[Congressional Record Volume 153, Number 19 (Wednesday, January 31, 2007)]
[Senate]
[Pages S1447-S1457]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. GRASSLEY (for himself, Mr. Dodd, Ms. Mikulski, and Mr. 
        Bingaman):
  S. 468. A bill to amend the Federal Food, Drug, and Cosmetic Act with 
respect to drug safety, and for other purposes; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. DODD. Mr. President, I rise today to introduce the Fair Access to 
Clinical Trials (FACT) Act. I want to begin by thanking Senators 
Grassley, Wyden, Bingaman, Durbin, and Harkin for joining me in 
introducing this legislation. I also would like to recognize the 
leadership of Senator Johnson who was involved in the crafting of this 
legislation from the beginning and who has been a long-standing 
supporter of the FACT Act.
  Our bill will create an electronic databank for clinical trials of 
drugs, biological products, and medical devices. Such a databank will 
ensure that physicians, researchers, the general public, and patients 
seeking to enroll in clinical trials have access to basic information 
about those trials. It will require manufacturers and other researchers 
to reveal the results of clinical trials so that clinically important 
information will be available to all Americans, and physicians will 
have all the information necessary to make appropriate treatment 
decisions for their patients.
  Events of the past few years have made it clear that such a databank 
is needed. For example, serious questions were raised about the 
effectiveness and safety of antidepressants when used in children and 
youth. It has now become clear that the existing data indicates that 
these drugs may very well put children at risk. However, because the 
data from antidepressant clinical trials was not publicly available, it 
took years for this risk to be realized. In the meantime, millions of 
children have been prescribed antidepressants by well-meaning 
physicians. While these drugs undoubtedly helped many of these 
children, they also led to greater suffering for others.
  The news is similarly disturbing for a popular class of painkillers 
known as Cox-2 inhibitors. These medicines, taken by millions of 
Americans, have been associated with an increased risk of 
cardiovascular adverse events, such as heart attack and stroke. It has 
been suggested that one of these medicines, which has since been pulled 
from the market, may have been responsible for tens of thousands of 
deaths.
  Most recently, a drug manufacturer acknowledged that it did not 
inform the Food and Drug Administration (FDA) or the public about the 
results of a 67,000 person study it conducted of an FDA-approved drug 
used commonly during heart surgery to reduce the need for a 
transfusion. The study revealed the drug may increase patients' risk of 
death, serious kidney damage, congestive heart failure, and stroke.
  Unfortunately, these are just a few examples of stories that have 
become all too common. It has been suggested that negative data might 
actually have been suppressed; and if this is discovered to be the 
case, those responsible should be dealt with harshly. However, because 
of what is known as ``publication bias,'' the information available to 
the public and physicians can be misleading even without nefarious 
motives. The simple fact is that studies with a positive result are far 
more likely to be published, and thus publicly available, than a study 
with a negative result. Physicians and patients hear the good news. 
Rarely do they hear the bad news. In the end, the imbalance of 
available information hurts patients.
  Our bill would correct this imbalance in information, and prevent 
manufacturers from suppressing negative data. It would do so by 
creating a two-part databank, consisting of an expansion of 
clinicaltrials.gov--an existing registry that is operated by the 
National Library of Medicine (NLM)--and a new database for clinical 
trial results.
  Under the FACT Act, the registry would continue to operate as a 
resource for patients seeking to enroll in clinical trials for drugs 
and biological products intended to treat serious or life-threatening 
conditions--and for the first time, it would also include medical 
device trials. The new results database would include all trials 
(except for preliminary safety trials), and would require the 
submission of clinical trial results data.
  Our legislation would enforce the requirement to submit information 
to the databank in two ways. First, by requiring registration as a 
condition of Institutional Review Board (IRB) approval, no trial could 
begin without submitting preliminary information to the registry and 
database. This information would include the purpose of the trial, the 
estimated date of trial completion, as well as all of the information 
necessary to help patients to enroll in the trial.
  Once the trial is completed, the researcher or manufacturer is 
required to submit the results to the database. If they refuse to do 
so, they are subject to monetary penalties or, in the case of 
federally-funded research, a restriction on future federal funding. It 
is my belief that these enforcement mechanisms will ensure broad 
compliance. However, in the rare case where a manufacturer does not 
comply, this legislation also gives the FDA the authority to publicize 
the required information.
  Let me also say that any time you are collecting large amounts of 
data and making it public, protecting patient privacy and 
confidentiality is

[[Page S1448]]

paramount. Our legislation would in no way threaten patient privacy. 
The simple fact is that under this bill, no individually-identifiable 
information would be available to the public.
  I believe that the establishment of a clinical trials databank is 
absolutely necessary for the health and well-being of the American 
public. But I would also like to highlight two other benefits that such 
a databank will have. First, it has the potential to reduce health care 
costs. Studies have shown that publication bias also leads to a bias 
toward new and more expensive treatment options. A databank could help 
make it clear that in some cases less expensive treatments are just as 
effective for patients.
  In addition, a databank will ensure that the sacrifice made by 
patients who enroll in clinical trials is not squandered. We owe it to 
patients to make sure that their participation in a trial will benefit 
other individuals suffering from the same illness or condition by 
making the results of the trial public, no matter the outcome of the 
trial.

  The problems associated with publication bias have recently drawn 
more attention from the medical community, and there is broad consensus 
that a clinical trials registry is one of the best ways to address the 
issue. Accordingly, the American Medical Association (AMA) has 
recommended creating such a databank. Additionally, the major medical 
journals have established a policy that they will only publish the 
results of trials that were registered in a public database before the 
trial began. Our legislation meets all of the minimum criteria for a 
trial registry set out by the International Committee of Medical 
Journal Editors. In fact, our bill closely follows recommendations 
issued by the Institute of Medicine (IOM) in its recent report on drug 
safety.
  To its credit, the pharmaceutical industry has also acknowledged the 
problem, and has created a database where manufacturers can voluntarily 
submit clinical trials data. I applaud this step. However, if our 
objective is to provide the public with a complete and consistent 
supply of information, a voluntary database is unlikely to achieve that 
goal. Some companies will provide information, but others may decide 
not to participate. We need a clinical trials framework that is not 
just fair to all companies, but provides patients with the peace of 
mind that they will receive complete information about the medicines 
they rely on.
  The American drug industry is an extraordinary success story. As a 
result of the innovations that this industry has spawned, millions of 
lives have been improved and saved in our country and around the globe. 
Due to the importance of these medicines to our health and well-being, 
I have consistently supported sound public policies to help the 
industry succeed in protecting the public's health and well-being. This 
legislation aims to build upon the successes of this industry, and help 
ensure that the positive changes to our health care system that 
prescription drugs have brought are not undermined by controversies 
such as the ones surrounding antidepressants and Cox-2 inhibitors, 
which are at least in part based on a lack of public information. This 
bill will help ensure that well-informed patients will use new and 
innovative medicines.
  Creating a clinical trials databank is a critical step toward 
ensuring the safety of drugs, biological products, and medical devices 
in this country--but it should not be the end of our efforts. However, 
other steps are necessary to fully restore patient confidence in the 
safety of the medicines they rely on.
  That is why today I am also introducing the Food and Drug 
Administration Safety Act (FDASA) with Senator Grassley. We are joined 
by Senators Mikulski and Bingaman in introducing this legislation and 
thank them for their support for reforming our nation's system to 
ensure that FDA-approved drugs being used by millions are safe and 
effective.
  Our legislation would enhance the FDA's drug-safety monitoring system 
by setting up an independent center within the FDA called the Center 
for Postmarket Evaluation and Research for Drugs and Biologics (CPER). 
This Center would be responsible for monitoring the safety of drugs and 
biologics once they are on the market, in consultation with other 
existing Centers at the FDA, and would have the authority to take 
corrective action if a drug or biologic presents a risk to patients. 
Under the bill, the Center Director is authorized to require 
manufacturers to conduct post-market clinical or observational studies 
if there are questions about the safety or efficacy of a drug or 
biologic once it is already on the market. The Center Director can take 
corrective actions to include labeling changes, restricted 
distribution, and other risk management tools if an unreasonable risk 
is found to exist. The bill also gives the Center Director the 
authority to review drug advertisements before they are disseminated, 
and to require certain disclosures about increased risk, and in extreme 
cases, the authority to pull the product off the market. Our bill 
authorizes $500 million over the next 5 years to provide the new center 
with the resources necessary to carry out the critically important 
provisions of this legislation.
  Under our legislation, the Director of CPER will report directly to 
the FDA Commissioner. Our bill will ensure that CPER consults with the 
other Centers at FDA as it conducts risk assessments, benefiting from 
their knowledge and expertise, but not being beholden to them if 
corrective action is needed.
  These new authorities will allow the FDA to act quickly to get 
answers when there are questions about the safety of a drug, and to act 
decisively to mitigate the risks when the evidence shows that a drug 
presents a safety issue. With these authorities, we will never again 
have a situation where a critical labeling change takes 2 years to 
complete, as was the case with Vioxx. When we are talking about drugs 
that are already on the market and in widespread use, any delay can put 
millions of patients in harm's way.
  By creating CPER we hope to restore confidence in the medicines that 
so many Americans rely on to safeguard their health and well-being. 
Patients should have the peace of mind that the drugs they take to help 
them will not hurt them instead. We must restore public confidence in 
the words ``FDA-Approved.'' Unfortunately, events of the past few years 
have seriously tarnished the FDA's image and put millions of patients 
at undue risk. Recent developments have cast into doubt the FDA's 
ability to ensure that the drugs that it approves are safe--especially 
once they are on the market. These concerns are bad for patients, bad 
for physicians, and bad for the pharmaceutical industry.
  Like many Americans, I have been deeply disturbed by the revelations 
of the significant risk associated with widely-used medications to 
treat pain and depression. These revelations raise legitimate questions 
about the safety of drugs that have already been approved. It would be 
one thing if these drugs were in a trial phase, but safety issues are 
being identified in drugs once they are on the market and in widespread 
use. Health risks significant enough to remove drugs from the market or 
significantly restrict their use are becoming clear only after millions 
of Americans have been exposed to real or potential harm.
  It has been estimated that more than 100,000 Americans might have 
been seriously injured or killed by a popular pain medication, while 
millions of children have been prescribed antidepressants that could 
put them at risk. This recent spate of popular medicines being 
identified as unsafe underscores the need to take additional steps to 
monitor and protect patient safety after a drug has been approved. 
Allowing the status quo on drug safety at the FDA is unacceptable. Real 
reform is needed now.
  An internal study conducted by the Department of Health and Human 
Services (HHS) Office of the Inspector General in 2002 revealed that 
approximately one-fifth of drug reviewers were pressured to approve a 
drug despite concerns about safety, efficacy, or quality. In addition, 
more than one-third said they were ``not at all'' or only ``somewhat'' 
confident that final decisions of the Center for Drug Evaluation and 
Research (CDER) adequately assessed safety. A more recent survey of 997 
FDA scientists conducted by the Union of Concerned Scientists and the 
Public Employees for Environmental Responsibility found that 420

[[Page S1449]]

FDA scientists reported that they knew of cases in which HHS or FDA 
political appointees inappropriately injected themselves into FDA 
determinations or actions.
  I look forward to working with industry, physicians, medical 
journals, patient groups, and my colleagues--including the Chairman and 
Ranking Member of the Health, Education, Labor, and Pensions Committee, 
Senator Kennedy and Senator Enzi--to move this legislation forward. 
These bills have already been endorsed by Consumers Union, the U.S. 
Public Interest Research Group (PIRG), the National Women's Health 
Network, and Public Citizen. I thank these organizations for lending 
their expertise as we crafted these bills. I also want to recognize the 
New England Journal of Medicine and the American Psychiatric 
Association for their support in the crafting of the FACT Act.
  Clinical trials are critically important to protecting the safety and 
health of the American public. For this reason, clinical trial results 
must not be treated as information that can be hidden from scrutiny. 
Recent events have made it clear that a clinical trials databank is 
needed. Patients and physicians agree that such a databank is important 
to our public health. At the same time, there have been disturbing 
reports that suggest the FDA does not place enough emphasis on drug 
safety, and that concerns raised by those in the Office of Surveillance 
and Epidemiology (formerly the Office of Drug Safety) at CDER are 
sometimes ignored and even suppressed. Our legislation will ensure that 
those who are responsible for monitoring the safety of drugs already on 
the market at the FDA will have the independence, resources, and 
authority to ensure medicines intended to help patients won't instead 
end up causing them harm. I urge my colleagues to support these bills, 
and I am hopeful that they will become law as soon as possible.
  I ask unanimous consent that a letter from the American Psychiatric 
Association supporting the FACT Act be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                             American Psychiatric Association,

                                  Arlington, VA, January 31, 2007.
     Hon. Christopher Dodd,
     U.S. Senate,
     Washington, DC.
       Dear Senator Dodd: The American Psychiatric Association 
     (APA) would like to commend and congratulate you on your 
     efforts to strengthen and improve clinical trial registries. 
     The FACT Act's goals of revamping the Food and Drug 
     Administration's post-marketing surveillance by ensuring that 
     access to clinical trials information is accessible and 
     available to the scientific community and the general public 
     is a goal shared by the APA.
       The APA is the national medical specialty society 
     representing more than 37,000 psychiatric physicians 
     nationwide who specialize in the diagnosis and treatment of 
     mental and emotional illnesses and substance use disorders. 
     APA advocates for patient access to information and supports 
     further post-market research of medications to ensure the 
     safety of patients. APA member David Fassler, M.D. testified 
     before the Senate Health, Education, Labor and Pensions 
     Committee on March 1, 2005 and subsequent FDA Advisory 
     Committee meetings. Dr. Fassler's testimony focused on key 
     recommendations to improve the FDA's drug approval process 
     outlining: The importance of access to comprehensive clinical 
     trial data including negative trials and unpublished results 
     to be housed in a publicly accessible registry; The need for 
     ongoing post-marketing surveillance with increased funding 
     for follow up; and The necessity of a workforce of 
     researchers, including experts who can assist with the 
     design, oversight, interpretation and reporting of clinical 
     research.
       The APA thanks you again for your dedication and commitment 
     to enhance the nation's drug safety monitoring system. We 
     look forward to working with you in ensuring that clinical 
     trial data is transparent and accountable in order for 
     patients to make well informed decisions. As your staff move 
     forward with further action on legislation, Lizbet Boroughs, 
     Deputy Director, Government Relations for the APA or Chatrane 
     Birbal, Federal Legislative Coordinator may be reached at 
     [email protected] 703/489-5907 or [email protected] 703/
     907-8584 respectively.
           Sincerely,
                                             James H. Scully, Jr.,
                                         CEO and Medical Director.

  Mr. DODD. Mr. President, I ask unanimous consent that the text of the 
bill be printed in the Record.

                                 S. 467

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Fair Access to Clinical 
     Trials Act of 2007'' or the ``FACT Act''.

     SEC. 2. PURPOSE.

       It is the purpose of this Act--
       (1) to create a publicly accessible national data bank of 
     clinical trial information comprised of a clinical trial 
     registry and a clinical trial results database;
       (2) to foster transparency and accountability in health-
     related intervention research and development;
       (3) to maintain a clinical trial registry accessible to 
     patients and health care practitioners seeking information 
     related to ongoing clinical trials for serious or life-
     threatening diseases and conditions; and
       (4) to establish a clinical trials results database of all 
     publicly and privately funded clinical trial results 
     regardless of outcome, that is accessible to the scientific 
     community, health care practitioners, and members of the 
     public.

     SEC. 3. CLINICAL TRIALS DATA BANK.

       (a) In General.--Subsection (i) of section 402 of the 
     Public Health Service Act (42 U.S.C. 282), as amended by 
     Public Law 109-482, is amended--
       (1) in paragraph (1)(A), by striking ``for drugs for 
     serious or life-threatening diseases and conditions'';
       (2) in paragraph (2), by striking ``available to 
     individuals with serious'' and all that follows through the 
     period and inserting ``accessible to patients, other members 
     of the public, health care practitioners, researchers and the 
     scientific community. In making information about clinical 
     trials publicly available, the Secretary shall seek to be as 
     timely and transparent as possible.'';
       (3) by redesignating paragraphs (4) and (5), as paragraphs 
     (8) and (9), respectively;
       (4) by striking paragraph (3) and inserting the following:
       ``(3) The data bank shall include the following:
       ``(A)(i) A registry of clinical trials (in this 
     subparagraph referred to as the `registry') of health-related 
     interventions (whether federally or privately funded).
       ``(ii) The registry shall include information for all 
     clinical trials conducted to test the safety or effectiveness 
     (including comparative effectiveness) of any drug, biological 
     product, or device (including those drugs, biological 
     products, or devices approved or cleared by the Secretary) 
     intended to treat serious or life-threatening diseases and 
     conditions, except those Phase I clinical trials conducted to 
     test solely the safety of an unapproved drug or unlicensed 
     biological product, or pilot or feasibility studies conducted 
     to confirm the design and operating specifications of an 
     unapproved or not yet cleared medical device. For purposes of 
     this section, Phase I clinical trials are trials described in 
     section 313.12(a) of title 21, Code of Federal Regulations 
     (or any successor regulations).
       ``(iii) The registry may include information for--
       ``(I) Phase I clinical trials conducted to test solely the 
     safety of an unapproved drug or unlicensed biological 
     product, or pilot or feasibility studies conducted to confirm 
     the design and operating specifications of an unapproved or 
     not yet cleared medical device with the consent of the 
     responsible person; and
       ``(II) clinical trials of other health-related 
     interventions with the consent of the responsible person.
       ``(iv) The information to be included in the registry under 
     this subparagraph shall include the following:
       ``(I) Descriptive information, including a brief title, 
     trial description in lay terminology, trial phase, trial 
     type, trial purpose, description of the primary and secondary 
     clinical outcome measures to be examined in the trial, the 
     time at which the outcome measures will be assessed, and the 
     dates and details of any revisions to such outcomes.
       ``(II) Recruitment information, including eligibility and 
     exclusion criteria, a description of whether, and through 
     what procedure, the manufacturer or sponsor of the 
     investigation of a new drug will respond to requests for 
     protocol exception, with appropriate safeguards, for single-
     patient and expanded protocol use of the new drug, 
     particularly in children, a statement as to whether the trial 
     is closed to enrollment of new patients, overall trial 
     status, individual site status, and estimated completion 
     date. For purposes of this section the term `completion date' 
     means the date of the last visit by subjects in the trial for 
     the outcomes described in subclause (I).
       ``(III) Location and contact information, including the 
     identity of the responsible person.
       ``(IV) Administrative data, including the study sponsor and 
     the study funding source.
       ``(V) Information pertaining to experimental treatments for 
     serious or life-threatening diseases and conditions (whether 
     federally or privately funded) that may be available--
       ``(aa) under a treatment investigational new drug 
     application that has been submitted to the Secretary under 
     section 360bbb(c) of title 21, Code of Federal Regulations; 
     or
       ``(bb) as a Group C cancer drug (as defined by the National 
     Cancer Institute).
       ``(B)(i) A clinical trial results database (in this 
     subparagraph referred to as the `database') of health-related 
     interventions (whether federally or privately funded).

[[Page S1450]]

       ``(ii) The database shall include information for all 
     clinical trials conducted to test the safety or effectiveness 
     (including comparative effectiveness) of any drug, biological 
     product, or device (including those drugs, biological 
     products, or devices approved or cleared by the Secretary), 
     except those Phase I clinical trials conducted to test solely 
     the safety of an unapproved drug or unlicensed biological 
     product, or pilot or feasibility studies conducted to confirm 
     the design and operating specifications of an unapproved or 
     not yet cleared medical device.
       ``(iii) The database may include information for--
       ``(I) Phase I clinical trials conducted to test solely the 
     safety of an unapproved drug or unlicensed biological 
     product, or pilot or feasibility studies conducted to confirm 
     the design and operating specifications of an unapproved or 
     not yet cleared medical device with the consent of the 
     responsible person; and
       ``(II) clinical trials of other health-related 
     interventions with the consent of the responsible person.
       ``(iv) The information to be included in the database under 
     this subparagraph shall include the following:
       ``(I) Descriptive information, including--
       ``(aa) a brief title;
       ``(bb) the drug, biological product or device to be tested;
       ``(cc) a trial description in lay terminology;
       ``(dd) the trial phase;
       ``(ee) the trial type;
       ``(ff) the trial purpose;
       ``(gg) demographic data such as age, gender, or ethnicity 
     of trial participants;
       ``(hh) the estimated completion date for the trial; and
       ``(ii) the study sponsor and the study funding source.
       ``(II) A description of the primary and secondary clinical 
     outcome measures to be examined in the trial, the time at 
     which the outcome measures will be assessed, and the dates 
     and details of any revisions to such outcomes.
       ``(III) The actual completion date of the trial and the 
     reasons for any difference from such actual date and the 
     estimated completion date submitted pursuant to subclause 
     (I)(ii). If the trial is not completed, the termination date 
     and reasons for such termination.
       ``(IV) A summary of the results of the trial in a standard, 
     non-promotional summary format (such as ICHE3 template form), 
     including the trial design and methodology, results of the 
     primary and secondary outcome measures as described in 
     subclause (II), summary data tables with respect to the 
     primary and secondary outcome measures, including information 
     on the statistical significance or lack thereof of such 
     results.
       ``(V) Safety data concerning the trial (including a summary 
     of all adverse events specifying the number and type of such 
     events, data on prespecified adverse events, data on serious 
     adverse events, and data on overall deaths).
       ``(VI) Any publications in peer reviewed journals relating 
     to the trial. If the trial results are published in a peer 
     reviewed journal, the database shall include a citation to 
     and, when available, a link to the journal article.
       ``(VII) A description of the process used to review the 
     results of the trial, including a statement about whether the 
     results have been peer reviewed by reviewers independent of 
     the trial sponsor.
       ``(VIII) If the trial addresses the safety, effectiveness, 
     or benefit of a use not described in the approved labeling 
     for the drug, biological product, or device, a statement, as 
     appropriate, displayed prominently at the beginning of the 
     data in the registry with respect to the trial, that the Food 
     and Drug Administration--
       ``(aa) is currently reviewing an application for approval 
     of such use to determine whether the use is safe and 
     effective;
       ``(bb) has disapproved an application for approval of such 
     use;
       ``(cc) has reviewed an application for approval of such use 
     but the application was withdrawn prior to approval or 
     disapproval; or
       ``(dd) has not reviewed or approved such use as safe and 
     effective.
       ``(IX) If data from the trial has not been submitted to the 
     Food and Drug Administration, an explanation of why it has 
     not been submitted.
       ``(X) A description of the protocol used in such trial to 
     the extent necessary to evaluate the results of such trial.
       ``(4)(A)(i) Not later than 90 days after the date of the 
     completion of the review by the Food and Drug Administration 
     of information submitted by a sponsor in support of a new 
     drug application, or a supplemental new drug application, 
     whether or not approved by the Food and Drug Administration, 
     the Commissioner of Food and Drugs shall make available to 
     the public the full reviews conducted by the Administration 
     of such application, including documentation of significant 
     differences of opinion and the resolution of those 
     differences.
       ``(ii) When submitting information in support of a new drug 
     application or a supplemental new drug application, the 
     sponsor shall certify, in writing, that the information 
     submitted to the Food and Drug Administration complies with 
     the requirements of the Federal Food, Drug, and Cosmetic Act 
     and that such information presented is accurate.
       ``(iii) If the sponsor fails to provide certification as 
     specified under clause (ii), the Secretary shall transmit to 
     the sponsor a notice stating that such sponsor shall submit 
     the certification by the date determined by the Secretary. 
     If, by the date specified by the Secretary in the notice 
     under this clause, the Secretary has not received the 
     certification, the Secretary, after providing the opportunity 
     for a hearing, shall order such sponsor to pay a civil 
     monetary penalty of $10,000 for each day after such date that 
     the certification is not submitted.
       ``(iv) If the Secretary determines, after notice and 
     opportunity for a hearing, that the sponsor knew or should 
     have known that the information submitted in support of a new 
     drug application or a supplemental new drug application was 
     inaccurate, the Secretary shall order such sponsor to pay a 
     civil monetary penalty of not less than $100,000 but not to 
     exceed $2,000,000 for any 30-day period.
       ``(B)(i) The Secretary shall deposit the funds collected 
     under subparagraph (A) into an account and use such funds, in 
     consultation with the Director of the Agency for Healthcare 
     Research and Quality, to fund studies that compare the 
     clinical effectiveness of 2 or more treatments for similar 
     diseases or conditions.
       ``(ii) The Secretary shall award funding under clause (i) 
     based on a priority list established not later than 6 months 
     after the date of enactment of the FACT Act by the Director 
     of the Agency for Healthcare Research and Quality and 
     periodically updated as determined appropriate by the 
     Director.
       ``(C) Not later than 90 days after the date of the 
     completion of a written consultation on a drug concerning the 
     drug's safety conducted by the Office of Surveillance and 
     Epidemiology, regardless of whether initiated by such Office 
     or outside of the Office, the Commissioner of Food and Drugs 
     shall make available to the public a copy of such 
     consultation in full.
       ``(D) Nothing in this paragraph shall be construed to alter 
     or amend section 301(j) or section 1905 of title 18, United 
     States Code.
       ``(E) This paragraph shall supersede section 552 of title 
     5, United States Code.
       ``(5) The information described in subparagraphs (A) and 
     (B) of paragraph (3) shall be in a format that can be readily 
     accessed and understood by members of the general public, 
     including patients seeking to enroll as subjects in clinical 
     trials.
       ``(6) The Secretary shall assign each clinical trial a 
     unique identifier to be included in the registry and in the 
     database described in subparagraphs (A) and (B) of paragraph 
     (3). To the extent practicable, this identifier shall be 
     consistent with other internationally recognized and used 
     identifiers.
       ``(7) To the extent practicable, the Secretary shall ensure 
     that where the same information is required for the registry 
     and the database described in subparagraphs (A) and (B) of 
     paragraph (3), a process exists to allow the responsible 
     person to make only one submission.''; and
       (5) by adding at the end the following:
       ``(10) In this section, the term `clinical trial' with 
     respect to the registry and the database described in 
     subparagraphs (A) and (B) of paragraph (3) means a research 
     study in human volunteers to answer specific health 
     questions, including treatment trials, prevention trials, 
     diagnostic trials, screening trials, and quality of life 
     trials.''.
       (b) Actions of Secretary Regarding Clinical Trials.--
     Section 402 of the Public Health Service Act (42 U.S.C. 282), 
     as amended by Public Law 109-482, is amended--
       (1) by redesignating subsections (j) and (k) as subsections 
     (o) and (p), respectively; and
       (2) by inserting after subsection (i), the following:
       ``(j) Federally Supported Trials.--
       ``(1) All federally supported trials.--With respect to any 
     clinical trial described in subsection (i)(3)(B) that is 
     supported solely by a grant, contract, or cooperative 
     agreement awarded by the Secretary, the principal 
     investigator of such trial shall, not later than the date 
     specified in paragraph (2), submit to the Secretary--
       ``(A) the information described in subclauses (II) through 
     (X) of subsection (i)(3)(B)(iv), and with respect to clinical 
     trials in progress on the date of enactment of the FACT Act, 
     the information described in subclause (I) of subsection 
     (i)(3)(B)(iv); or
       ``(B) a statement containing information sufficient to 
     demonstrate to the Secretary that the information described 
     in subparagraph (A) cannot reasonably be submitted, along 
     with an estimated date of submission of the information 
     described in such subparagraph.
       ``(2) Date specified.--The date specified in this paragraph 
     shall be the date that is 1 year from the earlier of--
       ``(A) the estimated completion date of the trial, as 
     submitted under subsection (i)(3)(B)(vi)(I)(ii); or
       ``(B) the actual date of the completion or termination of 
     the trial.
       ``(3) Condition of federal grants, contracts, and 
     cooperative agreements.--
       ``(A) Certification of compliance.--To be eligible to 
     receive a grant, contract, or cooperative agreement from the 
     Secretary for the conduct or support of a clinical trial 
     described in subsection (i)(3)(B), the principal investigator 
     involved shall certify to the Secretary that--
       ``(i) such investigator shall submit data to the Secretary 
     in accordance with this subsection; and
       ``(ii) such investigator has complied with the requirements 
     of this subsection with respect to other clinical trials 
     conducted by

[[Page S1451]]

     such investigator after the date of enactment of the FACT 
     Act.
       ``(B) Failure to submit certification.--An investigator 
     that fails to submit a certification as required under 
     subparagraph (A) shall not be eligible to receive a grant, 
     contract, or cooperative agreement from the Secretary for the 
     conduct or support of a clinical trial described in 
     subsection (i)(3)(B).
       ``(C) Failure to comply with certification.--If, by the 
     date specified in paragraph (2), the Secretary has not 
     received the information or statement described in paragraph 
     (1), the Secretary shall--
       ``(i) transmit to the principal investigator involved a 
     notice specifying the information or statement required to be 
     submitted to the Secretary and stating that such investigator 
     shall not be eligible to receive further funding from the 
     Secretary if such information or statement is not submitted 
     to the Secretary within 30 days of the date on which such 
     notice is transmitted; and
       ``(ii) include and prominently display, until such time as 
     the Secretary receives the information or statement described 
     in paragraph (1), as part of the record of such trial in the 
     database described in subsection (i), a notice stating that 
     the results of such trials have not been reported as required 
     by law.
       ``(D) Failure to comply with notice.--If by the date that 
     is 30 days after the date on which the notice described in 
     subparagraph (C) is transmitted, the Secretary has not 
     received from the principal investigator involved the 
     information or statement required pursuant to such notice, 
     the Secretary may not award a grant, contract, cooperative 
     agreement, or any other award to such principal investigator 
     until such principal investigator submits to the Secretary 
     the information or statement required pursuant to such 
     notice.
       ``(E) Submission of statement but not information.--
       ``(i) In general.--If by the date specified in paragraph 
     (2), the Secretary has received a statement described in 
     paragraph (1)(B) but not the information described in 
     paragraph (1)(A), the Secretary shall transmit to the 
     principal investigator involved a notice stating that such 
     investigator shall submit such information by the date 
     determined by the Secretary in consultation with such 
     investigator.
       ``(ii) Failure to comply with certification.--If, by the 
     date specified by the Secretary in the notice under clause 
     (i), the Secretary has not received the information described 
     in paragraph (1)(B), the Secretary shall--

       ``(I) transmit to the principal investigator involved a 
     notice specifying the information required to be submitted to 
     the Secretary and stating that such investigator shall not be 
     eligible to receive further funding from the Secretary if 
     such information is not submitted to the Secretary within 30 
     days of the date on which such notice is transmitted; and
       ``(II) include and prominently display, until such time as 
     the Secretary receives the information described in paragraph 
     (1)(B), as part of the record of such trial in the database 
     described in subsection (i), a notice stating that the 
     results of such trials have not been reported as required by 
     law.

       ``(F) Failure to comply with notice.--If by the date that 
     is 30 days after the date on which the notice described in 
     subparagraph (E)(ii)(I) is transmitted, the Secretary has not 
     received from the principal investigator involved the 
     information required pursuant to such notice, the Secretary 
     may not award a grant, contract, cooperative agreement, or 
     any other award to such principal investigator until such 
     principal investigator submits to the Secretary the 
     information required pursuant to such notice.
       ``(G) Rule of construction.--For purposes of this 
     paragraph, limitations on the awarding of grants, contracts, 
     cooperative agreements, or any other awards to principal 
     investigators for violations of this paragraph shall not be 
     construed to include any funding that supports the clinical 
     trial involved.
       ``(4) Rule of construction.--Nothing in this subsection 
     shall be construed to prevent an investigator other than the 
     investigator described in paragraph (3)(F) from receiving an 
     ongoing award, contract, or cooperative agreement.
       ``(5) Inclusion in registry.--
       ``(A) General rule.--The Secretary shall, pursuant to 
     subsection (i)(5), include--
       ``(i) the data described in subsection (i)(3)(A) and 
     submitted under the amendments made by section 4(a) of the 
     FACT Act in the registry described in subsection (i) as soon 
     as practicable after receiving such data; and
       ``(ii) the data described in clause (I) of subsection 
     (i)(3)(B)(iv) and submitted under this subsection or the 
     amendments made by section 4(a) of the FACT Act in the 
     database described in subsection (i) as soon as practicable 
     after receiving such data.
       ``(B) Other data.--
       ``(i) In general.--The Secretary shall, pursuant to 
     subsection (i)(5), include the data described in subclauses 
     (II) through (X) of subsection (i)(3)(B)(iv) and submitted 
     under this section in the database described in subsection 
     (i)--

       ``(I) as soon as practicable after receiving such data; or
       ``(II) in the case of data to which clause (ii) applies, by 
     the date described in clause (iii).

       ``(ii) Data described.--This clause applies to data 
     described in clause (i) if--

       ``(I) the principal investigator involved requests a delay 
     in the inclusion in the database of such data in order to 
     have such data published in a peer reviewed journal; and
       ``(II) the Secretary determines that an attempt will be 
     made to seek such publication.

       ``(iii) Date for inclusion in registry.--Subject to clause 
     (iv), the date described in this clause is the earlier of--

       ``(I) the date on which the data involved is published as 
     provided for in clause (ii); or
       ``(II) the date that is 18 months after the date on which 
     such data is submitted to the Secretary.

       ``(iv) Extension of date.--The Secretary may extend the 18-
     month period described in clause (iii)(II) for an additional 
     6 months if the principal investigator demonstrates to the 
     Secretary, prior to the expiration of such 18-month period, 
     that the data involved has been accepted for publication by a 
     journal described in clause (ii)(I).
       ``(v) Modification of data.--Prior to including data in the 
     database under clause (ii) or (iv), the Secretary shall 
     permit the principal investigator to modify the data 
     involved.
       ``(6) Memorandum of understanding.--Not later than 6 months 
     after the date of enactment of the FACT Act, the Secretary 
     shall seek a memorandum of understanding with the heads of 
     all other Federal agencies that conduct clinical trials to 
     include in the registry and the database clinical trials 
     sponsored by such agencies that meet the requirements of this 
     subsection.
       ``(7) Application to certain persons.--The provisions of 
     this subsection shall apply to a responsible person described 
     in subsections (n)(1)(A)(ii)(II) or (n)(1)(B)(i)(II).
       ``(k) Trials With Non-Federal Support.--
       ``(1) In general.--The responsible person for a clinical 
     trial described in subsection (i)(3)(B) shall, not later than 
     the date specified in paragraph (3), submit to the 
     Secretary--
       ``(A) the information described in subclauses (II) through 
     (X) of subsection (i)(3)(B)(iv), and with respect to clinical 
     trials in progress on the date of enactment of the FACT Act, 
     the information described in subclause (I) of subsection 
     (i)(3)(B)(iv); or
       ``(B) a statement containing information sufficient to 
     demonstrate to the Secretary that the information described 
     in subparagraph (A) cannot reasonably be submitted, along 
     with an estimated date of submission of the information 
     described in such subparagraph.
       ``(2) Sanction in case of noncompliance.--
       ``(A) Initial noncompliance.--If by the date specified in 
     paragraph (3), the Secretary has not received the information 
     or statement required to be submitted to the Secretary under 
     paragraph (1), the Secretary shall--
       ``(i) transmit to the responsible person for such trial a 
     notice stating that such responsible person shall be liable 
     for the civil monetary penalties described in subparagraph 
     (B) if the required information or statement is not submitted 
     to the Secretary within 30 days of the date on which such 
     notice is transmitted; and
       ``(ii) include and prominently display, until such time as 
     the Secretary receives the information described in paragraph 
     (1), as part of the record of such trial in the database 
     described in subsection (i), a notice stating that the 
     results of such trials have not been reported as required by 
     law.
       ``(B) Civil monetary penalties for noncompliance.--
       ``(i) In general.--If by the date that is 30 days after the 
     date on which a notice described in subparagraph (A) is 
     transmitted, the Secretary has not received from the 
     responsible person involved the information or statement 
     required pursuant to such notice, the Secretary shall, after 
     providing the opportunity for a hearing, order such 
     responsible person to pay a civil penalty of $10,000 for each 
     day after such date that the information or statement is not 
     submitted.
       ``(ii) Waivers.--In any case in which a responsible person 
     described in clause (i) is a nonprofit entity, the Secretary 
     may waive or reduce the penalties applicable under such 
     clause to such person.
       ``(C) Submission of statement but not information.--
       ``(i) In general.--If by the date specified in paragraph 
     (3), the Secretary has received a statement described in 
     paragraph (1)(B) but not the information described in 
     paragraph (1)(A) the Secretary shall transmit to the 
     responsible person involved a notice stating that such 
     responsible person shall submit such information by the date 
     determined by the Secretary in consultation with such 
     responsible person.
       ``(ii) Failure to comply.--If, by the date specified by the 
     Secretary in the notice under clause (i), the Secretary has 
     not received the information described in paragraph (1)(A), 
     the Secretary shall--

       ``(I) transmit to the responsible person involved a notice 
     specifying the information required to be submitted to the 
     Secretary and stating that such responsible person shall be 
     liable for the civil monetary penalties described in 
     subparagraph (D) if such information is not submitted to the 
     Secretary within 30 days of the date on which such notice is 
     transmitted; and
       ``(II) include and prominently display, until such time as 
     the Secretary receives the information described in paragraph 
     (1)(A), as part of the record of such trial in the database 
     described in subsection (i), a notice stating that the 
     results of such trials have not been reported as required by 
     law.

[[Page S1452]]

       ``(D) Noncompliance.--
       ``(i) In general.--If by the date that is 30 days after the 
     date on which a notice described in subparagraph (C)(ii)(I) 
     is transmitted, the Secretary has not received from the 
     responsible person involved the information required pursuant 
     to such notice, the Secretary, after providing the 
     opportunity for a hearing, shall order such responsible 
     person to pay a civil penalty of $10,000 for each day after 
     such date that the information is not submitted.
       ``(ii) Waivers.--In any case in which a responsible person 
     described in clause (i) is a nonprofit entity, the Secretary 
     may waive or reduce the penalties applicable under such 
     clause to such person.
       ``(E) Notice of publication of data.--If the responsible 
     person is the manufacturer or distributor of the drug, 
     biological product, or device involved, the notice under 
     subparagraphs (A)(i) and (C)(ii)(I) shall include a notice 
     that the Secretary shall publish the data described in 
     subsection (i)(3)(B) in the database if the responsible 
     person has not submitted the information specified in the 
     notice transmitted by the date that is 6 months after the 
     date of such notice.
       ``(F) Publication of data.--Notwithstanding section 301(j) 
     of the Federal Food, Drug, and Cosmetic Act, section 1905 of 
     title 18, United States Code, or any other provision of law, 
     if the responsible person is the manufacturer or distributor 
     of the drug, biological product, or device involved, and if 
     the responsible person has not submitted to the Secretary the 
     information specified in a notice transmitted pursuant to 
     subparagraph (A)(i) or (C)(ii)(I) by the date that is 6 
     months after the date of such notice, the Secretary shall 
     publish in the registry information that--
       ``(i) is described in subsection (i)(3)(B); and
       ``(ii) the responsible person has submitted to the 
     Secretary in any application, including a supplemental 
     application, for the drug or device under section 505, 510, 
     515, or 520 of the Federal Food, Drug, and Cosmetic Act or 
     for the biological product under section 351.
       ``(3) Date specified.--The date specified in this paragraph 
     shall be the date that is 1 year from the earlier of--
       ``(A) the estimated completion date of the trial, submitted 
     under subsection (i)(3)(B)(vi)(I)(ii); or
       ``(B) the actual date of completion or termination of the 
     trial.
       ``(4) Use of funds.--
       ``(A) In general.--The Secretary shall deposit the funds 
     collected under paragraph (2) into an account and use such 
     funds, in consultation with the Director of the Agency for 
     Healthcare Research and Quality, to fund studies that compare 
     the clinical effectiveness of 2 or more treatments for 
     similar diseases or conditions.
       ``(B) Funding decisions.--The Secretary shall award funding 
     under subparagraph (A) based on a priority list established 
     not later than 6 months after the date of enactment of the 
     FACT Act by the Director of the Agency for Healthcare 
     Research and Quality and periodically updated as determined 
     appropriate by the Director.
       ``(5) Inclusion in registry.--
       ``(A) General rule.--The Secretary shall, pursuant to 
     subsection (i)(5), include--
       ``(i) the data described in subsection (i)(3)(A) and 
     submitted under the amendments made by section 4(a) of the 
     FACT Act in the registry described in subsection (i) as soon 
     as practicable after receiving such data; and
       ``(ii) the data described in clause (I) of subsection 
     (i)(3)(B)(iv) and submitted under this subsection in the 
     database described in subsection (i) as soon as practicable 
     after receiving such data.
       ``(B) Other data.--
       ``(i) In general.--The Secretary shall, pursuant to 
     subsection (i)(5), include the data described in subclauses 
     (II) through (X) of subsection (i)(3)(B)(iv) and submitted 
     under this section in the database described in subsection 
     (i)--

       ``(I) as soon as practicable after receiving such data; or
       ``(II) in the case of data to which clause (ii) applies, by 
     the date described in clause (iii).

       ``(ii) Data described.--This clause applies to data 
     described in clause (i) if--

       ``(I) the responsible person involved requests a delay in 
     the inclusion in the database of such data in order to have 
     such data published in a peer reviewed journal; and
       ``(II) the Secretary determines that an attempt will be 
     made to seek such publication.

       ``(iii) Date for inclusion in registry.--Subject to clause 
     (iv), the date described in this clause is the earlier of--

       ``(I) the date on which the data involved is published as 
     provided for in clause (ii); or
       ``(II) the date that is 18 months after the date on which 
     such data is submitted to the Secretary.

       ``(iv) Extension of date.--The Secretary may extend the 18-
     month period described in clause (iii)(II) for an additional 
     6 months if the responsible person demonstrates to the 
     Secretary, prior to the expiration of such 18-month period, 
     that the data involved has been accepted for publication by a 
     journal described in clause (ii)(I).
       ``(v) Modification of data.--Prior to including data in the 
     database under clause (ii) or (iv), the Secretary shall 
     permit the responsible person to modify the data involved.
       ``(6) Effect.--The information with respect to a clinical 
     trial submitted to the Secretary under this subsection, 
     including data published by the Secretary pursuant to 
     paragraph (2)(F), may not be submitted by a person other than 
     the responsible person as part of, or referred to in, an 
     application for approval of a drug or device under section 
     505, 510, 515, or 520 of the Federal Food, Drug, and Cosmetic 
     Act or of a biological product under section 351, unless the 
     information is available from a source other than the 
     registry or database described in subsection (i).
       ``(l) Procedures and Waivers.--
       ``(1) Submission prior to notice.--Nothing in subsections 
     (j) through (k) shall be construed to prevent a principal 
     investigator or a responsible person from submitting any 
     information required under this subsection to the Secretary 
     prior to receiving any notice described in such subsections.
       ``(2) Ongoing trials.--A factually accurate statement that 
     a clinical trial is ongoing shall be deemed to be information 
     sufficient to demonstrate to the Secretary that the 
     information described in subsections (j)(1)(A) and (k)(1)(A) 
     cannot reasonably be submitted.
       ``(3) Information previously submitted.--Nothing in 
     subsections (j) through (k) shall be construed to require the 
     Secretary to send a notice to any principal investigator or 
     responsible person requiring the submission to the Secretary 
     of information that has already been submitted.
       ``(4) Submission format and technical standards.--
       ``(A) In general.--The Secretary shall, to the extent 
     practicable, accept submissions required under this 
     subsection in an electronic format and shall establish 
     interoperable technical standards for such submissions.
       ``(B) Consistency of standards.--To the extent practicable, 
     the standards established under subparagraph (A) shall be 
     consistent with standards adopted by the Consolidated Health 
     Informatics Initiative (or a successor organization to such 
     Initiative) to the extent such Initiative (or successor) is 
     in operation.
       ``(5) Trials completed prior to enactment.--The Secretary 
     shall establish procedures and mechanisms to allow for the 
     voluntary submission to the database of the information 
     described in subsection (i)(3)(B) with respect to clinical 
     trials completed prior to the date of enactment of the FACT 
     Act. In cases in which it is in the interest of public 
     health, the Secretary may require that information from such 
     trials be submitted to the database. To the extent 
     practicable, submissions to the database shall comply with 
     paragraph (4). Failure to comply with a requirement to submit 
     information to the database under this paragraph shall be 
     deemed to be a failure to submit information as required 
     under this section, and the appropriate remedies and 
     sanctions under this section shall apply.
       ``(6) Trials not involving drugs, biological products, or 
     devices.--The Secretary shall establish procedures and 
     mechanisms to allow for the voluntary submission to the 
     database of the information described in subsection (i)(3)(B) 
     with respect to clinical trials that do not involve drugs, 
     biological products, or devices. In cases in which it is in 
     the interest of public health, the Secretary may require that 
     information from such trials be submitted to the database. 
     Failure to comply with such a requirement shall be deemed to 
     be a failure to submit information as required under this 
     section, and the appropriate remedies and sanctions under 
     this section shall apply.
       ``(7) Submission of inaccurate information.--
       ``(A) In general.--If the Secretary determines that 
     information submitted by a principal investigator or a 
     responsible person under this section is factually and 
     substantively inaccurate, the Secretary shall submit a notice 
     to the investigator or responsible person concerning such 
     inaccuracy that includes--
       ``(i) a summary of the inaccuracies involved; and
       ``(ii) a request for corrected information within 30 days.
       ``(B) Audit of information.--
       ``(i) In general.--The Secretary may conduct audits of any 
     information submitted under subsection (i).
       ``(ii) Requirement.--Any principal investigator or 
     responsible person that has submitted information under 
     subsection (i) shall permit the Secretary to conduct the 
     audit described in clause (i).
       ``(C) Changes to information.--Any change in the 
     information submitted by a principal investigator or a 
     responsible person under this section shall be reported to 
     the Secretary within 30 days of the date on which such 
     investigator or person became aware of the change for 
     purposes of updating the registry or the database.
       ``(D) Failure to correct.--If a principal investigator or a 
     responsible person fails to permit an audit under 
     subparagraph (B), provide corrected information pursuant to a 
     notice under subparagraph (A), or provide changed information 
     under subparagraph (C), the investigator or responsible 
     person involved shall be deemed to have failed to submit 
     information as required under this section and the 
     appropriate remedies and sanction under this section shall 
     apply.
       ``(E) Corrections.--
       ``(i) In general.--The Secretary may correct, through any 
     means deemed appropriate by the Secretary to protect public 
     health, any information included in the registry or the 
     database described in subsection (i) (including information 
     described or contained in a publication referred to under 
     subclause (VI) of subsection (i)(3)(B)(iv)) that is--

[[Page S1453]]

       ``(I) submitted to the Secretary for inclusion in the 
     registry or the database; and
       ``(II) factually and substantively inaccurate or false or 
     misleading.

       ``(ii) Reliance on information.--The Secretary may rely on 
     any information from a clinical trial or a report of an 
     adverse event acquired or produced under the authority of 
     section 351 of this Act or of the Federal Food, Drug, and 
     Cosmetic Act in determining whether to make corrections as 
     provided for in clause (i).
       ``(iii) Determinations relating to misleading 
     information.--For purposes of clause (i)(II), in determining 
     whether information is misleading, the Secretary shall use 
     the standard described in section 201(n) of the Federal Food, 
     Drug, and Cosmetic Act that is used to determine whether 
     labeling or advertising is misleading.
       ``(iv) Rule of construction.--This subparagraph shall not 
     be construed to authorize the disclosure of information if--

       ``(I) such disclosure would constitute an invasion of 
     personal privacy;
       ``(II) such information concerns a method or process which 
     as a trade secret is entitled to protection within the 
     meaning of section 301(j) of the Federal Food, Drug, and 
     Cosmetic Act;
       ``(III) such disclosure would disclose confidential 
     commercial information or a trade secret, other than a trade 
     secret described in subclause (II), unless such disclosure is 
     necessary--

       ``(aa) to make a correction as provided for under clause 
     (i); and
       ``(bb) protect the public health; or

       ``(IV) such disclosure relates to a biological product for 
     which no license is in effect under section 351, a drug for 
     which no approved application is in effect under section 
     505(c) of the Federal Food, Drug, and Cosmetic Act, or a 
     device that is not cleared under section 510(k) of such Act 
     or for which no application is in effect under section 515 of 
     such Act.

       ``(v) Notice.--In the case of a disclosure under clause 
     (iv)(III), the Secretary shall notify the manufacturer or 
     distributor of the drug, biological product, or device 
     involved--

       ``(I) at least 30 days prior to such disclosure; or
       ``(II) if immediate disclosure is necessary to protect the 
     public health, concurrently with such disclosure.

       ``(8) Waivers regarding clinical trial results.--The 
     Secretary may waive the requirements of subsections (j)(1) 
     and (k)(1) that the results of clinical trials be submitted 
     to the Secretary, upon a written request from the responsible 
     person if the Secretary determines that extraordinary 
     circumstances justify the waiver and that providing the 
     waiver is in the public interest, consistent with the 
     protection of public health, or in the interest of national 
     security. Not later than 30 days after any part of a waiver 
     is granted, the Secretary shall notify, in writing, the 
     appropriate committees of Congress of the waiver and provide 
     an explanation for why the waiver was granted.
       ``(m) Trials Conducted Outside of the United States.--
       ``(1) In general.--With respect to clinical trials 
     described in paragraph (2), the responsible person shall 
     submit to the Secretary the information required under 
     subclauses (II) through (X) of subsection (i)(3)(B)(iv). The 
     Secretary shall ensure that the information described in the 
     preceding sentence is made available in the database under 
     subsection (i) in a timely manner. Submissions to the 
     database shall comply with subsection (l)(4) to the extent 
     practicable. The Secretary shall include the information 
     described in the preceding sentence in the database under 
     subsection (i) as soon as practicable after receiving such 
     information. Failure to comply with this paragraph shall be 
     deemed to be a failure to submit information as required 
     under this section, and the appropriate remedies and 
     sanctions under this section shall apply.
       ``(2) Clinical trial described.--A clinical trial is 
     described in this paragraph if--
       ``(A) such trial is conducted outside of the United States; 
     and
       ``(B) the data from such trial is--
       ``(i) submitted to the Secretary as part of an application, 
     including a supplemental application, for a drug or device 
     under section 505, 510, 515, or 520 of the Federal Food, 
     Drug, and Cosmetic Act or for the biological product under 
     section 351; or
       ``(ii) used in advertising or labeling to make a claim 
     about the drug, device, or biological product involved.
       ``(n) Definitions; Individual Liability.--
       ``(1) Responsible person.--
       ``(A) In general.--In this section, the term `responsible 
     person' with respect to a clinical trial, means--
       ``(i) if such clinical trial is the subject of an 
     investigational new drug application or an application for an 
     investigational device exemption, the sponsor of such 
     investigational new drug application or such application for 
     an investigational device exemption; or
       ``(ii) except as provided in subparagraph (B), if such 
     clinical trial is not the subject of an investigational new 
     drug application or an application for an investigational 
     device exemption--

       ``(I) the person that provides the largest share of the 
     monetary support (such term does not include in-kind support) 
     for the conduct of such trial; or
       ``(II) in the case in which the person described in 
     subclause (I) is a Federal or State agency, the principal 
     investigator of such trial.

       ``(B) Nonprofit entities and requesting persons.--
       ``(i) Nonprofit entities.--For purposes of subparagraph 
     (A)(ii)(I), if the person that provides the largest share of 
     the monetary support for the conduct of the clinical trial 
     involved is a nonprofit entity, the responsible person for 
     purposes of this section shall be--

       ``(I) the nonprofit entity; or
       ``(II) if the nonprofit entity and the principal 
     investigator of such trial jointly certify to the Secretary 
     that the principal investigator will be responsible for 
     submitting the information described in subsection (i)(3)(B) 
     for such trial, the principal investigator.

       ``(ii) Requesting persons.--For purposes of subparagraph 
     (A)(ii)(I), if a person--

       ``(I) has submitted a request to the Secretary that the 
     Secretary recognize the person as the responsible person for 
     purposes of this section; and
       ``(II) the Secretary determines that such person--

       ``(aa) provides monetary support for the conduct of such 
     trial;
       ``(bb) is responsible for the conduct of such trial; and
       ``(cc) will be responsible for submitting the information 
     described in subsection (i)(3)(B) for such trial;

     such person shall be the responsible person for purposes of 
     this section.
       ``(2) Drug, device, biological product.--In this section--
       ``(A) the terms `drug' and `device' have the meanings given 
     such terms in section 201 of the Federal Food, Drug, and 
     Cosmetic Act; and
       ``(B) the term `biological product' has the meaning given 
     such term in section 351 of this Act.
       ``(3) Individual liability.--
       ``(A) Limitation on liability of individuals.--No 
     individual shall be liable for any civil monetary penalty 
     under this section.
       ``(B) Individuals who are responsible persons.--If a 
     responsible person under subparagraph (A) or (B) of paragraph 
     (1) is an individual, such individual shall be subject to the 
     procedures and conditions described in subsection (j).''.
       (c) Authorization of Appropriations.--Section 402 of the 
     Public Health Service Act (42 U.S.C. 282), as amended by this 
     section, is further amended by adding at the end the 
     following:
       ``(q) Authorization of Appropriations.--There are 
     authorized to be appropriated such sums as may be necessary 
     to carry out this section.''.
       (d) Conforming Amendment.--Section 402(c)(1)(D) of the 
     Public Health Service Act (42 U.S.C. 282(c)(1)(D)), as 
     amended by Public Law 109-482, is amended by striking 
     ``402(k)'' and inserting ``402(p)''.

     SEC. 4. REVIEW AND APPROVAL OF PROPOSALS FOR RESEARCH.

       (a) Amendments.--Section 492A(a) of the Public Health 
     Service Act (42 U.S.C. 289a-1(a)) is amended--
       (1) in paragraph (1)(A), by striking ``unless'' and all 
     that follows through the period and inserting the following: 
     ``unless--
       ``(i) the application has undergone review in accordance 
     with such section and has been recommended for approval by a 
     majority of the members of the Board conducting the review;
       ``(ii) such Board has submitted to the Secretary a 
     notification of such approval; and
       ``(iii) with respect to an application involving a clinical 
     trial to which section 402(i) applies, the principal 
     investigator who has submitted such application has submitted 
     to the Secretary for inclusion in the registry and the 
     database described in section 402(i) the information 
     described in paragraph (3)(A) and subclause (I) of paragraph 
     (3)(B)(iv) of such section.''; and
       (2) by adding at the end the following:
       ``(3) Cost recovery.--Nonprofit entities may recover the 
     full costs associated with compliance with the requirements 
     of paragraph (1) from the Secretary as a direct cost of 
     research.''.
       (b) Regulations.--The Secretary of Health and Human 
     Services shall modify the regulations promulgated at part 46 
     of title 45, Code of Federal Regulations, part 50 of title 
     21, Code of Federal Regulations, and part 56 of title 21, 
     Code of Federal Regulations, to reflect the amendments made 
     by subsection (a).
       (c) Conforming Amendment.--Section 492A(a)(2) of the Public 
     Health Service Act (42 U.S.C. 289a-1(a)(2)), as amended by 
     Public Law 109-482, is amended by striking ``402(k)'' and 
     inserting ``402(p)''.

     SEC. 5. PROHIBITED ACTS.

       Section 301 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 331) is amended by adding at the end the following:
       ``(ii)(1) The entering into of a contract or other 
     agreement by a responsible person or a manufacturer of a 
     drug, biological product, or device with an individual who is 
     not an employee of such responsible person or manufacturer, 
     or the performance of any other act by such a responsible 
     person or manufacturer, that prohibits, limits, or imposes 
     unreasonable delays on the ability of such individual to--
       ``(A) discuss the results of a clinical trial at a 
     scientific meeting or any other public or private forum; or
       ``(B) publish the results of a clinical trial or a 
     description or discussion of the results of a clinical trial 
     in a scientific journal or any other publication.

[[Page S1454]]

       ``(2) The entering into a contract or other agreement by a 
     responsible person or a manufacturer of a drug, biological 
     product, or device with an academic institution or a health 
     care facility, or the performance of any other act by such a 
     responsible person or manufacturer, that prohibits, limits, 
     or imposes unreasonable delays on the ability of an 
     individual who is not an employee of such responsible person 
     or manufacturer to--
       ``(A) discuss the results of a clinical trial at a 
     scientific meeting or any other public or private forum; or
       ``(B) publish the results of a clinical trial or a 
     description or discussion of the results of a clinical trial 
     in a scientific journal or any other publication.''.

     SEC. 6. REPORTS.

       (a) Implementation Report.--Not later than 1 year after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services shall submit to the appropriate committees of 
     Congress a report on the status of the implementation of the 
     requirements of the amendments made by section 3 that 
     includes a description of the number and types of clinical 
     trials for which information has been submitted under such 
     amendments.
       (b) Data Collection.--
       (1) In general.--The Secretary of Health and Human Services 
     shall enter into a contract with the Institute of Medicine 
     for the conduct of a study concerning the extent to which 
     data submitted to the registry under section 402(i) of the 
     Public Health Service Act (42 U.S.C. 282(i)) has impacted the 
     public health.
       (2) Report.--Not later than 6 months after the date on 
     which a contract is entered into under paragraph (1), the 
     Institute of Medicine shall submit to the Secretary of Health 
     and Human Services a report on the results of the study 
     conducted under such paragraph. Such report shall include 
     recommendations for changes to the registry, the database, 
     and the data submission requirements that would benefit the 
     public health.

  Mr. GRASSLEY. Madam President, I am pleased to have bipartisan 
sponsorship of two very important bills with Senator Dodd of 
Connecticut that are being introduced today, the Food and Drug 
Administration Safety Act of 2007 and the Fair Access to Clinical 
Trials Act of 2007.
  These bills are part of a sustained effort to restore public 
confidence in the Federal Government's food and drug safety program and 
to make sure the agency does all it can to protect the public.
  Enactment of those two bills would provide doctors and patients with 
more information about the risks and benefits of their medicines and 
bring about greater transparency and accountability of the Food and 
Drug Administration.
  I am sure my colleagues realize I have been involved in oversight of 
the Food and Drug Administration for now at least 3 years, and it has 
been in response to concerns about the reluctance of the Food and Drug 
Administration to provide information to the public about the increased 
suicide risks for young people taking antidepressants.
  In November 2004, I chaired a groundbreaking hearing on drug safety 
involving the Food and Drug Administration and the drug Vioxx. That 
hearing and other critical drug safety concerns that have come to light 
since then highlight the need for comprehensive and systematic reforms 
as well as more stringent oversight of the Food and Drug 
Administration.
  Over the past 3 years, it has become increasingly apparent that the 
Food and Drug Administration has repeatedly failed to protect the 
public from an industry that focuses all too often on profits, even 
when those profits come at the expense of ``John Q. Public.''
  In 2005, then, and because of this, Senator Dodd and I introduced 
almost identical companion bills to advance serious reforms at the Food 
and Drug Administration. In the 2 years following the introduction of 
those bills, however, the Food and Drug Administration failed to take 
comprehensive and systematic steps toward restoring public confidence 
in that agency, as well as the necessity of strengthening public 
safety.
  Yesterday, the Food and Drug Administration released its response to 
the Institute of Medicine's 2006 report on drug safety. The two safety 
bills introduced today are not intended to supplant the plans 
articulated in the Food and Drug Administration's response but, rather, 
to augment those plans and to provide the FDA with additional 
enforcement tools, something they now lack.
  In fact, one of our bills is intended to specifically address a 
serious problem that was also identified by the Institute of Medicine. 
Dr. Alta Charo, a member of the Institute of Medicine committee that 
wrote the report on drug safety, stated in the newspaper USA Today:

       I have to confess I'm disappointed that they--

  Meaning the FDA--

     ignored one of our most critical recommendations.

  According to the USA Today article, she was referring to the 
Institute of Medicine's recommendation that the Food and Drug 
Administration give more clout to the office that monitors drugs after 
they go to market. I want you to know I agree with Dr. Charo.
  The Food and Drug Administration Safety Act of 2007 would then 
establish an independent center within the Food and Drug 
Administration. The name of the center would be the Center for 
Postmarket Evaluation and Research for Drugs and Biologics. The 
director of this center would report directly to the Food and Drug 
Administration Commissioner and would be responsible for conducting 
risk assessments for approved drugs and biological products.
  The new center would also be responsible for ensuring the safety and 
effectiveness of drugs once they are on the market. Unfortunately, the 
problem we are trying to solve is that now at the FDA, the office that 
reviews drug safety postmarketing is a mere consultant and under the 
thumb of the office that puts the drugs on the market in the first 
place.
  Even more troubling is the fact that those who speak out of line are 
targeted. Whistleblowers, as we call them, are targeted. They are very 
helpful to Congress in ferreting out wrongdoing, that laws are not 
being faithfully executed, that money is not being spent according to 
congressional intent. So they speak out at the FDA and point out a lot 
of things that are wrong. And what do they get for it? They are treated 
like a skunk at a picnic. They are targeted.
  So this legislation we put before us would provide the new center 
with the independence and authority to promptly identify serious safety 
risks and take necessary actions to protect the public, and I hope 
eliminate some of the intimidation against whistleblowers.
  At the same time, the intra-agency communication is essential in 
addressing drug safety. So this legislation would encourage 
communication between the center and other centers and offices, or 
let's say subagencies at the Food and Drug Administration that handle 
drugs and biological products, to do what is best for the consumer and 
not have big PhRMA having undue influence.
  The second bill we are introducing would expand an existing Web site, 
www.clinicaltrials.gov, to create a publicly accessible national 
databank of clinical trial information. The databank would be comprised 
of a clinical trial registry and a clinical trial results database of 
all publicly and privately funded clinical trials so that everything is 
out there for the public to consider, not letting somebody choose: 
Well, if this is a little negative toward our drug, we will not make 
that public. All the positive stuff, of course, we will make public.
  So I think this legislation is going to foster transparency. But it 
is going to bring about a great deal of accountability in health 
research and development and ensure that the scientific community and, 
most importantly, the general public whom we are trying to protect have 
access to basic information about clinical trials, about new drugs 
going out on the market.
  The legislation would also create an environment that would encourage 
companies from withholding clinically important information about their 
products from the Food and Drug Administration and from the public.
  By the way, the information that is coming out now about Vioxx in the 
newspapers today will even tell you that a long time before Vioxx went 
on the market there were scientists within the company who were raising 
questions about whether it was going to cause harm to the heart. All of 
this information should be out there. The public ought to know it. Your 
doctor ought to know it. Transparency and accountability should not 
hurt anybody in an open society such as we have in

[[Page S1455]]

America. Oh, there might be some legitimate reasons for intellectual 
property privacy, but nothing beyond that.
  If we have learned anything over the last few years, it is that the 
Food and Drug Administration is a troubled agency that lost sight of 
its fundamental function. That fundamental function is to protect the 
safety and the efficacy of new prescription drugs.
  Two very important things for them to answer: Are the drugs safe for 
you? Are they effective?
  Unfortunately, the public has good reason to doubt the Food and Drug 
Administration's ability to do its job. And experts from all over the 
country have expressed concern. These two bills, then, that Senator 
Dodd and I are introducing--and let me parenthetically say for the 
public, people are always thinking that Democrats are hitting on 
Republicans and Republicans are hitting on Democrats. There is a lot 
going on around here you never see on evening television that is 
bipartisan because there is not controversy about it, or at least there 
is no controversy between Republicans and Democrats. But what they want 
to put in the news media every night is when some Republican is 
fighting some Democrat. So our constituents get a view about this 
Congress that is very distorted.
  I would like to have people read on a regular basis about how Senator 
Baucus and I meet on a regular basis to determine the agenda for the 
Finance Committee. I would like to have them read about how he and I 
have put out bipartisan bills for the last 6 years--whether he was 
chairman or I was chairman--and that every one of them got to the 
President to be signed. But you do not hear those things.
  So I want to emphasize, this is a Dodd--and Senator Dodd is a 
Democrat from Connecticut--and a Grassley bill--and Grassley is a 
Republican Senator from Iowa. So this bill is being introduced to 
ensure the safety and efficacy of new prescription drugs, not to do 
something new for the FDA, just to give them the tools to do what they 
have had a responsibility to do for several decades.
  So the public has doubts about the FDA's ability to do it. These two 
bills will help put the FDA back on the path to fulfilling its mission 
and, most importantly, put the American consumer first.
  So, Madam President, in closing, I ask unanimous consent that my 
statement in the Record that I give today be coupled with the statement 
of Senator Dodd, which will be given later today, regarding the 
introduction of these important bills.
  By giving me this unanimous consent, it will assure the public, when 
they read about these bills, knows that Dodd is a Democrat, Grassley is 
a Republican, and they are bipartisan bills.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 468

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food and Drug Administration 
     Safety Act of 2007''.

     SEC. 2. CENTER FOR POSTMARKET EVALUATION AND RESEARCH FOR 
                   DRUGS AND BIOLOGICS.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 506C the following:

     ``SEC. 507. DRUG SAFETY.

       ``(a) Establishment of the Center for Postmarket Evaluation 
     and Research for Drugs and Biologics.--There is established 
     within the Food and Drug Administration a Center for 
     Postmarket Evaluation and Research for Drugs and Biologics 
     (referred to in the section as the `Center'). The Director of 
     the Center shall report directly to the Commissioner of Food 
     and Drugs.
       ``(b) Duties of the Center for Postmarket Evaluation and 
     Research for Drugs and Biologics.--
       ``(1) Responsibilities of director.--The Director of the 
     Center, in consultation with the Director of the Center for 
     Drug Evaluation and Research or the Director of the Center 
     for Biologics Evaluation and Research, as appropriate, 
     shall--
       ``(A) conduct postmarket risk assessment of drugs approved 
     under section 505 of this Act and of biological products 
     licensed under section 351 of the Public Health Service Act;
       ``(B) conduct and improve postmarket surveillance of 
     approved drugs and licensed biological products using 
     postmarket surveillance programs and activities (including 
     MedWatch), risk-benefit analyses, adverse event reports, the 
     scientific literature, any clinical or observational studies 
     (including studies required under subsection (d) or (e)), and 
     any other resources that the Director of the Center 
     determines appropriate;
       ``(C) determine whether a study is required under 
     subsection (d) or (e) and consult with the sponsors of drugs 
     and biological products to ensure that such studies are 
     completed by the date, and according to the terms, specified 
     by the Director of the Center;
       ``(D) contract, or require the sponsor of an application or 
     the holder of an approved application or license to contract, 
     with the holders of domestic and international patient 
     databases to conduct epidemiologic and other observational 
     studies;
       ``(E) determine, based on postmarket surveillance programs 
     and activities (including MedWatch), risk-benefit analyses, 
     adverse event reports, the scientific literature, and any 
     clinical or observational studies (including studies required 
     under subsection (d) or (e)), and any other resources that 
     the Director of the Center determines appropriate, whether a 
     drug or biological product may present an unreasonable risk 
     to the health of patients or the general public, and take 
     corrective action if such an unreasonable risk may exist;
       ``(F) make information about the safety and effectiveness 
     of approved drugs and licensed biological products available 
     to the public and healthcare providers in a timely manner; 
     and
       ``(G) conduct other activities as the Director of the 
     Center determines appropriate to ensure the safety and 
     effectiveness of all drugs approved under section 505 and all 
     biological products licensed under section 351 of the Public 
     Health Service Act.
       ``(2) Determination of unreasonable risk.--In determining 
     whether a drug or biological product may present an 
     unreasonable risk to the health of patients or the general 
     public, the Director of the Center, in consultation with the 
     Director of the Center for Drug Evaluation and Research or 
     the Director of the Center for Biologics Evaluation and 
     Research, as appropriate, shall consider the risk in relation 
     to the known benefits of such drug or biological product.
       ``(c) Secretarial Authority.--
       ``(1) In general.--Approval of a drug under section 505 of 
     this Act or issuance of a license for a biological product 
     under section 351 of the Public Health Service Act may be 
     subject to the requirement that the sponsor conduct 1 or more 
     postmarket studies as described in subsection (d) or (e) of 
     this section, or other postmarket studies as required by the 
     Secretary, to validate the safety and effectiveness of the 
     drug or biological product.
       ``(2) Definition.--For purposes of this section, the term 
     `postmarket' means--
       ``(A) with respect to a drug, after approval of an 
     application under section 505; and
       ``(B) with respect to a biological product, after licensure 
     under section 351 of the Public Health Service Act.
       ``(d) Preapproval Review.--
       ``(1) Review of application.--
       ``(A) In general.--
       ``(i) Review.--At any time before a drug is approved under 
     section 505 of this Act or a biological product is licensed 
     under section 351 of the Public Health Service Act, the 
     Director of the Center shall review the application (or 
     supplement to the application), and any analyses associated 
     with the application, of such drug or biological product.
       ``(ii) Effect of approval or licensure.--The approval of a 
     drug under section 505 or the licensure of a biological 
     product under such section 351 shall not affect the 
     continuation and completion of a review under clause (i).
       ``(B) Limitation.--In no case shall the review under 
     subparagraph (A) delay a decision with respect to an 
     application for a drug under section 505 of this Act or for a 
     biological product under section 351 of the Public Health 
     Service Act.
       ``(2) Result of review.--The Director of the Center may, 
     based on the review under paragraph (1)--
       ``(A) require that the sponsor of the application agree to 
     conduct 1 or more postmarket studies to determine the safety 
     or effectiveness of a drug or biological product, including 
     such safety or effectiveness as compared to other drugs or 
     biological products, to be completed by a date, and according 
     to the terms, specified by the Director of the Center; or
       ``(B) contract, or require the sponsor of the application 
     to contract, with a holder of a domestic or an international 
     patient database to conduct 1 or more epidemiologic or other 
     observational studies.
       ``(e) Postmarketing Studies of Drug Safety.--
       ``(1) In general.--At any time after a drug is approved 
     under section 505 of this Act or a biological product is 
     licensed under section 351 of the Public Health Service Act, 
     the Director of the Center, may--
       ``(A) require that the holder of an approved application or 
     license conduct 1 or more studies to determine the safety or 
     effectiveness of such drug or biological product, including 
     such safety and effectiveness as compared to other drugs or 
     biological products, to be completed by a date, and according 
     to the terms, specified by such Director; or
       ``(B) contract, or require the holder of the approved 
     application or license to contract, with a holder of a 
     domestic or an international patient database to conduct 1 or 
     more epidemiologic or other observational studies.

[[Page S1456]]

       ``(2) Review of outstanding studies.--Not later than 90 
     days after the date of enactment of the Food and Drug 
     Administration Safety Act of 2007, the Director of the Center 
     shall--
       ``(A) review and publish a list in the Federal Register of 
     any postmarketing studies outstanding on the date of 
     enactment of the Food and Drug Administration Safety Act of 
     2007; and
       ``(B) as the Director determines appropriate, require the 
     sponsor of a study described in subparagraph (A) to conduct 
     such study under this subsection.
       ``(f) Publication of Progress Reports and Completed 
     Studies.--
       ``(1) In general.--The Director of the Center shall require 
     that the sponsor of a study under subsection (d) or (e) 
     submit to the Secretary--
       ``(A) not less frequently than every 90 days, an up-to-date 
     report describing the progress of such study; and
       ``(B) upon the completion date of such study, the results 
     of such study.
       ``(2) Completion date.--For purposes of this section, the 
     completion date of such study shall be determined by the 
     Director of the Center.
       ``(g) Determinations by Director.--
       ``(1) Results of study.--The Director of the Center shall 
     determine, upon receipt of the results of a study required 
     under subsection (d) or (e)--
       ``(A) whether the drug or biological product studied may 
     present an unreasonable risk to the health of patients or the 
     general public; and
       ``(B) what, if any, corrective action under subsection (k) 
     shall be taken to protect patients and the public health.
       ``(2) Results of evidence.--The Director of the Center may, 
     at any time, based on the empirical evidence from postmarket 
     surveillance programs and activities (including MedWatch), 
     risk-benefit analyses, adverse event reports, the scientific 
     literature, any clinical or observational studies (including 
     studies required under subsection (d) or (e)), or any other 
     resources that the Director of the Center determines 
     appropriate--
       ``(A) make a determination that a drug or biological 
     product may present an unreasonable risk to the health of 
     patients or the general public; and
       ``(B) order a corrective action under subsection (k) be 
     taken to protect patients and the public health.
       ``(3) Required consultation and considerations.--Before 
     making a determination under paragraph (2), ordering a study 
     under subsection (d) or (e), or taking a corrective action 
     under subsection (k), the Director of the Center shall--
       ``(A) consult with the Director of the Center for Drug 
     Evaluation and Research or the Director of the Center for 
     Biologics Evaluation and Research, as appropriate; and
       ``(B) consider--
       ``(i) the benefit-to-risk profile of the drug or biological 
     product;
       ``(ii) the effect that a corrective action, or failure to 
     take corrective action, will have on the patient population 
     that relies on the drug or biological product; and
       ``(iii) the extent to which the drug or biological product 
     presents a meaningful therapeutic benefit as compared to 
     other available treatments.
       ``(h) Public Information.--Periodically, but not less often 
     than every 90 days, the Secretary shall make available to the 
     public, by publication in the Federal Register and posting on 
     an Internet website, the following information:
       ``(1) Studies required under subsection (d) or (e) 
     including--
       ``(A) the type of study;
       ``(B) the nature of the study;
       ``(C) the primary and secondary outcomes of the study;
       ``(D) the date the study was required under subsection (d) 
     or (e) or was agreed to by the sponsor;
       ``(E) the deadline for completion of the study; and
       ``(F) if the study has not been completed by the deadline 
     under subparagraph (E), a statement that explains why.
       ``(2) The periodic progress reports and results of 
     completed studies described under subsection (f).
       ``(3) Any determinations made by the Director of the Center 
     under subsection (g), including--
       ``(A) reasons for the determination, including factual 
     basis for such determination;
       ``(B) reference to supporting empirical data; and
       ``(C) an explanation that describes why contrary data is 
     insufficient.
       ``(i) Drug Advisory Committee.--The Drug Safety and Risk 
     Management Advisory Committee within the Center of the Food 
     and Drug Administration shall--
       ``(1) meet not less frequently than every 180 days; and
       ``(2) make recommendations to the Director of the Center 
     with respect to--
       ``(A) which drugs and biological products should be the 
     subject of a study under subsection (d) or (e);
       ``(B) the design and duration for studies under subsection 
     (d) or (e);
       ``(C) which drugs and biological products may present an 
     unreasonable risk to the health of patients or the general 
     public; and
       ``(D) appropriate corrective actions under subsection (k).
       ``(j) Penalties.--
       ``(1) In general.--If the Secretary determines, after 
     notice and opportunity for an informal hearing, that a 
     sponsor of a drug or biological product or other entity has 
     failed to complete a study required under subsection (d) or 
     (e) by the date or to the terms specified by the Secretary 
     under such subsection, the Secretary may order such sponsor 
     or other entity to--
       ``(A) complete the study in a specified time;
       ``(B) revise the study to comply with the terms specified 
     by the Secretary under subsection (d) or (e); or
       ``(C) pay a civil penalty.
       ``(2) Amount of penalties.--
       ``(A) In general.--The civil penalty ordered under 
     paragraph (1) shall be $250,000 for the first 30-day period 
     after the date specified by the Secretary that the study is 
     not completed, and shall double in amount for every 30-day 
     period thereafter that the study is not completed.
       ``(B) Limitation.--In no case shall a penalty under 
     subparagraph (A) exceed $2,000,000 for any 30-day period.
       ``(3) Notification of penalty.--The Secretary shall publish 
     in the Federal Register any civil penalty ordered under this 
     subsection.
       ``(k) Result of Determination.--
       ``(1) In general.--If the Director of the Center makes a 
     determination that a drug or biological product may present 
     an unreasonable risk to the health of patients or the general 
     public under subsection (g), such Director shall order a 
     corrective action, as described under paragraph (2).
       ``(2) Corrective actions.--The corrective action described 
     under subsection (g)--
       ``(A) may include--
       ``(i) requiring a change to the drug or biological product 
     label by a date specified by the Director of the Center;
       ``(ii) modifying the approved indication of the drug or 
     biological product to restrict use to certain patients;
       ``(iii) placing restriction on the distribution of the drug 
     or biological product to ensure safe use;
       ``(iv) requiring the sponsor of the drug or biological 
     product or license to establish a patient registry;
       ``(v) requiring patients to sign a consent form prior to 
     receiving a prescription of the drug or biological product;
       ``(vi) requiring the sponsor to monitor sales and usage of 
     the drug or biological product to detect unsafe use;
       ``(vii) requiring patient or physician education; and
       ``(viii) requiring the establishment of a risk management 
     plan by the sponsor; and
       ``(B) shall include the requirements with respect to 
     promotional material under subsection (l)(1).
       ``(3) Penalties.--
       ``(A) In general.--If the Secretary determines, after 
     notice and opportunity for an informal hearing, that a 
     sponsor of a drug or biological product has failed to take 
     the corrective action ordered by the Director of the Center 
     under this subsection or has failed to comply with subsection 
     (l)(2), the Secretary may order such sponsor to pay a civil 
     penalty.
       ``(B) Amount of penalties.--
       ``(i) In general.--The civil penalty ordered under 
     subparagraph (A) shall be $250,000 for the first 30-day 
     period that the sponsor does not comply with the order under 
     paragraph (1), and shall double in amount for every 30-day 
     period thereafter that the order is not complied with.
       ``(ii) Limitation.--In no case shall a penalty under clause 
     (i) exceed $2,000,000 for any 30-day period.
       ``(C) Notification of penalty.--The Secretary shall publish 
     in the Federal Register any civil penalty ordered under this 
     paragraph.
       ``(l) Promotion Material.--
       ``(1) Safety issue.--If the Director of the Center makes a 
     determination that a drug or biological product may present 
     an unreasonable risk to the health of patients or the general 
     public under subsection (g), such Director, in consultation 
     with the Division of Drug Marketing, Advertising, and 
     Communications of the Food and Drug Administration, shall--
       ``(A) notwithstanding section 502(n), require that the 
     sponsor of such drug or biological product submit to the 
     Director of the Center copies of all promotional material 
     with respect to the drug or biological product not less than 
     30 days prior to the dissemination of such material; and
       ``(B) require that all promotional material with respect to 
     the drug or biological product include certain disclosures, 
     which shall be displayed prominently and in a manner easily 
     understood by the general public, including--
       ``(i) a statement that describes the unreasonable risk to 
     the health of patients or the general public as determined by 
     the Director of the Center;
       ``(ii) a statement that encourages patients to discuss 
     potential risks and benefits with their healthcare provider;
       ``(iii) a description of the corrective actions required 
     under subsection (k);
       ``(iv) where appropriate, a statement explaining that there 
     may be products available to treat the same disease or 
     condition that present a more favorable benefit-to-risk 
     profile, and that patients should talk to their healthcare 
     provider about the risks and benefits of alternative 
     treatments;

[[Page S1457]]

       ``(v) a description of any requirements of outstanding 
     clinical and observational studies, including the purpose of 
     each study; and
       ``(vi) contact information to report a suspected adverse 
     reaction.
       ``(2) New products; outstanding studies.--For the first 2-
     year period after a drug is approved under section 505 of 
     this Act or a biological product is licensed under section 
     351 of the Public Health Service Act, and with respect to 
     drugs and biological products for which there are outstanding 
     study requirements under subsection (d) or (e), the Director 
     of the Center, in consultation with the Division of Drug 
     Marketing, Advertising, and Communications of the Food and 
     Drug Administration, shall--
       ``(A) notwithstanding section 502(n), require that the 
     sponsor of such drug or biological product submit to the 
     Director of the Center copies of all promotional material 
     with respect to the drug or biological product not less than 
     30 days prior to the dissemination of such material; and
       ``(B) require that all promotional material with respect to 
     the drug or biological product include certain disclosures, 
     which shall be displayed prominently and in a manner easily 
     understood by the general public, including--
       ``(i) a statement explaining that the drug or biological 
     product is newly approved or licensed or the subject of 
     outstanding clinical or observational studies, as the case 
     may be, and, as a result, not all side effects or drug 
     interactions may be known;
       ``(ii) the number of people in which the drug or biological 
     product has been studied and the duration of time during 
     which the drug or biological product has been studied;
       ``(iii) a statement that encourages patients to discuss the 
     potential risks and benefits of treatment with their 
     healthcare provider;
       ``(iv) a description of any requirements of outstanding 
     clinical and observational studies, including the purpose of 
     each study; and
       ``(v) contact information to report a suspected adverse 
     reaction.
       ``(3) Effect of voluntary submission.--Paragraphs (1)(A) 
     and (2)(A) shall not apply to the sponsor of a drug or 
     biological product if such sponsor has voluntarily submitted 
     to the Division of Drug Marketing, Advertising, and 
     Communications of the Food and Drug Administration all 
     promotional material with respect to the drug or biological 
     product prior to the dissemination of such material.
       ``(m) Withdrawal or Suspension of Approval or Licensure.--
       ``(1) In general.--The Director of the Center, may withdraw 
     or suspend approval of a drug or licensure of a biological 
     product using expedited procedures (as prescribed by the 
     Secretary in regulations promulgated not later than 1 year 
     after the date of enactment of the Food and Drug 
     Administration Safety Act of 2007, which shall include an 
     opportunity for an informal hearing) after consultation with 
     the Director of the Center for Drug Evaluation and Research 
     or the Director of the Center for Biologics Evaluation and 
     Research, as appropriate, and any other person as determined 
     appropriate by the Director of the Center, if--
       ``(A) the Director of the Center makes a determination that 
     the drug or biological product may present an unreasonable 
     risk to the health of patients or the general public, and 
     that risk cannot be satisfactorily alleviated by a corrective 
     action under subsection (k); or
       ``(B) the sponsor fails to comply with an order or 
     requirement under this section.
       ``(2) Public information.--The Secretary shall make 
     available to the public, by publication in the Federal 
     Register and posting on an Internet website, the details of 
     the consultation described in paragraph (1), including--
       ``(A) the reason for the determination to withdraw, 
     suspend, or failure to withdraw or suspend, approval for the 
     drug or licensure for the biological product;
       ``(B) the factual basis for such determination;
       ``(C) reference to supporting empirical data;
       ``(D) an explanation that describes why contrary data is 
     insufficient; and
       ``(E) the position taken by each individual consulted.
       ``(n) Effect of Section.--The authorities conferred by this 
     section shall be separate from and in addition to the 
     authorities conferred by section 505B.
       ``(o) Administration of Section.--The provisions of this 
     section shall be carried out by the Secretary, acting through 
     the Director of the Center.''.
       (b) Misbranding.--Section 502 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352) is amended by inserting 
     after subsection (j) the following:
       ``(k) If it is a drug or biological product for which the 
     sponsor of an application or holder of an approved 
     application or license has not complied with an order or 
     requirement under section 507.''.
       (c) Report on Devices.--Not later than 6 months after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services, in consultation with the Commissioner of Food 
     and Drugs, the Director of the Center for Postmarket 
     Evaluation and Research for Drugs and Biologics, and the 
     Director of the Center for Devices and Radiological Health, 
     shall submit to Congress a report that--
       (1) identifies gaps in the current process of postmarket 
     surveillance of devices approved under the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 321 et seq.);
       (2) includes recommendations on ways to improve gaps in 
     postmarket surveillance of devices; and
       (3) identifies the changes in authority needed to make 
     those improvements, recognizing the legitimate differences 
     between devices and other medical products regulated by the 
     Food and Drug Administration.
       (d) Transfer of Functions.--The functions and duties of the 
     Office of Surveillance and Epidemiology, including the Drug 
     Safety and Risk Management Advisory Committee, of the Food 
     and Drug Administration on the day before the date of 
     enactment of this Act shall be transferred to the Center for 
     Postmarket Evaluation and Research for Drugs and Biologics 
     established under section 507 of the Federal Food, Drug, and 
     Cosmetic Act (as added by this section). The Center for 
     Postmarket Evaluation and Research for Drugs and Biologics 
     shall be a separate entity within the Food and Drug 
     Administration and shall not be an administrative office of 
     the Center for Drug Evaluation and Research or the Center for 
     Biologics Evaluation and Research.
       (e) Authorization of Appropriations.--There are authorized 
     to be appropriated to carry out this Act (and the amendments 
     made by this Act)--
       (1) $50,000,000 for fiscal year 2008;
       (2) $75,000,000 for fiscal year 2009;
       (3) $100,000,000 for fiscal year 2010;
       (4) $125,000,000 for fiscal year 2011; and
       (5) $150,000,000 for fiscal year 2012.
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