premarket Approval Fees.--
          (1) In general.--The Secretary shall grant a waiver 
        of the fee required under subsection (a) for one 
        premarket application, or one premarket report, where 
        the Secretary finds that the applicant involved is a 
        small business submitting its first premarket 
        application to the Secretary, or its first premarket 
        report, respectively, for review. For the purposes of 
        this paragraph, the term ``small business'' means an 
        entity that reported $30,000,000 or less of gross 
        receipts or sales in its most recent Federal income tax 
        return for a taxable year, including such returns of 
        all of its affiliates[, partners, and parent firms]. In 
        addition, for subsequent premarket applications, 
        premarket reports, and supplements where the Secretary 
        finds that the applicant involved is a small business, 
        the fees specified in [clauses (i) through (vi) of 
        subsection (a)(2)(A)] clauses (i) through (v) and 
        clauses (vii), (ix), and (x) of subsection (a)(2)(A) 
        may be paid at a reduced rate in accordance with 
        paragraph (2)(C).
          (2) Rules relating to premarket approval fees.--
                  (A) Definition.--For purposes of this 
                paragraph, the term ``small business'' means an 
                entity that reported $100,000,000 or less of 
                gross receipts or sales in its most recent 
                Federal income tax return for a taxable year, 
                including such returns of all of its 
                affiliates[, partners, and parent firms].
                  [(B) Evidence of qualification.--An 
                applicant]
                  (B) Evidence of qualification.--
                          (i) In general.--An applicant shall 
                        pay the higher fees established by the 
                        Secretary each year unless the 
                        applicant submits evidence that it 
                        qualifies for a waiver of the fee or 
                        the lower fee rate. [The applicant 
                        shall support its claim]
                          (ii) Firms submitting tax returns to 
                        the United States Internal Revenue 
                        Service.--The applicant shall support 
                        its claim that it meets the definition 
                        under subparagraph (A) by submission of 
                        a copy of its most recent Federal 
                        income tax return for a taxable year, 
                        and a copy of such returns of its 
                        affiliates[, partners, and parent 
                        firms], which show an amount of gross 
                        sales or receipts that is less than the 
                        maximum established in subparagraph 
                        (A). The applicant, and each of such 
                        affiliates[, partners, and parent 
                        firms], shall certify that the 
                        information provided is a true and 
                        accurate copy of the actual tax forms 
                        they submitted to the Internal Revenue 
                        Service. [If no tax forms are submitted 
                        for affiliates, partners, or parent 
                        firms, the applicant shall certify that 
                        the applicant has no affiliates, 
                        partners, or parent firms, 
                        respectively.] If no tax forms are 
                        submitted for any affiliate, the 
                        applicant shall certify that the 
                        applicant has no affiliates.
                          (iii) Firms not submitting tax 
                        returns to the united states internal 
                        revenue service.--In the case of an 
                        applicant that has not previously 
                        submitted a Federal income tax return, 
                        the applicant and each of its 
                        affiliates shall demonstrate that it 
                        meets the definition under subparagraph 
                        (A) by submission of a signed 
                        certification, in such form as the 
                        Secretary may direct through a notice 
                        published in the Federal Register, that 
                        the applicant or affiliate meets the 
                        criteria for a small business and a 
                        certification, in English, from the 
                        national taxing authority of the 
                        country in which the applicant or, if 
                        applicable, affiliate is headquartered. 
                        The certification from such taxing 
                        authority shall bear the official seal 
                        of such taxing authority and shall 
                        provide the applicant's or affiliate's 
                        gross receipts and sales for the most 
                        recent year in both the local currency 
                        of such country and in United States 
                        dollars, the exchange rate used in 
                        converting such local currency to 
                        dollars, and the dates during which 
                        these receipts and sales were 
                        collected. The applicant shall also 
                        submit a statement signed by the head 
                        of the applicant's firm or by its chief 
                        financial officer that the applicant 
                        has submitted certifications for all of 
                        its affiliates, or that the applicant 
                        has no affiliates.
                  [(C) Reduced fees.--Where the Secretary finds 
                that the applicant involved meets the 
                definition under subparagraph (A), the fees 
                established under subsection (c)(1) may be paid 
                at a reduced rate of 38 percent of the fee 
                established under such subsection for a 
                premarket application, a premarket report, or a 
                supplement.]
                  (C) Reduced fees.--Where the Secretary finds 
                that the applicant involved meets the 
                definition under subparagraph (A), the fees 
                established under subsection (c)(1) may be paid 
                at a reduced rate of--
                          (i) 25 percent of the fee established 
                        under such subsection for a premarket 
                        application, a premarket report, a 
                        supplement (other than a 30-day 
                        notice), or periodic reporting 
                        concerning a class III device; and
                          (ii) 50 percent of the fee 
                        established under such subsection for a 
                        30-day notice or a request for 
                        classification information.

           *       *       *       *       *       *       *

  (e) Small Businesses; Fee Reduction Regarding Premarket 
Notification Submissions.--
          (1) In general.--For fiscal year [2004] 2008 and each 
        subsequent fiscal year, where the Secretary finds that 
        the applicant involved is a small business, the fee 
        specified in subsection [(a)(2)(A)(vii)] 
        (a)(2)(A)(viii) may be paid at a reduced rate in 
        accordance with paragraph (2)(C).
          (2) Rules relating to premarket notification 
        submissions.--
                  (A) Definition.--For purposes of this 
                subsection, the term ``small business'' means 
                an entity that reported $100,000,000 or less of 
                gross receipts or sales in its most recent 
                Federal income tax return for a taxable year, 
                including such returns of all of its 
                affiliates[, partners, and parent firms].
                  (B) Evidence of qualification.--
                          (i) In general.--An applicant shall 
                        pay the higher fees established by the 
                        Secretary each year unless the 
                        applicant submits evidence that it 
                        qualifies for the lower fee rate. [The 
                        applicant shall support its claim]
                          (ii) Firms submitting tax returns to 
                        the United States Internal Revenue 
                        Service.--The applicant shall support 
                        its claim that it meets the definition 
                        under subparagraph (A) by submission of 
                        a copy of its most recent Federal 
                        income tax return for a taxable year, 
                        and a copy of such returns of its 
                        affiliates[, partners, and parent 
                        firms], which show an amount of gross 
                        sales or receipts that is less than the 
                        maximum established in subparagraph 
                        (A). The applicant, and each of such 
                        affiliates[, partners, and parent 
                        firms], shall certify that the 
                        information provided is a true and 
                        accurate copy of the actual tax forms 
                        they submitted to the Internal Revenue 
                        Service. [If no tax forms are submitted 
                        for affiliates, partners, or parent 
                        firms, the applicant shall certify that 
                        the applicant has no affiliates, 
                        partners, or parent firms, 
                        respectively.] If no tax forms are 
                        submitted for any affiliate, the 
                        applicant shall certify that the 
                        applicant has no affiliates.
                          (iii) Firms not submitting tax 
                        returns to the united states internal 
                        revenue service.--In the case of an 
                        applicant that has not previously 
                        submitted a Federal income tax return, 
                        the applicant and each of its 
                        affiliates shall demonstrate that it 
                        meets the definition under subparagraph 
                        (A) by submission of a signed 
                        certification, in such form as the 
                        Secretary may direct through a notice 
                        published in the Federal Register, that 
                        the applicant or affiliate meets the 
                        criteria for a small business and a 
                        certification, in English, from the 
                        national taxing authority of the 
                        country in which the applicant or, if 
                        applicable, affiliate is headquartered. 
                        The certification from such taxing 
                        authority shall bear the official seal 
                        of such taxing authority and shall 
                        provide the applicant's or affiliate's 
                        gross receipts and sales for the most 
                        recent year in both the local currency 
                        of such country and in United States 
                        dollars, the exchange rate used in 
                        converting such local currency to 
                        dollars, and the dates during which 
                        these receipts and sales were 
                        collected. The applicant shall also 
                        submit a statement signed by the head 
                        of the applicant's firm or by its chief 
                        financial officer that the applicant 
                        has submitted certifications for all of 
                        its affiliates, or that the applicant 
                        has no affiliates.
                  [(C) Reduced fees.--
                          [(i) In general.--For fiscal year 
                        2004 and each subsequent fiscal year, 
                        where the Secretary finds that the 
                        applicant involved meets the definition 
                        under subparagraph (A), the fee for a 
                        premarket notification submission may 
                        be paid at 80 percent of the fee that 
                        applies under subsection 
                        (a)(2)(A)(vii), as adjusted under 
                        clause (ii) and as established under 
                        subsection (c)(1).
                          [(ii) Adjustment per fee revenue 
                        amount.--For fiscal year 2004 and each 
                        subsequent fiscal year, the Secretary, 
                        in setting the revenue amount under 
                        subsection (c)(1) for premarket 
                        notification submissions, shall 
                        determine the revenue amount that would 
                        apply if all such submissions for the 
                        fiscal year involved paid a fee equal 
                        to 1.42 percent of the amount that 
                        applies under subsection (a)(2)(A)(i) 
                        for premarket applications, and shall 
                        adjust the fee under subsection 
                        (a)(2)(A)(vii) for premarket 
                        notification submissions such that the 
                        reduced fees collected under clause (i) 
                        of this subparagraph, when added to 
                        fees for such submissions that are not 
                        paid at the reduced rate, will equal 
                        such revenue amount for the fiscal 
                        year.]
                  (C) Reduced fees.--For fiscal year 2008 and 
                each subsequent fiscal year, where the 
                Secretary finds that the applicant involved 
                meets the definition under subparagraph (A), 
                the fee for a premarket notification submission 
                may be paid at 50 percent of the fee that 
                applies under subsection (a)(2)(A)(viii), and 
                as established under subsection (c)(1).

           *       *       *       *       *       *       *

  [(f) Effect of Failure to Pay Fees.--A premarket application, 
premarket report, supplement, or premarket notification 
submission submitted by a person subject to fees under 
subsection (a) shall be considered incomplete and shall not be 
accepted by the Secretary until all fees owed by such person 
have been paid.]
  (f) Effect of Failure to Pay Fees.--
          (1) No acceptance of submissions.--A premarket 
        application, premarket report, supplement, premarket 
        notification submission, 30-day notice, request for 
        classification information, or periodic reporting 
        concerning a class III device submitted by a person 
        subject to fees under subsection (a)(2) and (a)(3) 
        shall be considered incomplete and shall not be 
        accepted by the Secretary until all fees owed by such 
        person have been paid.
          (2) No registration.--Registration information 
        submitted under section 510 by an establishment subject 
        to registration shall be considered incomplete and 
        shall not be accepted by the Secretary until the 
        registration fee under subsection (a)(3) owed for the 
        establishment has been paid. Until the fee is paid and 
        the registration is complete, the establishment is 
        deemed to have failed to register in accordance with 
        section 510.
  (g) Conditions.--
          (1) Performance goals through fiscal year 2005; 
        termination of program after fiscal year 2005.--With 
        respect to the amount that, under the salaries and 
        expenses account of the Food and Drug Administration, 
        is appropriated for a fiscal year for devices and 
        radiological products:
                  (A) * * *

           *       *       *       *       *       *       *

                  (D) [For fiscal year 2007] For fiscal year 
                2007 and for each subsequent year, fees may not 
                be assessed under subsection (a) for the fiscal 
                year, and the Secretary is not expected to meet 
                any performance goals identified for the fiscal 
                year, if--
                          (i) the amount so appropriated for 
                        the fiscal year, excluding the amount 
                        of fees appropriated for the fiscal 
                        year, is more than 1 percent less than 
                        $205,720,000 multiplied by the 
                        adjustment factor [applicable to fiscal 
                        year 2007] applicable to such fiscal 
                        year; or
                          (ii) pursuant to [subparagraph (C)] 
                        this subparagraph, fees were not 
                        assessed under subsection (a) [for 
                        fiscal year 2006] for the previous 
                        fiscal year.
          [(2) Authority.--If the Secretary does not assess 
        fees under subsection (a) during any portion of a 
        fiscal year because of subparagraph (C) or (D) of 
        paragraph (1) and if at a later date in such fiscal 
        year the Secretary may assess such fees, the Secretary 
        may assess and collect such fees, without any 
        modification in the rate for premarket applications, 
        supplements, premarket reports, and premarket 
        notification submissions, and at any time in such 
        fiscal year, notwithstanding the provisions of 
        subsection (a) relating to the date fees are to be 
        paid.]
          (2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal 
        year because of subparagraph (C) or (D) of paragraph 
        (1) and if at a later date in such fiscal year the 
        Secretary may assess such fees, the Secretary may 
        assess and collect such fees, without any modification 
        in the rate for premarket applications, supplements, 
        premarket reports, premarket notification submissions, 
        30-day notices, requests for classification 
        information, periodic reporting concerning a class III 
        device, and establishment registrations at any time in 
        such fiscal year, notwithstanding the provisions of 
        subsection (a) relating to the date fees are to be 
        paid.
  (h) Crediting and Availability of Fees.--
          (1) * * *

           *       *       *       *       *       *       *

          [(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this 
        section--
                  [(A) $25,125,000 for fiscal year 2003;
                  [(B) $27,255,000 for fiscal year 2004;
                  [(C) $29,785,000 for fiscal year 2005; and
                  [(D) such sums as may be necessary for each 
                of fiscal years 2006 and 2007.
        as adjusted to reflect adjustments in the total fee 
        revenues made under this section and changes in the 
        total amounts collected by application fees.
          [(4) Offset.--Any amount of fees collected for a 
        fiscal year under this section that exceeds the amount 
        of fees specified in appropriation Acts for such fiscal 
        year shall be credited to the appropriation account of 
        the Food and Drug Administration as provided in 
        paragraph (1), and shall be subtracted from the amount 
        of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation 
        Acts for a subsequent fiscal year.]
          (3) Authorizations of appropriations.--There are 
        authorized to be appropriated for fees under this 
        section--
                  (A) $48,431,000 for fiscal year 2008;
                  (B) $52,547,000 for fiscal year 2009;
                  (C) $57,014,000 for fiscal year 2010;
                  (D) $61,860,000 for fiscal year 2011; and
                  (E) $67,118,000 for fiscal year 2012.
          (4) Offset.--If the cumulative amount of fees 
        collected during fiscal years 2008, 2009, and 2010, 
        added to the amount estimated to be collected for 
        fiscal year 2011, which estimate shall be based upon 
        the amount of fees received by the Secretary through 
        June 30, 2011, exceeds the amount of fees specified in 
        aggregate in paragraph (3) for these four fiscal years, 
        the aggregate amount in excess shall be credited to the 
        appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall 
        be subtracted from the amount of fees that would 
        otherwise be authorized to be collected under this 
        section pursuant to appropriation Acts for fiscal year 
        2012.

           *       *       *       *       *       *       *


Subchapter D--Information and Education

           *       *       *       *       *       *       *


SEC. 742. EDUCATION.

  (a) * * *
  (b) Intramural Fellowships and Other Training Programs.--The 
Secretary, acting through the Commissioner, may, through 
fellowships and other training programs, conduct and support 
intramural research training for predoctoral and postdoctoral 
scientists and physicians. Any such fellowships and training 
programs under this section or under section 770(d)(2)(A)(ix) 
may include provision by such scientists and physicians of 
services on a voluntary and uncompensated basis, as the 
Secretary determines appropriate. Such scientists and 
physicians shall be subject to all legal and ethical 
requirements otherwise applicable to officers or employees of 
the Department of Health and Human Services.

           *       *       *       *       *       *       *


      Subchapter I--Reagan-Udall Foundation for the Food and Drug 
                             Administration

SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.

  (a) In General.--A nonprofit corporation to be known as the 
Reagan-Udall Foundation for the Food and Drug Administration 
(referred to in this subchapter as the ``Foundation'') shall be 
established in accordance with this section. The Foundation 
shall be headed by an Executive Director, appointed by the 
members of the Board of Directors under subsection (e). The 
Foundation shall not be an agency or instrumentality of the 
United States Government.
  (b) Purpose of Foundation.--The purpose of the Foundation is 
to advance the mission of the Food and Drug Administration to 
modernize medical, veterinary, food, food ingredient, and 
cosmetic product development, accelerate innovation, and 
enhance product safety.
  (c) Duties of the Foundation.--The Foundation shall--
          (1) taking into consideration the Critical Path 
        reports and priorities published by the Food and Drug 
        Administration, identify unmet needs in the 
        development, manufacture, and evaluation of the safety 
        and effectiveness, including postapproval, of devices, 
        including diagnostics, biologics, and drugs, and the 
        safety of food, food ingredients, and cosmetics, and 
        including the incorporation of more sensitive and 
        predictive tools and devices to measure safety;
          (2) establish goals and priorities in order to meet 
        the unmet needs identified in paragraph (1);
          (3) in consultation with the Secretary, identify 
        existing and proposed Federal intramural and extramural 
        research and development programs relating to the goals 
        and priorities established under paragraph (2), 
        coordinate Foundation activities with such programs, 
        and minimize Foundation duplication of existing 
        efforts;
          (4) award grants to, or enter into contracts, 
        memoranda of understanding, or cooperative agreements 
        with, scientists and entities, which may include the 
        Food and Drug Administration, university consortia, 
        public-private partnerships, institutions of higher 
        education, entities described in section 501(c)(3) of 
        the Internal Revenue Code (and exempt from tax under 
        section 501(a) of such Code), and industry, to 
        efficiently and effectively advance the goals and 
        priorities established under paragraph (2);
          (5) recruit meeting participants and hold or sponsor 
        (in whole or in part) meetings as appropriate to 
        further the goals and priorities established under 
        paragraph (2);
          (6) release and publish information and data and, to 
        the extent practicable, license, distribute, and 
        release material, reagents, and techniques to maximize, 
        promote, and coordinate the availability of such 
        material, reagents, and techniques for use by the Food 
        and Drug Administration, nonprofit organizations, and 
        academic and industrial researchers to further the 
        goals and priorities established under paragraph (2);
          (7) ensure that--
                  (A) action is taken as necessary to obtain 
                patents for inventions developed by the 
                Foundation or with funds from the Foundation;
                  (B) action is taken as necessary to enable 
                the licensing of inventions developed by the 
                Foundation or with funds from the Foundation; 
                and
                  (C) executed licenses, memoranda of 
                understanding, material transfer agreements, 
                contracts, and other such instruments, promote, 
                to the maximum extent practicable, the broadest 
                conversion to commercial and noncommercial 
                applications of licensed and patented 
                inventions of the Foundation to further the 
                goals and priorities established under 
                paragraph (2);
          (8) provide objective clinical and scientific 
        information to the Food and Drug Administration and, 
        upon request, to other Federal agencies to assist in 
        agency determinations of how to ensure that regulatory 
        policy accommodates scientific advances and meets the 
        agency's public health mission;
          (9) conduct annual assessments of the unmet needs 
        identified in paragraph (1); and
          (10) carry out such other activities consistent with 
        the purposes of the Foundation as the Board determines 
        appropriate.
  (d) Board of Directors.--
          (1) Establishment.--
                  (A) In general.--The Foundation shall have a 
                Board of Directors (referred to in this 
                subchapter as the ``Board''), which shall be 
                composed of ex officio and appointed members in 
                accordance with this subsection. All appointed 
                members of the Board shall be voting members.
                  (B) Ex officio members.--The ex officio 
                members of the Board shall be the following 
                individuals or their designees:
                          (i) The Commissioner.
                          (ii) The Director of the National 
                        Institutes of Health.
                          (iii) The Director of the Centers for 
                        Disease Control and Prevention.
                          (iv) The Director of the Agency for 
                        Healthcare Research and Quality.
                  (C) Appointed members.--
                          (i) In general.--The ex officio 
                        members of the Board under subparagraph 
                        (B) shall, by majority vote, appoint to 
                        the Board 12 individuals, from a list 
                        of candidates to be provided by the 
                        National Academy of Sciences. Of such 
                        appointed members--
                                  (I) 4 shall be 
                                representatives of the general 
                                pharmaceutical, device, food, 
                                cosmetic, and biotechnology 
                                industries;
                                  (II) 3 shall be 
                                representatives of academic 
                                research organizations;
                                  (III) 2 shall be 
                                representatives of Government 
                                agencies, including the Food 
                                and Drug Administration and the 
                                National Institutes of Health;
                                  (IV) 2 shall be 
                                representatives of patient or 
                                consumer advocacy 
                                organizations; and
                                  (V) 1 shall be a 
                                representative of health care 
                                providers.
                          (ii) Requirement.--The ex officio 
                        members shall ensure the Board 
                        membership includes individuals with 
                        expertise in areas including the 
                        sciences of developing, manufacturing, 
                        and evaluating the safety and 
                        effectiveness of devices, including 
                        diagnostics, biologics, and drugs, and 
                        the safety of food, food ingredients, 
                        and cosmetics.
          (D) Initial meeting.--
                  (i) In general.--Not later than 30 days after 
                the date of the enactment of this Act, the 
                Secretary shall convene a meeting of the ex 
                officio members of the Board to--
                          (I) incorporate the Foundation; and
                          (II) appoint the members of the Board 
                        in accordance with subparagraph (C).
                  (ii) Service of ex officio members.--Upon the 
                appointment of the members of the Board under 
                clause (i)(II), the terms of service of the ex 
                officio members of the Board as members of the 
                Board shall terminate.
                  (iii) Chair.--The ex officio members of the 
                Board under subparagraph (B) shall designate an 
                appointed member of the Board to serve as the 
                Chair of the Board.
          (2) Duties of board.--The Board shall--
                  (A) establish bylaws for the Foundation 
                that--
                          (i) are published in the Federal 
                        Register and available for public 
                        comment;
                          (ii) establish policies for the 
                        selection of the officers, employees, 
                        agents, and contractors of the 
                        Foundation;
                          (iii) establish policies, including 
                        ethical standards, for the acceptance, 
                        solicitation, and disposition of 
                        donations and grants to the Foundation 
                        and for the disposition of the assets 
                        of the Foundation, including 
                        appropriate limits on the ability of 
                        donors to designate, by stipulation or 
                        restriction, the use or recipient of 
                        donated funds;
                          (iv) establish policies that would 
                        subject all employees, fellows, and 
                        trainees of the Foundation to the 
                        conflict of interest standards under 
                        section 208 of title 18, United States 
                        Code;
                          (v) establish licensing, 
                        distribution, and publication policies 
                        that support the widest and least 
                        restrictive use by the public of 
                        information and inventions developed by 
                        the Foundation or with Foundation funds 
                        to carry out the duties described in 
                        paragraphs (6) and (7) of subsection 
                        (c), and may include charging cost-
                        based fees for published material 
                        produced by the Foundation;
                          (vi) specify principles for the 
                        review of proposals and awarding of 
                        grants and contracts that include peer 
                        review and that are consistent with 
                        those of the Foundation for the 
                        National Institutes of Health, to the 
                        extent determined practicable and 
                        appropriate by the Board;
                          (vii) specify a cap on administrative 
                        expenses for recipients of a grant, 
                        contract, or cooperative agreement from 
                        the Foundation;
                          (viii) establish policies for the 
                        execution of memoranda of understanding 
                        and cooperative agreements between the 
                        Foundation and other entities, 
                        including the Food and Drug 
                        Administration;
                          (ix) establish policies for funding 
                        training fellowships, whether at the 
                        Foundation, academic or scientific 
                        institutions, or the Food and Drug 
                        Administration, for scientists, 
                        doctors, and other professionals who 
                        are not employees of regulated 
                        industry, to foster greater 
                        understanding of and expertise in new 
                        scientific tools, diagnostics, 
                        manufacturing techniques, and potential 
                        barriers to translating basic research 
                        into clinical and regulatory practice;
                          (x) specify a process for annual 
                        Board review of the operations of the 
                        Foundation; and
                          (xi) establish specific duties of the 
                        Executive Director;
                  (B) prioritize and provide overall direction 
                to the activities of the Foundation;
                  (C) evaluate the performance of the Executive 
                Director; and
                  (D) carry out any other necessary activities 
                regarding the functioning of the Foundation.
          (3) Terms and vacancies.--
                  (A) Term.--The term of office of each member 
                of the Board appointed under paragraph (1)(C) 
                shall be 4 years, except that the terms of 
                offices for the initial appointed members of 
                the Board shall expire on a staggered basis as 
                determined by the ex officio members.
                  (B) Vacancy.--Any vacancy in the membership 
                of the Board--
                          (i) shall not affect the power of the 
                        remaining members to execute the duties 
                        of the Board; and
                          (ii) shall be filled by appointment 
                        by the appointed members described in 
                        paragraph (1)(C) by majority vote.
                  (C) Partial term.--If a member of the Board 
                does not serve the full term applicable under 
                subparagraph (A), the individual appointed 
                under subparagraph (B) to fill the resulting 
                vacancy shall be appointed for the remainder of 
                the term of the predecessor of the individual.
                  (D) Serving past term.--A member of the Board 
                may continue to serve after the expiration of 
                the term of the member until a successor is 
                appointed.
          (4) Compensation.--Members of the Board may not 
        receive compensation for service on the Board. Such 
        members may be reimbursed for travel, subsistence, and 
        other necessary expenses incurred in carrying out the 
        duties of the Board, as set forth in the bylaws issued 
        by the Board.
  (e) Incorporation.--The ex officio members of the Board shall 
serve as incorporators and shall take whatever actions 
necessary to incorporate the Foundation.
  (f) Nonprofit Status.--The Foundation shall be considered to 
be a corporation under section 501(c) of the Internal Revenue 
Code of 1986, and shall be subject to the provisions of such 
section.
  (g) Executive Director.--
          (1) In general.--The Board shall appoint an Executive 
        Director who shall serve at the pleasure of the Board. 
        The Executive Director shall be responsible for the 
        day-to-day operations of the Foundation and shall have 
        such specific duties and responsibilities as the Board 
        shall prescribe.
          (2) Compensation.--The compensation of the Executive 
        Director shall be fixed by the Board but shall not be 
        greater than the compensation of the Commissioner.
  (h) Administrative Powers.--In carrying out this subchapter, 
the Board, acting through the Executive Director, may--
          (1) adopt, alter, and use a corporate seal, which 
        shall be judicially noticed;
          (2) hire, promote, compensate, and discharge 1 or 
        more officers, employees, and agents, as may be 
        necessary, and define their duties;
          (3) prescribe the manner in which--
                  (A) real or personal property of the 
                Foundation is acquired, held, and transferred;
                  (B) general operations of the Foundation are 
                to be conducted; and
                  (C) the privileges granted to the Board by 
                law are exercised and enjoyed;
          (4) with the consent of the applicable executive 
        department or independent agency, use the information, 
        services, and facilities of such department or agencies 
        in carrying out this section;
          (5) enter into contracts with public and private 
        organizations for the writing, editing, printing, and 
        publishing of books and other material;
          (6) hold, administer, invest, and spend any gift, 
        devise, or bequest of real or personal property made to 
        the Foundation under subsection (i);
          (7) enter into such other contracts, leases, 
        cooperative agreements, and other transactions as the 
        Board considers appropriate to conduct the activities 
        of the Foundation;
          (8) modify or consent to the modification of any 
        contract or agreement to which it is a party or in 
        which it has an interest under this subchapter;
          (9) take such action as may be necessary to obtain 
        patents and licenses for devices and procedures 
        developed by the Foundation and its employees;
          (10) sue and be sued in its corporate name, and 
        complain and defend in courts of competent 
        jurisdiction;
          (11) appoint other groups of advisors as may be 
        determined necessary to carry out the functions of the 
        Foundation; and
          (12) exercise other powers as set forth in this 
        section, and such other incidental powers as are 
        necessary to carry out its powers, duties, and 
        functions in accordance with this subchapter.
  (i) Acceptance of Funds from Other Sources.--The Executive 
Director may solicit and accept on behalf of the Foundation, 
any funds, gifts, grants, devises, or bequests of real or 
personal property made to the Foundation, including from 
private entities, for the purposes of carrying out the duties 
of the Foundation.
  (j) Service of Federal Employees.--Federal Government 
employees may serve on committees advisory to the Foundation 
and otherwise cooperate with and assist the Foundation in 
carrying out its functions, so long as such employees do not 
direct or control Foundation activities.
  (k) Detail of Government Employees; Fellowships.--
          (1) Detail from federal agencies.--Federal Government 
        employees may be detailed from Federal agencies with or 
        without reimbursement to those agencies to the 
        Foundation at any time, and such detail shall be 
        without interruption or loss of civil service status or 
        privilege. Each such employee shall abide by the 
        statutory, regulatory, ethical, and procedural 
        standards applicable to the employees of the agency 
        from which such employee is detailed and those of the 
        Foundation.
          (2) Voluntary service; acceptance of federal 
        employees.--
                  (A) Foundation.--The Executive Director of 
                the Foundation may accept the services of 
                employees detailed from Federal agencies with 
                or without reimbursement to those agencies.
                  (B) Food and drug administration.--The 
                Commissioner may accept the uncompensated 
                services of Foundation fellows or trainees. 
                Such services shall be considered to be 
                undertaking an activity under contract with the 
                Secretary as described in section 708.
  (l) Annual Reports.--
          (1) Reports to foundation.--Any recipient of a grant, 
        contract, fellowship, memorandum of understanding, or 
        cooperative agreement from the Foundation under this 
        section shall submit to the Foundation a report on an 
        annual basis for the duration of such grant, contract, 
        fellowship, memorandum of understanding, or cooperative 
        agreement, that describes the activities carried out 
        under such grant, contract, fellowship, memorandum of 
        understanding, or cooperative agreement.
          (2) Report to congress and the fda.--Beginning with 
        fiscal year 2009, the Executive Director shall submit 
        to Congress and the Commissioner an annual report 
        that--
                  (A) describes the activities of the 
                Foundation and the progress of the Foundation 
                in furthering the goals and priorities 
                established under subsection (c)(2), including 
                the practical impact of the Foundation on 
                regulated product development;
                  (B) provides a specific accounting of the 
                source and use of all funds used by the 
                Foundation to carry out such activities; and
                  (C) provides information on how the results 
                of Foundation activities could be incorporated 
                into the regulatory and product review 
                activities of the Food and Drug Administration.
  (m) Separation of Funds.--The Executive Director shall ensure 
that the funds received from the Treasury are held in separate 
accounts from funds received from entities under subsection 
(i).
  (n) Funding.--From amounts appropriated to the Food and Drug 
Administration for each fiscal year, the Commissioner shall 
transfer not less than $500,000 and not more than $1,250,000, 
to the Foundation to carry out subsections (a), (b), and (d) 
through (m).

SEC. 771. LOCATION OF FOUNDATION.

  The Foundation shall, if practicable, be located not more 
than 20 miles from the District of Columbia.

SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

  (a) In General.--The Commissioner shall receive and assess 
the report submitted to the Commissioner by the Executive 
Director of the Foundation under section 770(l)(2).
  (b) Report to Congress.--Beginning with fiscal year 2009, the 
Commissioner shall submit to Congress an annual report 
summarizing the incorporation of the information provided by 
the Foundation in the report described under section 770(l)(2) 
and by other recipients of grants, contracts, memoranda of 
understanding, or cooperative agreements into regulatory and 
product review activities of the Food and Drug Administration.
  (c) Extramural Grants.--The provisions of this subchapter 
shall have no effect on any grant, contract, memorandum of 
understanding, or cooperative agreement between the Food and 
Drug Administration and any other entity entered into before, 
on, or after the date of enactment of this subchapter.

           *       *       *       *       *       *       *


CHAPTER IX--MISCELLANEOUS

           *       *       *       *       *       *       *


SEC. 910. OFFICE OF THE CHIEF SCIENTIST.

  (a) Establishment; Appointment.--The Secretary shall 
establish within the Office of the Commissioner an office to be 
known as the Office of the Chief Scientist. The Secretary shall 
appoint a Chief Scientist to lead such Office.
  (b) Duties of the Office.--The Office of the Chief Scientist 
shall--
          (1) oversee, coordinate, and ensure quality and 
        regulatory focus of the intramural research programs of 
        the Food and Drug Administration;
          (2) track and, to the extent necessary, coordinate 
        intramural research awards made by each center of the 
        Administration or science-based office within the 
        Office of the Commissioner, and ensure that there is no 
        duplication of research efforts supported by the 
        Reagan-Udall Foundation for the Food and Drug 
        Administration;
          (3) develop and advocate for a budget to support 
        intramural research;
          (4) develop a peer review process by which intramural 
        research can be evaluated; and
          (5) identify and solicit intramural research 
        proposals from across the Food and Drug Administration 
        through an advisory board composed of employees of the 
        Administration that shall include--
                  (A) representatives of each of the centers 
                and the science-based offices within the Office 
                of the Commissioner; and
                  (B) experts on trial design, epidemiology, 
                demographics, pharmacovigilance, basic science, 
                and public health.
                              ----------                              


BEST PHARMACEUTICALS FOR CHILDREN ACT

           *       *       *       *       *       *       *


SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS.

  (a) * * *
  (b) Duties.--The Office of Pediatric Therapeutics shall be 
responsible for coordination and facilitation of all activities 
of the Food and Drug Administration that may have any effect on 
a pediatric population or the practice of pediatrics or may in 
any other way involve pediatric issues, including increasing 
pediatric access to medical devices.

           *       *       *       *       *       *       *


SEC. 14. PEDIATRIC PHARMACOLOGY ADVISORY COMMITTEE.

  (a) In General.--The Secretary of Health and Human Services 
shall, under section 222 of the Public Health Service Act (42 
U.S.C. 217a) or other appropriate authority, convene and 
consult an advisory committee on pediatric therapeutics 
(including drugs and biological products) and medical devices 
(referred to in this section as the ``advisory committee'').
  (b) Purpose.--
          (1) In general.--The advisory committee shall advise 
        and make recommendations to the Secretary, through the 
        Commissioner of Food and Drugs, on matters relating to 
        pediatric therapeutics (including drugs and biological 
        products) and medical devices.
          (2) Matters included.--The matters referred to in 
        paragraph (1) include--
                  (A) pediatric research conducted under 
                sections 351, 409I, and 499 of the Public 
                Health Service Act and sections 501, 502, 505, 
                505A, [and 505B] 505B, 510(k), 515, and 520(m) 
                of the Federal Food, Drug, and Cosmetic Act;
                  [(B) identification of research priorities 
                related to pediatric therapeutics and the need 
                for additional treatments of specific pediatric 
                diseases or conditions; and]
                  (B) identification of research priorities 
                related to therapeutics (including drugs and 
                biological products) and medical devices for 
                pediatric populations and the need for 
                additional diagnostics and treatments for 
                specific pediatric diseases or conditions;
                  (C) the ethics, design, and analysis of 
                clinical trials related to pediatric 
                therapeutics (including drugs and biological 
                products) and medical devices.

           *       *       *       *       *       *       *

  (d) Continuation of Operation of Committee.--Notwithstanding 
section 14 of the Federal Advisory Committee Act, the advisory 
committee shall continue to operate during the five-year period 
beginning on the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007.

SEC. 15. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY 
                    COMMITTEE.

  (a) Clarification of Authorities.--
          (1) In general.--The Pediatric Subcommittee of the 
        Oncologic Drugs Advisory Committee (referred to in this 
        section as the ``Subcommittee''), in carrying out the 
        mission of reviewing and evaluating the data concerning 
        the safety and effectiveness of marketed and 
        investigational human drug products for use in the 
        treatment of pediatric cancers, shall--
                  (A) * * *
                  (B) provide recommendations and guidance to 
                help ensure that children with cancer have 
                timely access to the most promising new cancer 
                therapies; [and]
                  (C) advise on ways to improve consistency in 
                the availability of new therapeutic agents[.]; 
                and
                  (D) provide recommendations to the internal 
                review committee created under section 505A(f) 
                of the Federal Food, Drug, and Cosmetic Act 
                regarding the implementation of amendments to 
                sections 505A and 505B of the Federal Food, 
                Drug, and Cosmetic Act with respect to the 
                treatment of pediatric cancers.

           *       *       *       *       *       *       *

          (3) Continuation of operation of subcommittee.--
        Notwithstanding section 14 of the Federal Advisory 
        Committee Act, the Subcommittee shall continue to 
        operate during the five-year period beginning on the 
        date of the enactment of the Best Pharmaceuticals for 
        Children Act of 2007.

           *       *       *       *       *       *       *

  (d) Report.--Not later than January 31, [2003] 2009, the 
Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs and in consultation with the 
Director of the National Institutes of Health, shall submit to 
the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives a report on patient access to new therapeutic 
agents for pediatric cancer, including access to single patient 
use of new therapeutic agents.

           *       *       *       *       *       *       *

                              ----------                              


PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *


TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *


    Part F--Licensing--Biological Products and Clinical Laboratories

                     Subpart 1--Biological Products

                   REGULATION OF BIOLOGICAL PRODUCTS

  Sec. 351. (a)(1) * * *
  (2)(A) * * *

           *       *       *       *       *       *       *

  (D) Risk evaluation and mitigation strategy.--A person that 
submits an application for a license under this paragraph is 
subject to section 505(p) of the Federal Food, Drug, and 
Cosmetic Act.

           *       *       *       *       *       *       *

  (j) The Federal Food, Drug, and Cosmetic Act, including the 
requirements under section 505(p) of such Act, applies to a 
biological product subject to regulation under this section, 
except that a product for which a license has been approved 
under subsection (a) shall not be required to have an approved 
application under section 505 of such Act.

           *       *       *       *       *       *       *


                 TITLE IV--NATIONAL RESEARCH INSTITUTES

Part A--National Institutes of Health

           *       *       *       *       *       *       *


              APPOINTMENT AND AUTHORITY OF DIRECTOR OF NIH

  Sec. 402. (a) * * *

           *       *       *       *       *       *       *

  [(i)(1)(A) The Secretary, acting through the Director of NIH, 
shall establish, maintain, and operate a data bank of 
information on clinical trials for drugs for serious or life-
threatening diseases and conditions (in this subsection 
referred to as the ``data bank''). The activities of the data 
bank shall be integrated and coordinated with related 
activities of other agencies of the Department of Health and 
Human Services, and to the extent practicable, coordinated with 
other data banks containing similar information.
  [(B) The Secretary shall establish the data bank after 
consultation with the Commissioner of Food and Drugs, the 
directors of the appropriate agencies of the National 
Institutes of Health (including the National Library of 
Medicine), and the Director of the Centers for Disease Control 
and Prevention.
  [(2) In carrying out paragraph (1), the Secretary shall 
collect, catalog, store, and disseminate the information 
described in such paragraph. The Secretary shall disseminate 
such information through information systems, which shall 
include toll-free telephone communications, available to 
individuals with serious or life-threatening diseases and 
conditions, to other members of the public, to health care 
providers, and to researchers.
  [(3) The data bank shall include the following:
          [(A) A registry of clinical trials (whether federally 
        or privately funded) of experimental treatments for 
        serious or life-threatening diseases and conditions 
        under regulations promulgated pursuant to section 
        505(i) of the Federal Food, Drug, and Cosmetic Act, 
        which provides a description of the purpose of each 
        experimental drug, either with the consent of the 
        protocol sponsor, or when a trial to test effectiveness 
        begins. Information provided shall consist of 
        eligibility criteria for participation in the clinical 
        trials, a description of the location of trial sites, 
        and a point of contact for those wanting to enroll in 
        the trial, and shall be in a form that can be readily 
        understood by members of the public. Such information 
        shall be forwarded to the data bank by the sponsor of 
        the trial not later than 21 days after the approval of 
        the protocol.
          [(B) Information pertaining to experimental 
        treatments for serious or life-threatening diseases and 
        conditions that may be available--
                  [(i) under a treatment investigational new 
                drug application that has been submitted to the 
                Secretary under section 561(c) of the Federal 
                Food, Drug, and Cosmetic Act; or
                  [(ii) as a Group C cancer drug (as defined by 
                the National Cancer Institute).
                The data bank may also include information 
                pertaining to the results of clinical trials of 
                such treatments, with the consent of the 
                sponsor, including information concerning 
                potential toxicities or adverse effects 
                associated with the use or administration of 
                such experimental treatments.
  [(4) The data bank shall not include information relating to 
an investigation if the sponsor has provided a detailed 
certification to the Secretary that disclosure of such 
information would substantially interfere with the timely 
enrollment of subjects in the investigation, unless the 
Secretary, after the receipt of the certification, provides the 
sponsor with a detailed written determination that such 
disclosure would not substantially interfere with such 
enrollment.
  [(5) Fees collected under section 736 of the Federal Food, 
Drug, and Cosmetic Act shall not be used in carrying out this 
subsection.]

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Part B--General Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *


[SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

  [(a) List of Drugs for Which Pediatric Studies Are Needed.--
          [(1) In general.--Not later than one year after the 
        date of enactment of this section, the Secretary, 
        acting through the Director of the National Institutes 
        of Health and in consultation with the Commissioner of 
        Food and Drugs and experts in pediatric research, shall 
        develop, prioritize, and publish an annual list of 
        approved drugs for which--
                  [(A)(i) there is an approved application 
                under section 505(j) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 355(j));
                  [(ii) there is a submitted application that 
                could be approved under the criteria of section 
                505(j) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355(j));
                  [(iii) there is no patent protection or 
                market exclusivity protection under the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
                seq.); or
                  [(iv) there is a referral for inclusion on 
                the list under section 505A(d)(4)(C) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355a(d)(4)(C)); and
                  [(B) in the case of a drug referred to in 
                clause (i), (ii), or (iii) of subparagraph (A), 
                additional studies are needed to assess the 
                safety and effectiveness of the use of the drug 
                in the pediatric population.
          [(2) Consideration of available information.--In 
        developing and prioritizing the list under paragraph 
        (1), the Secretary shall consider, for each drug on the 
        list--
                  [(A) the availability of information 
                concerning the safe and effective use of the 
                drug in the pediatric population;
                  [(B) whether additional information is 
                needed;
                  [(C) whether new pediatric studies concerning 
                the drug may produce health benefits in the 
                pediatric population; and
                  [(D) whether reformulation of the drug is 
                necessary.
  [(b) Contracts for Pediatric Studies.--The Secretary shall 
award contracts to entities that have the expertise to conduct 
pediatric clinical trials (including qualified universities, 
hospitals, laboratories, contract research organizations, 
federally funded programs such as pediatric pharmacology 
research units, other public or private institutions, or 
individuals) to enable the entities to conduct pediatric 
studies concerning one or more drugs identified in the list 
described in subsection (a).
  [(c) Process for Contracts and Labeling Changes.--
          [(1) Written request to holders of approved 
        applications for drugs lacking exclusivity.--The 
        Commissioner of Food and Drugs, in consultation with 
        the Director of the National Institutes of Health, may 
        issue a written request (which shall include a 
        timeframe for negotiations for an agreement) for 
        pediatric studies concerning a drug identified in the 
        list described in subsection (a)(1)(A) (except clause 
        (iv)) to all holders of an approved application for the 
        drug under section 505 of the Federal Food, Drug, and 
        Cosmetic Act. Such a written request shall be made in a 
        manner equivalent to the manner in which a written 
        request is made under subsection (a) or (b) of section 
        505A of the Federal Food, Drug, and Cosmetic Act, 
        including with respect to information provided on the 
        pediatric studies to be conducted pursuant to the 
        request.
          [(2) Requests for contract proposals.--If the 
        Commissioner of Food and Drugs does not receive a 
        response to a written request issued under paragraph 
        (1) within 30 days of the date on which a request was 
        issued, or if a referral described in subsection 
        (a)(1)(A)(iv) is made, the Secretary, acting through 
        the Director of the National Institutes of Health and 
        in consultation with the Commissioner of Food and 
        Drugs, shall publish a request for contract proposals 
        to conduct the pediatric studies described in the 
        written request.
          [(3) Disqualification.--A holder that receives a 
        first right of refusal shall not be entitled to respond 
        to a request for contract proposals under paragraph 
        (2).
          [(4) Guidance.--Not later than 270 days after the 
        date of enactment of this section, the Commissioner of 
        Food and Drugs shall promulgate guidance to establish 
        the process for the submission of responses to written 
        requests under paragraph (1).
          [(5) Contracts.--A contract under this section may be 
        awarded only if a proposal for the contract is 
        submitted to the Secretary in such form and manner, and 
        containing such agreements, assurances, and information 
        as the Secretary determines to be necessary to carry 
        out this section.
          [(6) Reporting of studies.--
                  [(A) In general.--On completion of a 
                pediatric study in accordance with a contract 
                awarded under this section, a report concerning 
                the study shall be submitted to the Director of 
                the National Institutes of Health and the 
                Commissioner of Food and Drugs. The report 
                shall include all data generated in connection 
                with the study.
                  [(B) Availability of reports.--Each report 
                submitted under subparagraph (A) shall be 
                considered to be in the public domain (subject 
                to section 505A(d)(4)(D) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 
                355a(d)(4)(D)) and shall be assigned a docket 
                number by the Commissioner of Food and Drugs. 
                An interested person may submit written 
                comments concerning such pediatric studies to 
                the Commissioner of Food and Drugs, and the 
                written comments shall become part of the 
                docket file with respect to each of the drugs.
                  [(C) Action by commissioner.--The 
                Commissioner of Food and Drugs shall take 
                appropriate action in response to the reports 
                submitted under subparagraph (A) in accordance 
                with paragraph (7).
          [(7) Requests for labeling change.--During the 180-
        day period after the date on which a report is 
        submitted under paragraph (6)(A), the Commissioner of 
        Food and Drugs shall--
                  [(A) review the report and such other data as 
                are available concerning the safe and effective 
                use in the pediatric population of the drug 
                studied;
                  [(B) negotiate with the holders of approved 
                applications for the drug studied for any 
                labeling changes that the Commissioner of Food 
                and Drugs determines to be appropriate and 
                requests the holders to make; and
                  [(C)(i) place in the public docket file a 
                copy of the report and of any requested 
                labeling changes; and
                  [(ii) publish in the Federal Register a 
                summary of the report and a copy of any 
                requested labeling changes.
          [(8) Dispute resolution.--
                  [(A) Referral to pediatric advisory 
                committee.--If, not later than the end of the 
                180-day period specified in paragraph (7), the 
                holder of an approved application for the drug 
                involved does not agree to any labeling change 
                requested by the Commissioner of Food and Drugs 
                under that paragraph, the Commissioner of Food 
                and Drugs shall refer the request to the 
                Pediatric Advisory Committee.
                  [(B) Action by the pediatric advisory 
                committee.--Not later than 90 days after 
                receiving a referral under subparagraph (A), 
                the Pediatric Advisory Committee shall--
                          [(i) review the available information 
                        on the safe and effective use of the 
                        drug in the pediatric population, 
                        including study reports submitted under 
                        this section; and
                          [(ii) make a recommendation to the 
                        Commissioner of Food and Drugs as to 
                        appropriate labeling changes, if any.
          [(9) FDA determination.--Not later than 30 days after 
        receiving a recommendation from the Pediatric Advisory 
        Committee under paragraph (8)(B)(ii) with respect to a 
        drug, the Commissioner of Food and Drugs shall consider 
        the recommendation and, if appropriate, make a request 
        to the holders of approved applications for the drug to 
        make any labeling change that the Commissioner of Food 
        and Drugs determines to be appropriate.
          [(10) Failure to agree.--If a holder of an approved 
        application for a drug, within 30 days after receiving 
        a request to make a labeling change under paragraph 
        (9), does not agree to make a requested labeling 
        change, the Commissioner may deem the drug to be 
        misbranded under the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 301 et seq.).
          [(11) No effect on authority.--Nothing in this 
        subsection limits the authority of the United States to 
        bring an enforcement action under the Federal Food, 
        Drug, and Cosmetic Act when a drug lacks appropriate 
        pediatric labeling. Neither course of action (the 
        Pediatric Advisory Committee process or an enforcement 
        action referred to in the preceding sentence) shall 
        preclude, delay, or serve as the basis to stay the 
        other course of action.
          [(12) Recommendation for formulation changes.--If a 
        pediatric study completed under public contract 
        indicates that a formulation change is necessary and 
        the Secretary agrees, the Secretary shall send a 
        nonbinding letter of recommendation regarding that 
        change to each holder of an approved application.]

SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

  (a) List of Priority Issues in Pediatric Therapeutics.--
          (1) In general.--Not later than one year after the 
        date of the enactment of the Best Pharmaceuticals for 
        Children Act of 2007, the Secretary, acting through the 
        Director of the National Institutes of Health and in 
        consultation with the Commissioner of Food and Drugs 
        and experts in pediatric research, shall develop and 
        publish a priority list of needs in pediatric 
        therapeutics, including drugs or indications that 
        require study. The list shall be revised every three 
        years.
          (2) Consideration of available information.--In 
        developing and prioritizing the list under paragraph 
        (1), the Secretary shall consider--
                  (A) therapeutic gaps in pediatrics that may 
                include developmental pharmacology, 
                pharmacogenetic determinants of drug response, 
                metabolism of drugs and biologics in children, 
                and pediatric clinical trials;
                  (B) particular pediatric diseases, disorders 
                or conditions where more complete knowledge and 
                testing of therapeutics, including drugs and 
                biologics, may be beneficial in pediatric 
                populations; and
                  (C) the adequacy of necessary infrastructure 
                to conduct pediatric pharmacological research, 
                including research networks and trained 
                pediatric investigators.
  (b) Pediatric Studies and Research.--The Secretary, acting 
through the National Institutes of Health, shall award funds to 
entities that have the expertise to conduct pediatric clinical 
trials or other research (including qualified universities, 
hospitals, laboratories, contract research organizations, 
practice groups, federally funded programs such as pediatric 
pharmacology research units, other public or private 
institutions, or individuals) to enable the entities to conduct 
the drug studies or other research on the issues described in 
subsection (a). The Secretary may use contracts, grants, or 
other appropriate funding mechanisms to award funds under this 
subsection.
  (c) Process for Proposed Pediatric Study Requests and 
Labeling Changes.--
          (1) Submission of proposed pediatric study request.--
        The Director of the National Institutes of Health 
        shall, as appropriate, submit proposed pediatric study 
        requests for consideration by the Commissioner of Food 
        and Drugs for pediatric studies of a specific pediatric 
        indication identified under subsection (a). Such a 
        proposed pediatric study request shall be made in a 
        manner equivalent to a written request made under 
        subsection (b) or (c) of section 505A of the Federal 
        Food, Drug, and Cosmetic Act, including with respect to 
        the information provided on the pediatric studies to be 
        conducted pursuant to the request. The Director of the 
        National Institutes of Health may submit a proposed 
        pediatric study request for a drug for which--
                  (A)(i) there is an approved application under 
                section 505(j) of the Federal Food, Drug, and 
                Cosmetic Act; or
                  (ii) there is a submitted application that 
                could be approved under the criteria of such 
                section; and
                  (B) there is no patent protection or market 
                exclusivity protection for at least one form of 
                the drug under the Federal Food, Drug, and 
                Cosmetic Act; and
                  (C) additional studies are needed to assess 
                the safety and effectiveness of the use of the 
                drug in the pediatric population.
          (2) Written request to holders of approved 
        applications for drugs lacking exclusivity.--The 
        Commissioner of Food and Drugs, in consultation with 
        the Director of the National Institutes of Health, may 
        issue a written request based on the proposed pediatric 
        study request for the indication or indications 
        submitted pursuant to paragraph (1) (which shall 
        include a timeframe for negotiations for an agreement) 
        for pediatric studies concerning a drug identified 
        under subsection (a) to all holders of an approved 
        application for the drug under section 505 of the 
        Federal Food, Drug, and Cosmetic Act. Such a written 
        request shall be made in a manner equivalent to the 
        manner in which a written request is made under 
        subsection (b) or (c) of section 505A of such Act, 
        including with respect to information provided on the 
        pediatric studies to be conducted pursuant to the 
        request and using appropriate formulations for each age 
        group for which the study is requested.
          (3) Requests for proposals.--If the Commissioner of 
        Food and Drugs does not receive a response to a written 
        request issued under paragraph (2) not later than 30 
        days after the date on which a request was issued, the 
        Secretary, acting through the Director of the National 
        Institutes of Health and in consultation with the 
        Commissioner of Food and Drugs, shall publish a request 
        for proposals to conduct the pediatric studies 
        described in the written request in accordance with 
        subsection (b).
          (4) Disqualification.--A holder that receives a first 
        right of refusal shall not be entitled to respond to a 
        request for proposals under paragraph (3).
          (5) Contracts, grants, or other funding mechanisms.--
        A contract, grant, or other funding may be awarded 
        under this section only if a proposal is submitted to 
        the Secretary in such form and manner, and containing 
        such agreements, assurances, and information as the 
        Secretary determines to be necessary to carry out this 
        section.
          (6) Reporting of studies.--
                  (A) In general.--On completion of a pediatric 
                study in accordance with an award under this 
                section, a report concerning the study shall be 
                submitted to the Director of the National 
                Institutes of Health and the Commissioner of 
                Food and Drugs. The report shall include all 
                data generated in connection with the study, 
                including a written request if issued.
                  (B) Availability of reports.--Each report 
                submitted under subparagraph (A) shall be 
                considered to be in the public domain (subject 
                to section 505A(d)(4) of the Federal Food, 
                Drug, and Cosmetic Act) and shall be assigned a 
                docket number by the Commissioner of Food and 
                Drugs. An interested person may submit written 
                comments concerning such pediatric studies to 
                the Commissioner of Food and Drugs, and the 
                written comments shall become part of the 
                docket file with respect to each of the drugs.
                  (C) Action by commissioner.--The Commissioner 
                of Food and Drugs shall take appropriate action 
                in response to the reports submitted under 
                subparagraph (A) in accordance with paragraph 
                (7).
          (7) Requests for labeling change.--During the 180-day 
        period after the date on which a report is submitted 
        under paragraph (6)(A), the Commissioner of Food and 
        Drugs shall--
                  (A) review the report and such other data as 
                are available concerning the safe and effective 
                use in the pediatric population of the drug 
                studied;
                  (B) negotiate with the holders of approved 
                applications for the drug studied for any 
                labeling changes that the Commissioner of Food 
                and Drugs determines to be appropriate and 
                requests the holders to make; and
                  (C)(i) place in the public docket file a copy 
                of the report and of any requested labeling 
                changes; and
                  (ii) publish in the Federal Register and 
                through a posting on the website of the Food 
                and Drug Administration a summary of the report 
                and a copy of any requested labeling changes.
          (8) Dispute resolution.--
                  (A) Referral to pediatric advisory 
                committee.--If, not later than the end of the 
                180-day period specified in paragraph (7), the 
                holder of an approved application for the drug 
                involved does not agree to any labeling change 
                requested by the Commissioner of Food and Drugs 
                under that paragraph, the Commissioner of Food 
                and Drugs shall refer the request to the 
                Pediatric Advisory Committee.
                  (B) Action by the pediatric advisory 
                committee.--Not later than 90 days after 
                receiving a referral under subparagraph (A), 
                the Pediatric Advisory Committee shall--
                          (i) review the available information 
                        on the safe and effective use of the 
                        drug in the pediatric population, 
                        including study reports submitted under 
                        this section; and
                          (ii) make a recommendation to the 
                        Commissioner of Food and Drugs as to 
                        appropriate labeling changes, if any.
          (9) FDA determination.--Not later than 30 days after 
        receiving a recommendation from the Pediatric Advisory 
        Committee under paragraph (8)(B)(ii) with respect to a 
        drug, the Commissioner of Food and Drugs shall consider 
        the recommendation and, if appropriate, make a request 
        to the holders of approved applications for the drug to 
        make any labeling change that the Commissioner of Food 
        and Drugs determines to be appropriate.
          (10) Failure to agree.--If a holder of an approved 
        application for a drug, within 30 days after receiving 
        a request to make a labeling change under paragraph 
        (9), does not agree to make a requested labeling 
        change, the Commissioner of Food and Drugs may deem the 
        drug to be misbranded under the Federal Food, Drug, and 
        Cosmetic Act.
          (11) No effect on authority.--Nothing in this 
        subsection limits the authority of the United States to 
        bring an enforcement action under the Federal Food, 
        Drug, and Cosmetic Act when a drug lacks appropriate 
        pediatric labeling. Neither course of action (the 
        Pediatric Advisory Committee process or an enforcement 
        action referred to in the preceding sentence) shall 
        preclude, delay, or serve as the basis to stay the 
        other course of action.
  (d) Dissemination of Pediatric Information.--Not later than 
one year after the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007, the Secretary, acting 
through the Director of the National Institutes of Health, 
shall study the feasibility of establishing a compilation of 
information on pediatric drug use and report the findings to 
Congress.
  (e) Authorization of Appropriations.--
          (1) In general.--There are authorized to be 
        appropriated to carry out this section--
                  (A) $200,000,000 for fiscal year 2008; and
                  (B) such sums as are necessary for each of 
                the four succeeding fiscal years.
          (2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this 
        section until expended.

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Part H--General Provisions

           *       *       *       *       *       *       *


SEC. 492C. CLINICAL TRIAL REGISTRY DATABASE; CLINICAL TRIAL RESULTS 
                    DATABASE.

  (a) Definitions.--In this section:
          (1) Applicable clinical trial.--The term ``applicable 
        clinical trial''--
                  (A) means a clinical trial that is conducted 
                to test the safety or effectiveness (including 
                comparative effectiveness) of a drug or device 
                (irrespective of whether the clinical trial is 
                federally or privately funded, and whether the 
                clinical trial involves an approved or 
                unapproved drug or device);
                  (B) includes such a clinical trial that is 
                conducted outside of the United States if--
                          (i) there is an application or 
                        premarket notification pending before 
                        the Food and Drug Administration for 
                        approval or clearance of the drug or 
                        device involved under section 505, 
                        510(k), or 515 of the Federal Food, 
                        Drug, and Cosmetic Act or section 351 
                        of this Act; or
                          (ii) the drug or device involved is 
                        so approved or cleared; and
                  (C) notwithstanding subparagraphs (A) and 
                (B), excludes--
                          (i) a clinical trial to determine the 
                        safety of a use of a drug that is 
                        designed solely to detect major 
                        toxicities in the drug or to 
                        investigate pharmacokinetics, unless 
                        the clinical trial is designed to 
                        investigate pharmacokinetics in a 
                        special population or populations; and
                          (ii) a small clinical trial to 
                        determine the feasibility of a device, 
                        or a clinical trial to test prototype 
                        devices where the primary focus is 
                        feasibility.
          (2) Clinical trial information.--The term ``clinical 
        trial information'' means those data elements that are 
        necessary to complete an entry in the clinical trial 
        registry database under subsection (b) or the clinical 
        trial results database under subsection (c), as 
        applicable.
          (3) Completion date.--The term ``completion date'' 
        means the date of the final collection of data from 
        subjects in the clinical trial for the primary and 
        secondary outcomes to be examined in the trial.
          (4) Device.--The term ``device'' has the meaning 
        given to that term in section 201(h) of the Federal 
        Food, Drug, and Cosmetic Act.
          (5) Drug.--The term ``drug'' means a drug as defined 
        in section 201(g) of the Federal Food, Drug, and 
        Cosmetic Act or a biological product as defined in 
        section 351 of this Act.
          (6) Responsible party.--The term ``responsible 
        party'', with respect to an applicable clinical trial, 
        means--
                  (A) the primary sponsor (as defined in the 
                International Clinical Trials Registry Platform 
                trial registration data set of the World Health 
                Organization) of the clinical trial; or
                  (B) the principal investigator of such 
                clinical trial if so designated by such 
                sponsor, so long as the principal investigator 
                is responsible for conducting the trial, has 
                access to and control over the data, has the 
                right to publish the results of the trial, and 
                has the responsibility to meet all of the 
                requirements under this section that are 
                applicable to responsible parties.
  (b) Clinical Trials Registry Database.--
          (1) Establishment.--To enhance patient enrollment and 
        provide a mechanism to track subsequent progress of 
        clinical trials, the Secretary, acting through the 
        Director of NIH, shall establish and administer a 
        clinical trial registry database in accordance with 
        this section (referred to in this section as the 
        ``registry database''). The Director of NIH shall 
        ensure that the registry database is made publicly 
        available through the Internet.
          (2) Content.--The Secretary shall promulgate 
        regulations for the submission to the registry database 
        of clinical trial information that--
                  (A) conforms to the International Clinical 
                Trials Registry Platform trial registration 
                data set of the World Health Organization;
                  (B) includes the city, State, and zip code 
                for each clinical trial location or a toll free 
                number through which such location information 
                may be accessed;
                  (C) includes a statement of the estimated 
                completion date for the clinical trial;
                  (D) includes the identity and contact 
                information of the responsible party;
                  (E) if the drug is not approved under section 
                505 of the Federal Food, Drug, and Cosmetic Act 
                or licensed under section 351 of this Act, or 
                the device is not cleared under section 510(k) 
                or approved under section 515 of the Federal 
                Food, Drug, and Cosmetic Act, specifies whether 
                or not there is expanded access to the drug or 
                device under section 561 of the Federal Food, 
                Drug, and Cosmetic Act for those who do not 
                qualify for enrollment in the clinical trial 
                and how to obtain information about such 
                access;
                  (F) includes, with respect to any individual 
                who is not an employee of the responsible party 
                for the clinical trial or of the manufacturer 
                of the drug or device involved, information on 
                whether the responsible party or manufacturer 
                has entered into any agreement with such 
                individual that restricts in any manner the 
                ability of the individual--
                          (i) to discuss the results of the 
                        trial at a scientific meeting or any 
                        other public or private forum; or
                          (ii) to publish the results of the 
                        trial, or a description or discussion 
                        of the results of the trial, in a 
                        scientific or academic journal; and
                  (G) requires the inclusion of such other data 
                elements to the registry database as 
                appropriate.
          (3) Format and structure.--
                  (A) Searchable categories.--The Director of 
                NIH shall ensure that the public may search the 
                entries in the registry database by 1 or more 
                of the following criteria:
                          (i) The indication being studied in 
                        the clinical trial, using Medical 
                        Subject Headers (MeSH) descriptors.
                          (ii) The safety issue being studied 
                        in the clinical trial.
                          (iii) The enrollment status of the 
                        clinical trial.
                          (iv) The sponsor of the clinical 
                        trial.
                  (B) Format.--The Director of the NIH shall 
                ensure that the registry database is easily 
                used by patients, and that entries are easily 
                compared.
          (4) Data submission.--The responsible party for an 
        applicable clinical trial shall submit to the Director 
        of NIH for inclusion in the registry database the 
        clinical trial information described in paragraph (2).
          (5) Truthful clinical trial information.--
                  (A) In general.--The clinical trial 
                information submitted by a responsible party 
                under this subsection shall not be false or 
                misleading.
                  (B) Effect.--Subparagraph (A) shall not have 
                the effect of requiring clinical trial 
                information to include information from any 
                source other than the clinical trial involved.
          (6) Timing of submission.--Except as provided in 
        paragraph (7), the clinical trial information for a 
        clinical trial required to be submitted under this 
        subsection shall be submitted not later than 14 days 
        after the first patient is enrolled in such clinical 
        trial.
          (7) Updates.--The responsible party for an applicable 
        clinical trial shall submit to the Director of NIH for 
        inclusion in the registry database periodic updates to 
        reflect changes to the clinical trial information 
        submitted under this subsection. Such updates--
                  (A) shall be provided not less than once 
                every 6 months until information on the results 
                of the trial is submitted under subsection (c);
                  (B) shall include identification of the dates 
                of any such changes;
                  (C) not later than 30 days after the 
                enrollment status of such clinical trial 
                changes, shall include an update of the 
                enrollment status; and
                  (D) not later than 30 days after the 
                completion date of the clinical trial, shall 
                include a report to the Director that such 
                clinical trial is complete.
          (8) Applicability of device trials.--In the case of 
        an applicable clinical trial regarding a device, the 
        responsible person for the trial shall submit to the 
        Director of NIH the clinical trial information as 
        required in paragraph (4), but the Director may not 
        make the information publicly available through the 
        registry database until the device is approved or 
        cleared (as the case may be).
  (c) Clinical Trials Results Database.--
          (1) Establishment.--To ensure that results of 
        clinical trials are made public and that patients and 
        providers have current information regarding the 
        results of clinical trials, the Secretary, acting 
        through the Director of NIH, shall establish and 
        administer a clinical trial results database in 
        accordance with this section (referred to in this 
        section as the ``results database''). The Director of 
        NIH shall ensure that the results database is made 
        publicly available through the Internet.
          (2) Searchable categories.--The Director of NIH shall 
        ensure that the public may search the entries in the 
        results database by 1 or more of the following:
                  (A) The indication studied in the clinical 
                trial, using Medical Subject Headers (MeSH) 
                descriptors.
                  (B) The safety issue studied in the clinical 
                trial.
                  (C) Whether an application for the tested 
                indication is approved, pending approval, 
                withdrawn, or not submitted.
                  (D) The phase of the clinical trial.
                  (E) The name of the drug or device that is 
                the subject of the clinical trial.
                  (F) Within the documents described in clauses 
                (i) and (ii) of paragraph (3)(B), the following 
                information, as applicable:
                          (i) The sponsor of the clinical 
                        trial.
                          (ii) Each financial sponsor of the 
                        clinical trial.
          (3) Contents.--
                  (A) In general.--The responsible party for an 
                applicable clinical trial shall submit to the 
                Director of NIH for inclusion in the results 
                database the clinical trial information 
                described in subparagraph (B).
                  (B) Required elements.--In submitting 
                clinical trial information for a clinical trial 
                to the Director of NIH for inclusion in the 
                results database, the responsible party shall 
                include, with respect to such clinical trial, 
                the following information:
                          (i) The information described in 
                        subparagraphs (A) through (E) of 
                        subsection (b)(2).
                          (ii) A summary that is written in 
                        non-technical, understandable language 
                        for patients that includes the 
                        following:
                                  (I) The purpose of the 
                                clinical trial.
                                  (II) The sponsor of the 
                                clinical trial.
                                  (III) A point of contact for 
                                information about the clinical 
                                trial.
                                  (IV) A description of the 
                                patient population tested in 
                                the clinical trial.
                                  (V) A general description of 
                                the clinical trial and results, 
                                including a description of and 
                                the reasons for any changes in 
                                the clinical trial design that 
                                occurred since the date of 
                                submission of clinical trial 
                                information for inclusion in 
                                the registry database 
                                established under subsection 
                                (b) and a description of any 
                                significant safety information.
                          (iii) A summary that is technical in 
                        nature that includes the following:
                                  (I) The purpose of the 
                                clinical trial.
                                  (II) The sponsor of the 
                                clinical trial.
                                  (III) Each financial sponsor 
                                of the clinical trial.
                                  (IV) A point of contact for 
                                scientific information about 
                                the clinical trial.
                                  (V) A description of the 
                                patient population tested in 
                                the clinical trial.
                                  (VI) A general description of 
                                the clinical trial and results, 
                                including a description of and 
                                the reasons for any changes in 
                                the clinical trial design that 
                                occurred since the date of 
                                submission of clinical trial 
                                information for the clinical 
                                trial in the registry database 
                                established under subsection 
                                (b).
                                  (VII) Summary data describing 
                                the results, including--
                                          (aa) whether the 
                                        primary endpoint was 
                                        achieved, including 
                                        relevant statistics;
                                          (bb) an assessment of 
                                        any secondary 
                                        endpoints, if 
                                        applicable, including 
                                        relevant statistics; 
                                        and
                                          (cc) any significant 
                                        safety information, 
                                        including a summary of 
                                        the incidence of 
                                        serious adverse events 
                                        observed in the 
                                        clinical trial and a 
                                        summary of the most 
                                        common adverse events 
                                        observed in the 
                                        clinical trial and the 
                                        frequencies of such 
                                        events.
                          (iv) With respect to the group of 
                        subjects receiving the drug or device 
                        involved, and each comparison group of 
                        subjects, the percentage of individuals 
                        who ceased participation as subjects 
                        and the reasons for ceasing 
                        participation.
                          (v) With respect to an individual who 
                        is not an employee of the responsible 
                        party for the clinical trial or of the 
                        manufacturer of the drug or device 
                        involved, information (to the extent 
                        not submitted under subsection 
                        (b)(2)(F)) on any agreement that the 
                        responsible party or manufacturer has 
                        entered into with such individual that 
                        restricts in any manner the ability of 
                        the individual--
                                  (I) to discuss the results of 
                                the trial at a scientific 
                                meeting or any other public or 
                                private forum; or
                                  (II) to publish the results 
                                of the trial, or a description 
                                or discussion of the results of 
                                the trial, in a scientific or 
                                academic journal.
                          (vi) The completion date of the 
                        clinical trial.
                          (vii) A link to the Internet web 
                        posting of any adverse regulatory 
                        actions taken by the Food and Drug 
                        Administration, such as a warning 
                        letter, that was substantively based on 
                        the clinical trial design, outcome, or 
                        representation made by the applicant 
                        about the design or outcome of the 
                        clinical trial.
                  (C) Links in database.--The Director of NIH 
                shall ensure that the results database includes 
                the following:
                          (i) Links to Medline citations to 
                        publications reporting results from 
                        each applicable drug clinical trial and 
                        applicable device clinical trial.
                          (ii) Links to the entry for the 
                        product that is the subject of an 
                        applicable drug clinical trial in the 
                        National Library of Medicine database 
                        of structured product labels, if 
                        available.
                          (iii) Links described in clauses (i) 
                        and (ii) for data bank entries for 
                        clinical trials submitted to the data 
                        bank prior to enactment of this 
                        section, as available.
          (4) Timing.--
                  (A) In general.--Except as provided in 
                subparagraphs (B) and (C), a responsible party 
                shall submit to the Director of NIH for 
                inclusion in the results database clinical 
                trial information for an applicable clinical 
                trial not later than 1 year after the earlier 
                of--
                          (i) the estimated completion date of 
                        the trial, as submitted under 
                        subsection (b)(2); or
                          (ii) the actual date of the 
                        completion, or termination before 
                        completion, of the trial, as 
                        applicable.
                  (B) Extensions.--The Director of NIH may 
                provide an extension of the deadline for 
                submission of clinical trial information under 
                subparagraph (A) if the responsible party for 
                the trial submits to the Director a written 
                request that demonstrates good cause for the 
                extension and provides an estimate of the date 
                on which the information will be submitted. The 
                Director of NIH may grant more than one such 
                extension for the clinical trial involved.
                  (C) Updates.--The responsible party for an 
                applicable clinical trial shall submit to the 
                Director of NIH for inclusion in the results 
                database periodic updates to reflect changes in 
                the clinical trial information submitted under 
                this subsection. Such updates--
                          (i) shall be provided not less 
                        frequently than once every 6 months 
                        during the 10-year period beginning on 
                        the date on which information is due 
                        under subparagraph (A);
                          (ii) shall identify the dates on 
                        which the changes were made; and
                          (iii) shall include, not later than 
                        30 days after any change in the 
                        regulatory status of the drug or device 
                        involved, an update informing the 
                        Director of NIH of such change.
          (5) Truthful clinical trial information.--
                  (A) In general.--The clinical trial 
                information submitted by a responsible party 
                under this subsection shall not be false or 
                misleading in any particular.
                  (B) Effect.--Subparagraph (A) shall not have 
                the effect of requiring clinical trial 
                information with respect to a clinical trial to 
                include information from any source other than 
                such clinical trial.
          (6) Public availability of results.--
                  (A) Pre-approval studies.--Except as provided 
                in subparagraph (E), with respect to an 
                applicable clinical trial that is completed 
                before the drug is initially approved under 
                section 505 of the Federal Food, Drug, and 
                Cosmetic Act or initially licensed under 
                section 351 of this Act, or the device is 
                initially cleared under section 510(k) or 
                approved under section 515 of the Federal Food, 
                Drug, and Cosmetic Act, the Director of NIH 
                shall make publicly available on the results 
                database the clinical trial information 
                submitted for such clinical trial not later 
                than 30 days after--
                          (i) the drug or device is approved 
                        under such section 505, licensed under 
                        such section 351, cleared under such 
                        section 510(k), or approved under such 
                        section 515, as applicable; or
                          (ii) the Secretary issues a not 
                        approvable letter or a not 
                        substantially equivalent letter for the 
                        drug or device under such section 505, 
                        351, 510(k), or 515, as applicable.
                  (B) Medical and clinical pharmacology reviews 
                of pre-approval studies.--Not later than 90 
                days after the date applicable under clause (i) 
                or (ii) of subparagraph (A) with respect to an 
                applicable clinical trial, the Director of NIH 
                shall make publicly available on the results 
                database a summary of the available medical and 
                clinical pharmacology reviews conducted by the 
                Food and Drug Administration for such trial.
                  (C) Post-approval studies.--Except as 
                provided in subparagraphs (D) and (E), with 
                respect to an applicable clinical trial that is 
                completed after the drug is initially approved 
                under such section 505 or licensed under such 
                section 351, or the device is initially cleared 
                under such section 510(k) or approved under 
                such section 515, the Director of NIH shall 
                make publicly available on the results database 
                the clinical trial information submitted for 
                such clinical trial not later than 30 days 
                after the date of such submission.
                  (D) Seeking approval of a new use for the 
                drug or device.--
                          (i) In general.--If the manufacturer 
                        of the drug or device is the sponsor or 
                        a financial sponsor of an applicable 
                        clinical trial, and such manufacturer 
                        certifies to the Director of NIH that 
                        such manufacturer has filed, or will 
                        file within 1 year, an application 
                        seeking approval under such section 
                        505, licensing under such section 351, 
                        clearance under such section 510(k), or 
                        approval under such section 515 for the 
                        use studied in such clinical trial 
                        (which use is not included in the 
                        labeling of the approved drug or 
                        device), then the Director of NIH shall 
                        make publicly available on the results 
                        database the clinical trial information 
                        submitted for such clinical trial on 
                        the earlier of the date that is 30 days 
                        after the date--
                                  (I) the new use of the drug 
                                or device is approved under 
                                such section 505, licensed 
                                under such section 351, cleared 
                                under such section 510(k), or 
                                approved under such section 
                                515;
                                  (II) the Secretary issues a 
                                not approvable letter or a not 
                                substantially equivalent letter 
                                for the new use of the drug or 
                                device under such section 505, 
                                351, 510(k), or 515; or
                                  (III) the application or 
                                premarket notification under 
                                such section 505, 351, 510(k), 
                                or 515 is withdrawn.
                          (ii) Limitation on certification.--If 
                        a manufacturer makes a certification 
                        under clause (i) with respect to a 
                        clinical trial, the manufacturer shall 
                        make such a certification with respect 
                        to each applicable clinical trial that 
                        is required to be submitted in an 
                        application for approval of the use 
                        studied in the clinical trial.
                          (iii) 2-year limitation.--The 
                        clinical trial information subject to 
                        clause (i) shall be made publicly 
                        available on the results database on 
                        the date that is 2 years after the date 
                        the certification referred to in clause 
                        (i) was made to the Director of NIH, if 
                        a regulatory action referred to in 
                        subclause (I), (II), or (III) of clause 
                        (i) has not occurred by such date.
                          (iv) Medical and clinical 
                        pharmacology reviews.--Not later than 
                        90 days after the date applicable under 
                        subclause (I), (II), or (III) of clause 
                        (i) or clause (iii) with respect to an 
                        applicable clinical trial, the Director 
                        of NIH shall make publicly available on 
                        the results database a summary of the 
                        available medical and clinical 
                        pharmacology reviews conducted by the 
                        Food and Drug Administration for such 
                        trial.
                  (E) Seeking publication.--
                          (i) In general.--If the principal 
                        investigator of an applicable clinical 
                        trial is seeking publication in a peer-
                        reviewed biomedical journal of a 
                        manuscript based on the results of the 
                        clinical trial and the responsible 
                        party so certifies to the Director of 
                        NIH--
                                  (I) the responsible party 
                                shall notify the Director of 
                                NIH of the publication date of 
                                such manuscript not later than 
                                15 days after such date; and
                                  (II) the Director of NIH 
                                shall make publicly available 
                                on the results database the 
                                clinical trial information 
                                submitted for such clinical 
                                trial on the date that is 30 
                                days after the publication date 
                                of such manuscript.
                          (ii) Limitations.--The clinical trial 
                        information subject to clause (i)--
                                  (I) shall be made publicly 
                                available on the results 
                                database on the date that is 2 
                                years after the date that the 
                                clinical trial information was 
                                required to be submitted to the 
                                Director of NIH if the 
                                manuscript referred to in such 
                                clause has not been published 
                                by such date; and
                                  (II) shall not be required to 
                                be made publicly available 
                                under section 552 of title 5, 
                                United States Code (commonly 
                                known as the ``Freedom of 
                                Information Act''), prior to 
                                the date applicable to such 
                                clinical trial information 
                                under this subparagraph.
          (7) Verification of submission prior to public 
        availability.--In the case of clinical trial 
        information that is submitted under this subsection, 
        but is not made publicly available pending either 
        regulatory action or publication under subparagraph (D) 
        or (E) of paragraph (6), as applicable, the Director of 
        NIH shall respond to inquiries from other Federal 
        agencies and peer-reviewed journals to confirm that 
        such clinical trial information has been submitted but 
        has not yet been made publicly available on the results 
        database.
  (d) Updates; Tracking of Changes in Submitted Information.--
The Director of NIH shall ensure that updates submitted to the 
Director under subsections (b)(7) and (c)(4) do not result in 
the removal from the registry database or the results database 
of the original submissions or of any preceding updates, and 
that information in such databases is presented in a manner 
that enables users to readily access each original submission 
and to track the changes made by the updates.
  (e) Coordination and Compliance.--
          (1) Consultation with other federal agencies.--The 
        Secretary shall--
                  (A) consult with other agencies that conduct 
                human studies in accordance with part 46 of 
                title 45, Code of Federal Regulations (or any 
                successor regulations), to determine if any 
                such studies are applicable clinical trials; 
                and
                  (B) develop with such agencies appropriate 
                procedures to ensure that clinical trial 
                information for such applicable clinical trials 
                is submitted under subsection (b) and (c).
          (2) Coordination of registry database and results 
        database.--
                  (A) In general.--Each entry in the registry 
                database under subsection (b) or the results 
                database under subsection (c) shall include a 
                link to the corresponding entry in the results 
                database or the registry database, 
                respectively.
                  (B) Missing entries.--
                          (i) In general.--If, based on a 
                        review of the entries in the registry 
                        database under subsection (b), the 
                        Director of NIH determines that a 
                        responsible party has failed to submit 
                        required clinical trial information to 
                        the results database under subsection 
                        (c), the Director of NIH shall inform 
                        the responsible party involved of such 
                        failure and permit the responsible 
                        party to correct the failure within 30 
                        days.
                          (ii) Failure to correct.--If the 
                        responsible party does not correct a 
                        failure to submit required clinical 
                        trial information within the 30-day 
                        period described under clause (i), the 
                        Director of NIH shall report such 
                        noncompliance to the scientific peer 
                        review committees of the Federal 
                        research agencies and to the Office of 
                        Human Research Protections.
                          (iii) Public notice of failure to 
                        correct.--The Director of NIH shall 
                        include in the clinical trial registry 
                        database entry and the clinical trial 
                        results database entry for each 
                        applicable clinical trial a notice of 
                        any uncorrected failure to submit 
                        required clinical trial information and 
                        shall provide that the public may 
                        easily search for such entries.
          (3) Action on applications.--
                  (A) Verification prior to filing.--The 
                Secretary, acting through the Commissioner of 
                Food and Drugs, shall verify that the clinical 
                trial information required under subsections 
                (b) and (c) for an applicable clinical trial is 
                submitted pursuant to such subsections, as 
                applicable--
                          (i) when considering a drug or device 
                        for an exemption under section 505(i) 
                        or section 520(g) of the Federal Food, 
                        Drug, and Cosmetic Act; and
                          (ii) prior to filing an application 
                        or premarket notification under section 
                        505, 510(k), or 515 of the Federal 
                        Food, Drug, and Cosmetic Act or section 
                        351 of this Act, that includes 
                        information from such clinical trial.
                  (B) Notification.--If the Secretary 
                determines under subparagraph (A) that clinical 
                trial information has not been submitted as 
                required by subsection (b) or (c), the 
                Secretary shall notify the applicant and the 
                responsible party of such noncompliance and 
                require submission of such information within 
                30 days.
                  (C) Refusal to file.--If the responsible 
                party does not remedy such noncompliance within 
                30 days of receipt of notification under 
                subparagraph (B), the Secretary shall refuse to 
                file, approve, or clear such application or 
                premarket notification.
          (4) Content review.--
                  (A) In general.--To ensure that the summary 
                documents described in subsection (c)(3) are 
                non-promotional, and are not false or 
                misleading in any particular under subsection 
                (c)(5), the Secretary shall compare such 
                documents to the results data of the clinical 
                trial for a representative sample of applicable 
                clinical trials by--
                          (i) acting through the Commissioner 
                        of Food and Drugs to examine the 
                        results data for such clinical trials 
                        submitted to Secretary when such data 
                        are submitted--
                                  (I) for review as part of an 
                                application under section 505 
                                or 515 of the Federal Food, 
                                Drug, and Cosmetic Act or under 
                                section 351 of this Act or a 
                                premarket notification under 
                                section 510(k) of the Federal 
                                Food, Drug, and Cosmetic Act; 
                                or
                                  (II) in an annual status 
                                report on the drug or device 
                                under such application;
                          (ii) acting with the Federal agency 
                        that funds such clinical trial in whole 
                        or in part by a grant to examine the 
                        results data for such clinical trials; 
                        and
                          (iii) acting through inspections 
                        under section 704 of the Federal Food, 
                        Drug, and Cosmetic Act to examine 
                        results data for such clinical trials 
                        not described in clause (i) or (ii).
                  (B) Notice of noncompliance.--If the 
                Secretary determines that the clinical trial 
                information submitted in such a summary 
                document is false or misleading in any 
                particular, the Secretary shall notify the 
                responsible party and give such party an 
                opportunity to remedy such noncompliance by 
                submitting the required revised clinical trial 
                information within 30 days of such 
                notification.
  (f) Penalties for Noncompliance.--
          (1) In general.--The following acts and the causing 
        thereof are unlawful:
                  (A) The failure to submit clinical trial 
                information as required by this section.
                  (B) The submission of clinical trial 
                information under this section that is false or 
                misleading in any particular in violation of 
                subsection (b)(5) or (c)(5).
          (2) Certain penaltiesSection 303(a) of the Federal 
        Food, Drug, and Cosmetic Act applies with respect to a 
        violation of paragraph (1) to the same extent and in 
        the same manner as such section 303(a) applies with 
        respect to a violation of section 301 of such Act.
          (3) Considerations.--In determining whether to apply 
        a penalty under paragraph (2) or under paragraph (4) 
        for a violation described in paragraph (1), the 
        Secretary, acting through the Commissioner of Food and 
        Drugs, shall consider--
                  (A) whether the responsible party promptly 
                corrects the noncompliance when provided 
                notice;
                  (B) whether the responsible party has engaged 
                in a pattern or practice of noncompliance; and
                  (C) the extent to which the noncompliance 
                involved may have significantly misled health 
                care providers or patients concerning the 
                safety or effectiveness of the drug involved.
          (4) Civil penalties.--
                  (A) In general.--A person is subject to a 
                civil penalty in accordance with this paragraph 
                if the person commits a violation described in 
                paragraph (1) and fails to correct the 
                violation by the end of the 30-day period 
                described in subparagraph (B).
                  (B) Notification.--If a person is in 
                violation of paragraph (1), the Secretary shall 
                notify the person of such noncompliance and 
                give the person a 30-day period to correct such 
                violation before imposing a civil penalty under 
                this paragraph.
                  (C) Amount of penalty.--The amount of a civil 
                penalty under this subsection shall be not more 
                than a total of $15,000 for all violations 
                adjudicated in a single proceeding in the case 
                of an individual, and not more than $10,000 per 
                day until the violation is corrected in the 
                case of any other person, except that if the 
                person is a nonprofit entity the penalty may 
                not exceed a total of $15,000 for all 
                violations adjudicated in a single proceeding.
                  (D) Procedures.--The provisions of paragraphs 
                (4) through (6) of section 303(f) of the 
                Federal Food, Drug, and Cosmetic Act apply to 
                the imposition of a penalty under this 
                subsection to the same extent and in the same 
                manner as such provisions apply to a penalty 
                imposed under such section 303(f).
  (g) Authorization of Appropriations.--There are authorized to 
be appropriated to carry out this section $10,000,000 for each 
fiscal year.

           *       *       *       *       *       *       *


        PART I--FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH

SEC. 499. ESTABLISHMENT AND DUTIES OF FOUNDATION.

  (a) * * *

           *       *       *       *       *       *       *

  (c) Certain Activities of Foundation.--
          (1) In general.--In carrying out subsection (b), the 
        Foundation may solicit and accept gifts, grants, and 
        other donations, establish accounts, and invest and 
        expend funds in support of the following activities 
        with respect to the purpose described in such 
        subsection:
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) A program to collect funds for pediatric 
                pharmacologic research [and studies listed by 
                the Secretary pursuant to section 409I(a)(1)(A) 
                of this Act and referred under section 
                505A(d)(4)(C) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355a(d)(4)(C))].

           *       *       *       *       *       *       *

                              ----------                              


ORPHAN DRUG ACT

           *       *       *       *       *       *       *


  GRANTS AND CONTRACTS FOR DEVELOPMENT OF DRUGS FOR RARE DISEASES AND 
                               CONDITIONS

  Sec. 5. (a) * * *

           *       *       *       *       *       *       *

  [(c) For grants and contracts under subsection (a), there are 
authorized to be appropriated such sums as already have been 
appropriated for fiscal year 2002, and $25,000,000 for each of 
the fiscal years 2003 through 2006.]
  (c) For grants and contracts under subsection (a), there is 
authorized to be appropriated $30,000,000 for each of fiscal 
years 2008 through 2012.

           *       *       *       *       *       *       *


                            ADDITIONAL VIEWS

    We support the goal and concept of enhancing access to 
information on clinical trials and providing a mechanism to 
enable health care professionals and the public to obtain 
information about trial results. In Committee Mr. Deal offered 
and withdrew an amendment which would accomplish our mutual 
objectives but leaves the Department of Health and Human 
Services the flexibility they need and requested to go forward.
    The current legislation presents significant conceptual and 
operational problems that need to be resolved if such proposed 
databases are to prove feasible. The proposed legislation 
requires the Department not only to monitor, track, and verify 
data submissions, and determine if and when certain trial 
information can be released, but to undertake numerous 
regulatory functions not associated with current NIH and FDA 
systems, such as notifying responsible parties of non-
compliance in data submission, monitoring subsequent 
performance to assure compliance, and, as necessary, taking 
certain compliance-related enforcement actions.
    The implementation challenges associated with establishing 
the results database would be daunting, particularly given the 
ambitious timeframes outlined in the bill.
    The proposed results database would contain large volumes 
of information--including summary reports intended for use by 
patients and clinicians--that have not been subject to 
external, scientific review.
    It is critical that such a database be defined in a way 
that recognizes the potential risks of posting unvalidated 
information and the difficulty of ensuring the accuracy and 
completeness of submitted data, and that accommodates the 
operational and resource limitations of NIH, FDA, and other 
federal agencies.
    The approach in the other body is a better starting point. 
We think it is important to set out a trial period for NIH to 
get further experience with a results data base. HHS would then 
provide regulatory authority to set out the requirements for 
such a data base.
    We do share the basic objectives of the authors. We believe 
there is a commitment from the authors and the Full Committee 
and Subcommittee Chairman to continue to work to a more 
workable model.
    We believe the bill as written may pose significant 
problems in a year. People will not know how to comply. There 
will be too many ambiguities. Methods for summarizing data, 
where such methods are not validated, will end up misinforming 
people. We know that is not our intention. At some point, it is 
useful to recognize the limitations of micromanaging efforts 
like this.

                                   Joe Barton.
                                   Nathan Deal.

                            ADDITIONAL VIEWS

    We strongly support this legislation to implement an 
aggressive post-market drug safety regulatory framework at the 
Food and Drug Administration (FDA) to better ensure the safety 
of the nation's drug supply. While we believe that Congress 
should enact these measures to protect the American public from 
adverse drug events, we are concerned that this legislation 
fails to adequately ensure consumers' continued access to State 
remedies in the event of personal injury or wrongful death from 
a pharmaceutical product regulated under this bill.
    Specifically, we are concerned about the unintended 
consequence of triggering field preemption, whereby a defendant 
could argue that this legislation creates a pervasive 
regulatory scheme under which the defendant could gain immunity 
from State liability claims. The additional regulation of 
pharmaceutical products proposed in this legislation is an 
effort to provide consumers with increased protection, not an 
effort to provide pharmaceutical manufacturers with immunity 
from liability when their products harm consumers. In no way do 
we intend to occupy this regulatory field to an extent that 
would limit the right of consumers to seek civil compensation 
in the event of personal injury or wrongful death resulting 
from a finding of liability on the part of pharmaceutical 
manufacturers.
    To address any unintended consequences this legislation may 
impose upon a consumer's access to State remedies, we support 
the future inclusion of language to clarify that nothing in 
this legislation or in current law is intended to preempt 
remedies for consumers injured by dangerous drugs. With the 
inclusion of this language, Congress would strike the 
appropriate balance between providing the FDA with the 
necessary authority to protect consumers from adverse drug 
events and ensuring that Congress does not inadvertently 
preempt common law remedies. Such language would preserve the 
status quo, allowing the FDA and state remedies to remain 
complementary and necessary safeguards to protect American 
families.
    We look forward to working with the Chairman and conferees 
to ensure that consumers are protected from the consequences of 
dangerous or deadly drugs.

                                   Gene Green.
                                   Lois Capps.
                                   Jay Inslee.
                                   Bart Stupak.
                                   Janice Schakowsky.
                                   Henry A. Waxman.
                                   Diana DeGette.
                                   Charles A. Gonzalez.
                                   Mike Doyle.
                                   Hilda L. Solis.
                                   Thomas Allen.
                                   Tammy Baldwin.
                                   John Barrow.
                                   Mike Ross.
                                   Anthony Weiner.

                                  
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