[Congressional Record Volume 153, Number 70 (Tuesday, May 1, 2007)]
[Senate]
[Pages S5332-S5362]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007--Continued
The PRESIDING OFFICER. The Senator from Oklahoma is recognized.
Mr. INHOFE. Mr. President, on the bill under consideration at the
present time, it is my intention to--and I have already placed at the
desk two amendments, 987 and 988.
Briefly, what is the order right now?
The PRESIDING OFFICER. The Senator is recognized. The Senator has as
much time as he may consume.
Mr. INHOFE. Today I have submitted amendments to S. 1082 requiring
parental consent for intrusive physical exams administered under the
Head Start Program. Young children attending Head Start Programs should
not be subjected to these intrusive types of physical exams. We had an
incident in my town of Tulsa, OK, where we felt that their rights,
children's rights, were violated. They were subjected to different
types of intrusive examinations. I will be bringing this up at an
appropriate time.
Secondly, briefly, as I see the manager of the bill is here, we will
be introducing an amendment No. 988, having to do with protecting
children from parents being coerced into administering a controlled
substance or psychotropic drug in order to attend school.
Mr. President, I yield the floor, and I suggest the absence of a
quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The bill clerk proceeded to call the roll.
The PRESIDING OFFICER. The Senator from Oklahoma is recognized.
Mr. INHOFE. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. INHOFE. Mr. President, I ask unanimous consent to withdraw my
amendments, No. 988 and No. 987, with the intention to resubmit them
when a substitute is made in a few minutes.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. INHOFE. Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Rhode Island.
Mr. REED. Mr. President, I believe the Food and Drug Administration
Revitalization Act before us today raises and addresses issues that are
critically important to the public's health and well-being. Congress
has a historic opportunity to strengthen and increase knowledge about
drug safety and effectiveness, bring more transparency to the process
of drug approval and surveillance, as well as reassess the goals of the
prescription drug and medical device user fee programs, and fortify and
expand essential safety programs for children. The FDA Revitalization
Act strikes a careful balance between these many important priorities
and objectives.
Recent serious adverse drug events related to several widely used
drugs on the market underscore the urgency with which we should address
and improve drug safety in this country. Moreover, as the population
ages and science inevitably advances, more and more drugs will come to
market, presenting potentially groundbreaking health benefits to the
public, but simultaneously increasing the need for sophisticated
mechanisms for monitoring and assuring drug safety.
The FDA Revitalization Act is an opportunity to improve our current
system of drug approval and drug monitoring, but it also adeptly
anticipates changes in the future of prescription drugs and consumer
safety brought about by advances in science and an ever expanding
market for prescription drugs.
The primary mechanism this bill uses to strengthen drug safety is to
strengthen and rearticulate the FDA's authority. The bill clarifies,
and in some cases fortifies, the FDA's authority with regard to drug
safety. Currently, if the FDA detects a problem, or a potential problem
with a drug post approval, they have few options beyond what is often
referred to as the ``nuclear option.'' That is, pulling a drug from the
market. While the FDA's authority to pull a drug from the marketplace
is a powerful tool, it is a blunt instrument. In order to prevent
problems from spiraling into major public health crises, the FDA needs
intermediary authority. The FDA's reluctance to pull a drug,
potentially a drug upon which millions of Americans depend to manage an
illness, unless it is overwhelmingly certain that the action is
necessary, is understandable. However, prescription drug users suffer
as a result since the ``nuclear option'' offers a forceful, but
ultimately limited response. Pulling a drug from the market potentially
delays action and places individuals at major health risks in the
interim. On the flip side, pulling a drug prematurely may needlessly
deny patients important, and in some cases, singular, treatments for
their health needs. This bill offers what I believe is a good solution
to this paradox; one that considers input from patients rights
organizations, industry representatives, and the FDA, but ultimately
places patients at the top of the list.
The risk evaluation and mitigation, REMS, system, the primary tool in
the drug safety title of this bill, bolsters the FDA's intermediary
authority to require drug manufacturers to monitor and provide
important information regarding their products. By so doing, the FDA
can actively require drug companies to provide information about the
medications millions of Americans are taking and not just passively
request drug companies to comply.
Most importantly, the REMS system focuses the FDA's efforts and
resources on postmarket surveillance. Increased drug user fees would be
used to review REMS as well as for general drug safety surveillance.
User fee revenue will increase by $50 million to fund drug
safety activities, of which $30 million is authorized for the routine
drug surveillance once they are marketed. Many of us would like to
eliminate the need for industry paid user fees, but this arrangement,
agreed on by industry and the FDA, offers the best workable solution in
this strained budget environment.
Another important objective of the FDA Revitalization Act is to
improve the integrity of the agency and to enhance transparency on its
actions. I am pleased that this bill improves the public's access to
information about clinical trials and, more importantly, the results of
those trials. The bill enhances patient enrollment in trials by
requiring late phase II, as well as phase III and phase IV clinical
trials on drugs are registered in a publicly available database. This
will improve the public's knowledge of important and potentially life
saving clinical studies. The bill also creates a publicly available
database of the results of those trials. This means, for instance, that
a parent who wishes to understand why a much-talked about treatment for
juvenile diabetes failed to advance past a clinical trial stage can
track the progress of a treatment using this database. It is important
that we empower patients and consumers to gather information from
primary sources so
[[Page S5333]]
that they can engage in treatment decisions and make informed choices
regarding their family's health care needs.
I am also pleased to see efforts to increase research on pediatric
drug safety, pediatric clinical trials, and pediatric medical devices
in title IV of the FDA Revitalization Act. The bill includes
reauthorizations of the Best Pharmaceuticals for Children Act, BPCA,
championed by my colleague, Senator Dodd, which I have cosponsored, and
the Pediatric Research Improvement Act, PRIA, championed by my
colleague, Senator Clinton, which have been particularly successful at
increasing the availability of pediatric specific data on drug
products, as well as greatly expanding the number of treatments that
have been tested and labeled for use in pediatric populations. The bill
also includes a new proposal to expand the collection and availability
of pediatric data on medical devices, an area of the medical device
market that remains seriously underdeveloped, and as a result places
infants and children at risk for inferior or inadequate care at best,
and tragic and needless loss of life at worst. Moreover, BPCA also
includes a new provision on patent exclusivity for blockbuster drugs
that strikes a sound compromise between creating an appropriate
financial incentive for drug companies to conduct much needed research,
while also providing the FDA with important information about pediatric
drugs.
Mr. President, the FDA is responsible for overseeing the safety of a
wide range of products consumed by millions of Americans each and every
day. We can and must ensure that this critical agency has the tools and
resources it needs to perform the myriad of tasks under its purview. We
need to get this right for the millions of Americans who rely on the
FDA to approve the drugs that they take to treat serious illnesses. The
FDA Revitalization Act creates an opportunity to improve science at the
FDA, strengthen drug safety by devoting resources to postmarket
surveillance, and ``revitalize'' the FDA's authority.
Mr. President, I yield the floor and suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The bill clerk proceeded to call the roll.
Mr. KENNEDY. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Modification To Reported Committee Substitute
Mr. KENNEDY. Mr. President, on behalf of the HELP Committee, I send
to the desk a modification to the committee substitute.
The PRESIDING OFFICER. The committee substitute is so modified.
The modification is as follows:
(Purpose: To provide a complete substitute)
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration
Revitalization Act''.
TITLE I--PRESCRIPTION DRUG USER FEES
SEC. 101. SHORT TITLE; REFERENCES IN TITLE.
(a) Short Title.--This title may be cited as the
``Prescription Drug User Fee Amendments of 2007''.
(b) References in Title.--Except as otherwise specified,
whenever in this title an amendment is expressed in terms of
an amendment to a section or other provision, the reference
shall be considered to be made to a section or other
provision of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
SEC. 102. DRUG FEES.
Section 735 (21 U.S.C. 379g) is amended--
(1) by striking the section designation and all that
follows through ``For purposes of this subchapter:'' and
inserting the following:
``SEC. 735. DRUG FEES.
``(a) Purpose.--It is the purpose of this part that the
fees authorized under this part be dedicated toward
expediting the drug development process, the process for the
review of human drug applications, and postmarket drug
safety, as set forth in the goals identified for purposes of
this part in the letters from the Secretary to the Chairman
of the Committee on Health, Education, Labor, and Pensions of
the Senate and the Chairman of the Committee on Energy and
Commerce of the House of Representatives, as set forth in the
Congressional Record.
``(b) Reports.--
``(1) Performance report.--For fiscal years 2008 through
2012, not later than 120 days after the end of each fiscal
year during which fees are collected under this part, the
Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, a report concerning the progress of the Food
and Drug Administration in achieving the goals identified in
the letters described in subsection (a) during such fiscal
year and the future plans of the Food and Drug Administration
for meeting the goals. The report for a fiscal year shall
include information on all previous cohorts for which the
Secretary has not given a complete response on all human drug
applications and supplements in the cohort.
``(2) Fiscal report.--For fiscal years 2008 through 2012,
not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the
Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, a report on the implementation of the
authority for such fees during such fiscal year and the use,
by the Food and Drug Administration, of the fees collected
during such fiscal year for which the report is made.
``(3) Public availability.--The Secretary shall make the
reports required under paragraphs (1) and (2) available to
the public on the Internet website of the Food and Drug
Administration.
``(c) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and plans for
meeting the goals, for the process for the review of human
drug applications for the first 5 fiscal years after fiscal
year 2012, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the House of
Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under paragraph
(1) to the Congressional committees specified in such
paragraph;
``(B) publish such recommendations in the Federal Register;
``(C) provide for a period of 30 days for the public to
provide written comments on such recommendations;
``(D) hold a meeting at which the public may present its
views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2012, the Secretary shall transmit to Congress
the revised recommendations under paragraph (2), a summary of
the views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
``(d) Definitions.--For purposes of this part:'';
(2) in subsection (d)--
(A) in paragraph (1)--
(i) in subparagraph (A), by striking ``505(b)(1),'' and
inserting ``505(b), or'';
(ii) by striking subparagraph (B);
(iii) by redesignating subparagraph (C) as subparagraph
(B); and
(iv) in the matter following subparagraph (B), as so
redesignated, by striking ``subparagraph (C)'' and inserting
``subparagraph (B)'';
(B) in paragraph (3)(C), by--
(i) striking ``the list'' and inserting ``the list (not
including the discontinued section of such list)''; and
(ii) striking ``a list'' and inserting ``a list (not
including the discontinued section of such a list)'';
(C) in paragraph (4), by inserting before the period at the
end the following: ``(such as capsules, tablets, and
lyophilized products before reconstitution)'';
(D) by amending paragraph (6)(F) to read as follows:
``(F) In the case of drugs approved under human drug
applications or supplements, postmarket safety activities,
including--
``(i) collecting, developing, and reviewing safety
information on approved drugs (including adverse event
reports);
``(ii) developing and using improved adverse event data
collection systems (including information technology
systems); and
``(iii) developing and using improved analytical tools to
assess potential safety problems (including by accessing
external data bases).'';
(E) in paragraph (8)--
(i) by striking ``April of the preceding fiscal year'' and
inserting ``October of the preceding fiscal year''; and
(ii) by striking ``April 1997'' and inserting ``October
1996'';
(F) by redesignating paragraph (9) as paragraph (10); and
(G) by inserting after paragraph (8) the following:
``(9) The term `person' includes an affiliate of such
person.''.
[[Page S5334]]
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is
amended--
(1) in the matter preceding paragraph (1), by striking
``2003'' and inserting ``2008'';
(2) in paragraph (1)--
(A) in subparagraph (D)--
(i) in the heading, by inserting ``or withdrawn before
filing'' after ``refund of fee if application refused for
filing''; and
(ii) by inserting before the period at the end the
following: ``or withdrawn without a waiver before filing'';
(B) by redesignating subparagraphs (E) and (F) as
subparagraphs (F) and (G), respectively; and
(C) by inserting after subparagraph (D) the following:
``(E) Fee for application previously refused for filing or
withdrawn before filing.--An application or supplement that
has been refused for filing or that was withdrawn before
filing, if filed under protest or resubmitted, shall be
subject to the fee under subparagraph (A) (unless an
exception under subparagraph (C) or (F) applies or the fee is
waived or reduced under subsection (d)), without regard to
previous payment of such a fee and the refund of 75 percent
of that fee under subparagraph (D).''; and
(3) in paragraph (2)--
(A) in subparagraph (A), by striking ``subparagraph (B)''
and inserting ``subparagraphs (B) and (C)''; and
(B) by adding at the end the following:
``(C) Special rules for compounded positron emission
tomography drugs.--
``(i) In general.--Except as provided in clause (ii), each
person who is named as the applicant in an approved human
drug application for a compounded positron emission
tomography drug shall be subject under subparagraph (A) to
one-fifth of an annual establishment fee with respect to each
such establishment identified in the application as producing
compounded positron emission tomography drugs under the
approved application.
``(ii) Exception from annual establishment fee.--Each
person who is named as the applicant in an application
described in clause (i) shall not be assessed an annual
establishment fee for a fiscal year if the person certifies
to the Secretary, at a time specified by the Secretary and
using procedures specified by the Secretary, that--
``(I) the person is a not-for-profit medical center that
has only 1 establishment for the production of compounded
positron emission tomography drugs; and
``(II) at least 95 percent of the total number of doses of
each compounded positron emission tomography drug produced by
such establishment during such fiscal year will be used
within the medical center.''.
(b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C.
379h(b)) is amended to read as follows:
``(b) Fee Revenue Amounts.--Except as provided in
subsections (c), (d), (f), and (g), fees under subsection (a)
shall be established to generate the following revenue
amounts, in each fiscal year beginning with fiscal year 2008
and continuing through fiscal year 2012: $392,783,000, plus
an adjustment for workload on $354,893,000 of this amount.
Such adjustment shall be made in accordance with the workload
adjustment provisions in effect for fiscal year 2007, except
that instead of commercial investigational new drug
applications submitted to the Secretary, all commercial
investigational new drug applications with a submission
during the previous 12-month period shall be used in the
determination. One-third of the revenue amount shall be
derived from application fees, one-third from establishment
fees, and one-third from product fees.''.
(c) Adjustments to Fees.--
(1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C.
379h(c)(1)) is amended--
(A) in the matter preceding subparagraph (A) by striking
``The revenues established in subsection (b)'' and inserting
``Beginning with fiscal year 2009, the revenues established
in subsection (b)'';
(B) in subparagraph (A) by striking ``or'' at the end;
(C) in subparagraph (B) by striking the period at the end
and inserting ``, or,'';
(D) by inserting after subparagraph (B) the following:
``(C) the average annual change in the cost, per full-time
equivalent position of the Food and Drug Administration, of
all personnel compensation and benefits paid with respect to
such positions, for the first 5 fiscal years of the previous
6 fiscal years.''; and
(E) in the matter following subparagraph (C) (as added by
this paragraph), by striking ``fiscal year 2003'' and
inserting ``fiscal year 2008''.
(2) Workload adjustment.--Section 736(c)(2) (21 U.S.C.
379h(c)(2)) is amended--
(A) in the matter preceding subparagraph (A,) by striking
``2004'' and inserting ``2009'';
(B) in the first sentence of subparagraph (A)--
(i) by striking ``, commercial investigational new drug
applications'' and inserting ``(adjusted for changes in
review activities)''; and
(ii) by inserting before the period at the end ``, and the
change in the number of commercial investigational new drug
applications with a submission during the previous 12-month
period (adjusted for changes in review activities)'';
(C) in subparagraph (B), by adding at the end the following
new sentence: ``Further, any adjustment for changes in review
activities made in setting fees and fee revenue amounts for
fiscal year 2009 may not result in the total workload
adjustment being more than 2 percentage points higher than it
would be absent the adjustment for changes in review
activities.''; and
(D) by adding at the end the following:
``(C) The Secretary shall contract with an independent
accounting firm to study the adjustment for changes in review
activities applied in setting fees for fiscal year 2009 and
to make recommendations, if warranted, on future changes in
the methodology for calculating the adjustment for changes in
review activity. After review of the recommendations by the
independent accounting firm, the Secretary shall make
appropriate changes to the workload adjustment methodology in
setting fees for fiscal years 2010 through 2012. If the study
is not conducted, no adjustment for changes in review
activities shall be made after fiscal year 2009.''.
(3) Rent and rent-related cost adjustment.--Section 736(c)
(21 U.S.C. 379h(c)) is amended--
(A) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) Rent and rent-related cost adjustment.--Beginning
with fiscal year 2010, the Secretary shall, before making the
adjustments under paragraphs (1) and (2), reduce the fee
amounts established in subsection (b), if actual costs paid
for rent and rent-related expenses are less than $11,721,000.
The reductions made under this paragraph, if any, shall not
exceed the amounts by which costs fell below $11,721,000, and
shall not exceed $11,721,000 in any fiscal year.''.
(4) Final year adjustment.--Section 736(c) (21 U.S.C.
379h(c)) is amended--
(A) in paragraph (4), as redesignated by this subsection--
(i) by striking ``2007'' each place it appears and
inserting ``2012''; and
(ii) by striking ``2008'' and inserting ``2013''; and
(B) in paragraph (5), as redesignated by this subsection,
by striking ``2002'' and inserting ``2007''.
(d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C.
379h(d)) is amended--
(1) in paragraph (1), in the matter preceding subparagraph
(A), by--
(A) inserting ``to a person who is named as the applicant''
after ``The Secretary shall grant'';
(B) inserting ``to that person'' after ``a waiver from or a
reduction of one or more fees assessed''; and
(C) striking ``finds'' and inserting ``determines'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively;
(3) by inserting after paragraph (1) the following:
``(2) Evaluation.--For the purpose of determining whether
to grant a waiver or reduction of a fee under paragraph (1),
the Secretary shall consider only the circumstances and
assets of the applicant and any affiliate of the
applicant.''; and
(4) in paragraph (4), as redesignated by this subsection,
in subparagraph (A), by inserting before the period at the
end ``, and that does not have a drug product that has been
approved under a human drug application and introduced or
delivered for introduction into interstate commerce''.
(e) Crediting and Availability of Fees.--
(1) Authorization of appropriations.--Section 736(g)(3) (21
U.S.C. 379h(g)(3)) is amended to read as follows:
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section
such sums as are authorized to be assessed and collected
under this section in each of fiscal years 2008 through
2012.''.
(2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is
amended to read as follows:
``(4) Offset.--If the cumulative amount of fees collected
during fiscal years 2008, 2009, and 2010, plus the amount
estimated to be collected for fiscal year 2011, exceeds the
amount of fees specified in aggregate in appropriation Acts
for such fiscal years, the aggregate amount in excess shall
be credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for fiscal year 2012.''.
(f) Conforming Amendments.--
(1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this
section, is amended--
(A) in paragraph (1)(A), by striking ``subsection (c)(4)''
each place it appears and inserting ``subsection (c)(5)'';
(B) in paragraph (2), by striking ``subsection (c)(4)'' and
inserting ``subsection (c)(5)''; and
(C) in paragraph (3), by striking ``subsection (c)(4)'' and
inserting ``subsection (c)(5)''.
(2) Section 736A(h)(3), as added by section 104 of this
title, is amended by striking ``735(3)'' and inserting
``735(d)(3)''.
SEC. 104. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG
ADVERTISING FEES.
Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.)
is amended by adding after section 736 the following new
section:
``SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY
REVIEW OF PRESCRIPTION DRUG ADVERTISING.
``(a) Types of Direct-to-Consumer Television Advertisement
Review Fees.--Beginning with fiscal year 2008, the Secretary
[[Page S5335]]
shall assess and collect fees in accordance with this section
as follows:
``(1) Advisory review fee.--
``(A) In general.--Except as provided in subparagraph (B),
each person that on or after October 1, 2007, submits a
proposed direct-to-consumer television advertisement for
advisory review by the Secretary prior to its initial public
dissemination shall be subject to a fee established under
subsection (c)(3).
``(B) Exception for required submissions.--A direct-to-
consumer television advertisement that is required to be
submitted to the Secretary prior to initial public
dissemination shall not be assessed a fee unless the sponsor
designates it as a submission for advisory review.
``(C) Payment.--The fee required by subparagraph (A) shall
be due not later than October 1 of the fiscal year in which
the direct-to-consumer television advertisement shall be
submitted to the Secretary for advisory review.
``(D) Modification of advisory review fee.--
``(i) Late payment.--If, on or before November 1 of the
fiscal year in which the fees are due, a person has not paid
all fees that were due and payable for advisory reviews
identified in response to the Federal Register notice
described in subsection (c)(3)(A), the fees shall be regarded
as late. Such fees shall be due and payable 20 days before
any direct-to-consumer television advertisement is submitted
by such person to the Secretary for advisory review.
Notwithstanding any other provision of this section, such
fees shall be due and payable for each of those advisory
reviews in the amount of 150 percent of the advisory review
fee established for that fiscal year pursuant to subsection
(c)(3).
``(ii) Late notice of submission.--If any person submits
any direct-to-consumer television advertisements for advisory
review that are in excess of the number identified by that
person in response to the Federal Register notice described
in subsection (c)(3)(A), that person must pay a fee for each
of those advisory reviews in the amount of 150 percent of the
advisory review fee established for that fiscal year pursuant
to subsection (c)(3). Fees under this subparagraph shall be
due 20 days before the direct-to-consumer television
advertisement is submitted by such person to the Secretary
for advisory review.
``(E) Limits.--
``(i) In general.--The payment of a fee under this
paragraph for a fiscal year entitles the person that pays the
fee to acceptance for advisory review by the Secretary of 1
direct-to-consumer television advertisement and acceptance of
1 resubmission for advisory review of the same advertisement.
The advertisement shall be submitted for review in the fiscal
year for which the fee was assessed, except that a person may
carry over no more than 1 paid advisory review submission to
the next fiscal year. Resubmissions may be submitted without
regard to the fiscal year of the initial advisory review
submission.
``(ii) No refund.--Except as provided by subsection (f),
fees paid under this paragraph shall not be refunded.
``(iii) No waiver, exemption, or reduction.--The Secretary
shall not grant a waiver, exemption, or reduction of any fees
due or payable under this section.
``(iv) Non-transferability.--The right to an advisory
review is not transferable, except to a successor in
interest.
``(2) Operating reserve fee.--
``(A) In general.--Each person that, on or after October 1,
2007, is assessed an advisory review fee under paragraph (1)
shall be subject to an operating reserve fee established
under subsection (d)(2) only in the first fiscal year in
which an advisory review fee is assessed.
``(B) Payment.--Except as provided in subparagraph (C), the
fee required by subparagraph (A) shall be due not later than
October 1 of the first fiscal year in which the person is
required to pay an advisory review fee under paragraph (1).
``(C) Late notice of submission.--If, in the first fiscal
year of a person's participation in the Program, that person
submits any direct-to-consumer television advertisements for
advisory review that are in excess of the number identified
by that person in response to the Federal Register notice
described in subsection (c)(3)(A), that person must pay an
operating reserve fee for each of those advisory reviews
equal to the advisory review fee for each submission
established under paragraph (1)(D)(ii). Fees required by this
subparagraph shall be in addition to the fees required under
subparagraph (B), if any. Fees under this subparagraph shall
be due 20 days before any direct-to-consumer television
advertisement is submitted by such person to the Secretary
for advisory review.
``(b) Advisory Review Fee Revenue Amounts.--Fees under
subsection (a)(1) shall be established to generate revenue
amounts of $6,250,000 for each of fiscal years 2008 through
2012, as adjusted pursuant to subsection (c).
``(c) Adjustments.--
``(1) Inflation adjustment.--Beginning with fiscal year
2009, the revenues established in subsection (b) shall be
adjusted by the Secretary by notice, published in the Federal
Register, for a fiscal year to reflect the greater of--
``(A) the total percentage change that occurred in the
Consumer Price Index for all urban consumers (all items;
United States city average), for the 12-month period ending
June 30 preceding the fiscal year for which fees are being
established;
``(B) the total percentage change for the previous fiscal
year in basic pay under the General Schedule in accordance
with section 5332 of title 5, as adjusted by any locality-
based comparability payment pursuant to section 5304 of such
title for Federal employees stationed in the District of
Columbia; or
``(C) the average annual change in the cost, per full-time
equivalent position of the Food and Drug Administration, of
all personnel compensation and benefits paid with respect to
such positions, for the first 5 fiscal years of the previous
6 fiscal years.
The adjustment made each fiscal year by this paragraph shall
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2008 under this
subsection.
``(2) Workload adjustment.--
``(A) In general.--Beginning with fiscal year 2009, after
the fee revenues established in subsection (b) of this
section are adjusted for a fiscal year for inflation in
accordance with paragraph (1), the fee revenues shall be
adjusted further for such fiscal year to reflect changes in
the workload of the Secretary with respect to the submission
of proposed direct-to-consumer television advertisements for
advisory review prior to initial broadcast.
``(B) Determination of workload adjustment.--
``(i) In general.--The workload adjustment under this
paragraph for a fiscal year shall be determined by the
Secretary--
``(I) based upon the number of direct-to-consumer
television advertisements identified pursuant to paragraph
(3)(A) for that fiscal year, excluding allowable previously
paid carry over submissions; and
``(II) by multiplying the number of such advertisements
projected for that fiscal year that exceeds 150 by $27,600
(adjusted each year beginning with fiscal year 2009 for
inflation in accordance with paragraph (1)).
``(ii) Publication in federal register.--The Secretary
shall publish in the Federal Register, as part of the notice
described in paragraph (1), the fee revenues and fees
resulting from the adjustment made under this paragraph and
the supporting methodologies.
``(C) Limitation.--Under no circumstances shall the
adjustment made under this paragraph result in fee revenues
for a fiscal year that are less than the fee revenues
established for the prior fiscal year.
``(3) Annual fee setting.--
``(A) Number of advertisements.--The Secretary shall, 120
days before the start of each fiscal year, publish a notice
in the Federal Register requesting any person to notify the
Secretary within 30 days of the number of direct-to-consumer
television advertisements the person intends to submit for
advisory review by the Secretary in the next fiscal year.
Notification to the Secretary of the number of advertisements
a person intends to submit for advisory review prior to
initial broadcast shall be a legally binding commitment by
that person to pay the annual advisory review fee for that
number of submissions on or before October 1 of the fiscal
year in which the advertisement is intended to be submitted.
A person shall at the same time also notify the Secretary if
such person intends to use a paid submission from the
previous fiscal year under subsection (a)(1)(E)(i). If such
person does not so notify the Secretary, all submissions for
advisory review shall be subject to advisory review fees.
``(B) Annual fee.--The Secretary shall, 60 days before the
start of each fiscal year, establish, for the next fiscal
year, the direct-to-consumer television advertisement
advisory review fee under subsection (a)(1), based on the
revenue amounts established under subsection (b), the
adjustments provided under this subsection and the number of
direct-to-consumer television advertisements identified
pursuant to subparagraph (A), excluding allowable previously
paid carry over submissions. The annual advisory review fee
shall be established by dividing the fee revenue for a fiscal
year (as adjusted pursuant to this subsection) by the number
of direct-to-consumer television advertisements identified
pursuant to subparagraph (A), excluding allowable previously
paid carry over submissions.
``(C) Fiscal year 2008 fee limit.--Notwithstanding
subsection (b), the fee established under subparagraph (B)
for fiscal year 2008 may not be more than $83,000 per
submission for advisory review.
``(D) Annual fee limit.--Notwithstanding subsection (b),
the fee established under subparagraph (B) for a fiscal year
after fiscal year 2008 may not be more than 50 percent more
than the fee established for the prior fiscal year.
``(E) Limit.--The total amount of fees obligated for a
fiscal year may not exceed the total costs for such fiscal
year for the resources allocated for the process for the
advisory review of prescription drug advertising.
``(d) Operating Reserves.--
``(1) In general.--The Secretary shall establish in the
Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation a
Direct-to-Consumer Advisory Review Operating Reserve, of at
least $6,250,000 in fiscal year 2008, to continue the Program
in the event the fees collected in any subsequent fiscal year
pursuant to subsection (c)(3) do not generate the fee revenue
amount established for that fiscal year.
[[Page S5336]]
``(2) Fee setting.--The Secretary shall establish the
operating reserve fee under subsection (a)(2)(A) for each
person required to pay the fee by multiplying the number of
direct-to-consumer television advertisements identified by
that person pursuant to subsection (c)(3)(A) by the advisory
review fee established pursuant to subsection (c)(3) for that
fiscal year. In no case shall the operating reserve fee
assessed be less than the operating reserve fee assessed if
the person had first participated in the Program in fiscal
year 2008.
``(3) Use of operating reserve.--The Secretary may use
funds from the reserves under this subsection only to the
extent necessary in any fiscal year to make up the difference
between the fee revenue amount established for that fiscal
year under subsection (b) and the amount of fees collected
for that fiscal year pursuant to subsection (a), or to pay
costs of ending the Program if it is terminated pursuant to
subsection (f) or if it is not reauthorized after fiscal year
2012.
``(4) Refund of operating reserves.--Within 120 days of the
end of fiscal year 2012, or if the Program is terminated
pursuant to subsection (f), the Secretary, after setting
aside sufficient operating reserve amounts to terminate the
Program, shall refund all amounts remaining in the operating
reserve on a pro rata basis to each person that paid an
operating reserve fee assessment. In no event shall the
refund to any person exceed the total amount of operating
reserve fees paid by such person pursuant to subsection
(a)(2).
``(e) Effect of Failure To Pay Fees.--Notwithstanding any
other law or regulation of the Secretary, a submission for
advisory review of a direct-to-consumer television
advertisement submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not
be accepted for review by the Secretary until all fees owed
by such person under this section have been paid.
``(f) Effect of Inadequate Funding of Program.--
``(1) First fiscal year.--If on November 1, 2007, or 120
days after enactment of the Prescription Drug User Fee
Amendments of 2007, whichever is later, the Secretary has
received less than $11,250,000 in advisory review fees and
operating reserve fees combined, the Program shall be
terminated and all collected fees shall be refunded.
``(2) Subsequent fiscal years.--Beginning in fiscal year
2009, if, on November 1 of a fiscal year, the combination of
the operating reserves, annual fee revenues from that fiscal
year, and unobligated fee revenues from prior fiscal years is
less than $9,000,000, adjusted for inflation (in accordance
with subsection (c)(1)), the Program shall be terminated, and
the Secretary shall notify all participants, retain any money
from the unused advisory review fees and the operating
reserves needed to terminate the Program, and refund the
remainder of the unused fees and operating reserves. To the
extent required to terminate the Program, the Secretary shall
first use unobligated advisory review fee revenues from prior
fiscal years, then the operating reserves, and then unused
advisory review fees from the relevant fiscal year.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in
appropriations Acts. Such fees are authorized to remain
available until expended. Such sums as may be necessary may
be transferred from the Food and Drug Administration salaries
and expenses appropriation account without fiscal year
limitation to such appropriation account for salaries and
expenses with such fiscal year limitation. The sums
transferred shall be available solely for the process for the
advisory review of prescription drug advertising.
``(2) Collections and appropriation acts.--The fees
authorized by this section--
``(A) shall be retained in each fiscal year in an amount
not to exceed the amount specified in appropriation Acts, or
otherwise made available for obligation for such fiscal year;
and
``(B) shall be available for obligation only if
appropriated budget authority continues to support at least
the total combined number of full-time equivalent employees
in the Food and Drug Administration, Center for Drug
Evaluation and Research, Division of Drug Marketing,
Advertising, and Communications, and the Center for Biologics
Evaluation and Research, Advertising and Promotional Labeling
Branch supported in fiscal year 2007.
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section not
less than $6,250,000 for each of fiscal years 2008, 2009,
2010, 2011, and 2012, as adjusted to reflect adjustments in
the total fee revenues made under this section, plus amounts
collected for the reserve fund under subsection (d).
``(4) Offset.--Any amount of fees collected for a fiscal
year under this section that exceeds the amount of fees
specified in appropriation Acts for such fiscal year shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
collected under this section pursuant to appropriation Acts
for a subsequent fiscal year.
``(h) Definitions.--For purposes of this section:
``(1) The term `advisory review' means reviewing and
providing advisory comments regarding compliance of a
proposed advertisement with the requirements of this Act
prior to its initial public dissemination.
``(2) The term `carry over submission' means a submission
for an advisory review for which a fee was paid in a fiscal
year that is submitted for review in the following fiscal
year.
``(3) The term `direct-to-consumer television
advertisement' means an advertisement for a prescription drug
product as defined in section 735(3) intended to be displayed
on any television channel for less than 2 minutes.
``(4) The term `person' includes an individual, a
partnership, a corporation, and an association, and any
affiliate thereof or successor in interest.
``(5) The term `process for the advisory review of
prescription drug advertising' means the activities necessary
to review and provide advisory comments on proposed direct-
to-consumer television advertisements prior to public
dissemination and, to the extent the Secretary has additional
staff resources available under the Program that are not
necessary for the advisory review of direct-to-consumer
television advertisements, the activities necessary to review
and provide advisory comments on other proposed
advertisements and promotional material prior to public
dissemination.
``(6) The term `Program' means the Program to assess,
collect, and use fees for the advisory review of prescription
drug advertising established by this section.
``(7) The term `resources allocated for the process for the
advisory review of prescription drug advertising' means the
expenses incurred in connection with the process for the
advisory review of prescription drug advertising for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to
such officers, employees, and committees, and to contracts
with such contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies;
``(D) collection of fees under this section and accounting
for resources allocated for the advisory review of
prescription drug advertising; and
``(E) terminating the Program under subsection (f)(2), if
necessary.
``(8) The term `resubmission' means a subsequent submission
for advisory review of a direct-to-consumer television
advertisement that has been revised in response to the
Secretary's comments on an original submission. A
resubmission may not introduce significant new concepts or
creative themes into the television advertisement.
``(9) The term `submission for advisory review' means an
original submission of a direct-to-consumer television
advertisement for which the sponsor voluntarily requests
advisory comments before the advertisement is publicly
disseminated.
``SEC. 736B. SUNSET.
``This part shall cease to be effective on October 1, 2012,
except that subsection (b) of section 736 with respect to
reports shall cease to be effective on January 31, 2013.''.
SEC. 105. SAVINGS CLAUSE.
Notwithstanding section 509 of the Prescription Drug User
Fee Amendments of 2002 (21 U.S.C. 379g note), and
notwithstanding the amendments made by this title, part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of
enactment of this title, shall continue to be in effect with
respect to human drug applications and supplements (as
defined in such part as of such day) that on or after October
1, 2002, but before October 1, 2007, were accepted by the
Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2008.
SEC. 106. TECHNICAL AMENDMENT.
Section 739 (21 U.S.C. 379j-11) is amended in the matter
preceding paragraph (1), by striking ``subchapter'' and
inserting ``part''.
SEC. 107. EFFECTIVE DATES.
(a) In General.--Except as provided in subsection (b), the
amendments made by this title shall take effect October 1,
2007.
(b) Exception.--The amendment made by section 104 of this
title shall take effect on the date of enactment of this
title.
TITLE II--DRUG SAFETY
SEC. 200. SHORT TITLE.
This title may be cited as the ``Enhancing Drug Safety and
Innovation Act of 2007''.
Subtitle A--Risk Evaluation and Mitigation Strategies
SEC. 201. ROUTINE ACTIVE SURVEILLANCE AND ASSESSMENT.
(a) In General.--Subsection (k) of section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is
amended by adding at the end the following:
``(3) Routine active surveillance and assessment.--
``(A) Development of the postmarket risk identification and
analysis system.--The Secretary shall, not later than 2 years
after the date of enactment of the Enhancing Drug Safety and
Innovation Act of 2007, act
[[Page S5337]]
in collaboration with academic institutions and private
entities to--
``(i) establish minimum standards for collection and
transmission of postmarketing data elements from electronic
health data systems; and
``(ii) establish, through partnerships, a validated and
integrated postmarket risk identification and analysis system
to integrate and analyze safety data from multiple sources,
with the goals of including, in aggregate--
``(I) at least 25,000,000 patients by July 1, 2010; and
``(II) at least 100,000,000 patients by July 1, 2012.
``(B) Data collection activities.--
``(i) In general.--The Secretary shall, not later than 1
year after the establishment of the minimum standards and the
identification and analysis system under subparagraph (A),
establish and maintain an active surveillance
infrastructure--
``(I) to collect and report data for pharmaceutical
postmarket risk identification and analysis, in compliance
with the regulations promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of 1996;
and
``(II) that includes, in addition to the collection and
monitoring (in a standardized form) of data on all serious
adverse drug experiences (as defined in subsection (o)(2)(C))
required to be submitted to the Secretary under paragraph
(1), and those events voluntarily submitted from patients,
providers, and drug, when appropriate, procedures to--
``(aa) provide for adverse event surveillance by collecting
and monitoring Federal health-related electronic data (such
as data from the Medicare program and the health systems of
the Department of Veterans Affairs);
``(bb) provide for adverse event surveillance by collecting
and monitoring private sector health-related electronic data
(such as pharmaceutical purchase data and health insurance
claims data);
``(cc) provide for adverse event surveillance by monitoring
standardized electronic health records, as available;
``(dd) provide for adverse event surveillance by collecting
and monitoring other information as the Secretary deems
necessary to create a robust system to identify adverse
events and potential drug safety signals;
``(ee) enable the program to identify certain trends and
patterns with respect to data reported to the program;
``(ff) enable the program to provide regular reports to the
Secretary concerning adverse event trends, adverse event
patterns, incidence and prevalence of adverse events,
laboratory data, and other information determined
appropriate, which may include data on comparative national
adverse event trends; and
``(gg) enable the program to export data in a form
appropriate for further aggregation, statistical analysis,
and reporting.
``(ii) Timeliness of reporting.--The procedures developed
under clause (i) shall ensure that such data are collected,
monitored, and reported in a timely, routine, and automatic
manner, taking into consideration the need for data
completeness, coding, cleansing, and transmission.
``(iii) Private sector resources.--To ensure the
establishment of the active surveillance infrastructure by
the date described under clause (i), the Secretary may, on a
temporary or permanent basis, implement systems or products
developed by private entities.
``(iv) Complementary approaches.--To the extent the active
surveillance infrastructure established under clause (i) is
not sufficient to gather data and information relevant to
priority drug safety questions, the Secretary shall develop,
support, and participate in complementary approaches to
gather and analyze such data and information, including--
``(I) approaches that are complementary with respect to
assessing the safety of use of a drug in domestic populations
not included in the trials used to approve the drug (such as
older people, people with comorbidities, pregnant women, or
children); and
``(II) existing approaches such as the Vaccine Adverse
Event Reporting System and the Vaccine Safety Datalink or
successor databases.
``(v) Authority for contracts.--The Secretary may enter
into contracts with public and private entities to fulfill
the requirements of this subparagraph.
``(C) Risk identification and analysis.--
``(i) Purpose.--To carry out this paragraph, the Secretary
shall establish collaborations with other Government,
academic, and private entities, including the Centers for
Education and Research on Therapeutics under section 912 of
the Public Health Service Act, to provide for the risk
identification and analysis of the data collected under
subparagraph (B) and data that is publicly available or is
provided by the Secretary, in order to--
``(I) improve the quality and efficiency of postmarket drug
safety risk-benefit analysis;
``(II) provide the Secretary with routine access to
expertise to study advanced drug safety data; and
``(III) enhance the ability of the Secretary to make timely
assessments based on drug safety data.
``(ii) Public process for priority questions.--At least
biannually, the Secretary shall seek recommendations from the
Drug Safety and Risk Management Advisory Committee (or
successor committee) and from other advisory committees, as
appropriate, to the Food and Drug Administration on--
``(I) priority drug safety questions; and
``(II) mechanisms for answering such questions, including
through--
``(aa) routine active surveillance under subparagraph (B);
and
``(bb) when such surveillance is not sufficient, postmarket
studies under subsection (o)(4)(B) and postapproval clinical
trials under subsection (o)(4)(C).
``(iii) Procedures for the development of drug safety
collaborations.--
``(I) In general.--Not later than 180 days after the date
of the establishment of the active surveillance
infrastructure under subparagraph (B), the Secretary shall
establish and implement procedures under which the Secretary
may routinely collaborate with a qualified entity to--
``(aa) clean, classify, or aggregate data collected under
subparagraph (B) and data that is publicly available or is
provided by the Secretary;
``(bb) allow for prompt investigation of priority drug
safety questions, including--
``(AA) unresolved safety questions for drugs or classes of
drugs; and
``(BB) for a newly-approved drug: safety signals from
clinical trials used to approve the drug and other
preapproval trials; rare, serious drug side effects; and the
safety of use in domestic populations not included in the
trials used to approve the drug (such as older people, people
with comorbidities, pregnant women, or children);
``(cc) perform advanced research and analysis on identified
drug safety risks;
``(dd) convene an expert advisory committee to oversee the
establishment of standards for the ethical and scientific
uses for, and communication of, postmarketing data collected
under subparagraph (B), including advising on the development
of effective research methods for the study of drug safety
questions;
``(ee) focus postmarket studies under subsection (o)(4)(B)
and postapproval clinical trials under subsection (o)(4)(C)
more effectively on cases for which reports under paragraph
(1) and other safety signal detection is not sufficient to
resolve whether there is an elevated risk of a serious
adverse event associated with the use of a drug; and
``(ff) carry out other activities as the Secretary deems
necessary to carry out the purposes of this paragraph.
``(II) Request for specific methodology.--The procedures
described in subclause (I) shall permit the Secretary to
request that a specific methodology be used by the qualified
entity. The qualified entity shall work with the Secretary to
finalize the methodology to be used.
``(iv) Use of analyses.--The Secretary shall provide the
analyses described under this subparagraph, including the
methods and results of such analyses, about a drug to the
sponsor or sponsors of such drug.
``(v) Qualified entities.--
``(I) In general.--The Secretary shall enter into contracts
with a sufficient number of qualified entities to develop and
provide information to the Secretary in a timely manner.
``(II) Qualification.--The Secretary shall enter into a
contract with an entity under subclause (I) only if the
Secretary determines that the entity--
``(aa) has the research capability and expertise to conduct
and complete the activities under this paragraph;
``(bb) has in place an information technology
infrastructure to support adverse event surveillance data and
operational standards to provide security for such data;
``(cc) has experience with, and expertise on, the
development of drug safety and effectiveness research using
electronic population data;
``(dd) has an understanding of drug development and risk/
benefit balancing in a clinical setting; and
``(ee) has a significant business presence in the United
States.
``(vi) Contract requirements.--Each contract with a
qualified entity shall contain the following requirements:
``(I) Ensuring privacy.--The qualified entity shall provide
assurances that the entity will not use the data provided by
the Secretary in a manner that violates--
``(aa) the regulations promulgated under section 264(c) of
the Health Insurance Portability and Accountability Act of
1996; or
``(bb) sections 552 or 552a of title 5, United States Code,
with regard to the privacy of individually-identifiable
beneficiary health information.
``(II) Component of another organization.--If a qualified
entity is a component of another organization--
``(aa) the qualified entity shall maintain the data related
to the activities carried out under this paragraph separate
from the other components of the organization and establish
appropriate security measures to maintain the confidentiality
and privacy of such data; and
``(bb) the entity shall not make an unauthorized disclosure
of such data to the other components of the organization in
breach of such confidentiality and privacy requirement.
``(III) Termination or nonrenewal.--If a contract with a
qualified entity under this subparagraph is terminated or not
renewed, the following requirements shall apply:
[[Page S5338]]
``(aa) Confidentiality and privacy protections.--The entity
shall continue to comply with the confidentiality and privacy
requirements under this paragraph with respect to all data
disclosed to the entity.
``(bb) Disposition of data.--The entity shall return to the
Secretary all data disclosed to the entity or, if returning
the data is not practicable, destroy the data.
``(vii) Competitive procedures.--The Secretary shall use
competitive procedures (as defined in section 4(5) of the
Federal Procurement Policy Act) to enter into contracts under
clause (v).
``(viii) Review of contract in the even of a merger or
acquisition.--The Secretary shall review the contract with a
qualified entity under this paragraph in the event of a
merger or acquisition of the entity in order to ensure that
the requirements under this subparagraph will continue to be
met.
``(D) Coordination.--In carrying out this paragraph, the
Secretary shall provide for appropriate communications to the
public, scientific, public health, and medical communities,
and other key stakeholders, and provide for the coordination
of the activities of private entities, professional
associations, or other entities that may have sources of
surveillance data.''.
(b) Authorization of Appropriations.--To carry out
activities under the amendment made by this section for which
funds are made available under section 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h), there are
authorized to be appropriated to carry out the amendment made
by this section, in addition to such funds, $25,000,000 for
each of fiscal years 2008 through 2012.
SEC. 202. RISK EVALUATION AND MITIGATION STRATEGIES.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) is amended by adding at the end the following:
``(o) Risk Evaluation and Mitigation Strategy.--
``(1) In general.--In the case of any drug subject to
subsection (b) or to section 351 of the Public Health Service
Act for which a risk evaluation and mitigation strategy is
approved as provided for in this subsection, the applicant
shall comply with the requirements of such strategy.
``(2) Definitions.--In this subsection:
``(A) Adverse drug experience.--The term `adverse drug
experience' means any adverse event associated with the use
of a drug in humans, whether or not considered drug related,
including--
``(i) an adverse event occurring in the course of the use
of the drug in professional practice;
``(ii) an adverse event occurring from an overdose of the
drug, whether accidental or intentional;
``(iii) an adverse event occurring from abuse of the drug;
``(iv) an adverse event occurring from withdrawal of the
drug; and
``(v) any failure of expected pharmacological action of the
drug.
``(B) New safety information.--The term `new safety
information' with respect to a drug means information about--
``(i) a serious risk or an unexpected serious risk with use
of the drug that the Secretary has become aware of since the
later of--
``(I) the date of initial approval of the drug under this
section or initial licensure of the drug under section 351 of
the Public Health Service Act; or
``(II) if applicable, the last assessment of the approved
risk evaluation and mitigation strategy for the drug; or
``(ii) the effectiveness of the approved risk evaluation
and mitigation strategy for the drug obtained since the later
of--
``(I) the approval of such strategy; or
``(II) the last assessment of such strategy.
``(C) Serious adverse drug experience.--The term `serious
adverse drug experience' is an adverse drug experience that--
``(i) results in--
``(I) death;
``(II) the placement of the patient at immediate risk of
death from the adverse drug experience as it occurred (not
including an adverse drug experience that might have caused
death had it occurred in a more severe form);
``(III) inpatient hospitalization or prolongation of
existing hospitalization;
``(IV) a persistent or significant incapacity or
substantial disruption of the ability to conduct normal life
functions; or
``(V) a congenital anomaly or birth defect; or
``(ii) based on appropriate medical judgment, may
jeopardize the patient and may require a medical or surgical
intervention to prevent an outcome described under clause
(i).
``(D) Serious risk.--The term `serious risk' means a risk
of a serious adverse drug experience.
``(E) Signal of a serious risk.--The term `signal of a
serious risk' means information related to a serious adverse
drug experience derived from--
``(i) a clinical trial;
``(ii) adverse event reports under subsection (k)(1);
``(iii) routine active surveillance under subsection
(k)(3);
``(iv) a postapproval study, including a study under
paragraph (4)(B); or
``(v) peer-reviewed biomedical literature.
``(F) Unexpected serious risk.--The term `unexpected
serious risk' means a serious adverse drug experience that--
``(i) is not listed in the labeling of a drug; or
``(ii) is symptomatically and pathophysiologically related
to an adverse drug experience listed in the labeling of the
drug, but differs from such adverse drug experience because
of greater severity, specificity, or prevalence.
``(3) Required elements of a risk evaluation and mitigation
strategy.--If a risk evaluation and mitigation strategy for a
drug is required, such strategy shall include--
``(A) the labeling for the drug for use by health care
providers as approved under subsection (c);
``(B) a timetable for submission of assessments of the
strategy, that--
``(i) for a drug no active ingredient (including any ester
or salt of the active ingredient) of which has been approved
in any other application under this section or section 351 of
the Public Health Service Act--
``(I) shall be no less frequently than 18 months and 3
years after the drug is initially approved and at a frequency
specified in the strategy for subsequent years; and
``(II) may be eliminated after the first 3 years if the
Secretary determines that serious risks of the drug have been
adequately identified and assessed and are being adequately
managed;
``(ii) for a drug other than a drug described under clause
(i), shall occur at a frequency determined by the Secretary;
and
``(iii) may be increased or reduced in frequency as
necessary as provided for in paragraph (7)(B)(v)(VI).
``(4) Additional potential evaluation elements of a risk
evaluation and mitigation strategy.--
``(A) Risk evaluation.--If a risk evaluation and mitigation
strategy for a drug is required, such strategy may include 1
or more of the additional evaluation elements described in
this paragraph, so long as the Secretary makes the
determination required with respect to each additional
included element.
``(B) Postapproval studies.--If the Secretary determines
that the reports under subsection (k)(1) and routine active
surveillance as available under subsection (k)(3) (including
available complementary approaches under subsection
(k)(3)(B)(iv)) will not be sufficient to--
``(i) assess a signal of a serious risk with use of a drug;
or
``(ii) identify, based on a review of a demonstrated
pattern of use of the drug, unexpected serious risks in a
domestic population, including older people, people with
comorbidities, pregnant women, or children,
the risk evaluation and mitigation strategy for the drug may
require that the applicant conduct an appropriate
postapproval study, such as a prospective or retrospective
observational study, of the drug (which shall include a
timeframe specified by the Secretary for completing the study
and reporting the results to the Secretary).
``(C) Postapproval clinical trials.--If the Secretary
determines that the reports under subsection (k)(1), routine
active surveillance as available under subsection (k)(3)
(including available complementary approaches under
subsection (k)(3)(B)(iv)), and a study or studies under
subparagraph (B) will likely be inadequate to assess a signal
of a serious risk with use of a drug, and there is no
effective approved application for the drug under subsection
(j) as of the date that the requirement is first imposed, the
risk evaluation and mitigation strategy for the drug may
require that the applicant conduct an appropriate
postapproval clinical trial of the drug (which shall include
a timeframe specified by the Secretary for completing the
clinical trial and reporting the results to the Secretary) to
be included in the clinical trial registry data bank provided
for under subsections (i) and (j) of section 402 of the
Public Health Service Act.
``(5) Additional potential communication elements of a risk
evaluation and mitigation strategy.--
``(A) Risk communication.--If a risk evaluation and
mitigation strategy for a drug is required, such strategy may
include 1 or more of the additional communication elements
described in this paragraph, so long as the Secretary makes
the determination required with respect to each additional
included element.
``(B) Medguide; patient package insert.--The risk
evaluation and mitigation strategy for a drug may require
that the applicant develop for distribution to each patient
when the drug is dispensed either or both of the following:
``(i) A Medication Guide, as provided for under part 208 of
title 21, Code of Federal Regulations (or any successor
regulations).
``(ii) A patient package insert, if the Secretary
determines that such insert may help mitigate a serious risk
listed in the labeling of the drug.
``(C) Communication plan.--If the Secretary determines that
a communication plan to health care providers may support
implementation of an element of the risk evaluation and
mitigation strategy for a drug, such as a labeling change,
the strategy may require that the applicant conduct such a
plan, which may include--
``(i) sending letters to health care providers;
``(ii) disseminating information about the elements of the
strategy to encourage implementation by health care providers
of components that apply to such health care providers, or to
explain certain safety protocols
[[Page S5339]]
(such as medical monitoring by periodic laboratory tests); or
``(iii) disseminating information to health care providers
through professional societies about any serious risks of the
drug and any protocol to assure safe use.
``(D) Prereview.--
``(i) In general.--If the Secretary determines that
prereview of advertisements is necessary to ensure the
inclusion of a true statement in such advertisements of
information in brief summary relating to a serious risk
listed in the labeling of a drug, or relating to a protocol
to ensure the safe use described in the labeling of the drug,
the risk evaluation and mitigation strategy for the drug may
require that the applicant submit to the Secretary
advertisements of the drug for prereview not later than 45
days before dissemination of the advertisement
``(ii) Specification of advertisements.--The Secretary may
specify the advertisements required to be submitted under
clause (i).
``(E) Specific disclosures.--
``(i) Serious risk; safety protocol.--If the Secretary
determines that advertisements lacking a specific disclosure
about a serious risk listed in the labeling of a drug or
about a protocol to ensure safe use described in the labeling
of the drug would be false or misleading, the risk evaluation
and mitigation strategy for the drug may require that the
applicant include in advertisements of the drug such
disclosure.
``(ii) Date of approval.--If the Secretary determines that
advertisements lacking a specific disclosure of the date a
drug was approved and notification that the existing
information may not have identified or allowed for full
assessment of all serious risks of using the drug would be
false or misleading, the risk evaluation and mitigation
strategy for the drug may require that the applicant include
in advertisements of the drug such disclosure
``(iii) Specification of advertisements.--The Secretary may
specify the advertisements required to include a specific
disclosure under clause (i) or (ii).
``(F) Temporary moratorium.--
``(i) In general.--To the extent consistent with the
Constitution, the risk evaluation and mitigation strategy for
a drug may require that the applicant not issue or cause to
be issued direct-to-consumer advertisements of the drug for a
fixed period after initial approval of the drug, not to
exceed 2 years.
``(ii) Conditions.--The Secretary may require the strategy
for a drug to include such a temporary moratorium on direct-
to-consumer advertising only if the Secretary determines
that--
``(I) direct-to-consumer advertisements of the drug would
be inherently misleading even if the disclosure under
subparagraph (E)(ii) were required; and
``(II) other elements under this subsection would not be
sufficient to mitigate the concern that clinical trials used
to approve the drug may not have identified serious risks
that might occur among patients expected to be treated with
the drug.
``(iii) Considerations.--Before making such determinations,
the Secretary shall consider--
``(I) the number of patients who may be treated with the
drug;
``(II) the seriousness of the condition for which the drug
will be used; and
``(III) the serious risks listed in the labeling of the
drug.
``(iv) Required safety monitoring.--If the approved risk
evaluation and mitigation strategy for a drug includes a
temporary moratorium on direct-to-consumer advertisements of
the drug under this subparagraph, the Secretary shall--
``(I) consider the concern identified under clause (ii)(II)
with respect to such drug to be a priority drug safety
question under subsection (k)(3)(B);
``(II) no less frequently than every 3 months, evaluate the
reports under subsection (k)(1) and the routine active
surveillance as available under subsection (k)(3) with
respect to such concern to determine whether serious risks
that might occur among patients expected to be treated with
the drug have been adequately identified; and
``(III) if such serious risks have been adequately
identified, remove such temporary moratorium as an element of
such strategy.
``(6) Providing safe access for patients to drugs with
known serious risks that would otherwise be unavailable.--
``(A) Allowing safe access to drugs with known serious
risks.--The Secretary may require that the risk evaluation
and mitigation strategy for a drug include such elements as
are necessary to assure safe use of the drug, because of its
inherent toxicity or potential harmfulness, if the Secretary
determines that--
``(i) the drug, which has been shown to be effective, but
is associated with a serious adverse drug experience, can be
approved only if, or would be withdrawn unless, such elements
are required as part of such strategy to mitigate a specific
serious risk listed in the labeling of the drug; and
``(ii) for a drug initially approved without elements to
assure safe use, other elements under paragraphs (3), (4),
and (5) are not sufficient to mitigate such serious risk.
``(B) Assuring access and minimizing burden.--Such elements
to assure safe use under subparagraph (A) shall--
``(i) be commensurate with the specific serious risk listed
in the labeling of the drug;
``(ii) within 30 days of the date on which any element
under subparagraph (A) is imposed, be posted publicly by the
Secretary with an explanation of how such elements will
mitigate the observed safety risk;
``(iii) considering such risk, not be unduly burdensome on
patient access to the drug, considering in particular--
``(I) patients with serious or life-threatening diseases or
conditions; and
``(II) patients who have difficulty accessing health care
(such as patients in rural or medically underserved areas);
and
``(iv) to the extent practicable, so as to minimize the
burden on the health care delivery system--
``(I) conform with elements to assure safe use for other
drugs with similar, serious risks; and
``(II) be designed to be compatible with established
distribution, procurement, and dispensing systems for drugs.
``(C) Elements to assure safe use.--The elements to assure
safe use under subparagraph (A) shall include 1 or more goals
to mitigate a specific serious risk listed in the labeling of
the drug and, to mitigate such risk, may require that--
``(i) health care providers that prescribe the drug have
particular training or experience, or are specially certified
(which training or certification shall be available to any
willing provider from a frontier area);
``(ii) pharmacies, practitioners, or health care settings
that dispense the drug are specially certified (which
certification shall be available to any willing provider from
a frontier area);
``(iii) the drug be dispensed to patients only in certain
health care settings, such as hospitals;
``(iv) the drug be dispensed to patients with evidence or
other documentation of safe-use conditions, such as
laboratory test results;
``(v) each patient using the drug be subject to certain
monitoring; or
``(vi) each patient using the drug be enrolled in a
registry.
``(D) Implementation system.--The elements to assure safe
use under subparagraph (A) that are described in clauses
(ii), (iii), or (iv) of subparagraph (C) may include a system
through which the applicant is able to take reasonable steps
to--
``(i) monitor and evaluate implementation of such elements
by health care providers, pharmacists, and other parties in
the health care system who are responsible for implementing
such elements; and
``(ii) work to improve implementation of such elements by
such persons.
``(E) Evaluation of elements to assure safe use.--The
Secretary, through the Drug Safety and Risk Management
Advisory Committee (or successor committee) of the Food and
Drug Administration, shall--
``(i) seek input from patients, physicians, pharmacists,
and other health care providers about how elements to assure
safe use under this paragraph for 1 or more drugs may be
standardized so as not to be--
``(I) unduly burdensome on patient access to the drug; and
``(II) to the extent practicable, minimize the burden on
the health care delivery system;
``(ii) at least annually, evaluate, for 1 or more drugs,
the elements to assure safe use of such drug to assess
whether the elements--
``(I) assure safe use of the drug;
``(II) are not unduly burdensome on patient access to the
drug; and
``(III) to the extent practicable, minimize the burden on
the health care delivery system; and
``(iii) considering such input and evaluations--
``(I) issue or modify agency guidance about how to
implement the requirements of this paragraph; and
``(II) modify elements under this paragraph for 1 or more
drugs as appropriate.
``(F) Additional mechanisms to assure access.--The
mechanisms under section 561 to provide for expanded access
for patients with serious or life-threatening diseases or
conditions may be used to provide access for patients with a
serious or life-threatening disease or condition, the
treatment of which is not an approved use for the drug, to a
drug that is subject to elements to assure safe use under
this paragraph.
``(G) Waiver in public health emergencies.--The Secretary
may waive any requirement of this paragraph during the period
described in section 319(a) of the Public Health Service Act
with respect to a qualified countermeasure described under
section 319F-1(a)(2) of such Act, to which a requirement
under this paragraph has been applied, if the Secretary has--
``(i) declared a public health emergency under such section
319; and
``(ii) determined that such waiver is required to mitigate
the effects of, or reduce the severity of, such public health
emergency.
``(7) Submission and review of risk evaluation and
mitigation strategy.--
``(A) Proposed risk evaluation and mitigation strategy.--
``(i) Voluntary proposal.--If there is a signal of a
serious risk with a drug, an applicant may include a proposed
risk evaluation and mitigation strategy for the drug in an
application, including in a supplemental application, for the
drug under subsection (b) or section 351 of the Public Health
Service Act.
``(ii) Required proposal.--
[[Page S5340]]
``(I) Determination necessary to require a proposal.--
``(aa) In general.--The Secretary may require that the
applicant for a drug submit a proposed risk evaluation and
mitigation strategy for a drug if the Secretary (acting
through the office responsible for reviewing the drug and the
office responsible for postapproval safety with respect to
the drug) determines that, based on a signal of a serious
risk with the drug, a risk evaluation and mitigation strategy
is necessary to assess such signal or mitigate such serious
risk.
``(bb) Non-delegation.--A determination under item (aa) for
a drug shall be made by individuals at or above the level of
individuals empowered to approve a drug (such as division
directors within the Center for Drug Evaluation and
Research).
``(II) Circumstances in which a proposal may be required.--
The applicant shall submit a proposed risk evaluation and
mitigation strategy for a drug--
``(aa) in response to a letter from the Secretary (acting
through the office responsible for reviewing the drug and the
office responsible for postapproval safety with respect to
the drug) sent regarding an application, including a
supplemental application, for the drug, if the Secretary
determines that data or information in the application
indicates that an element under paragraph (4), (5), or (6)
should be included in a strategy for the drug;
``(bb) within a timeframe specified by the Secretary, not
to be less than 45 days, when ordered by the Secretary
(acting through such offices), if the Secretary determines
that new safety information indicates that--
``(AA) the labeling of the drug should be changed; or
``(BB) an element under paragraph (4) or (5) should be
included in a strategy for the drug; or
``(cc) within 90 days when ordered by the Secretary (acting
through such offices), if the Secretary determines that new
safety information indicates that an element under paragraph
(6) should be included in a strategy for the drug.
``(iii) Content of letter.--A letter under clause
(ii)(II)(aa) shall describe--
``(I) the data or information in the application that
warrants the proposal of a risk evaluation and mitigation
strategy for the drug; and
``(II) what elements under paragraphs (4), (5), or (6)
should be included in a strategy for the drug.
``(iv) Content of order.--An order under item (aa) or (bb)
of clause (ii)(II) shall describe--
``(I) the new safety information with respect to the drug
that warrants the proposal of a risk evaluation and
mitigation strategy for the drug; and
``(II) whether and how the labeling of the drug should be
changed and what elements under paragraphs (4), (5), or (6)
should be included in a strategy for the drug.
``(v) Content of proposal.--A proposed risk evaluation and
mitigation strategy--
``(I) shall include a timetable as described under
paragraph (3)(B); and
``(II) may also include additional elements as provided for
under paragraphs (4), (5), and (6).
``(B) Assessment and modification of a risk evaluation and
mitigation strategy.--
``(i) Voluntary assessments.--If a risk evaluation and
mitigation strategy for a drug is required, the applicant may
submit to the Secretary an assessment of, and propose a
modification to, such approved strategy for the drug at any
time.
``(ii) Required assessments.--If a risk evaluation and
mitigation strategy for a drug is required, the applicant
shall submit an assessment of, and may propose a modification
to, such approved strategy for the drug--
``(I) when submitting an application, including a
supplemental application, for a new indication under
subsection (b) or section 351 of the Public Health Service
Act;
``(II) when required by the strategy, as provided for in
the timetable under paragraph (3)(B);
``(III) within a timeframe specified by the Secretary, not
to be less than 45 days, when ordered by the Secretary
(acting through the offices described in subparagraph
(A)(ii)(I)), if the Secretary determines that new safety
information indicates that an element under paragraph (3) or
(4) should be modified or added to the strategy;
``(IV) within 90 days when ordered by the Secretary (acting
through such offices), if the Secretary determines that new
safety information indicates that an element under paragraph
(6) should be modified or added to the strategy; or
``(V) within 15 days when ordered by the Secretary (acting
through such offices), if the Secretary determines that there
may be a cause for action by the Secretary under subsection
(e).
``(iii) Content of order.--An order under subclauses (III),
(IV), or (V) of clause (ii) shall describe--
``(I) the new safety information with respect to the drug
that warrants an assessment of the approved risk evaluation
and mitigation strategy for the drug; and
``(II) whether and how such strategy should be modified
because of such information.
``(iv) Assessment.--An assessment of the approved risk
evaluation and mitigation strategy for a drug shall include--
``(I) a description of new safety information, if any, with
respect to the drug;
``(II) whether and how to modify such strategy because of
such information;
``(III) with respect to any postapproval study required
under paragraph (4)(B) or otherwise undertaken by the
applicant to investigate a safety issue, the status of such
study, including whether any difficulties completing the
study have been encountered;
``(IV) with respect to any postapproval clinical trial
required under paragraph (4)(C) or otherwise undertaken by
the applicant to investigate a safety issue, the status of
such clinical trial, including whether enrollment has begun,
the number of participants enrolled, the expected completion
date, whether any difficulties completing the clinical trial
have been encountered, and registration information with
respect to requirements under subsections (i) and (j) of
section 402 of the Public Health Service Act; and
``(V) with respect to any goal under paragraph (6) and
considering input and evaluations, if applicable, under
paragraph (6)(E), an assessment of how well the elements to
assure safe use are meeting the goal of increasing safe
access to drugs with known serious risks or whether the goal
or such elements should be modified.
``(v) Modification.--A modification (whether an enhancement
or a reduction) to the approved risk evaluation and
mitigation strategy for a drug may include the addition or
modification of any element under subparagraph (A) or (B) of
paragraph (3) or the addition, modification, or removal of
any element under paragraph (4), (5), or (6), such as--
``(I) a labeling change, including the addition of a boxed
warning;
``(II) adding a postapproval study or clinical trial
requirement;
``(III) modifying a postapproval study or clinical trial
requirement (such as a change in trial design due to
legitimate difficulties recruiting participants);
``(IV) adding, modifying, or removing an element on
advertising under subparagraph (D), (E), or (F) of paragraph
(5);
``(V) adding, modifying, or removing an element to assure
safe use under paragraph (6); or
``(VI) modifying the timetable for assessments of the
strategy under paragraph (3)(B), including to eliminate
assessments.
``(C) Review.--The Secretary (acting through the offices
described in subparagraph (A)(ii)(I)) shall promptly review
the proposed risk evaluation and mitigation strategy for a
drug submitted under subparagraph (A), or an assessment of
the approved risk evaluation and mitigation strategy for a
drug submitted under subparagraph (B).
``(D) Discussion.--The Secretary (acting through the
offices described in subparagraph (A)(ii)(I)) shall initiate
discussions of the proposed risk evaluation and mitigation
strategy for a drug submitted under subparagraph (A), or of
an assessment of the approved risk evaluation and mitigation
strategy for a drug submitted under subparagraph (B), with
the applicant to determine a strategy--
``(i) if the proposed strategy or assessment is submitted
as part of an application (including a supplemental
application) under subparagraph (A)(i), (A)(ii)(II)(aa), or
(B)(ii)(I), by the target date for communication of feedback
from the review team to the applicant regarding proposed
labeling and postmarketing study commitments, as set forth in
the letters described in section 735(a);
``(ii) if the proposed strategy is submitted under
subparagraph (A)(ii)(II)(bb) or the assessment is submitted
under subclause (II) or (III) of subparagraph (B)(ii), not
later than 20 days after such submission;
``(iii) if the proposed strategy is submitted under
subparagraph (A)(ii)(II)(cc) or the assessment is submitted
under subparagraph (B)(i) or under subparagraph (B)(ii)(IV),
not later than 30 days after such submission; or
``(iv) if the assessment is submitted under subparagraph
(B)(ii)(V), not later than 10 days after such submission.
``(E) Action.--
``(i) In general.--Unless the applicant requests the
dispute resolution process as described under subparagraph
(F) or (G), the Secretary (acting through the offices
described in subparagraph (A)(ii)(I)) shall approve and
include the risk evaluation and mitigation strategy for a
drug, or any modification to the strategy (including a
timeframe for implementing such modification), with--
``(I) the action letter on the application, if a proposed
strategy is submitted under subparagraph (A)(i) or
(A)(ii)(II)(aa) or an assessment of the strategy is submitted
under subparagraph (B)(ii)(I); or
``(II) an order, which shall be made public, issued not
later than 50 days after the date discussions of such
proposed strategy or modification begin under subparagraph
(D), if a proposed strategy is submitted under item (bb) or
(cc) of subparagraph (A)(ii)(II) or an assessment of the
strategy is submitted under subparagraph (B)(i) or under
subclause (II), (III), (IV), or (V) of subparagraph (B)(ii).
``(ii) Inaction.--An approved risk evaluation and
mitigation strategy shall remain in effect until the
Secretary acts, if the Secretary fails to act as provided
under clause (i).
``(F) Dispute resolution at initial approval.--If a
proposed risk evaluation and mitigation strategy is submitted
under subparagraph (A)(i) or (A)(ii)(II)(aa) in an
application for initial approval of a drug and
[[Page S5341]]
there is a dispute about the strategy, the applicant shall
use the major dispute resolution procedures as set forth in
the letters described in section 735(a).
``(G) Dispute resolution in all other cases.--
``(i) Request for review.--In any case other than a
submission under subparagraph (A)(i) or (A)(ii)(II)(aa) in an
application for initial approval of a drug if there is a
dispute about the strategy, not earlier than 15 days, and not
later than 35 days, after discussions under subparagraph (D)
have begun, the applicant shall request in writing that the
dispute be reviewed by the Drug Safety Oversight Board.
``(ii) Scheduling review.--If the applicant requests review
under clause (i), the Secretary--
``(I)(aa) shall schedule the dispute for review at 1 of the
next 2 regular meetings of the Drug Safety Oversight Board,
whichever meeting date is more practicable; or
``(bb) may convene a special meeting of the Drug Safety
Oversight Board to review the matter more promptly, including
to meet an action deadline on an application (including a
supplemental application);
``(II) shall give advance notice to the public through the
Federal Register and on the Internet website of the Food and
Drug Administration--
``(aa) that the drug is to be discussed by the Drug Safety
Oversight Board; and
``(bb) of the date on which the Drug Safety Oversight Board
shall discuss such drug; and
``(III) shall apply section 301(j), section 552 of title 5,
and section 1905 of title 18, United States Code, to any
request for information about such review.
``(iii) Agreement after discussion or administrative
appeals.--
``(I) Further discussion or administrative appeals.--A
request for review under clause (i) shall not preclude--
``(aa) further discussions to reach agreement on the risk
evaluation and mitigation strategy; or
``(bb) the use of administrative appeals within the Food
and Drug Administration to reach agreement on the strategy,
including the major dispute resolution procedures as set
forth in the letters described in section 735(a).
``(II) Agreement terminates dispute resolution.--At any
time before a decision and order is issued under clause (vi),
the Secretary (acting through the offices described in
subparagraph (A)(ii)(I)) and the applicant may reach an
agreement on the risk evaluation and mitigation strategy
through further discussion or administrative appeals,
terminating the dispute resolution process, and the Secretary
shall issue an action letter or order, as appropriate, that
describes the strategy.
``(iv) Meeting of the board.--At the meeting of the Drug
Safety Oversight Board described in clause (ii), the Board
shall--
``(I) hear from both parties; and
``(II) review the dispute.
``(v) Recommendation of the board.--Not later than 5 days
after such meeting of the Drug Safety Oversight Board, the
Board shall provide a written recommendation on resolving the
dispute to the Secretary.
``(vi) Action by the secretary.--
``(I) Action letter.--With respect to a proposed risk
evaluation and mitigation strategy submitted under
subparagraph (A)(i) or (A)(ii)(II)(aa) or to an assessment of
the strategy submitted under subparagraph (B)(ii)(I), the
Secretary shall issue an action letter that resolves the
dispute not later than the later of--
``(aa) the action deadline for the action letter on the
application; or
``(bb) 7 days after receiving the recommendation of the
Drug Safety Oversight Board.
``(II) Order.--With respect to a proposed risk evaluation
and mitigation strategy submitted under item (bb) or (cc) of
subparagraph (A)(ii)(II) or an assessment of the risk
evaluation and mitigation strategy under subparagraph (B)(i)
or under subclause (II), (III), (IV), or (V) of subparagraph
(B)(ii), the Secretary shall issue an order, which (with the
recommendation of the Drug Safety Oversight Board) shall be
made public, that resolves the dispute not later than 7 days
after receiving the recommendation of the Drug Safety
Oversight Board.
``(vii) Inaction.--An approved risk evaluation and
mitigation strategy shall remain in effect until the
Secretary acts, if the Secretary fails to act as provided for
under clause (vi).
``(viii) Effect on action deadline.--With respect to the
application or supplemental application in which a proposed
risk evaluation and mitigation strategy is submitted under
subparagraph (A)(i) or (A)(ii)(II)(aa) or in which an
assessment of the strategy is submitted under subparagraph
(B)(ii)(I), the Secretary shall be considered to have met the
action deadline for the action letter on such application if
the applicant requests the dispute resolution process
described in this subparagraph and if the Secretary--
``(I) has initiated the discussions described under
subparagraph (D) by the target date referred to in
subparagraph (D)(i); and
``(II) has complied with the timing requirements of
scheduling review by the Drug Safety Oversight Board,
providing a written recommendation, and issuing an action
letter under clauses (ii), (v), and (vi), respectively.
``(ix) Disqualification.--No individual who is an employee
of the Food and Drug Administration and who reviews a drug or
who participated in an administrative appeal under clause
(iii)(I) with respect to such drug may serve on the Drug
Safety Oversight Board at a meeting under clause (iv) to
review a dispute about the risk evaluation and mitigation
strategy for such drug.
``(x) Additional expertise.--The Drug Safety Oversight
Board may add members with relevant expertise from the Food
and Drug Administration, including the Office of Pediatrics,
the Office of Women's Health, or the Office of Rare Diseases,
or from other Federal public health or health care agencies,
for a meeting under clause (iv) of the Drug Safety Oversight
Board.
``(H) Use of advisory committees.--The Secretary (acting
through the offices described in subparagraph (A)(ii)(I)) may
convene a meeting of 1 or more advisory committees of the
Food and Drug Administration to--
``(i) review a concern about the safety of a drug or class
of drugs, including before an assessment of the risk
evaluation and mitigation strategy or strategies of such drug
or drugs is required to be submitted under subclause (II),
(III), (IV), or (V) of subparagraph (B)(ii);
``(ii) review the risk evaluation and mitigation strategy
or strategies of a drug or group of drugs; or
``(iii) with the consent of the applicant, review a dispute
under subparagraph (G).
``(I) Process for addressing drug class effects.--
``(i) In general.--When a concern about a serious risk of a
drug may be related to the pharmacological class of the drug,
the Secretary (acting through the offices described in
subparagraph (A)(ii)(I)) may defer assessments of the
approved risk evaluation and mitigation strategies for such
drugs until the Secretary has--
``(I) convened, after appropriate public notice, 1 or more
public meetings to consider possible responses to such
concern; or
``(II) gathered additional information or data about such
concern.
``(ii) Public meetings.--Such public meetings may include--
``(I) 1 or more meetings of the applicants for such drugs;
``(II) 1 or more meetings of 1 or more advisory committees
of the Food and Drug Administration, as provided for under
subparagraph (H); or
``(III) 1 or more workshops of scientific experts and other
stakeholders.
``(iii) Action.--After considering the discussions from any
meetings under clause (ii), the Secretary may--
``(I) announce in the Federal Register a planned regulatory
action, including a modification to each risk evaluation and
mitigation strategy, for drugs in the pharmacological class;
``(II) seek public comment about such action; and
``(III) after seeking such comment, issue an order
addressing such regulatory action.
``(J) International coordination.--The Secretary (acting
through the offices described in subparagraph (A)(ii)(I)) may
coordinate the timetable for submission of assessments under
paragraph (3)(B), a study under paragraph (4)(B), or a
clinical trial under paragraph (4)(C), with efforts to
identify and assess the serious risks of such drug by the
marketing authorities of other countries whose drug approval
and risk management processes the Secretary deems comparable
to the drug approval and risk management processes of the
United States.
``(K) Effect.--Use of the processes described in
subparagraphs (I) and (J) shall not delay action on an
application or a supplement to an application for a drug.
``(L) No effect on labeling changes that do not require
preapproval.--In the case of a labeling change to which
section 314.70 of title 21, Code of Federal Regulations (or
any successor regulation), applies for which the submission
of a supplemental application is not required or for which
distribution of the drug involved may commence upon the
receipt by the Secretary of a supplemental application for
the change, the submission of an assessment of the approved
risk evaluation and mitigation strategy for the drug under
this subsection is not required.
``(8) Drug safety oversight board.--
``(A) In general.--There is established a Drug Safety
Oversight Board.
``(B) Composition; meetings.--The Drug Safety Oversight
Board shall--
``(i) be composed of scientists and health care
practitioners appointed by the Secretary, each of whom is an
employee of the Federal Government;
``(ii) include representatives from offices throughout the
Food and Drug Administration (including the offices
responsible for postapproval safety of drugs);
``(iii) include at least 1 representative each from the
National Institutes of Health, the Department of Health and
Human Services (other than the Food and Drug Administration),
and the Veterans Health Administration; and
``(iv) meet at least monthly to provide oversight and
advice to the Secretary on the management of important drug
safety issues.''.
SEC. 203. ENFORCEMENT.
(a) Misbranding.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352) is amended by adding at the
end the following:
``(x) If it is a drug subject to an approved risk
evaluation and mitigation strategy
[[Page S5342]]
under section 505(o) and the applicant for such drug fails
to--
``(1) make a labeling change required by such strategy
after the Secretary has approved such strategy or completed
review of, and acted on, an assessment of such strategy under
paragraph (7) of such section; or
``(2) comply with a requirement of such strategy with
respect to advertising as provided for under subparagraph
(D), (E), or (F) of paragraph (5) of such section.''.
(b) Civil Penalties.--Section 303(f) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended--
(1) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), respectively;
(2) by inserting after paragraph (2) the following:
``(3) An applicant (as such term is used in section 505(o))
who knowingly fails to comply with a requirement of an
approved risk evaluation and mitigation strategy under such
section 505(o) shall be subject to a civil money penalty of
not less than $15,000 and not more than $250,000 per
violation, and not to exceed $1,000,000 for all such
violations adjudicated in a single proceeding.'';
(3) in paragraph (2)(C), by striking ``paragraph (3)(A)''
and inserting ``paragraph (4)(A)'';
(4) in paragraph (4), as so redesignated, by striking
``paragraph (1) or (2)'' each place it appears and inserting
``paragraph (1), (2), or (3)''; and
(5) in paragraph (6), as so redesignated, by striking
``paragraph (4)'' each place it appears and inserting
``paragraph (5)''.
SEC. 204. REGULATION OF DRUGS THAT ARE BIOLOGICAL PRODUCTS.
Section 351 of the Public Health Service Act (42 U.S.C.
262) is amended--
(1) in subsection (a)(2), by adding at the end the
following:
``(D) Risk Evaluation and Mitigation Strategy.--A person
that submits an application for a license for a drug under
this paragraph may submit to the Secretary as part of the
application a proposed risk evaluation and mitigation
strategy as described under section 505(o) of the Federal
Food, Drug, and Cosmetic Act.''; and
(2) in subsection (j), by inserting ``, including the
requirements under section 505(o) of such Act,'' after ``,
and Cosmetic Act''.
SEC. 205. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.
Section 505(e) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(e)) is amended by adding at the end the
following: ``The Secretary may withdraw the approval of an
application submitted under this section, or suspend the
approval of such an application, as provided under this
subsection, without first ordering the applicant to submit an
assessment of the approved risk evaluation and mitigation
strategy for the drug under subsection (o)(7)(B)(ii)(V).''.
SEC. 206. DRUGS SUBJECT TO AN ABBREVIATED NEW DRUG
APPLICATION.
Section 505(j)(2) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(2)) is amended by adding at the end the
following:
``(E) Risk Evaluation and Mitigation Strategy
Requirement.--
``(i) In general.--A drug that is the subject of an
abbreviated new drug application under this subsection shall
be subject to only the following elements of the approved
risk evaluation and mitigation strategy if required under
subsection (o) for the applicable listed drug:
``(I) Labeling, as required under subsection (o)(3)(A) for
the applicable listed drug.
``(II) A Medication Guide or patient package insert, if
required under subsection (o)(5)(B) for the applicable listed
drug.
``(III) Prereview of advertising, if required under
subsection (o)(5)(D) for the applicable listed drug.
``(IV) Specific disclosures in advertising, if required
under subsection (o)(5)(E) for the applicable listed drug.
``(V) A temporary moratorium on direct-to-consumer
advertising, if required under subsection (o)(5)(F) for the
applicable listed drug.
``(VI) Elements to assure safe use, if required under
subsection (o)(6) for the applicable listed drug, except that
such drug may use a different, comparable aspect of such
elements as are necessary to assure safe use of such drug if
--
``(aa) the corresponding aspect of the elements to assure
safe use for the applicable listed drug is claimed by a
patent that has not expired or is a method or process that as
a trade secret is entitled to protection; and
``(bb) the applicant certifies that it has sought a license
for use of such aspect of the elements to assure safe use for
the applicable listed drug.
``(ii) Action by secretary.--For an applicable listed drug
for which a drug is approved under this subsection, the
Secretary--
``(I) shall undertake any communication plan to health care
providers required under section (o)(5)(C) for the applicable
listed drug;
``(II) shall conduct, or contract for, any postapproval
study required under subsection (o)(4)(B) for the applicable
listed drug;
``(III) shall inform the applicant for a drug approved
under this subsection if the approved risk evaluation and
mitigation strategy for the applicable listed drug is
modified; and
``(IV) in order to minimize the burden on the health care
delivery system of different elements to assure safe use for
the drug approved under this subsection and the applicable
listed drug, may seek to negotiate a voluntary agreement with
the owner of the patent, method, or process for a license
under which the applicant for such drug may use an aspect of
the elements to assure safe use, if required under subsection
(o)(6) for the applicable listed drug, that is claimed by a
patent that has not expired or is a method or process that as
a trade secret is entitled to protection.''.
SEC. 207. RESOURCES.
(a) User Fees.--Subparagraph (F) of section 735(d)(6) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379g(d)(6)), as amended by section 103, as amended--
(1) in clause (ii), by striking ``systems); and'' and
inserting ``systems);''
(2) in clause (iii), by striking ``bases).'' and inserting
``bases); and''; and
(3) by adding at the end the following:
``(iv) reviewing, implementing, and ensuring compliance
with risk evaluation and mitigation strategies.''.
(b) Additional Fee Revenues for Drug Safety.--Section 736
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h),
as amended by section 103, is amended by--
(1) striking the subsection designation and all that
follows through ``.--Except'' and inserting the following:
``(b) Fee Revenue Amounts.--
``(1) In general.--Except''; and
(2) adding at the end the following:
``(2) Additional fee revenues for drug safety.--
``(A) In general.--Subject to subparagraph (C), in each of
fiscal years 2008 through 2012, paragraph (1) shall be
applied by substituting the amount determined under
subparagraph (B) for `$392,783,000'.
``(B) Amount determined.--For any fiscal year 2008 through
2012, the amount determined under this subparagraph is the
sum of--
``(i) $392,783,000; plus
``(ii) the amount equal to--
``(I)(aa) for fiscal year 2008, $25,000,000;
``(bb) for fiscal year 2009, $35,000,000;
``(cc) for fiscal year 2010, $45,000,000;
``(dd) for fiscal year 2011, $55,000,000; and
``(ee) for fiscal year 2012, $65,000,000; minus
``(II) the amount equal to one-fifth of the amount by which
the appropriations for salaries and expenses of the Food and
Drug Administration for such fiscal year (excluding the
amount of fees appropriated for such fiscal year) exceed the
amount of appropriations for the salaries and expenses of the
Food and Drug Administration for the fiscal year 2007
(excluding the amount of fees appropriated for such fiscal
year), adjusted as provided under subsection (c)(1).
In making the adjustment under subclause (II) for any fiscal
year 2008 through 2012, subsection (c)(1) shall be applied by
substituting `2007' for `2008'.
``(C) Limitation.--This paragraph shall not apply for any
fiscal year if the amount described under subparagraph
(B)(ii) is less than 0.''.
(c) Strategic Plan for Information Technology.--Not later
than 1 year after the date of enactment of this title, the
Secretary of Health and Human Services (referred to in this
title as the ``Secretary'') shall submit to the Committee on
Health, Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives, a strategic plan on information technology
that includes--
(1) an assessment of the information technology
infrastructure, including systems for data collection, access
to data in external health care databases, data mining
capabilities, personnel, and personnel training programs,
needed by the Food and Drug Administration to--
(A) comply with the requirements of this subtitle (and the
amendments made by this subtitle);
(B) achieve interoperability within and among the centers
of the Food and Drug Administration and between the Food and
Drug Administration and product application sponsors;
(C) utilize electronic health records;
(D) implement routine active surveillance under section
505(k)(3) (including complementary approaches under
subsection (c) of such section) of the Federal Food, Drug,
and Cosmetic Act, as added by section 201 of this Act; and
(E) communicate drug safety information to physicians and
other health care providers;
(2) an assessment of the extent to which the current
information technology assets of the Food and Drug
Administration are sufficient to meet the needs assessments
under paragraph (1);
(3) a plan for enhancing the information technology assets
of the Food and Drug Administration toward meeting the needs
assessments under paragraph (1); and
(4) an assessment of additional resources needed to so
enhance the information technology assets of the Food and
Drug Administration.
SEC. 208. SAFETY LABELING CHANGES.
(a) In General.--Subchapter A of 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. 506D. SAFETY LABELING CHANGES.
``(a) New Safety Information.--
``(1) Notification.--The holder of an approved application
under section 505 of this
[[Page S5343]]
Act or a license under section 351 of the Public Health
Service Act (referred to in this section as a `holder') shall
promptly notify the Secretary if the holder becomes aware of
new safety information that the holder believes should be
included in the labeling of the drug. The Secretary shall
promptly notify the holder if the Secretary becomes aware of
new safety information that the Secretary believes should be
included in the labeling of the drug.
``(2) Discussion regarding labeling changes.--Following
notification pursuant to paragraph (1), the Secretary and
holder shall initiate discussions of the new safety
information in order to reach agreement on whether the
labeling for the drug should be modified to reflect the new
safety information and, if so, on the contents of such
labeling changes.
``(3) Supplement.--If the Secretary determines that there
is reasonable scientific evidence that an adverse event is
associated with use of the drug, the Secretary may request
the holder to submit a supplement to an application under
section 505 of this Act or to a license under section 351 of
the Public Health Service Act (referred to in this section as
a `supplement') proposing changes to the approved labeling to
reflect the new safety information, including changes to
boxed warnings, contraindications, warnings, precautions, or
adverse reactions (referred to in this section as a `safety
labeling change'). If the Secretary determines that no safety
labeling change is necessary or appropriate based upon the
new safety information, the Secretary shall notify the holder
of this determination in writing.
``(b) Labeling Supplements.--
``(1) In general.--The holder shall submit a supplement
whenever the holder seeks, either at the holder's own
initiative or at the request of the Secretary, to make a
safety labeling change.
``(2) Nonaccelerated process.--Unless the accelerated
labeling review process described in subsection (c) is
initiated, any supplement proposing a safety labeling change
shall be reviewed and acted upon by the Secretary not later
than 30 days after the date the Secretary receives the
supplement. Until the Secretary acts on such a supplement
proposing a safety labeling change, the existing approved
labeling shall remain in effect and be distributed by the
holder without change.
``(3) New safety information.--Nothing in this section
shall prohibit the Secretary from informing health care
professionals or the public about new safety information
prior to approval of a supplement proposing a safety labeling
change.
``(c) Accelerated Labeling Review Process.--An accelerated
labeling review process shall be available to resolve
disagreements in a timely manner between the Secretary and a
holder about the need for, or content of, a safety labeling
change, as follows:
``(1) Request to initiate accelerated process.--The
accelerated labeling review process shall be initiated upon
the written request of either the Secretary or the holder.
Such request may be made at any time after the notification
described in subsection (a)(1), including during the
Secretary's review of a supplement proposing a safety
labeling change.
``(2) Scientific discussion and meetings.--
``(A) In general.--Following initiation of the accelerated
labeling review process, the Secretary and holder shall
immediately initiate discussions to review and assess the new
safety information and to reach agreement on whether safety
labeling changes are necessary and appropriate and, if so,
the content of such safety labeling changes.
``(B) Time period.--The discussions under this paragraph
shall not extend for more than 45 calendar days after the
initiation of the accelerated labeling review process.
``(C) Dispute proceedings.--If the Secretary and holder do
not reach an agreement regarding the safety labeling changes
by not later than 25 calendar days after the initiation of
the accelerated labeling review process, the dispute
automatically shall be referred to the director of the drug
evaluation office responsible for the drug under
consideration, who shall be required to take an active role
in such discussions.
``(3) Request for safety labeling change and failure to
agree.--If the Secretary and holder fail to reach an
agreement on appropriate safety labeling changes by not later
than 45 calendar days after the initiation of the accelerated
labeling review process--
``(A) on the next calendar day (other than a weekend or
Federal holiday) after such period, the Secretary shall--
``(i) request in writing that the holder make any safety
labeling change that the Secretary determines to be necessary
and appropriate based upon the new safety information; or
``(ii) notify the holder in writing that the Secretary has
determined that no safety labeling change is necessary or
appropriate; and
``(B) if the Secretary fails to act within the specified
time, or if the holder does not agree to make a safety
labeling change requested by the Secretary or does not agree
with the Secretary's determination that no labeling change is
necessary or appropriate, the Secretary (on his own
initiative or upon request by the holder) shall refer the
matter for expedited review to the Drug Safety Oversight
Board.
``(4) Action by the drug safety oversight board.--Not later
than 45 days after receiving a referral under paragraph
(3)(B), the Drug Safety Oversight Board shall--
``(A) review the new safety information;
``(B) review all written material submitted by the
Secretary and the holder;
``(C) convene a meeting to hear oral presentations and
arguments from the Secretary and holder; and
``(D) make a written recommendation to the Secretary--
``(i) concerning appropriate safety labeling changes, if
any; or
``(ii) stating that no safety labeling changes are
necessary or appropriate based upon the new safety
information.
``(5) Consideration of recommendations.--
``(A) Action by the secretary.--The Secretary shall
consider the recommendation of the Drug Safety Oversight
Board made under paragraph (4)(D) and, not later than 20 days
after receiving the recommendation--
``(i) issue an order requiring the holder to make any
safety labeling change that the Secretary determines to be
necessary and appropriate; or
``(ii) if the Secretary determines that no safety labeling
change is necessary or appropriate, the Secretary shall
notify the holder of this determination in writing.
``(B) Failure to act.--If the Secretary fails to act by not
later than 20 days after receiving the recommendation of the
Drug Safety Oversight Board, the written recommendation of
the Drug Safety Oversight Board shall be considered the order
of the Secretary under this paragraph.
``(C) Nondelegation.--The Secretary's authority under this
paragraph shall not be redelegated to an individual below the
level of the Director of the Center for Drug Evaluation and
Research, or the Director of the Center for Biologics
Evaluation and Research, of the Food and Drug Administration.
``(6) Misbranding.--If the holder, not later than 10 days
after receiving an order under subparagraph (A) or (B) of
paragraph (5), does not agree to make a safety labeling
change ordered by the Secretary, the Secretary may deem the
drug that is the subject of the request to be misbranded.
``(d) Rule of Construction.--Nothing in this section shall
be construed to change the standards in existence on the date
of enactment of this section for determining whether safety
labeling changes are necessary or appropriate.''.
(b) Conforming Amendment.--Section 502 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 352 et seq.), as amended by
section 203, is further amended by adding at the end the
following:
``(y) If it is a drug and the holder does not agree to make
a safety labeling change ordered by the Secretary under
section 506D(c) within 10 days after issuance of such an
order.''.
SEC. 209. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND
PROVIDERS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by section 251, is amended by adding
at the end the following:
``(r) Postmarket Drug Safety Information for Patients and
Providers.--
``(1) Establishment.--Not later than 1 year after the date
of enactment of the Enhancing Drug Safety and Innovation Act
of 2007, the Secretary shall improve the transparency of
pharmaceutical data and allow patients and health care
providers better access to pharmaceutical data by developing
and maintaining an Internet website that--
``(A) provides comprehensive drug safety information for
prescription drugs that are approved by the Secretary under
this section or licensed under section 351 of the Public
Health Service Act; and
``(B) improves communication of drug safety information to
patients and providers.
``(2) Internet website.--The Secretary shall carry out
paragraph (1) by--
``(A) developing and maintaining an accessible,
consolidated Internet website with easily searchable drug
safety information, including the information found on United
States Government Internet websites, such as the United
States National Library of Medicine's Daily Med and Medline
Plus websites, in addition to other such websites maintained
by the Secretary;
``(B) ensuring that the information provided on the
Internet website is comprehensive and includes, when
available and appropriate--
``(i) patient labeling and patient packaging inserts;
``(ii) a link to a list of each drug, whether approved
under this section or licensed under such section 351, for
which a Medication Guide, as provided for under part 208 of
title 21, Code of Federal Regulations (or any successor
regulations), is required;
``(iii) a link to the clinical trial registry data bank
provided for under subsections (i) and (j) of section 402 of
the Public Health Service Act;
``(iv) the most recent safety information and alerts issued
by the Food and Drug Administration for drugs approved by the
Secretary under this section, such as product recalls,
warning letters, and import alerts;
``(v) publicly available information about implemented
RiskMAPs and risk evaluation and mitigation strategies under
subsection (o);
``(vi) guidance documents and regulations related to drug
safety; and
``(vii) other material determined appropriate by the
Secretary;
``(C) including links to non-Food and Drug Administration
Internet resources that provide access to relevant drug
safety information, such as medical journals and studies;
[[Page S5344]]
``(D) providing access to summaries of the assessed and
aggregated data collected from the active surveillance
infrastructure under subsection (k)(3) to provide information
of known and serious side-effects for drugs approved by the
Secretary under this section or licensed under such section
351;
``(E) enabling patients, providers, and drug sponsors to
submit adverse event reports through the Internet website;
``(F) providing educational materials for patients and
providers about the appropriate means of disposing of
expired, damaged, or unusable medications; and
``(G) supporting initiatives that the Secretary determines
to be useful to fulfill the purposes of the Internet website.
``(3) Posting of drug labeling.--The Secretary shall post
on the Internet website established under paragraph (1) the
approved professional labeling and any required patient
labeling of a drug approved under this section or licensed
under such section 351 not later than 21 days after the date
the drug is approved or licensed, including in a supplemental
application with respect to a labeling change.
``(4) Private sector resources.--To ensure development of
the Internet website by the date described in paragraph (1),
the Secretary may, on a temporary or permanent basis,
implement systems or products developed by private entities.
``(5) Authority for contracts.--The Secretary may enter
into contracts with public and private entities to fulfill
the requirements of this subsection.
``(6) Review.--The Advisory Committee on Risk Communication
under section 566 shall, on a regular basis, perform a
comprehensive review and evaluation of the types of risk
communication information provided on the Internet website
established under paragraph (1) and, through other means,
shall identify, clarify, and define the purposes and types of
information available to facilitate the efficient flow of
information to patients and providers, and shall recommend
ways for the Food and Drug Administration to work with
outside entities to help facilitate the dispensing of risk
communication information to patients and providers.''.
SEC. 210. ACTION PACKAGE FOR APPROVAL.
Section 505(l) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(l)) is amended by--
(1) redesignating paragraphs (1), (2), (3), (4), and (5) as
subparagraphs (A), (B), (C), (D), and (E), respectively;
(2) striking ``(l) Safety and'' and inserting ``(l)(1)
Safety and''; and
(3) adding at the end the following:
``(2) Action Package for Approval.--
``(A) Action package.--The Secretary shall publish the
action package for approval of an application under
subsection (b) or section 351 of the Public Health Service
Act on the Internet website of the Food and Drug
Administration-
``(i) not later than 30 days after the date of approval of
such application for a drug no active ingredient (including
any ester or salt of the active ingredient) of which has been
approved in any other application under this section or
section 351 of the Public Health Service Act; and
``(ii) not later than 30 days after the third request for
such action package for approval received under section 552
of title 5, United States Code, for any other drug.
``(B) Immediate publication of summary review.--
Notwithstanding subparagraph (A), the Secretary shall
publish, on the Internet website of the Food and Drug
Administration, the materials described in subparagraph
(C)(iv) not later than 48 hours after the date of approval of
the drug, except where such materials require redaction by
the Secretary.
``(C) Contents.--An action package for approval of an
application under subparagraph (A) shall be dated and shall
include the following:
``(i) Documents generated by the Food and Drug
Administration related to review of the application.
``(ii) Documents pertaining to the format and content of
the application generated during drug development.
``(iii) Labeling submitted by the applicant.
``(iv) A summary review that documents conclusions from all
reviewing disciplines about the drug, noting any critical
issues and disagreements with the applicant and how they were
resolved, recommendation for action, and an explanation of
any nonconcurrence with review conclusions.
``(v) If applicable, a separate review from a supervisor
who does not concur with the summary review.
``(vi) Identification by name of each officer or employee
of the Food and Drug Administration who--
``(I) participated in the decision to approve the
application; and
``(II) consents to have his or her name included in the
package.
``(D) Disagreements.--A scientific review of an application
is considered the work of the reviewer and shall not be
altered by management or the reviewer once final.
Disagreements by team leaders, division directors, or office
directors with any or all of the major conclusions of a
reviewer shall be document in a separate review or in an
addendum to the review.
``(E) Confidential information.--This paragraph does not
authorize the disclosure of any trade secret or confidential
commercial or financial information described in section
552(b)(4) of title 5, United States Code, unless the
Secretary declares an emergency under section 319 of the
Public Health Service Act and such disclosure is necessary to
mitigate the effects of such emergency.''.
SEC. 211. RISK COMMUNICATION.
Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding
at the end the following:
``SEC. 566. RISK COMMUNICATION.
``(a) Advisory Committee on Risk Communication.--
``(1) In general.--The Secretary shall establish an
advisory committee to be known as the `Advisory Committee on
Risk Communication' (referred to in this section as the
`Committee').
``(2) Duties of committee.--The Committee shall advise the
Commissioner on methods to effectively communicate risks
associated with the products regulated by the Food and Drug
Administration.
``(3) Members.--The Secretary shall ensure that the
Committee is composed of experts on risk communication,
experts on the risks described in subsection (b), and
representatives of patient, consumer, and health professional
organizations.
``(4) Permanence of committee.--Section 14 of the Federal
Advisory Committee Act shall not apply to the Committee
established under this subsection.
``(b) Partnerships for Risk Communication.--
``(1) In general.--The Secretary shall partner with
professional medical societies, medical schools, academic
medical centers, and other stakeholders to develop robust and
multi-faceted systems for communication to health care
providers about emerging postmarket drug risks.
``(2) Partnerships.--The systems developed under paragraph
(1) shall--
``(A) account for the diversity among physicians in terms
of practice, affinity for technology, and focus; and
``(B) include the use of existing communication channels,
including electronic communications, in place at the Food and
Drug Administration.''.
SEC. 212. REFERRAL TO ADVISORY COMMITTEE.
Section 505 of the Federal Food, Drug, and Cosmetic Act, as
amended by section 202, is further amended by adding at the
end the following:
``(p) Referral to Advisory Committee.--
``(1) In general.--Prior to the approval of a drug no
active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other
application under this section or section 351 of the Public
Health Service Act, the Secretary shall refer such drug to a
Food and Drug Administration advisory committee for review at
a meeting of such advisory committee.
``(2) Exception.--Notwithstanding paragraph (1), an
advisory committee review of a drug described under such
paragraph may occur within 1 year after approval of such a
drug if--
``(A) the clinical trial that formed the primary basis of
the safety and efficacy determination was halted by a drug
safety monitoring board or an Institutional Review Board
before its scheduled completion due to early unanticipated
therapeutic results; or
``(B) the Secretary determines that it would be beneficial
to the public health.''.
SEC. 213. RESPONSE TO THE INSTITUTE OF MEDICINE.
(a) In General.--Not later than 1 year after the date of
enactment of this title, the Secretary shall issue a report
responding to the 2006 report of the Institute of Medicine
entitled ``The Future of Drug Safety--Promoting and
Protecting the Health of the Public''.
(b) Content of Report.--The report issued by the Secretary
under subsection (a) shall include--
(1) an update on the implementation by the Food and Drug
Administration of its plan to respond to the Institute of
Medicine report described under such subsection; and
(2) an assessment of how the Food and Drug Administration
has implemented--
(A) the recommendations described in such Institute of
Medicine report; and
(B) the requirement under paragraph (7) of section 505(o)
of the Federal Food, Drug, and Cosmetic Act (as added by this
title), that the appropriate office responsible for reviewing
a drug and the office responsible for postapproval safety
with respect to the drug act together to assess, implement,
and ensure compliance with the requirements of such section
505(o).
SEC. 214. EFFECTIVE DATE AND APPLICABILITY.
(a) Effective Dates.--
(1) In general.--Except as provided in paragraph (2), this
subtitle shall take effect 180 days after the date of
enactment of this title.
(2) User fees.--The amendments made by subsections (a)
through (c) of section 207 shall take effect on October 1,
2007.
(b) Drugs Deemed To Have Risk Evaluation and Mitigation
Strategies.--
(1) In general.--A drug that was approved before the
effective date of this subtitle shall be deemed to have an
approved risk evaluation and mitigation strategy under
section 505(o) of the Federal Food, Drug, and Cosmetic Act
(as added by this subtitle) if there are in effect on the
effective date of this subtitle restrictions on distribution
or use--
(A) required under section 314.520 or section 601.42 of
title 21, Code of Federal Regulations; or
(B) otherwise agreed to by the applicant and the Secretary
for such drug.
[[Page S5345]]
(2) Risk evaluation and mitigation strategy.--The approved
risk evaluation and mitigation strategy deemed in effect for
a drug under paragraph (1) shall consist of the elements
described in subparagraphs (A) and (B) of paragraph (3) of
such section 505(o) and any other additional elements under
paragraphs (4), (5), and (6) in effect for such drug on the
effective date of this subtitle.
(3) Notification.--Not later than 30 days after the
effective date of this subtitle, the Secretary shall notify
the applicant for each drug described in paragraph (1)--
(A) that such drug is deemed to have an approved risk
evaluation and mitigation strategy pursuant to such
paragraph; and
(B) of the date, which, unless a safety issue with the drug
arises, shall be no earlier than 6 months after the applicant
is so notified, by which the applicant shall submit to the
Secretary an assessment of such approved strategy under
paragraph (7)(B) of such section 505(o).
(4) Enforcement only after assessment and review.--Neither
the Secretary nor the Attorney General may seek to enforce a
requirement of a risk evaluation and mitigation strategy
deemed in effect under paragraph (1) before the Secretary has
completed review of, and acted on, the first assessment of
such strategy under such section 505(o).
(c) No Effect on Veterinary Medicine.--This subtitle, and
the amendments made by this subtitle, shall have no effect on
the use of drugs approved under section 505 of the Federal
Food, Drug, and Cosmetic Act by, or on the lawful written or
oral order of, a licensed veterinarian within the context of
a veterinarian-client-patient relationship, as provided for
under section 512(a)(5) of such Act.
Subtitle B--Reagan-Udall Foundation for the Food and Drug
Administration
SEC. 221. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
ADMINISTRATION.
(a) In General.--Chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at
the end the following:
``Subchapter I--Reagan-Udall Foundation for the Food and Drug
Administration
``SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.
``(a) In General.--A nonprofit corporation to be known as
the Reagan-Udall Foundation for the Food and Drug
Administration (referred to in this subchapter as the
`Foundation') shall be established in accordance with this
section. The Foundation shall be headed by an Executive
Director, appointed by the members of the Board of Directors
under subsection (e). The Foundation shall not be an agency
or instrumentality of the United States Government.
``(b) Purpose of Foundation.--The purpose of the Foundation
is to advance the mission of the Food and Drug Administration
to modernize medical, veterinary, food, food ingredient, and
cosmetic product development, accelerate innovation, and
enhance product safety.
``(c) Duties of the Foundation.--The Foundation shall--
``(1) taking into consideration the Critical Path reports
and priorities published by the Food and Drug Administration,
identify unmet needs in the development, manufacture, and
evaluation of the safety and effectiveness, including
postapproval, of devices, including diagnostics, biologics,
and drugs, and the safety of food, food ingredients, and
cosmetics;
``(2) establish goals and priorities in order to meet the
unmet needs identified in paragraph (1);
``(3) in consultation with the Secretary, identify existing
and proposed Federal intramural and extramural research and
development programs relating to the goals and priorities
established under paragraph (2), coordinate Foundation
activities with such programs, and minimize Foundation
duplication of existing efforts;
``(4) award grants to, or enter into contracts, memoranda
of understanding, or cooperative agreements with, scientists
and entities, which may include the Food and Drug
Administration, university consortia, public-private
partnerships, institutions of higher education, entities
described in section 501(c)(3) of the Internal Revenue Code
(and exempt from tax under section 501(a) of such Code), and
industry, to efficiently and effectively advance the goals
and priorities established under paragraph (2);
``(5) recruit meeting participants and hold or sponsor (in
whole or in part) meetings as appropriate to further the
goals and priorities established under paragraph (2);
``(6) release and publish information and data and, to the
extent practicable, license, distribute, and release
material, reagents, and techniques to maximize, promote, and
coordinate the availability of such material, reagents, and
techniques for use by the Food and Drug Administration,
nonprofit organizations, and academic and industrial
researchers to further the goals and priorities established
under paragraph (2);
``(7) ensure that--
``(A) action is taken as necessary to obtain patents for
inventions developed by the Foundation or with funds from the
Foundation;
``(B) action is taken as necessary to enable the licensing
of inventions developed by the Foundation or with funds from
the Foundation; and
``(C) executed licenses, memoranda of understanding,
material transfer agreements, contracts, and other such
instruments, promote, to the maximum extent practicable, the
broadest conversion to commercial and noncommercial
applications of licensed and patented inventions of the
Foundation to further the goals and priorities established
under paragraph (2);
``(8) provide objective clinical and scientific information
to the Food and Drug Administration and, upon request, to
other Federal agencies to assist in agency determinations of
how to ensure that regulatory policy accommodates scientific
advances and meets the agency's public health mission;
``(9) conduct annual assessments of the unmet needs
identified in paragraph (1); and
``(10) carry out such other activities consistent with the
purposes of the Foundation as the Board determines
appropriate.
``(d) Board of Directors.--
``(1) Establishment.--
``(A) In general.--The Foundation shall have a Board of
Directors (referred to in this subchapter as the `Board'),
which shall be composed of ex officio and appointed members
in accordance with this subsection. All appointed members of
the Board shall be voting members.
``(B) Ex officio members.--The ex officio members of the
Board shall be the following individuals or their designees:
``(i) The Commissioner.
``(ii) The Director of the National Institutes of Health.
``(iii) The Director of the Centers for Disease Control and
Prevention.
``(iv) The Director of the Agency for Healthcare Research
and Quality.
``(C) Appointed members.--
``(i) In general.--The ex officio members of the Board
under subparagraph (B) shall, by majority vote, appoint to
the Board 12 individuals, from a list of candidates to be
provided by the National Academy of Sciences. Of such
appointed members--
``(I) 4 shall be representatives of the general
pharmaceutical, device, food, cosmetic, and biotechnology
industries;
``(II) 3 shall be representatives of academic research
organizations;
``(III) 2 shall be representatives of Government agencies,
including the Food and Drug Administration and the National
Institutes of Health;
``(IV) 2 shall be representatives of patient or consumer
advocacy organizations; and
``(V) 1 shall be a representative of health care providers.
``(ii) Requirement.--The ex officio members shall ensure
the Board membership includes individuals with expertise in
areas including the sciences of developing, manufacturing,
and evaluating the safety and effectiveness of devices,
including diagnostics, biologics, and drugs, and the safety
of food, food ingredients, and cosmetics.
``(D) Initial meeting.--
``(i) In general.--Not later than 30 days after the date of
the enactment of the Enhancing Drug Safety and Innovation Act
of 2007, the Secretary shall convene a meeting of the ex
officio members of the Board to--
``(I) incorporate the Foundation; and
``(II) appoint the members of the Board in accordance with
subparagraph (C).
``(ii) Service of ex officio members.--Upon the appointment
of the members of the Board under clause (i)(II), the terms
of service of the ex officio members of the Board as members
of the Board shall terminate.
``(iii) Chair.--The ex officio members of the Board under
subparagraph (B) shall designate an appointed member of the
Board to serve as the Chair of the Board.
``(2) Duties of board.--The Board shall--
``(A) establish bylaws for the Foundation that--
``(i) are published in the Federal Register and available
for public comment;
``(ii) establish policies for the selection of the
officers, employees, agents, and contractors of the
Foundation;
``(iii) establish policies, including ethical standards,
for the acceptance, solicitation, and disposition of
donations and grants to the Foundation and for the
disposition of the assets of the Foundation, including
appropriate limits on the ability of donors to designate, by
stipulation or restriction, the use or recipient of donated
funds;
``(iv) establish policies that would subject all employees,
fellows, and trainees of the Foundation to the conflict of
interest standards under section 208 of title 18, United
States Code;
``(v) establish licensing, distribution, and publication
policies that support the widest and least restrictive use by
the public of information and inventions developed by the
Foundation or with Foundation funds to carry out the duties
described in paragraphs (6) and (7) of subsection (c), and
may include charging cost-based fees for published material
produced by the Foundation;
``(vi) specify principles for the review of proposals and
awarding of grants and contracts that include peer review and
that are consistent with those of the Foundation for the
National Institutes of Health, to the extent determined
practicable and appropriate by the Board;
``(vii) specify a cap on administrative expenses for
recipients of a grant, contract, or cooperative agreement
from the Foundation;
``(viii) establish policies for the execution of memoranda
of understanding and cooperative agreements between the
Foundation and other entities, including the Food and Drug
Administration;
``(ix) establish policies for funding training fellowships,
whether at the Foundation, academic or scientific
institutions, or the Food
[[Page S5346]]
and Drug Administration, for scientists, doctors, and other
professionals who are not employees of regulated industry, to
foster greater understanding of and expertise in new
scientific tools, diagnostics, manufacturing techniques, and
potential barriers to translating basic research into
clinical and regulatory practice;
``(x) specify a process for annual Board review of the
operations of the Foundation; and
``(xi) establish specific duties of the Executive Director;
``(B) prioritize and provide overall direction to the
activities of the Foundation;
``(C) evaluate the performance of the Executive Director;
and
``(D) carry out any other necessary activities regarding
the functioning of the Foundation.
``(3) Terms and vacancies.--
``(A) Term.--The term of office of each member of the Board
appointed under paragraph (1)(C) shall be 4 years, except
that the terms of offices for the initial appointed members
of the Board shall expire on a staggered basis as determined
by the ex officio members.
``(B) Vacancy.--Any vacancy in the membership of the
Board--
``(i) shall not affect the power of the remaining members
to execute the duties of the Board; and
``(ii) shall be filled by appointment by the appointed
members described in paragraph (1)(C) by majority vote.
``(C) Partial term.--If a member of the Board does not
serve the full term applicable under subparagraph (A), the
individual appointed under subparagraph (B) to fill the
resulting vacancy shall be appointed for the remainder of the
term of the predecessor of the individual.
``(D) Serving past term.--A member of the Board may
continue to serve after the expiration of the term of the
member until a successor is appointed.
``(4) Compensation.--Members of the Board may not receive
compensation for service on the Board. Such members may be
reimbursed for travel, subsistence, and other necessary
expenses incurred in carrying out the duties of the Board, as
set forth in the bylaws issued by the Board.
``(e) Incorporation.--The ex officio members of the Board
shall serve as incorporators and shall take whatever actions
necessary to incorporate the Foundation.
``(f) Nonprofit Status.--The Foundation shall be considered
to be a corporation under section 501(c) of the Internal
Revenue Code of 1986, and shall be subject to the provisions
of such section.
``(g) Executive Director.--
``(1) In general.--The Board shall appoint an Executive
Director who shall serve at the pleasure of the Board. The
Executive Director shall be responsible for the day-to-day
operations of the Foundation and shall have such specific
duties and responsibilities as the Board shall prescribe.
``(2) Compensation.--The compensation of the Executive
Director shall be fixed by the Board but shall not be greater
than the compensation of the Commissioner.
``(h) Administrative Powers.--In carrying out this
subchapter, the Board, acting through the Executive Director,
may--
``(1) adopt, alter, and use a corporate seal, which shall
be judicially noticed;
``(2) hire, promote, compensate, and discharge 1 or more
officers, employees, and agents, as may be necessary, and
define their duties;
``(3) prescribe the manner in which--
``(A) real or personal property of the Foundation is
acquired, held, and transferred;
``(B) general operations of the Foundation are to be
conducted; and
``(C) the privileges granted to the Board by law are
exercised and enjoyed;
``(4) with the consent of the applicable executive
department or independent agency, use the information,
services, and facilities of such department or agencies in
carrying out this section;
``(5) enter into contracts with public and private
organizations for the writing, editing, printing, and
publishing of books and other material;
``(6) hold, administer, invest, and spend any gift, devise,
or bequest of real or personal property made to the
Foundation under subsection (i);
``(7) enter into such other contracts, leases, cooperative
agreements, and other transactions as the Board considers
appropriate to conduct the activities of the Foundation;
``(8) modify or consent to the modification of any contract
or agreement to which it is a party or in which it has an
interest under this subchapter;
``(9) take such action as may be necessary to obtain
patents and licenses for devices and procedures developed by
the Foundation and its employees;
``(10) sue and be sued in its corporate name, and complain
and defend in courts of competent jurisdiction;
``(11) appoint other groups of advisors as may be
determined necessary to carry out the functions of the
Foundation; and
``(12) exercise other powers as set forth in this section,
and such other incidental powers as are necessary to carry
out its powers, duties, and functions in accordance with this
subchapter.
``(i) Acceptance of Funds From Other Sources.--The
Executive Director may solicit and accept on behalf of the
Foundation, any funds, gifts, grants, devises, or bequests of
real or personal property made to the Foundation, including
from private entities, for the purposes of carrying out the
duties of the Foundation.
``(j) Service of Federal Employees.--Federal Government
employees may serve on committees advisory to the Foundation
and otherwise cooperate with and assist the Foundation in
carrying out its functions, so long as such employees do not
direct or control Foundation activities.
``(k) Detail of Government Employees; Fellowships.--
``(1) Detail from federal agencies.--Federal Government
employees may be detailed from Federal agencies with or
without reimbursement to those agencies to the Foundation at
any time, and such detail shall be without interruption or
loss of civil service status or privilege. Each such employee
shall abide by the statutory, regulatory, ethical, and
procedural standards applicable to the employees of the
agency from which such employee is detailed and those of the
Foundation.
``(2) Voluntary service; acceptance of federal employees.--
``(A) Foundation.--The Executive Director of the Foundation
may accept the services of employees detailed from Federal
agencies with or without reimbursement to those agencies.
``(B) Food and drug administration.--The Commissioner may
accept the uncompensated services of Foundation fellows or
trainees. Such services shall be considered to be undertaking
an activity under contract with the Secretary as described in
section 708.
``(l) Annual Reports.--
``(1) Reports to foundation.--Any recipient of a grant,
contract, fellowship, memorandum of understanding, or
cooperative agreement from the Foundation under this section
shall submit to the Foundation a report on an annual basis
for the duration of such grant, contract, fellowship,
memorandum of understanding, or cooperative agreement, that
describes the activities carried out under such grant,
contract, fellowship, memorandum of understanding, or
cooperative agreement.
``(2) Report to congress and the fda.--Beginning with
fiscal year 2009, the Executive Director shall submit to
Congress and the Commissioner an annual report that--
``(A) describes the activities of the Foundation and the
progress of the Foundation in furthering the goals and
priorities established under subsection (c)(2), including the
practical impact of the Foundation on regulated product
development;
``(B) provides a specific accounting of the source and use
of all funds used by the Foundation to carry out such
activities; and
``(C) provides information on how the results of Foundation
activities could be incorporated into the regulatory and
product review activities of the Food and Drug
Administration.
``(m) Separation of Funds.--The Executive Director shall
ensure that the funds received from the Treasury are held in
separate accounts from funds received from entities under
subsection (i).
``(n) Funding.--From amounts appropriated to the Food and
Drug Administration for each fiscal year, the Commissioner
shall transfer not less than $500,000 and not more than
$1,250,000, to the Foundation to carry out subsections (a),
(b), and (d) through (m).''.
(b) Other Foundation Provisions.--Chapter VII (21 U.S.C.
371 et seq.) (as amended by subsection (a)) is amended by
adding at the end the following:
``SEC. 771. LOCATION OF FOUNDATION.
``The Foundation shall, if practicable, be located not more
than 20 miles from the District of Columbia.
``SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.
``(a) In General.--The Commissioner shall receive and
assess the report submitted to the Commissioner by the
Executive Director of the Foundation under section 770(l)(2).
``(b) Report to Congress.--Beginning with fiscal year 2009,
the Commissioner shall submit to Congress an annual report
summarizing the incorporation of the information provided by
the Foundation in the report described under section
770(l)(2) and by other recipients of grants, contracts,
memoranda of understanding, or cooperative agreements into
regulatory and product review activities of the Food and Drug
Administration.
``(c) Extramural Grants.--The provisions of this subchapter
shall have no effect on any grant, contract, memorandum of
understanding, or cooperative agreement between the Food and
Drug Administration and any other entity entered into before,
on, or after the date of enactment of the Enhancing Drug
Safety and Innovation Act of 2007.''.
(c) Conforming Amendment.--Section 742(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended
by adding at the end the following: ``Any such fellowships
and training programs under this section or under section
770(d)(2)(A)(ix) may include provision by such scientists and
physicians of services on a voluntary and uncompensated
basis, as the Secretary determines appropriate. Such
scientists and physicians shall be subject to all legal and
ethical requirements otherwise applicable to officers or
employees of the Department of Health and Human Services.''.
SEC. 222. OFFICE OF THE CHIEF SCIENTIST.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.) is amended by adding at the end the
following:
[[Page S5347]]
``SEC. 910. OFFICE OF THE CHIEF SCIENTIST.
``(a) Establishment; Appointment.--The Secretary shall
establish within the Office of the Commissioner an office to
be known as the Office of the Chief Scientist. The Secretary
shall appoint a Chief Scientist to lead such Office.
``(b) Duties of the Office.--The Office of the Chief
Scientist shall--
``(1) oversee, coordinate, and ensure quality and
regulatory focus of the intramural research programs of the
Food and Drug Administration;
``(2) track and, to the extent necessary, coordinate
intramural research awards made by each center of the
Administration or science-based office within the Office of
the Commissioner, and ensure that there is no duplication of
research efforts supported by the Reagan-Udall Foundation for the Food
and Drug Administration;
``(3) develop and advocate for a budget to support
intramural research;
``(4) develop a peer review process by which intramural
research can be evaluated; and
``(5) identify and solicit intramural research proposals
from across the Food and Drug Administration through an
advisory board composed of employees of the Administration
that shall include--
``(A) representatives of each of the centers and the
science-based offices within the Office of the Commissioner;
and
``(B) experts on trial design, epidemiology, demographics,
pharmacovigilance, basic science, and public health.''.
Subtitle C--Clinical Trials
SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.
(a) In General.--Section 402 of the Public Health Service
Act (42 U.S.C. 282) is amended by--
(1) redesignating subsections (j) and (k) as subsections
(k) and (l), respectively; and
(2) inserting after subsection (i) the following:
``(j) Expanded Clinical Trial Registry Data Bank.--
``(1) Definitions; requirement.--
``(A) Definitions.--In this subsection:
``(i) Applicable device clinical trial.--The term
`applicable device clinical trial' means--
``(I) a prospective study of health outcomes comparing an
intervention against a control in human subjects intended to
support an application under section 515 or 520(m), or a
report under section 510(k), of the Federal Food, Drug, and
Cosmetic Act (other than a limited study to gather essential
information used to refine the device or design a pivotal
trial and that is not intended to determine safety and
effectiveness of a device); and
``(II) a pediatric postmarket surveillance as required
under section 522 of the Federal Food, Drug, and Cosmetic
Act.
``(ii) Applicable drug clinical trial.--
``(I) In general.--The term `applicable drug clinical
trial' means a controlled clinical investigation, other than
a phase I clinical investigation, of a product subject to
section 505 of the Federal Food, Drug, and Cosmetic Act or to
section 351 of this Act.
``(II) Clinical investigation.--For purposes of subclause
(I), the term `clinical investigation' has the meaning given
that term in section 312.3 of title 21, Code of Federal
Regulations.
``(III) Phase i.--The term `phase I' has the meaning given
that term in section 312.21 of title 21, Code of Federal
Regulations.
``(iii) Clinical trial information.--The term `clinical
trial information' means those data elements that are
necessary to complete an entry in the clinical trial registry
data bank under paragraph (2).
``(iv) Completion date.--The term `completion date' means,
with respect to an applicable drug clinical trial or an
applicable device clinical trial, the date on which the last
patient enrolled in the clinical trial has completed his or
her last medical visit of the clinical trial, whether the
clinical trial concluded according to the prespecified
protocol plan or was terminated.
``(v) Device.--The term `device' means a device as defined
in section 201(h) of the Federal Food, Drug, and Cosmetic
Act.
``(vi) Drug.--The term `drug' means a drug as defined in
section 201(g) of the Federal Food, Drug, and Cosmetic Act or
a biological product as defined in section 351 of this Act.
``(vii) Responsible party.--The term `responsible party',
with respect to a clinical trial of a drug or device, means--
``(I) the sponsor of the clinical trial (as defined in
section 50.3 of title 21, Code of Federal Regulations (or any
successor regulations)) or the principal investigator of such
clinical trial if so designated by such sponsor; or
``(II) if no sponsor exists, the grantee, contractor, or
awardee for a trial funded by a Federal agency or the
principal investigator of such clinical trial if so
designated by such grantee, contractor, or awardee.
``(B) Requirement.--The Secretary shall develop a mechanism
by which--
``(i) the responsible party for each applicable drug
clinical trial and applicable device clinical trial shall
submit the identity and contact information of such
responsible party to the Secretary at the time of submission
of clinical trial information under paragraph (2); and
``(ii) other Federal agencies may identify the responsible
party for an applicable drug clinical trial or applicable
device clinical trial.
``(2) Expansion of clinical trial registry data bank with
respect to clinical trial information.--
``(A) In general.--
``(i) Expansion of data bank.--To enhance patient
enrollment and provide a mechanism to track subsequent
progress of clinical trials, the Secretary, acting through
the Director of NIH, shall expand, in accordance with this
subsection, the clinical trials registry of the data bank
described under subsection (i)(3)(A) (referred to in this
subsection as the `registry data bank'). The Director of NIH
shall ensure that the registry data bank is made publicly
available through the Internet.
``(ii) Content.--Not later than 18 months after the date of
enactment of the Enhancing Drug Safety and Innovation Act of
2007, and after notice and comment, the Secretary shall
promulgate regulations to expand the registry data bank to
require the submission to the registry data bank of clinical
trial information for applicable drug clinical trials and
applicable device clinical trials that--
``(I) conforms to the International Clinical Trials
Registry Platform trial registration data set of the World
Health Organization;
``(II) includes the city, State, and zip code for each
clinical trial location, or a toll-free number through which
such location information may be accessed;
``(III) if the drug is not approved under section 505 of
the Federal Food, Drug, and Cosmetic Act or licensed under
section 351 of this Act, specifies whether or not there is
expanded access to the drug under section 561 of the Federal
Food, Drug, and Cosmetic Act for those who do not qualify for
enrollment in the clinical trial and how to obtain
information about such access;
``(IV) requires the inclusion of such other data elements
to the registry data bank as appropriate; and
``(V) becomes effective 90 days after issuance of the final
rule.
``(B) Format and structure.--
``(i) Searchable categories.--The Director of NIH shall
ensure that the public may search the entries in the registry
data bank by 1 or more of the following criteria:
``(I) The disease or condition being studied in the
clinical trial, using Medical Subject Headers (MeSH)
descriptors.
``(II) The treatment being studied in the clinical trial.
``(III) The location of the clinical trial.
``(IV) The age group studied in the clinical trial,
including pediatric subpopulations.
``(V) The study phase of the clinical trial.
``(VI) The source of support for the clinical trial, which
may be the National Institutes of Health or other Federal
agency, a private industry source, or a university or other
organization.
``(VII) The recruitment status of the clinical trial.
``(VIII) The National Clinical Trial number or other study
identification for the clinical trial.
``(ii) Format.--The Director of the NIH shall ensure that
the registry data bank is easily used by the public, and that
entries are easily compared.
``(C) Data submission.--The responsible party for an
applicable drug clinical trial shall submit to the Director
of NIH for inclusion in the registry data bank the clinical
trial information described in subparagraph (A)(ii).
``(D) Truthful clinical trial information.--
``(i) In general.--The clinical trial information submitted
by a responsible party under this paragraph shall not be
false or misleading in any particular.
``(ii) Effect.--Clause (i) shall not have the effect of
requiring clinical trial information with respect to an
applicable drug clinical trial or an applicable device
clinical trial to include information from any source other
than such clinical trial involved.
``(E) Changes in clinical trial status.--
``(i) Enrollment.--The responsible party for an applicable
drug clinical trial or an applicable device clinical trial
shall update the enrollment status not later than 30 days
after the enrollment status of such clinical trial changes.
``(ii) Completion.--The responsible party for an applicable
drug clinical trial or applicable device clinical trial shall
report to the Director of NIH that such clinical trial is
complete not later than 30 days after the completion date of
the clinical trial.
``(F) Timing of submission.--The clinical trial information
for an applicable drug clinical trial or an applicable device
clinical trial required to be submitted under this paragraph
shall be submitted not later than 21 days after the first
patient is enrolled in such clinical trial.
``(G) Posting of data.--
``(i) Applicable drug clinical trial.--The Director of NIH
shall ensure that clinical trial information for an
applicable drug clinical trial submitted in accordance with
this paragraph is posted publicly within 30 days of such
submission.
``(ii) Applicable device clinical trial.--The Director of
NIH shall ensure that clinical trial information for an
applicable device clinical trial submitted in accordance with
this paragraph is posted publicly within 30 days of clearance
under section 510(k) of the Federal Food, Drug, and Cosmetic
Act, or approval under section 515 or section 520(m) of such
Act, as applicable.
[[Page S5348]]
``(H) Voluntary submissions.--A responsible party for a
clinical trial that is not an applicable drug clinical trial
or an applicable device clinical trial may submit clinical
trial information to the registry data bank in accordance
with this subsection.
``(3) Expansion of registry data bank to include results of
clinical trials.--
``(A) Linking registry data bank to existing results.--
``(i) In general.--Beginning not later than 90 days after
the date of enactment of the Enhancing Drug Safety and
Innovation Act of 2007, for those clinical trials that form
the primary basis of an efficacy claim or are conducted after
the drug involved is approved or after the device involved is
cleared or approved, the Secretary shall ensure that the
registry data bank includes links to results information for
such clinical trial--
``(I) not earlier than 30 days after the date of the
approval of the drug involved or clearance or approval of the
device involved; or
``(II) not later than 30 days after such information
becomes publicly available, as applicable.
``(ii) Required information.--
``(I) FDA information.--The Secretary shall ensure that the
registry data bank includes links to the following
information:
``(aa) If an advisory committee considered at a meeting an
applicable drug clinical trial or an applicable device
clinical trial, any posted Food and Drug Administration
summary document regarding such applicable drug clinical
trial or applicable clinical device trial.
``(bb) If an applicable drug clinical trial was conducted
under section 505A or 505B of the Federal Food, Drug, and
Cosmetic Act, a link to the posted Food and Drug
Administration assessment of the results of such trial.
``(cc) Food and Drug Administration public health
advisories regarding the drug or device that is the subject
of the applicable drug clinical trial or applicable device
clinical trial, respectively, if any.
``(dd) For an applicable drug clinical trial, the Food and
Drug Administration action package for approval document
required under section 505(l)(2) of the Food Drug and
Cosmetic Act.
``(ee) For an applicable device clinical trial, in the case
of a premarket application, the detailed summary of
information respecting the safety and effectiveness of the
device required under section 520(h)(1) of the Federal Food,
Drug, and Cosmetic Act, or, in the case of a report under
section 510(k) of such Act, the section 510(k) summary of the
safety and effectiveness data required under section
807.95(d) of title 21, Code of Federal Regulations (or any
successor regulations).
``(II) NIH information.--The Secretary shall ensure that
the registry data bank includes links to the following
information:
``(aa) Medline citations to any publications regarding each
applicable drug clinical trial and applicable device clinical
trial.
``(bb) The entry for the drug that is the subject of an
applicable drug clinical trial in the National Library of
Medicine database of structured product labels, if available.
``(iii) Results for existing data bank entries.--The
Secretary may include the links described in clause (ii) for
data bank entries for clinical trials submitted to the data
bank prior to enactment of the Enhancing Drug Safety and
Innovation Act of 2007, as available.
``(B) Feasibility study.--The Director of NIH shall--
``(i) conduct a study to determine the best, validated
methods of making the results of clinical trials publicly
available after the approval of the drug that is the subject
of an applicable drug clinical trial; and
``(ii) not later than 18 months after initiating such
study, submit to the Secretary any findings and
recommendations of such study.
``(C) Negotiated rulemaking.--
``(i) In general.--The Secretary shall establish a
negotiated rulemaking process pursuant to subchapter IV of
chapter 5 of title 5, United States Code, to determine, for
applicable drug clinical trials--
``(I) how to ensure quality and validate methods of
expanding the registry data bank to include clinical trial
results information for trials not within the scope of this
Act;
``(II) the clinical trials of which the results information
is appropriate for adding to the expanded registry data bank;
and
``(III) the appropriate timing of the posting of such
results information.
``(ii) Time requirement.--The process described in
paragraph (1) shall be conducted in a timely manner to ensure
that--
``(I) any recommendation for a proposed rule--
``(aa) is provided to the Secretary not later than 21
months after the date of the enactment of the Enhancing Drug
Safety and Innovation Act of 2007; and
``(bb) includes an assessment of the benefits and costs of
the recommendation; and
``(II) a final rule is promulgated not later than 30 months
after the date of the enactment of the Enhancing Drug Safety
and Innovation Act of 2007, taking into account the
recommendations under subclause (I) and the results of the
feasibility study conducted under subparagraph (B).
``(iii) Representation on negotiated rulemaking
committee.--The negotiated rulemaking committee established
by the Secretary pursuant to clause (i) shall include members
representing--
``(I) the Food and Drug Administration;
``(II) the National Institutes of Health;
``(III) other Federal agencies as the Secretary determines
appropriate;
``(IV) patient advocacy and health care provider groups;
``(V) the pharmaceutical industry;
``(VI) contract clinical research organizations;
``(VII) the International Committee of Medical Journal
Editors; and
``(VIII) other interested parties, including experts in
privacy protection, pediatrics, health information
technology, health literacy, communication, clinical trial
design and implementation, and health care ethics.
``(iv) Content of regulations.--The regulations promulgated
pursuant to clause (i) shall establish--
``(I) procedures to determine which clinical trials results
information data elements shall be included in the registry
data bank, taking into account the needs of different
populations of users of the registry data bank;
``(II) a standard format for the submission of clinical
trials results to the registry data bank;
``(III) a standard procedure for the submission of clinical
trial results information, including the timing of submission
and the timing of posting of results information, to the
registry data bank, taking into account the possible impacts
on publication of manuscripts based on the clinical trial;
``(IV) a standard procedure for the verification of
clinical trial results information, including ensuring that
free text data elements are non-promotional; and
``(V) an implementation plan for the prompt inclusion of
clinical trials results information in the registry data
bank.
``(D) Consideration of world health organization data
set.--The Secretary shall consider the status of the
consensus data elements set for reporting clinical trial
results of the World Health Organization when promulgating
the regulations under subparagraph (C).
``(E) Truthful clinical trial information.--
``(i) In general.--The clinical trial information submitted
by a responsible party under this paragraph shall not be
false or misleading in any particular.
``(ii) Effect.--Clause (i) shall not have the effect of
requiring clinical trial information with respect to an
applicable drug clinical trial or an applicable device
clinical trial to include information from any source other
than such clinical trial involved.
``(F) Waivers regarding certain clinical trial results.--
The Secretary may waive any applicable requirements of this
paragraph for an applicable drug clinical trial or an
applicable device clinical trial, 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.
``(4) Coordination and compliance.--
``(A) Clinical trials supported by grants from federal
agencies.--
``(i) In general.--No Federal agency may release funds
under a research grant to an awardee who has not complied
with paragraph (2) for any applicable drug clinical trial or
applicable device clinical trial for which such person is the
responsible party.
``(ii) Grants from certain federal agencies.--If an
applicable drug clinical trial or applicable device clinical
trial is funded in whole or in part by a grant from the Food
and Drug Administration, National Institutes of Health, the
Agency for Healthcare Research and Quality, or the Department
of Veterans Affairs, any grant or progress report forms
required under such grant shall include a certification that
the responsible party has made all required submissions to
the Director of NIH under paragraph (2).
``(iii) Verification by federal agencies.--The heads of the
agencies referred to in clause (ii), as applicable, shall
verify that the clinical trial information for each
applicable drug clinical trial or applicable device clinical
trial for which a grantee is the responsible party has been
submitted under paragraph (2) before releasing any remaining
funding for a grant or funding for a future grant to such
grantee.
``(iv) Notice and opportunity to remedy.--If the head of an
agency referred to in clause (ii), as applicable, verifies
that a grantee has not submitted clinical trial information
as described in clause (iii), such agency head shall provide
notice to such grantee of such non-compliance and allow such
grantee 30 days to correct such non-compliance and submit the
required clinical trial information.
``(v) Consultation with other federal agencies.--The
Secretary shall--
``(I) consult with other agencies that conduct research
involving human subjects in accordance with any section of
part 46 of title 45, Code of Federal Regulations (or any
successor regulations), to determine if any such research is
an applicable drug clinical trial or an applicable device
clinical trial under paragraph (1); and
``(II) develop with such agencies procedures comparable to
those described in clauses (ii), (iii), and (iv) to ensure
that clinical trial information for such applicable drug
clinical trials and applicable device clinical trial is
submitted under paragraph (2).
[[Page S5349]]
``(B) Certification to accompany drug, biological product,
and device submissions.--At the time of submission of an
application under section 505 of the Federal Food, Drug, and
Cosmetic Act, section 515 of such Act, section 520(m) of such
Act, or section 351 of this Act, or submission of a report
under section 510(k) of such Act, such application or
submission shall be accompanied by a certification that all
applicable requirements of this subsection have been met.
Where available, such certification shall include the
appropriate National Clinical Trial control numbers.
``(C) Verification of submission prior to posting.--In the
case of clinical trial information that is submitted under
paragraph (2), but is not made publicly available pending
regulatory approval or clearance, as applicable, the Director
of NIH shall respond to inquiries from other Federal agencies
and peer-reviewed scientific journals to confirm that such
clinical trial information has been submitted but has not yet
been posted.
``(5) Limitation on disclosure of clinical trial
information.--
``(A) In general.--Nothing in this subsection (or under
section 552 of title 5, United States Code) shall require the
Secretary to publicly disclose, from any record or source
other than the registry data bank expanded under this
subsection, information described in subparagraph (B).
``(B) Information described.--Information described in this
subparagraph is--
``(i) information submitted to the Director of NIH under
this subsection, or information of the same general nature as
(or integrally associated with) the information so submitted;
and
``(ii) not otherwise publicly available, including because
it is protected from disclosure under section 552 of title 5,
United States Code.
``(6) Authorization of appropriations.--There are
authorized to be appropriated to carry out this subsection
$10,000,000 for each fiscal year.''.
(b) Conforming Amendments.--
(1) 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:
``(jj)(1) The failure to submit the certification required
by section 402(j)(4)(B) of the Public Health Service Act, or
knowingly submitting a false certification under such
section.
``(2) The submission of clinical trial information under
subsection (i) or (j) of section 402 of the Public Health
Service Act that is promotional or false or misleading in any
particular under paragraph (2) or (3) of such subsection
(j).''.
(2) Civil money penalties.--Section 303(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)), as amended
by section 203, is further amended by--
(A) redesignating paragraphs (4), (5), and (6) as
paragraphs (5), (6), and (7), respectively;
(B) inserting after paragraph (3) the following:
``(4) Any person who violates section 301(jj) shall be
subject to a civil monetary penalty of not more than $10,000
for the first violation, and not more than $20,000 for each
subsequent violation.'';
(C) in paragraph (2)(C), by striking ``paragraph (4)(A)''
and inserting ``paragraph (5)(A)'';
(D) in paragraph (5), as so redesignated, by striking
``paragraph (1), (2), or (3)'' each place it appears and
inserting ``paragraph (1), (2), (3), or (4)''; and
(E) in paragraph (7), as so redesignated, by striking
``paragraph (5)'' each place it appears and inserting
``paragraph (6)''.
(3) New drugs and devices.--
(A) Investigational new drugs.--Section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is
amended in paragraph (4), by adding at the end the following:
``The Secretary shall update such regulations to require
inclusion in the informed consent form a statement that
clinical trial information for such clinical investigation
has been or will be submitted for inclusion in the registry
data bank pursuant to subsections (i) and (j) of section 402
of the Public Health Service Act.''.
(B) New drug applications.--Section 505(b) of the Federal,
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by
adding at the end the following:
``(6) An application submitted under this subsection shall
be accompanied by the certification required under section
402(j)(4)(B) of the Public Health Service Act. Such
certification shall not be considered an element of such
application.''.
(C) Device reports under section 510(k).--Section 510(k) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k))
is amended by adding at the end the following:
``A notification submitted under this subsection that
contains clinical trial data for an applicable device
clinical trial (as defined in section 402(j)(1) of the Public
Health Service Act) shall be accompanied by the certification
required under section 402(j)(4)(B) of such Act. Such
certification shall not be considered an element of such
notification.''.
(D) Device premarket approval application.--Section 515(c)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360e(c)) is amended--
(i) in subparagraph (F), by striking ``; and'' and
inserting a semicolon;
(ii) by redesignating subparagraph (G) as subparagraph (H);
and
(iii) by inserting after subparagraph (F) the following:
``(G) the certification required under section 402(j)(4)(B)
of the Public Health Service Act (which shall not be
considered an element of such application); and''.
(E) Humanitarian device exemption.--Section 520(m)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c))
is amended in the first sentence in the matter following
subparagraph (C), by inserting at the end before the period
``and such application shall include the certification
required under section 402(j)(4)(B) of the Public Health
Service Act (which shall not be considered an element of such
application)''.
(c) Preemption.--
(1) In general.--No State or political subdivision of a
State may establish or continue in effect any requirement for
the registration of clinical trials or for the inclusion of
information relating to the results of clinical trials in a
database.
(2) Rule of construction.--The fact of submission of
clinical trial information, if submitted in compliance with
subsection (i) and (j) of section 402 of the Public Health
Service Act (as amended by this section), that relates to a
use of a drug or device not included in the official labeling
of the approved drug or device shall not be construed by the
Secretary or in any administrative or judicial proceeding, as
evidence of a new intended use of the drug or device that is
different from the intended use of the drug or device set
forth in the official labeling of the drug or device. The
availability of clinical trial information through the data
bank under such subsections (i) and (j), if submitted in
compliance with such subsections, shall not be considered as
labeling, adulteration, or misbranding of the drug or device
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.).
(d) Transition Rule; Effective Date of Funding
Restrictions.--
(1) Transition rule for clinical trials initiated prior to
expansion of registry data bank.--The responsible party (as
defined in paragraph (1) of section 402(j) of the Public
Health Service Act (as added by this section)) for an
applicable drug clinical trial or applicable device clinical
trial (as defined under such paragraph (1)) that is initiated
after the date of enactment of this subtitle and before the
effective date of the regulations promulgated under paragraph
(2) of such section 402(j), shall submit required clinical
trial information under such section not later than 120 days
after such effective date.
(2) Funding restrictions.--Subparagraph (A) of paragraph
(4) of such section 402(j) shall take effect 210 days after
the effective date of the regulations promulgated under
paragraph (2) of such section 402(j).
(e) Effective Date.--
(1) In general.--Beginning 90 days after the date of
enactment of this title, the responsible party for an
applicable drug clinical trial or an applicable device
clinical trial (as that term is defined in such section
402(j)) that is initiated after the date of enactment of this
title and before the effective date of the regulations issued
under subparagraph (A) of paragraph (2) of such subsection,
shall submit clinical trial information under such paragraph
(2).
(2) Rulemaking.--
(A) In general.--Except as provided in subparagraph (B),
subsection (c)(1) shall become effective on the date on which
the regulation promulgated pursuant to section
402(j)(3)(C)(i) of the Public Health Service Act, as added by
this section, becomes effective.
(B) Exception.--Subsection (c)(1) shall apply with respect
to any clinical trial for which the registry data bank
includes links to results information, as provided for under
section 402(j)(3)(A) of such Act, as added by this section.
Subtitle D--Conflicts of Interest
SEC. 241. CONFLICTS OF INTEREST.
(a) In General.--Subchapter A of chapter VII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is
amended by inserting at the end the following:
``SEC. 712. CONFLICTS OF INTEREST.
``(a) Definitions.--For purposes of this section:
``(1) Advisory committee.--The term `advisory committee'
means an advisory committee under the Federal Advisory
Committee Act that provides advice or recommendations to the
Secretary regarding activities of the Food and Drug
Administration.
``(2) Financial interest.--The term `financial interest'
means a financial interest under section 208(a) of title 18,
United States Code.
``(b) Appointments to Advisory Committees.--
``(1) Recruitment.--
``(A) In general.--Given the importance of advisory
committees to the review process at the Food and Drug
Administration, the Secretary shall carry out informational
and recruitment activities for purposes of recruiting
individuals to serve as advisory committee members. The
Secretary shall seek input from professional medical and
scientific societies to determine the most effective
informational and recruitment activities. The Secretary shall
also take into account the advisory committees with the
greatest number of vacancies.
``(B) Recruitment activities.--The recruitment activities
under subparagraph (A) may include--
[[Page S5350]]
``(i) advertising the process for becoming an advisory
committee member at medical and scientific society
conferences;
``(ii) making widely available, including by using existing
electronic communications channels, the contact information
for the Food and Drug Administration point of contact
regarding advisory committee nominations; and
``(iii) developing a method through which an entity
receiving National Institutes of Health funding can identify
a person who the Food and Drug Administration can contact
regarding the nomination of individuals to serve on advisory
committees.
``(2) Evaluation and criteria.--When considering a term
appointment to an advisory committee, the Secretary shall
review the expertise of the individual and the financial
disclosure report filed by the individual pursuant to the
Ethics in Government Act of 1978 for each individual under
consideration for the appointment, so as to reduce the
likelihood that an appointed individual will later require a
written determination as referred to in section 208(b)(1) of
title 18, United States Code, a written certification as
referred to in section 208(b)(3) of title 18, United States
Code, or a waiver as referred to in subsection (c)(3) of this
section for service on the committee at a meeting of the
committee.
``(c) Granting and Disclosure of Waivers.--
``(1) In general.--Prior to a meeting of an advisory
committee regarding a `particular matter' (as that term is
used in section 208 of title 18, United States Code), each
member of the committee who is a full-time Government
employee or special Government employee shall disclose to the
Secretary financial interests in accordance with subsection
(b) of such section 208.
``(2) Financial interest of advisory committee member or
family member.--No member of an advisory committee may vote
with respect to any matter considered by the advisory
committee if such member (or an immediate family member of
such member) has a financial interest that could be affected
by the advice given to the Secretary with respect to such
matter, excluding interests exempted in regulations issued by
the Director of the Office of Government Ethics as too remote
or inconsequential to affect the integrity of the services of
the Government officers or employees to which such
regulations apply.
``(3) Waiver.--The Secretary may grant a waiver of the
prohibition in paragraph (2) if such waiver is necessary to
afford the advisory committee essential expertise.
``(4) Limitation.--The Secretary may not grant a waiver
under paragraph (3) for a member of an advisory committee
when the member's own scientific work is involved.
``(5) Disclosure of waiver.--Notwithstanding section
107(a)(2) of the Ethics in Government Act (5 U.S.C. App.),
the following shall apply:
``(A) 15 or more days in advance.--As soon as practicable,
but in no case later than 15 days prior to a meeting of an
advisory committee to which a written determination as
referred to in section 208(b)(1) of title 18, United States
Code, a written certification as referred to in section
208(b)(3) of title 18, United States Code, or a waiver as
referred to in paragraph (3) applies, the Secretary shall
disclose (other than information exempted from disclosure
under section 552 of title 5, United States Code, and section
552a of title 5, United States Code (popularly known as the
Freedom of Information Act and the Privacy Act of 1974,
respectively)) on the Internet website of the Food and Drug
Administration--
``(i) the type, nature, and magnitude of the financial
interests of the advisory committee member to which such
determination, certification, or waiver applies; and
``(ii) the reasons of the Secretary for such determination,
certification, or waiver.
``(B) Less than 30 days in advance.--In the case of a
financial interest that becomes known to the Secretary less
than 30 days prior to a meeting of an advisory committee to
which a written determination as referred to in section
208(b)(1) of title 18, United States Code, a written
certification as referred to in section 208(b)(3) of title
18, United States Code, or a waiver as referred to in
paragraph (3) applies, the Secretary shall disclose (other
than information exempted from disclosure under section 552
of title 5, United States Code, and section 552a of title 5,
United States Code) on the Internet website of the Food and
Drug Administration, the information described in clauses (i)
and (ii) of subparagraph (A) as soon as practicable after the
Secretary makes such determination, certification, or waiver,
but in no case later than the date of such meeting.
``(d) Public Record.--The Secretary shall ensure that the
public record and transcript of each meeting of an advisory
committee includes the disclosure required under subsection
(c)(5) (other than information exempted from disclosure under
section 552 of title 5, United States Code, and section 552a
of title 5, United States Code).
``(e) Annual Report.--Not later than February 1 of each
year, the Secretary shall submit to the Inspector General of
the Department of Health and Human Services, the Committee on
Appropriations and the Committee on Health, Education, Labor,
and Pensions of the Senate, and the Committee on
Appropriations and the Committee on Energy and Commerce of
the House of Representatives, a report that describes--
``(1) with respect to the fiscal year that ended on
September 30 of the previous year, the number of vacancies on
each advisory committee, the number of nominees received for
each committee, and the number of such nominees willing to
serve;
``(2) with respect to such year, the aggregate number of
disclosures required under subsection (c)(5) for each meeting
of each advisory committee and the percentage of individuals
to whom such disclosures did not apply who served on such
committee for each such meeting;
``(3) with respect to such year, the number of times the
disclosures required under subsection (c)(5) occurred under
subparagraph (B) of such subsection; and
``(4) how the Secretary plans to reduce the number of
vacancies reported under paragraph (1) during the fiscal year
following such year, and mechanisms to encourage the
nomination of individuals for service on an advisory
committee, including those who are classified by the Food and
Drug Administration as academicians or practitioners.
``(f) Periodic Review of Guidance.--Not less than once
every 5 years, the Secretary shall review guidance of the
Food and Drug Administration regarding conflict of interest
waiver determinations with respect to advisory committees and
update such guidance as necessary.''.
(b) Conforming Amendment.--Section 505(n) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended
by--
(1) striking paragraph (4); and
(2) redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (4), (5), (6), and (7), respectively.
(c) Effective Date.--The amendments made by this section
shall take effect on October 1, 2007.
Subtitle E--Other Drug Safety Provisions
SEC. 251. DATABASE FOR AUTHORIZED GENERIC DRUGS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by this title, is further amended by
adding at the end the following:
``(q) Database for Authorized Generic Drugs.--
``(1) In general.--
``(A) Publication.--The Commissioner shall--
``(i) not later than 9 months after the date of enactment
of the Enhancing Drug Safety and Innovation Act of 2007,
publish a complete list on the Internet website of the Food
and Drug Administration of all authorized generic drugs
(including drug trade name, brand company manufacturer, and
the date the authorized generic drug entered the market); and
``(ii) update the list quarterly to include each authorized
generic drug included in an annual report submitted to the
Secretary by the sponsor of a listed drug during the
preceding 3-month period.
``(B) Notification.--The Commissioner shall notify relevant
Federal agencies, including the Centers for Medicare &
Medicaid Services and the Federal Trade Commission, any time
the Commissioner updates the information described in
subparagraph (A).
``(2) Inclusion.--The Commissioner shall include in the
list described in paragraph (1) each authorized generic drug
included in an annual report submitted to the Secretary by
the sponsor of a listed drug after January 1, 1999.
``(3) Authorized generic drug.--In this section, the term
`authorized generic drug' means a listed drug (as that term
is used in subsection (j)) that--
``(A) has been approved under subsection (c); and
``(B) is marketed, sold, or distributed directly or
indirectly to retail class of trade under a different
labeling, packaging (other than repackaging as the listed
drug in blister packs, unit doses, or similar packaging for
use in institutions), product code, labeler code, trade name,
or trade mark than the listed drug.''.
SEC. 252. MEDICAL MARIJUANA.
The Secretary shall require that State-legalized medical
marijuana be subject to the full regulatory requirements of
the Food and Drug Administration, including a risk evaluation
and mitigation strategy and all other requirements and
penalties of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) regarding safe and effective reviews,
approval, sale, marketing, and use of pharmaceuticals.
TITLE III--MEDICAL DEVICES
SEC. 300. REFERENCES.
Except as otherwise specified, whenever in this title an
amendment is expressed in terms of an amendment to a section
or other provision, the reference shall be considered to be
made to a section or other provision of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
Subtitle A--Device User Fees
SEC. 301. SHORT TITLE.
This subtitle may be cited as the ``Medical Device User Fee
Amendments of 2007''.
SEC. 302. DEVICE FEES.
Section 737 (21 U.S.C. 379i) is amended--
(1) by striking the section designation and all that
follows through ``For purposes of this subchapter'' and
inserting the following:
``SEC. 737. DEVICE FEES.
``(a) Purpose.--It is the purpose of this part that the
fees authorized under this part be dedicated toward
expediting the process
[[Page S5351]]
for the review of device applications and for assuring the
safety and effectiveness of devices, as set forth in the
goals identified for purposes of this part in the letters
from the Secretary to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record.
``(b) Reports.--
``(1) Performance report.--For fiscal years 2008 through
2012, not later than 120 days after the end of each fiscal
year during which fees are collected under this part, the
Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, a report concerning the progress of the Food
and Drug Administration in achieving the goals identified in
the letters described in subsection (a) during such fiscal
year and the future plans of the Food and Drug Administration
for meeting the goals. The report for a fiscal year shall
include information on all previous cohorts for which the
Secretary has not given a complete response on all device
premarket applications, supplements, and premarket
notifications in the cohort.
``(2) Fiscal report.--For fiscal years 2008 through 2012,
not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the
Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, a report on the implementation of the
authority for such fees during such fiscal year and the use,
by the Food and Drug Administration, of the fees collected
during such fiscal year for which the report is made.
``(3) Public availability.--The Secretary shall make the
reports required under paragraphs (1) and (2) available to
the public on the Internet website of the Food and Drug
Administration.
``(c) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and plans for
meeting the goals, for the process for the review of device
applications for the first 5 fiscal years after fiscal year
2012, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the House of
Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under paragraph
(1) to the Congressional committees specified in such
paragraph;
``(B) publish such recommendations in the Federal Register;
``(C) provide for a period of 30 days for the public to
provide written comments on such recommendations;
``(D) hold a meeting at which the public may present its
views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2012, the Secretary shall transmit to Congress
the revised recommendations under paragraph (2), a summary of
the views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
``(d) Definitions.--For purposes of this part:'';
(2) by redesignating paragraphs (5), (6), (7), and (8), as
paragraphs (7), (8), (9), and (11), respectively;
(3) in paragraph (4)--
(A) in subparagraph (A), by striking ``or an efficacy
supplement,'' and inserting ``an efficacy supplement, or a
30-day notice,''; and
(B) by adding at the end the following:
``(F) The term `30-day notice' means a supplement to an
approved premarket application or premarket report under
section 515 that is limited to a request to make
modifications to manufacturing procedures or methods of
manufacture affecting the safety and effectiveness of the
device.'';
(4) by inserting after paragraph (4) the following:
``(5) The term `request for classification information'
means a request made under section 513(g) for information
respecting the class in which a device has been classified or
the requirements applicable to a device.
``(6) The term `annual fee for periodic reporting
concerning a class III device' means the fee associated with
reports imposed by a premarket application approval order (as
described in section 814.82(a)(7) of title 21, Code of
Federal Regulations), usually referred to as `annual
reports.' '';
(5) in paragraph (9), as redesignated by paragraph (2)--
(A) by striking ``April of'' and inserting ``October of'';
and
(B) by striking ``April 2002'' and inserting ``October
2001'';
(6) by inserting after paragraph (9), as redesignated by
paragraph (2), the following:
``(10) The term `person' includes an affiliate of such
person.''; and
(7) by adding at the end the following:
``(12) The term `establishment subject to a registration
fee' means an establishment required to register with the
Secretary under section 510 at which any of the following
types of activities are conducted:
``(A) Manufacturer.--An establishment that makes by any
means any article that is a device including an establishment
that sterilizes or otherwise makes such article for or on
behalf of a specification developer or any other person.
``(B) Single-use device reprocessor.--An establishment that
performs manufacturing operations on a single-use device that
has previously been used on a patient.
``(C) Specification developer.--An establishment that
develops specifications for a device that is distributed
under the establishment's name but that performs no
manufacturing, including establishments that, in addition to
developing specifications, arrange for the manufacturing of
devices labeled with another establishment's name by a
contract manufacturer.
``(13) The term `establishment registration fee' means a
fee assessed under section 738(a)(3) for the registration of
an establishment subject to a registration fee.
``(e) Sunset.--This part shall cease to be effective on
October 1, 2012, except that subsection (b) with respect to
reports shall cease to be effective January 31, 2013.''.
SEC. 303. AUTHORITY TO ASSESS AND USE DEVICE FEES.
Section 738 (21 U.S.C. 379j) is amended--
(1) in subsection (a)--
(A) in paragraph (2)--
(i) in the header, by inserting ``, and annual fee for
periodic reporting concerning a class iii device'' after
``fee'';
(ii) in subparagraph (A)--
(I) in clause (iii), by inserting ``75 percent of'' after
``a fee equal to'';
(II) in clause (iv), by striking ``21.5'' and inserting
``15'';
(III) in clause (v), by striking ``7.2'' and inserting
``7'';
(IV) by redesignating clauses (vi) and (vii) as clauses
(vii) and (viii), respectively;
(V) by inserting after clause (v) the following:
``(vi) For a 30-day notice, a fee equal to 1.6 percent of
the fee that applies under clause (i).'';
(VI) in clause (viii), as redesignated by subclause (IV)--
(aa) by striking ``1.42'' and inserting ``1.84''; and
(bb) by striking ``, subject to any adjustment under
subsection (e)(2)(C)(ii)''; and
(VII) by adding at the end the following:
``(ix) For a request for classification information, a fee
equal to 1.35 percent of the fee that applies under clause
(i).
``(x) For periodic reporting concerning a class III device,
the annual fee shall be equal to 3.5 percent of the fee that
applies under clause (i).'';
(iii) in subparagraph (C)--
(I) in the first sentence--
(aa) by striking ``or''; and
(bb) by striking ``except that'' and all that follows
through the period and inserting ``, 30-day notice, request
for classification information, or periodic report concerning
a class III device.''; and
(II) by striking the third sentence; and
(iv) in subparagraph (D)--
(I) in clause (iii), by striking the last two sentences;
and
(II) by adding at the end the following:
``(iv) Modular application withdrawn before first action.--
The Secretary shall refund 75 percent of the application fee
paid for a modular application submitted under section
515(c)(4) that is withdrawn before a second module is
submitted and before a first action on the first module. If
the modular application is withdrawn after a second or
subsequent module is submitted but before any first action,
the Secretary may return a portion of the fee. The amount of
refund, if any, shall be based on the level of effort already
expended on the review of the modules submitted.
``(v) Sole discretion to refund.--The Secretary shall have
sole discretion to refund a fee or portion of the fee under
this subparagraph. A determination by the Secretary
concerning a refund under this paragraph shall not be
reviewable.''; and
(B) by adding at the end the following:
``(3) Annual establishment registration fee.--
``(A) In general.--Except as provided in subparagraph (B),
each establishment subject to a registration fee shall be
subject to a fee for each initial or annual registration
beginning with its registration for fiscal year 2008.
``(B) Exception for federal or state government
establishment.--No fee shall be required under subparagraph
(A) for an establishment operated by a Federal or State
government entity unless a device manufactured by the
establishment is to be distributed commercially.
``(C) Payment.--The annual establishment registration fee
shall be due once each fiscal year, upon the initial
registration of the establishment or upon the annual
registration under section 510.'';
(2) by striking subsection (b) and inserting the following:
``(b) Fee Amounts.--Except as provided in subsections (c),
(d), and (e), the fees under subsection (a) shall be based on
the following fee amounts:
[[Page S5352]]
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
Fee Type Year 2008 Year 2009 Year 2010 Year 2011 Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application............................... $185,000 $200,725 $217,787 $236,298 $256,384
..........
Establishment Registration Fee...................... $1,706 $1,851 $2,008 $2,179 $2,364'';
----------------------------------------------------------------------------------------------------------------
(3) in subsection (c)--
(A) in the heading, by striking ``Annual Fee Setting.--''
and inserting ``Annual Fee Setting.--'';
(B) in paragraph (1), by striking the second sentence;
(C) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively;
(D) by inserting after paragraph (1) the following:
``(2) Adjustment of annual establishment registration
fee.--
``(A) In general.--When setting the fees for fiscal year
2010, the Secretary may increase the establishment
registration fee specified in subsection (b) only if the
Secretary estimates that the number of establishments
submitting fees for fiscal year 2009 is less than 12,250. The
percent increase shall be the percent by which the estimate
of establishments submitting fees in fiscal year 2009 is less
than 12,750, but in no case shall the percent increase be
more than 8.5 percent over the amount for such fee specified
in subsection (b) for fiscal year 2010. If the Secretary
makes any adjustment to the establishment registration fee
for fiscal year 2010, then the establishment registration fee
for fiscal years 2011 and 2012 under subsection (b) shall be
adjusted as follows: the fee for fiscal year 2011 shall be
equal to the adjusted fee for fiscal year 2010, increased by
8.5 percent, and the fee for fiscal year 2012 shall be equal
to the adjusted fee for fiscal year 2011, increased by 8.5
percent.
``(B) Publication in the federal register.--The Secretary
shall publish any determination with respect to any
establishment registration fee adjustment made under
subparagraph (A), and the rationale for such determination,
in the Federal Register.''; and
(E) in paragraph (4)(A), as so redesignated--
(i) by striking ``For fiscal years 2006 and 2007, the'' and
inserting ``The''; and
(ii) by striking ``of fiscal year 2008'' and inserting ``of
the next fiscal year'';
(4) in subsection (d)--
(A) in paragraph (1), by striking ``, partners, and parent
firms'';
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``, partners, and
parent firms'';
(ii) in subparagraph (B)--
(I) by striking ``An applicant shall'' and inserting the
following:
``(i) In general.--An applicant shall'';
(II) by striking ``The applicant shall support'' and
inserting the following:
``(ii) Firms submitting tax returns to the united states
internal revenue service.--The applicant shall support'';
(III) by striking ``, partners, and parent firms'' both
places the term appears;
(IV) by striking ``partners, or parent firms, the'' and
inserting ``the'';
(V) by striking ``, partners, or parent firms,
respectively''; and
(VI) by adding at the end the following:
``(iii) Firms not submitting tax returns to the united
states internal revenue service.--The applicant shall support
its claim that it meets the definition under subparagraph (A)
by submission of the following:
``(I) A signed certification, in such form as the Secretary
may direct through a notice published in the Federal
Register, that the applicant meets the criteria for a small
business.
``(II) A certification, in English, from the national
taxing authority of the country in which it is headquartered.
Such certification shall provide the applicant's gross
receipts and sales for the most recent year, in both the
local currency and in United States dollars, the exchange
rate used in making this conversion to dollars, and the dates
during which these receipts and sales were collected, and it
shall bear the official seal of the national taxing
authority.
``(III) Identical certifications shall be provided for each
of the applicant's affiliates.
``(IV) A statement signed by the head of the applicant or
its chief financial officer that it has submitted
certifications for all of its affiliates, or that it had no
affiliates, whichever is applicable.''; and
(iii) in subparagraph (C)--
(I) by striking ``reduced rate of'' and inserting ``reduced
rate of--''; and
(II) by striking ``38 percent'' and all that follows
through the period and inserting the following:
``(i) 25 percent of the fee established under such
subsection for a premarket application, a premarket report, a
supplement, or a periodic report concerning a class III
device; and
``(ii) 50 percent of the fee established under such
subsection for a 30-day notice or a request for
classification information.'';
(5) in subsection (e)--
(A) in paragraph (1), by striking ``2004'' and inserting
``2008''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``, partners, and
parent firms'';
(ii) by striking subparagraph (B) and inserting the
following:
``(B) Evidence of qualification.--
``(i) In general.--An applicant shall pay the higher fees
established by the Secretary each year unless the applicant
submits evidence that it qualifies for the lower fee rate.
``(ii) Firms submitting tax returns to the united states
internal revenue service.--The applicant shall support its
claim that it meets the definition under subparagraph (A) by
submission of a copy of its most recent Federal income tax
return for a taxable year, and a copy of such returns of its
affiliates, which show an amount of gross sales or receipts
that is less than the maximum established in subparagraph
(A). The applicant, and each of such affiliates, shall
certify that the information provided is a true and accurate
copy of the actual tax forms they submitted to the Internal
Revenue Service. If no tax forms are submitted for
affiliates, the applicant shall certify that the applicant
has no affiliates.
``(iii) Firms not submitting tax returns to the united
states internal revenue service.--The applicant shall support
its claim that it meets the definition under subparagraph (A)
by submission of the following:
``(I) A signed certification, in such form as the Secretary
may direct through a notice published in the Federal
Register, that the applicant meets the criteria for a small
business.
``(II) A certification, in English, from the national
taxing authority of the country in which it is headquartered.
Such certification shall provide the applicant's gross
receipts and sales for the most recent year, in both the
local currency and in United States dollars, and the exchange
rate used in making such conversion to dollars, and the dates
during which such receipts and sales were collected, and it
shall bear the official seal of the national taxing
authority.
``(III) Identical certifications shall be provided for each
of the applicant's affiliates.
``(IV) A statement signed by the head of the applicant or
its chief financial officer that it has submitted
certifications for all of its affiliates, or that it had no
affiliates, whichever is applicable.''; and
(iii) by striking subparagraph (C) and inserting the
following:
``(C) Reduced fees.--For fiscal year 2008 and each
subsequent fiscal year, where the Secretary finds that the
applicant involved meets the definition under subparagraph
(A), the fee for a premarket notification submission may be
paid at 50 percent of the fee that applies under subsection
(a)(2)(A)(viii) and as established under subsection
(c)(1).'';
(6) by striking subsection (f) and inserting the following:
``(f) Effect of Failure to Pay Fees.--
``(1) In general.--A premarket application, premarket
report, supplement, or premarket notification submission, 30-
day notice, request for classification information, or
periodic report concerning a class III device submitted by a
person subject to fees under paragraphs (2) and (3) of
subsection (a) shall be considered incomplete and shall not
be accepted by the Secretary until all fees owed by such
person have been paid.
``(2) Registration information.--Registration information
submitted by an establishment subject to a registration fee
under subsection (a)(3) shall be considered incomplete and
shall not be accepted by the Secretary until the registration
fee owed for the establishment has been paid. Until the fee
is paid and the registration is complete, the establishment
shall be deemed to have failed to register in accordance with
section 510.'';
(7) in subsection (g)--
(A) by striking paragraph (1) and inserting the following:
``(1) Performance goals; termination of program.--With
respect to the amount that, under the salaries and expenses
account of the Food and Drug Administration, is appropriated
for a fiscal year for devices and radiological products, fees
may not be assessed under subsection (a) for the fiscal year,
and the Secretary is not expected to meet any performance
goals identified for the fiscal year, if--
``(A) the amount so appropriated for the fiscal year,
excluding the amount of fees appropriated for the fiscal
year, is more than 1 percent less than $205,720,000
multiplied by the adjustment factor applicable to such fiscal
year; or
``(B) fees were not assessed under subsection (a) for the
previous fiscal year.''; and
(B) in paragraph (2), by striking ``and premarket
notification submissions, and'' and inserting ``premarket
notification submissions, 30-day notices, requests for
classification information, periodic reports concerning a
class III device, and establishment registrations''; and
(8) in subsection (h), by striking paragraphs (3) and (4)
and inserting the following:
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section--
[[Page S5353]]
``(A) $48,431,000 for fiscal year 2008;
``(B) $52,547,000 for fiscal year 2009;
``(C) $57,014,000 for fiscal year 2010;
``(D) $61,860,000 for fiscal year 2011; and
``(E) $67,118,000 for fiscal year 2012.
``(4) Offset.--If the cumulative amount of fees collected
during fiscal years 2008, 2009, and 2010, added to the amount
estimated to be collected for fiscal year 2011 (which
estimate shall be based upon the amount of fees received by
the Secretary through June 30, 2011), exceeds the amount of
fees specified in aggregate in paragraph (3) for such 4
fiscal years, the aggregate amount in excess shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for fiscal year 2012.''.
SEC. 304. SAVINGS CLAUSE.
Notwithstanding section 107 of the Medical Device User Fee
and Modernization Act of 2002 (Public Law 107-250), and
notwithstanding the amendments made by this subtitle, part 3
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of
enactment of this subtitle, shall continue to be in effect
with respect to premarket applications, premarket reports,
premarket notification submissions, and supplements (as
defined in such part as of such day) that on or after October
1, 2002, but before October 1, 2007, were accepted by the
Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2008.
SEC. 305. EFFECTIVE DATE.
The amendments made by this subtitle shall take effect on
October 1, 2007.
Subtitle B--Amendments Regarding Regulation of Medical Devices
SEC. 311. INSPECTIONS BY ACCREDITED PERSONS.
Section 704(g) (21 U.S.C. 374(g)) is amended--
(1) in paragraph (1), by striking ``Not later than one year
after the date of enactment of this subsection, the
Secretary'' and inserting ``The Secretary'';
(2) in paragraph (2), by--
(A) striking ``Not later than 180 days after the date of
enactment of this subsection, the'' and inserting ``The
Secretary''; and
(B) striking the fifth sentence;
(3) in paragraph (3), by adding at the end the following:
``(F) Such person shall notify the Secretary of any
withdrawal, suspension, restriction, or expiration of
certificate of conformance with the quality systems standard
referred to in paragraph (7) for any device establishment
that such person inspects under this subsection not later
than 30 days after such withdrawal, suspension, restriction,
or expiration.
``(G) Such person may conduct audits to establish
conformance with the quality systems standard referred to in
paragraph (7).'';
(4) by amending paragraph (6) to read as follows:
``(6)(A) Subject to subparagraphs (B) and (C), a device
establishment is eligible for inspection by persons
accredited under paragraph (2) if the following conditions
are met:
``(i) The Secretary classified the results of the most
recent inspection of the establishment as `no action
indicated' or `voluntary action indicated'.
``(ii) With respect to inspections of the establishment to
be conducted by an accredited person, the owner or operator
of the establishment submits to the Secretary a notice that--
``(I) provides the date of the last inspection of the
establishment by the Secretary and the classification of that
inspection;
``(II) states the intention of the owner or operator to use
an accredited person to conduct inspections of the
establishment;
``(III) identifies the particular accredited person the
owner or operator intends to select to conduct such
inspections; and
``(IV) includes a certification that, with respect to the
devices that are manufactured, prepared, propagated,
compounded, or processed in the establishment--
``(aa) at least 1 of such devices is marketed in the United
States; and
``(bb) at least 1 of such devices is marketed, or is
intended to be marketed, in 1 or more foreign countries, 1 of
which countries certifies, accredits, or otherwise recognizes
the person accredited under paragraph (2) and identified
under subclause (III) as a person authorized to conduct
inspections of device establishments.
``(B)(i) Except with respect to the requirement of
subparagraph (A)(i), a device establishment is deemed to have
clearance to participate in the program and to use the
accredited person identified in the notice under subparagraph
(A)(ii) for inspections of the establishment unless the
Secretary, not later than 30 days after receiving such
notice, issues a response that--
``(I) denies clearance to participate as provided under
subparagraph (C); or
``(II) makes a request under clause (ii).
``(ii) The Secretary may request from the owner or operator
of a device establishment in response to the notice under
subparagraph (A)(ii) with respect to the establishment, or
from the particular accredited person identified in such
notice--
``(I) compliance data for the establishment in accordance
with clause (iii)(I); or
``(II) information concerning the relationship between the
owner or operator of the establishment and the accredited
person identified in such notice in accordance with clause
(iii)(II).
The owner or operator of the establishment, or such
accredited person, as the case may be, shall respond to such
a request not later than 60 days after receiving such
request.
``(iii)(I) The compliance data to be submitted by the owner
or operation of a device establishment in response to a
request under clause (ii)(I) are data describing whether the
quality controls of the establishment have been sufficient
for ensuring consistent compliance with current good
manufacturing practice within the meaning of section 501(h)
and with other applicable provisions of this Act. Such data
shall include complete reports of inspectional findings
regarding good manufacturing practice or other quality
control audits that, during the preceding 2-year period, were
conducted at the establishment by persons other than the
owner or operator of the establishment, together with all
other compliance data the Secretary deems necessary. Data
under the preceding sentence shall demonstrate to the
Secretary whether the establishment has facilitated
consistent compliance by promptly correcting any compliance
problems identified in such inspections.
``(II) A request to an accredited person under clause
(ii)(II) may not seek any information that is not required to
be maintained by such person in records under subsection
(f)(1).
``(iv) A device establishment is deemed to have clearance
to participate in the program and to use the accredited
person identified in the notice under subparagraph (A)(ii)
for inspections of the establishment unless the Secretary,
not later than 60 days after receiving the information
requested under clause (ii), issues a response that denies
clearance to participate as provided under subparagraph (C).
``(C)(i) The Secretary may deny clearance to a device
establishment if the Secretary has evidence that the
certification under subparagraph (A)(ii)(IV) is untrue and
the Secretary provides to the owner or operator of the
establishment a statement summarizing such evidence.
``(ii) The Secretary may deny clearance to a device
establishment if the Secretary determines that the
establishment has failed to demonstrate consistent compliance
for purposes of subparagraph (B)(iii)(I) and the Secretary
provides to the owner or operator of the establishment a
statement of the reasons for such determination.
``(iii)(I) The Secretary may reject the selection of the
accredited person identified in the notice under subparagraph
(A)(ii) if the Secretary provides to the owner or operator of
the establishment a statement of the reasons for such
rejection. Reasons for the rejection may include that the
establishment or the accredited person, as the case may be,
has failed to fully respond to the request, or that the
Secretary has concerns regarding the relationship between the
establishment and such accredited person.
``(II) If the Secretary rejects the selection of an
accredited person by the owner or operator of a device
establishment, the owner or operator may make an additional
selection of an accredited person by submitting to the
Secretary a notice that identifies the additional selection.
Clauses (i) and (ii) of subparagraph (B), and subclause (I)
of this clause, apply to the selection of an accredited
person through a notice under the preceding sentence in the
same manner and to the same extent as such provisions apply
to a selection of an accredited person through a notice under
subparagraph (A)(ii).
``(iv) In the case of a device establishment that is denied
clearance under clause (i) or (ii) or with respect to which
the selection of the accredited person is rejected under
clause (iii), the Secretary shall designate a person to
review the statement of reasons, or statement summarizing
such evidence, as the case may be, of the Secretary under
such clause if, during the 30-day period beginning on the
date on which the owner or operator of the establishment
receives such statement, the owner or operator requests the
review. The review shall commence not later than 30 days
after the owner or operator requests the review, unless the
Secretary and the owner or operator otherwise agree.'';
(5) in paragraph (7)--
(A) by amending subparagraph (A) to read as follows:
``(A) Persons accredited under paragraph (2) to conduct
inspections shall record in writing their inspection
observations and shall present the observations to the device
establishment's designated representative and describe each
observation. Additionally, such accredited person shall
prepare an inspection report in a form and manner designated
by the Secretary to conduct inspections, taking into
consideration the goals of international harmonization of
quality systems standards. Any official classification of the
inspection shall be determined by the Secretary.''; and
(B) by adding at the end the following:
``(F) For the purpose of setting risk-based inspectional
priorities, the Secretary shall accept voluntary submissions
of reports of audits assessing conformance with appropriate
quality systems standards set by the International
Organization for Standardization (ISO) and identified by the
Secretary in public notice. If the owner or operator of an
establishment elects to submit audit reports under this
subparagraph, the owner or operator shall submit all such
audit reports with
[[Page S5354]]
respect to the establishment during the preceding 2-year
periods.''; and
(6) in paragraphs (10)(C)(iii), by striking ``based'' and
inserting ``base''.
SEC. 312. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF
PREMARKET NOTIFICATION.
Section 523(c) (21 U.S.C. 360m(c)) is amended by striking
``2007'' and inserting ``2012''.
SEC. 313. REGISTRATION.
(a) Annual Registration of Producers of Drugs and
Devices.--Section 510(b) (21 U.S.C. 359(b)) is amended--
(1) by redesignating the existing text as paragraph (1),
and indenting and relocating it appropriately;
(2) in paragraph (1), as so redesignated, by striking ``or
a device or devices''; and
(3) by adding at the end the following new paragraph:
``(2) Between October 1 and December 31 of each year every
person who owns or operates any establishment in any State
engaged in the manufacture, preparation, propagation,
compounding, or processing of a device or devices shall
register with the Secretary his name, places of business, and
all such establishments.''.
(b) Registration of Foreign Establishments.--Section
510(i)(1) (21 U.S.C. 359(i)(1)) is amended--
(1) by redesignating the existing text as subparagraph (A),
and indenting and relocating it appropriately;
(2) in subparagraph (A), as so redesignated--
(A) by striking ``processing of a drug or a device that is
imported'' and inserting ``processing of a drug that is
imported''; and
(B) by striking ``or device'' each place it appears; and
(3) by adding after such subparagraph (A) the following new
subparagraph:
``(B) Between October 1 and December 31 of each year, any
establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or
processing of a device that is imported or offered for import
into the United States shall, through electronic means in
accordance with the criteria of the Secretary, register with
the Secretary the name and place of business of the
establishment, the name of the United States agent for the
establishment, the name of each importer of such device in
the United States that is known to the establishment, and the
name of each person who imports or offers for import such
device to the United States for purposes of importation.''.
SEC. 314. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED
PREPARED, PROPAGATED AND COMPOUNDED BY
REGISTRANTS; STATEMENTS; ACCOMPANYING
DISCLOSURES.
Section 510(j)(2) (21 U.S.C. 360(j)(2) is amended, in the
matter preceding subparagraph (A), to read as follows:
``(2) Each person who registers with the Secretary under
this section shall report to the Secretary (i) with regard to
drugs, once during the month of June of each year and once
during the month of December of each year, and (ii) with
regard to devices, once each year between October 1 and
December 31, the following information:''.
SEC. 315. ELECTRONIC REGISTRATION AND LISTING.
Section 510(p) (21 U.S.C. 360(p)) is amended to read as
follows:
``(p)(1) With regard to any establishment engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug, registrations under subsections (b),
(c), (d), and (i) of this section (including the submission
of updated information) shall be submitted to the Secretary
by electronic means, upon a finding by the Secretary that the
electronic receipt of such registrations is feasible, unless
the Secretary grants a request for waiver of such requirement
because use of electronic means is not reasonable for the
person requesting such waiver.
``(2) With regard to any establishment engaged in the
manufacture, preparation, propagation, compounding, or
processing of a device, the registration and listing
information required by this section shall be submitted to
the Secretary by electronic means, unless the Secretary
grants a waiver because electronic registration and listing
is not reasonable for the person requesting such waiver.''.
TITLE IV--PEDIATRIC MEDICAL PRODUCTS
Subtitle A--Best Pharmaceuticals for Children
SEC. 401. SHORT TITLE.
This subtitle may be cited as the ``Best Pharmaceuticals
for Children Amendments of 2007''.
SEC. 402. PEDIATRIC STUDIES OF DRUGS.
(a) In General.--Section 505A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a) is amended--
(1) in subsection (a), by inserting before the period at
the end the following: ``, and, at the discretion of the
Secretary, may include preclinical studies'';
(2) in subsection (b)--
(A) in paragraph (1)(A)(i), by striking ``(D)'' both places
it appears and inserting ``(E)'';
(B) in paragraph (1)(A)(ii), by striking ``(D)'' and
inserting ``(E)'';
(C) by striking ``(1)(A)(i)'' and inserting ``(A)(i)(I)'';
(D) by striking ``(ii) the'' and inserting ``(II) the'';
(E) by striking ``(B) if the drug is designated'' and
inserting ``(ii) if the drug is designated'';
(F) by striking ``(2)(A)'' and inserting ``(B)(i)'';
(G) by striking ``(i) a listed patent'' and inserting ``(I)
a listed patent'';
(H) by striking ``(ii) a listed patent'' and inserting
``(II) a listed patent'';
(I) by striking ``(B) if the drug is the subject'' and
inserting ``(ii) if the drug is the subject'';
(J) by striking ``If'' and all that follows through
``subsection (d)(3)'' and inserting the following:
``(1) In general.--Except as provided in paragraph (2), if,
prior to approval of an application that is submitted under
section 505(b)(1), the Secretary determines that information
relating to the use of a new drug in the pediatric population
may produce health benefits in that population, the Secretary
makes a written request for pediatric studies (which shall
include a timeframe for completing such studies), the
applicant agrees to the request, such studies are completed
using appropriate formulations for each age group for which
the study is requested within any such timeframe, and the
reports thereof are submitted and accepted in accordance with
subsection (d)(3), and if the Secretary determines that
labeling changes are appropriate, such changes are made
within the timeframe requested by the Secretary--''; and
(K) by adding at the end the following:
``(2) Exception.--The Secretary shall not extend a period
referred to in paragraph (1)(A) or in paragraph (1)(B) later
than 9 months prior to the expiration of such period.'';
(3) in subsection (c)--
(A) in paragraph (1)(A)(i), by striking ``(D)'' both places
it appears and inserting ``(E)'';
(B) in paragraph (1)(A)(ii), by striking ``(D)'' and
inserting ``(E)'';
(C) by striking ``(1)(A)(i)'' and inserting ``(A)(i)(I)'';
(D) by striking ``(ii) the'' and inserting ``(II) the'';
(E) by striking ``(B) if the drug is designated'' and
inserting ``(ii) if the drug is designated'';
(F) by striking ``(2)(A)'' and inserting ``(B)(i)'';
(G) by striking ``(i) a listed patent'' and inserting ``(I)
a listed patent'';
(H) by striking ``(ii) a listed patent'' and inserting
``(II) a listed patent'';
(I) by striking ``(B) if the drug is the subject'' and
inserting ``(ii) if the drug is the subject'';
(J) by striking ``If'' and all that follows through
``subsection (d)(3)'' and inserting the following:
``(1) In general.--Except as provided in paragraph (2), if
the Secretary determines that information relating to the use
of an approved drug in the pediatric population may produce
health benefits in that population and makes a written
request to the holder of an approved application under
section 505(b)(1) for pediatric studies (which shall include
a timeframe for completing such studies), the holder agrees
to the request, such studies are completed using appropriate
formulations for each age group for which the study is
requested within any such timeframe, and the reports thereof
are submitted and accepted in accordance with subsection
(d)(3), and if the Secretary determines that labeling changes
are appropriate, such changes are made within the timeframe
requested by the Secretary--''; and
(K) by adding at the end the following:
``(2) Exception.--The Secretary shall not extend a period
referred to in paragraph (1)(A) or in paragraph (1)(B) later
than 9 months prior to the expiration of such period.'';
(4) by striking subsection (d) and inserting the following:
``(d) Conduct of Pediatric Studies.--
``(1) Request for studies.--
``(A) In general.--The Secretary may, after consultation
with the sponsor of an application for an investigational new
drug under section 505(i), the sponsor of an application for
a new drug under section 505(b)(1), or the holder of an
approved application for a drug under section 505(b)(1),
issue to the sponsor or holder a written request for the
conduct of pediatric studies for such drug. In issuing such
request, the Secretary shall take into account adequate
representation of children of ethnic and racial minorities.
Such request to conduct pediatric studies shall be in writing
and shall include a timeframe for such studies and a request
to the sponsor or holder to propose pediatric labeling
resulting from such studies.
``(B) Single written request.--A single written request--
``(i) may relate to more than 1 use of a drug; and
``(ii) may include uses that are both approved and
unapproved.
``(2) Written request for pediatric studies.--
``(A) Request and response.--
``(i) In general.--If the Secretary makes a written request
for pediatric studies (including neonates, as appropriate)
under subsection (b) or (c), the applicant or holder, not
later than 180 days after receiving the written request,
shall respond to the Secretary as to the intention of the
applicant or holder to act on the request by--
``(I) indicating when the pediatric studies will be
initiated, if the applicant or holder agrees to the request;
or
``(II) indicating that the applicant or holder does not
agree to the request and the reasons for declining the
request.
``(ii) Disagree with request.--If, on or after the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, the applicant or holder does not agree
[[Page S5355]]
to the request on the grounds that it is not possible to
develop the appropriate pediatric formulation, the applicant
or holder shall submit to the Secretary the reasons such
pediatric formulation cannot be developed.
``(B) Adverse event reports.--An applicant or holder that,
on or after the date of enactment of the Best Pharmaceuticals
for Children Amendments of 2007, agrees to the request for
such studies shall provide the Secretary, at the same time as
submission of the reports of such studies, with all
postmarket adverse event reports regarding the drug that is
the subject of such studies and are available prior to
submission of such reports.
``(3) Meeting the studies requirement.--Not later than 180
days after the submission of the reports of the studies, the
Secretary shall accept or reject such reports and so notify
the sponsor or holder. The Secretary's only responsibility in
accepting or rejecting the reports shall be to determine,
within the 180 days, whether the studies fairly respond to
the written request, have been conducted in accordance with
commonly accepted scientific principles and protocols, and
have been reported in accordance with the requirements of the
Secretary for filing.
``(4) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.'';
(5) by striking subsections (e) and (f) and inserting the
following:
``(e) Notice of Determinations on Studies Requirement.--
``(1) In general.--The Secretary shall publish a notice of
any determination, made on or after the date of enactment of
the Best Pharmaceuticals for Children Amendments of 2007,
that the requirements of subsection (d) have been met and
that submissions and approvals under subsection (b)(2) or (j)
of section 505 for a drug will be subject to the provisions
of this section. Such notice shall be published not later
than 30 days after the date of the Secretary's determination
regarding market exclusivity and shall include a copy of the
written request made under subsection (b) or (c).
``(2) Identification of certain drugs.--The Secretary shall
publish a notice identifying any drug for which, on or after
the date of enactment of the Best Pharmaceuticals for
Children Amendments of 2007, a pediatric formulation was
developed, studied, and found to be safe and effective in the
pediatric population (or specified subpopulation) if the
pediatric formulation for such drug is not introduced onto
the market within 1 year of the date that the Secretary
publishes the notice described in paragraph (1). Such notice
identifying such drug shall be published not later than 30
days after the date of the expiration of such 1 year period.
``(f) Internal Review of Written Requests and Pediatric
Studies.--
``(1) Internal review.--
``(A) In general.--The Secretary shall create an internal
review committee to review all written requests issued and
all reports submitted on or after the date of enactment of
the Best Pharmaceuticals for Children Amendments of 2007, in
accordance with paragraphs (2) and (3).
``(B) Members.--The committee under subparagraph (A) shall
include individuals, each of whom is an employee of the Food
and Drug Administration, with the following expertise:
``(i) Pediatrics.
``(ii) Biopharmacology.
``(iii) Statistics.
``(iv) Drugs and drug formulations.
``(v) Legal issues.
``(vi) Appropriate expertise pertaining to the pediatric
product under review.
``(vii) One or more experts from the Office of Pediatric
Therapeutics, including an expert in pediatric ethics.
``(viii) Other individuals as designated by the Secretary.
``(2) Review of written requests.--All written requests
under this section shall be reviewed and approved by the
committee established under paragraph (1) prior to being
issued.
``(3) Review of pediatric studies.--The committee
established under paragraph (1) shall review all studies
conducted pursuant to this section to determine whether to
accept or reject such reports under subsection (d)(3).
``(4) Tracking pediatric studies and labeling changes.--The
committee established under paragraph (1) shall be
responsible for tracking and making available to the public,
in an easily accessible manner, including through posting on
the website of the Food and Drug Administration--
``(A) the number of studies conducted under this section;
``(B) the specific drugs and drug uses, including labeled
and off-labeled indications, studied under this section;
``(C) the types of studies conducted under this section,
including trial design, the number of pediatric patients
studied, and the number of centers and countries involved;
``(D) the number of pediatric formulations developed and
the number of pediatric formulations not developed and the
reasons such formulations were not developed;
``(E) the labeling changes made as a result of studies
conducted under this section;
``(F) an annual summary of labeling changes made as a
result of studies conducted under this section for
distribution pursuant to subsection (k)(2); and
``(G) information regarding reports submitted on or after
the date of enactment of the Best Pharmaceuticals for
Children Amendments of 2007.'';
(6) in subsection (g)--
(A) in paragraph (1)--
(i) by striking ``(c)(1)(A)(ii)'' and inserting
``(c)(1)(A)(i)(II)''; and
(ii) by striking ``(c)(2)'' and inserting ``(c)(1)(B)'';
(B) in paragraph (2), by striking ``(c)(1)(B)'' and
inserting ``(c)(1)(A)(ii)'';
(C) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively;
(D) by striking ``Limitations.--A drug'' and inserting
``Limitations.--
``(1) In general.--Notwithstanding subsection (c)(2), a
drug''; and
(E) by adding at the end the following:
``(2) Exclusivity adjustment.--
``(A) Adjustment.--
``(i) In general.--With respect to any drug, if the
organization designated under subparagraph (B) notifies the
Secretary that the combined annual gross sales for all drugs
with the same active moiety exceeded $1,000,000,000 in any
calendar year prior to the time the sponsor or holder agrees
to the initial written request pursuant to subsection (d)(2),
then each period of market exclusivity deemed or extended
under subsection (b) or (c) shall be reduced by 3 months for
such drug.
``(ii) Determination.--The determination under clause (i)
of the combined annual gross sales shall be determined--
``(I) taking into account only those sales within the
United States; and
``(II) taking into account only the sales of all drugs with
the same active moiety of the sponsor or holder and its
affiliates.
``(B) Designation.--The Secretary shall designate an
organization other than the Food and Drug Administration to
evaluate whether the combined annual gross sales for all
drugs with the same active moiety exceeded $1,000,000,000 in
a calendar year as described in subparagraph (A). Prior to
designating such organization, the Secretary shall determine
that such organization is independent and is qualified to
evaluate the sales of pharmaceutical products. The Secretary
shall re-evaluate the designation of such organization once
every 3 years.
``(C) Notification.--Once a year at a time designated by
the Secretary, the organization designated under subparagraph
(B) shall notify the Food and Drug Administration of all
drugs with the same active moiety with combined annual gross
sales that exceed $1,000,000,000 during the previous calendar
year.'';
(7) in subsection (i)--
(A) in the heading, by striking ``Supplements'' and
inserting ``Changes'';
(B) in paragraph (1)--
(i) in the heading, by inserting ``applications and'' after
``pediatric'';
(ii) by inserting ``application or'' after ``Any'';
(iii) by striking ``change pursuant to a report on a
pediatric study under'' and inserting ``change as a result of
any pediatric study conducted pursuant to''; and
(iv) by inserting ``application or'' after ``to be a
priority''; and
(C) in paragraph (2)(A), by--
(i) striking ``If the Commissioner'' and inserting ``If, on
or after the date of enactment of the Best Pharmaceuticals
for Children Amendments of 2007, the Commissioner''; and
(ii) striking ``an application with'' and all that follows
through ``on appropriate'' and inserting ``the sponsor and
the Commissioner have been unable to reach agreement on
appropriate'';
(8) by striking subsection (m);
(9) by redesignating subsections (j), (k), (l), and (n), as
subsections (k), (m), (o), and (p), respectively;
(10) by inserting after subsection (i) the following:
``(j) Other Labeling Changes.--If, on or after the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, the Secretary determines that a pediatric study
conducted under this section does or does not demonstrate
that the drug that is the subject of the study is safe and
effective, including whether such study results are
inconclusive, in pediatric populations or subpopulations, the
Secretary shall order the labeling of such product to include
information about the results of the study and a statement of
the Secretary's determination.'';
(11) in subsection (k), as redesignated by paragraph (9)--
(A) in paragraph (1)--
(i) by striking ``a summary of the medical and'' and
inserting ``the medical, statistical, and''; and
(ii) by striking ``for the supplement'' and all that
follows through the period and inserting ``under subsection
(b) or (c).'';
(B) by redesignating paragraph (2) as paragraph (3); and
(C) by inserting after paragraph (1) the following:
``(2) Dissemination of information regarding labeling
changes.--Beginning on the date of enactment of the Best
Pharmaceuticals for Children Amendments of 2007, the
Secretary shall require that the sponsors of the studies that
result in labeling changes that are reflected in the annual
summary developed pursuant to subsection (f)(4)(F)
distribute, at least annually (or more frequently if the
Secretary determines that it would be beneficial to the
public health), such information to physicians and other
health care providers.'';
[[Page S5356]]
(12) by inserting after subsection (k), as redesignated by
paragraph (9), the following:
``(l) Adverse Event Reporting.--
``(1) Reporting in year one.--Beginning on the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, during the 1-year period beginning on the date a
labeling change is made pursuant to subsection (i), the
Secretary shall ensure that all adverse event reports that
have been received for such drug (regardless of when such
report was received) are referred to the Office of Pediatric
Therapeutics established under section 6 of the Best
Pharmaceuticals for Children Act (Public Law 107-109). In
considering such reports, the Director of such Office shall
provide for the review of the report by the Pediatric
Advisory Committee, including obtaining any recommendations
of such Committee regarding whether the Secretary should take
action under this section in response to such reports.
``(2) Reporting in subsequent years.--Following the 1-year
period described in paragraph (1), the Secretary shall, as
appropriate, refer to the Office of Pediatric Therapeutics
all pediatric adverse event reports for a drug for which a
pediatric study was conducted under this section. In
considering such reports, the Director of such Office may
provide for the review of such reports by the Pediatric
Advisory Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should take
action in response to such reports.
``(3) Effect.--The requirements of this subsection shall
supplement, not supplant, other review of such adverse event
reports by the Secretary.'';
(13) by inserting after subsection (m), as redesignated by
paragraph (9), the following:
``(n) Referral if Pediatric Studies Not Completed.--
``(1) In general.--Beginning on the date of enactment of
the Best Pharmaceuticals for Children Amendments of 2007, if
pediatric studies of a drug have not been completed under
subsection (d) and if the Secretary, through the committee
established under subsection (f), determines that there is a
continuing need for information relating to the use of the
drug in the pediatric population (including neonates, as
appropriate), the Secretary shall carry out the following:
``(A) For a drug for which a listed patent has not expired,
make a determination regarding whether an assessment shall be
required to be submitted under section 505B. Prior to making
such determination, the Secretary may take not more than 60
days to certify whether the Foundation for the National
Institutes of Health has sufficient funding at the time of
such certification to initiate 1 or more of the pediatric
studies of such drug referred to in the sentence preceding
this paragraph and fund 1 or more of such studies in their
entirety. Only if the Secretary makes such certification in
the affirmative, the Secretary shall refer such pediatric
study or studies to the Foundation for the National
Institutes of Health for the conduct of such study or
studies.
``(B) For a drug that has no listed patents or has 1 or
more listed patents that have expired, the Secretary shall
refer the drug for inclusion on the list established under
section 409I of the Public Health Service Act for the conduct
of studies.
``(2) Public notice.--The Secretary shall give the public
notice of--
``(A) a decision under paragraph (1)(A) not to require an
assessment under section 505B and the basis for such
decision; and
``(B) any referral under paragraph (1)(B) of a drug for
inclusion on the list established under section 409I of the
Public Health Service Act.
``(3) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.'';
and
(14) in subsection (p), as redesignated by paragraph (9)--
(A) striking ``6-month period'' and inserting ``3-month or
6-month period'';
(B) by striking ``subsection (a)'' and inserting
``subsection (b)''; and
(C) by striking ``2007'' both places it appears and
inserting ``2012''.
(b) Effective Date.--Except as otherwise provided in the
amendments made by subsection (a), such amendments shall
apply to written requests under section 505A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) made after the
date of enactment of this subtitle.
SEC. 403. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
Section 409I of the Public Health Service Act (42 U.S.C.
284m) is amended--
(1) by striking subsections (a) and (b) and inserting the
following:
``(a) List of Priority Issues in Pediatric Therapeutics.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, the Secretary, acting through the Director of the
National Institutes of Health and in consultation with the
Commissioner of Food and Drugs and experts in pediatric
research, shall develop and publish a priority list of needs
in pediatric therapeutics, including drugs or indications
that require study. The list shall be revised every 3 years.
``(2) Consideration of available information.--In
developing and prioritizing the list under paragraph (1), the
Secretary shall consider--
``(A) therapeutic gaps in pediatrics that may include
developmental pharmacology, pharmacogenetic determinants of
drug response, metabolism of drugs and biologics in children,
and pediatric clinical trials;
``(B) particular pediatric diseases, disorders or
conditions where more complete knowledge and testing of
therapeutics, including drugs and biologics, may be
beneficial in pediatric populations; and
``(C) the adequacy of necessary infrastructure to conduct
pediatric pharmacological research, including research
networks and trained pediatric investigators.
``(b) Pediatric Studies and Research.--The Secretary,
acting through the National Institutes of Health, shall award
funds to entities that have the expertise to conduct
pediatric clinical trials or other research (including
qualified universities, hospitals, laboratories, contract
research organizations, practice groups, federally funded
programs such as pediatric pharmacology research units, other
public or private institutions, or individuals) to enable the
entities to conduct the drug studies or other research on the
issues described in subsection (a). The Secretary may use
contracts, grants, or other appropriate funding mechanisms to
award funds under this subsection.'';
(2) in subsection (c)--
(A) in the heading, by striking ``Contracts'' and inserting
``Proposed Pediatric Study Requests'';
(B) by striking paragraphs (4) and (12);
(C) by redesignating paragraphs (1), (2), and (3), as
paragraphs (2), (3), and (4);
(D) by inserting before paragraph (2), as redesignated by
subparagraph (C), the following:
``(1) Submission of proposed pediatric study request.--The
Director of the National Institutes of Health shall, as
appropriate, submit proposed pediatric study requests for
consideration by the Commissioner of Food and Drugs for
pediatric studies of a specific pediatric indication
identified under subsection (a). Such a proposed pediatric
study request shall be made in a manner equivalent to a
written request made under subsection (b) or (c) of section
505A of the Federal Food, Drug, and Cosmetic Act, including
with respect to the information provided on the pediatric
studies to be conducted pursuant to the request. The Director
of the National Institutes of Health may submit a proposed
pediatric study request for a drug for which--
``(A)(i) there is an approved application under section
505(j) of the Federal Food, Drug, and Cosmetic Act; or
``(ii) there is a submitted application that could be
approved under the criteria of section 505(j) of the Federal
Food, Drug, and Cosmetic Act;
``(B) there is no patent protection or market exclusivity
protection for at least 1 form of the drug under the Federal
Food, Drug, and Cosmetic Act; and
``(C) additional studies are needed to assess the safety
and effectiveness of the use of the drug in the pediatric
population.'';
(E) in paragraph (2), as redesignated by subparagraph (C)--
(i) by inserting ``based on the proposed pediatric study
request for the indication or indications submitted pursuant
to paragraph (1)'' after ``issue a written request'';
(ii) by striking ``in the list described in subsection
(a)(1)(A) (except clause (iv))'' and inserting ``under
subsection (a)''; and
(iii) by inserting ``and using appropriate formulations for
each age group for which the study is requested'' before the
period at the end;
(F) in paragraph (3), as redesignated by subparagraph (C)--
(i) in the heading, by striking ``contract'';
(ii) by striking ``paragraph (1)'' and inserting
``paragraph (2)'';
(iii) by striking ``or if a referral described in
subsection (a)(1)(A)(iv) is made,'';
(iv) by striking ``for contract proposals'' and inserting
``for proposals''; and
(v) by inserting ``in accordance with subsection (b)''
before the period at the end;
(G) in paragraph (4), as redesignated by subparagraph (C)--
(i) by striking ``contract''; and
(ii) by striking ``paragraph (2)'' and inserting
``paragraph (3)'';
(H) in paragraph (5)--
(i) by striking the heading and inserting ``Contracts,
grants, or other funding mechanisms''; and
(ii) by striking ``A contract'' and all that follows
through ``is submitted'' and inserting ``A contract, grant,
or other funding may be awarded under this section only if a
proposal is submitted'';
(I) in paragraph (6)(A)--
(i) by striking ``a contract awarded'' and inserting ``an
award''; and
(ii) by inserting ``, including a written request if
issued'' after ``with the study''; and
(3) by inserting after subsection (c) the following:
``(d) Dissemination of Pediatric Information.--Not later
than 1 year after the date of enactment of the Best
Pharmaceuticals for Children Amendments of 2007, the
Secretary, acting through the Director of the National
Institutes of Health, shall study the feasibility of
establishing a compilation of information on pediatric drug
use and report the findings to Congress.''
``(e) Authorization of Appropriations.--
``(1) In general.--There are authorized to be appropriated
to carry out this section--
``(A) $200,000,000 for fiscal year 2008; and
``(B) such sums as are necessary for each of the 4
succeeding fiscal years.
[[Page S5357]]
``(2) Availability.--Any amount appropriated under
paragraph (1) shall remain available to carry out this
section until expended.''.
SEC. 404. REPORTS AND STUDIES.
(a) GAO Report.--Not later than January 31, 2011, the
Comptroller General of the United States, in consultation
with the Secretary of Health and Human Services, shall submit
to Congress a report that addresses the effectiveness of
section 505A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a) in ensuring that medicines used by children are
tested and properly labeled, including--
(1) the number and importance of drugs for children that
are being tested as a result of the amendments made by this
subtitle and the importance for children, health care
providers, parents, and others of labeling changes made as a
result of such testing;
(2) the number and importance of drugs for children that
are not being tested for their use notwithstanding the
provisions of this subtitle and the amendments made by this
subtitle, and possible reasons for the lack of testing,
including whether the number of written requests declined by
sponsors or holders of drugs subject to section 505A(g)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a(g)(2)), has increased or decreased as a result of the
amendments made by this subtitle;
(3) the number of drugs for which testing is being done and
labeling changes required, including the date labeling
changes are made and which labeling changes required the use
of the dispute resolution process established pursuant to the
amendments made by this subtitle, together with a description
of the outcomes of such process, including a description of
the disputes and the recommendations of the Pediatric
Advisory Committee;
(4) any recommendations for modifications to the programs
established under section 505A of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public
Health Service Act (42 U.S.C. 284m) that the Secretary
determines to be appropriate, including a detailed rationale
for each recommendation; and
(5)(A) the efforts made by the Secretary to increase the
number of studies conducted in the neonate population; and
(B) the results of those efforts, including efforts made to
encourage the conduct of appropriate studies in neonates by
companies with products that have sufficient safety and other
information to make the conduct of the studies ethical and
safe.
(b) IOM Study.--Not later than 3 years after the date of
enactment of this subtitle, the Secretary of Health and Human
Services shall enter into a contract with the Institute of
Medicine to conduct a study and report to Congress regarding
the written requests made and the studies conducted pursuant
to section 505A of the Federal Food, Drug, and Cosmetic Act.
The Institute of Medicine may devise an appropriate mechanism
to review a representative sample of requests made and
studies conducted pursuant to such section in order to
conduct such study. Such study shall--
(1) review such representative written requests issued by
the Secretary since 1997 under subsections (b) and (c) of
such section 505A;
(2) review and assess such representative pediatric studies
conducted under such subsections (b) and (c) since 1997 and
labeling changes made as a result of such studies; and
(3) review the use of extrapolation for pediatric
subpopulations, the use of alternative endpoints for
pediatric populations, neonatal assessment tools, and ethical
issues in pediatric clinical trials.
SEC. 405. TRAINING OF PEDIATRIC PHARMACOLOGISTS.
(a) Investment in Tomorrow's Pediatric Researchers.--
Section 452G(2) of the Public Health Service Act (42 U.S.C.
285g-10(2)) is amended by adding before the period at the end
the following: ``, including pediatric pharmacological
research''.
(b) Pediatric Research Loan Repayment Program.--Section
487F(a)(1) of the Public Health Service Act (42 U.S.C. 288-
6(a)(1)) is amended by inserting ``including pediatric
pharmacological research,'' after ``pediatric research,''.
SEC. 406. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.
Section 499(c)(1)(C) of the Public Health Service Act (42
U.S.C. 290b(c)(1)(C)) is amended by striking ``and studies
listed by the Secretary pursuant to section 409I(a)(1)(A) of
the is Act and referred under section 505A(d)(4)(C) of the
Federal Food, Drug and Cosmetic Act (21 U.S.C.
355(a)(d)(4)(C)'' and inserting ``and studies for which the
Secretary issues a certification under section 505A(n)(1)(A)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a(n)(1)(A))''.
SEC. 407. CONTINUATION OF OPERATION OF COMMITTEE.
Section 14 of the Best Pharmaceuticals for Children Act (42
U.S.C. 284m note) is amended by adding at the end the
following:
``(d) Continuation of Operation of Committee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act (5 U.S.C. App.), the advisory committee shall continue to
operate during the 5-year period beginning on the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007.''.
SEC. 408. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS
ADVISORY COMMITTEE.
Section 15 of the Best Pharmaceuticals for Children Act (42
U.S.C. 284m note) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in subparagraph (B), by striking ``and'' after the
semicolon;
(ii) in subparagraph (C), by striking the period at the end
and inserting ``; and''; and
(iii) by adding at the end the following:
``(D) provide recommendations to the internal review
committee created under section 505A(f) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a(f)) regarding the
implementation of amendments to sections 505A and 505B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a and
355c) with respect to the treatment of pediatric cancers.'';
and
(B) by adding at the end the following:
``(3) Continuation of operation of subcommittee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act (5 U.S.C. App.), the Subcommittee shall continue to
operate during the 5-year period beginning on the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007.''; and
(2) in subsection (d), by striking ``2003'' and inserting
``2009''.
SEC. 409. EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO
TOLL-FREE NUMBER FOR ADVERSE EVENTS ON LABELING
FOR HUMAN DRUG PRODUCTS.
(a) In General.--Notwithstanding subchapter II of chapter
5, and chapter 7, of title 5, United States Code (commonly
known as the ``Administrative Procedure Act'') and any other
provision of law, the proposed rule issued by the
Commissioner of Food and Drugs entitled ``Toll-Free Number
for Reporting Adverse Events on Labeling for Human Drug
Products'', 69 Fed. Reg. 21778, (April 22, 2004) shall take
effect on January 1, 2008, unless such Commissioner issues
the final rule before such date.
(b) Limitation.--The proposed rule that takes effect under
subsection (a), or the final rule described under subsection
(a), shall, notwithstanding section 17(a) of the Best
Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not
apply to a drug--
(1) for which an application is approved under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
(2) that is not described under section 503(b)(1) of such
Act (21 U.S.C. 353(b)(1)); and
(3) the packaging of which includes a toll-free number
through which consumers can report complaints to the
manufacturer or distributor of the drug.
Subtitle B--Pediatric Research Improvement
SEC. 411. SHORT TITLE.
This subtitle may be cited as the ``Pediatric Research
Improvement Act''.
SEC. 412. PEDIATRIC FORMULATIONS, EXTRAPOLATIONS, AND
DEFERRALS.
Section 505B(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c(a)) is amended--
(1) in paragraph (4)(C), by adding at the end the
following: ``An applicant seeking either a partial or full
waiver on this ground shall submit to the Secretary
documentation detailing why a pediatric formulation cannot be
developed, and, if the waiver is granted, the applicant's
submission shall promptly be made available to the public in
an easily accessible manner, including through posting on the
website of the Food and Drug Administration'';
(2) in paragraph (2)(B), by adding at the end the
following:
``(iii) Information on extrapolation.--A brief
documentation of the scientific data supporting the
conclusion under clauses (i) and (ii) shall be included in
any pertinent reviews for the application under section 505
or section 351 of the Public Health Service Act.''; and
(3) by striking paragraph (3) and inserting the following:
``(3) Deferral.--
``(A) In general.--On the initiative of the Secretary or at
the request of the applicant, the Secretary may defer
submission of some or all assessments required under
paragraph (1) until a specified date after approval of the
drug or issuance of the license for a biological product if--
``(i) the Secretary finds that--
``(I) the drug or biological product is ready for approval
for use in adults before pediatric studies are complete;
``(II) pediatric studies should be delayed until additional
safety or effectiveness data have been collected; or
``(III) there is another appropriate reason for deferral;
and
``(ii) the applicant submits to the Secretary--
``(I) certification of the grounds for deferring the
assessments;
``(II) a description of the planned or ongoing studies;
``(III) evidence that the studies are being conducted or
will be conducted with due diligence and at the earliest
possible time; and
``(IV) a timeline for the completion of such studies.
``(B) Annual review.--
``(i) In general.--On an annual basis following the
approval of a deferral under subparagraph (A), the applicant
shall submit to the Secretary the following information:
``(I) Information detailing the progress made in conducting
pediatric studies.
``(II) If no progress has been made in conducting such
studies, evidence and documentation that such studies will be
conducted with due diligence and at the earliest possible
time.
[[Page S5358]]
``(ii) Public availability.--The information submitted
through the annual review under clause (i) shall promptly be
made available to the public in an easily accessible manner,
including through the website of the Food and Drug
Administration.''.
SEC. 413. IMPROVING AVAILABILITY OF PEDIATRIC DATA FOR
ALREADY MARKETED PRODUCTS.
Section 505B(b) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c(b)) is amended--
(1) by striking paragraph (1) and inserting the following:
``(1) In general.--After providing notice in the form of a
letter, or a written request under section 505A that was
declined by the sponsor or holder, and an opportunity for
written response and a meeting, which may include an advisory
committee meeting, the Secretary may (by order in the form of
a letter) require the sponsor or holder of an approved
application for a drug under section 505 or the holder of a
license for a biological product under section 351 of the
Public Health Service Act (42 U.S.C. 262) to submit by a
specified date the assessments described in subsection (a)(2)
and the written request, as appropriate, if the Secretary
finds that--
``(A)(i) the drug or biological product is used for a
substantial number of pediatric patients for the labeled
indications; and
``(ii) adequate pediatric labeling could confer a benefit
on pediatric patients;
``(B) there is reason to believe that the drug or
biological product would represent a meaningful therapeutic
benefit over existing therapies for pediatric patients for 1
or more of the claimed indications; or
``(C) the absence of adequate pediatric labeling could pose
a risk to pediatric patients.'';
(2) in paragraph (2)(C), by adding at the end the
following: ``An applicant seeking either a partial or full
waiver shall submit to the Secretary documentation detailing
why a pediatric formulation cannot be developed, and, if the
waiver is granted, the applicant's submission shall promptly
be made available to the public in an easily accessible
manner, including through posting on the website of the Food
and Drug Administration.''; and
(3) by striking paragraph (3) and inserting the following:
``(3) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.''.
SEC. 414. SUNSET; REVIEW OF PEDIATRIC ASSESSMENTS; ADVERSE
EVENT REPORTING; LABELING CHANGES; AND
PEDIATRIC ASSESSMENTS.
Section 505B of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c) is amended--
(1) redesignating subsection (h) as subsection (j);
(2) in subsection (j), as so redesignated, by striking
``505A(n)'' and inserting ``505A(p)'';
(3) by redesignating subsection (f) as subsection (k);
(4) by redesignating subsection (g) as subsection (l); and
(5) by inserting after subsection (e) the following:
``(f) Review of Pediatric Assessment Requests, Pediatric
Assessments, Deferrals, and Waivers.--
``(1) Review.--The Secretary shall create an internal
committee to review all pediatric assessment requests issued
under this section, all pediatric assessments conducted under
this section, and all deferral and waiver requests made
pursuant to this section. Such internal committee shall
include individuals, each of whom is an employee of the Food
and Drug Administration, with the following expertise:
``(A) Pediatrics.
``(B) Biopharmacology.
``(C) Statistics.
``(D) Drugs and drug formulations.
``(E) Pediatric ethics.
``(F) Legal issues.
``(G) Appropriate expertise pertaining to the pediatric
product under review.
``(H) 1 or more experts from the Office of Pediatric
Therapeutics.
``(I) Other individuals as designated by the Secretary.
``(2) Review of requests for pediatric assessments,
deferrals, and waivers.--All written requests for a pediatric
assessment issued pursuant to this section and all requests
for deferrals and waivers from the requirement to conduct a
pediatric assessment under this section shall be reviewed and
approved by the committee established under paragraph (1).
``(3) Review of assessments.--The committee established
under paragraph (1) shall review all assessments conducted
under this section to determine whether such assessments meet
the requirements of this section.
``(4) Tracking of assessments and labeling changes.--The
committee established under paragraph (1) is responsible for
tracking and making public in an easily accessible manner,
including through posting on the website of the Food and Drug
Administration--
``(A) the number of assessments conducted under this
section;
``(B) the specific drugs and drug uses assessed under this
section;
``(C) the types of assessments conducted under this
section, including trial design, the number of pediatric
patients studied, and the number of centers and countries
involved;
``(D) the total number of deferrals requested and granted
under this section, and, if granted, the reasons for such
deferrals, the timeline for completion, and the number
completed and pending by the specified date, as outlined in
subsection (a)(3);
``(E) the number of waivers requested and granted under
this section, and, if granted, the reasons for the waivers;
``(F) the number of pediatric formulations developed and
the number of pediatric formulations not developed and the
reasons any such formulations were not developed;
``(G) the labeling changes made as a result of assessments
conducted under this section;
``(H) an annual summary of labeling changes made as a
result of assessments conducted under this section for
distribution pursuant to subsection (i)(2); and
``(I) an annual summary of the information submitted
pursuant to subsection (a)(3)(B).
``(g) Labeling Changes.--
``(1) Priority status for pediatric supplement.--Any
supplement to an application under section 505 and section
351 of the Public Health Service Act proposing a labeling
change as a result of any pediatric assessments conducted
pursuant to this section--
``(A) shall be considered a priority supplement; and
``(B) shall be subject to the performance goals established
by the Commissioner for priority drugs.
``(2) Dispute resolution.--
``(A) Request for labeling change and failure to agree.--If
the Commissioner determines that a sponsor and the
Commissioner have been unable to reach agreement on
appropriate changes to the labeling for the drug that is the
subject of the application or supplement, not later than 180
days after the date of the submission of the application or
supplement--
``(i) the Commissioner shall request that the sponsor make
any labeling change that the Commissioner determines to be
appropriate; and
``(ii) if the sponsor does not agree to make a labeling
change requested by the Commissioner, the Commissioner shall
refer the matter to the Pediatric Advisory Committee.
``(B) Action by the pediatric advisory committee.--Not
later than 90 days after receiving a referral under
subparagraph (A)(ii), the Pediatric Advisory Committee
shall--
``(i) review the pediatric study reports; and
``(ii) make a recommendation to the Commissioner concerning
appropriate labeling changes, if any.
``(C) Consideration of recommendations.--The Commissioner
shall consider the recommendations of the Pediatric Advisory
Committee and, if appropriate, not later than 30 days after
receiving the recommendation, make a request to the sponsor
of the application or supplement to make any labeling changes
that the Commissioner determines to be appropriate.
``(D) Misbranding.--If the sponsor, within 30 days after
receiving a request under subparagraph (C), does not agree to
make a labeling change requested by the Commissioner, the
Commissioner may deem the drug that is the subject of the
application or supplement to be misbranded.
``(E) No effect on authority.--Nothing in this subsection
limits the authority of the United States to bring an
enforcement action under this Act when a drug lacks
appropriate pediatric labeling. Neither course of action (the
Pediatric Advisory Committee process or an enforcement action
referred to in the preceding sentence) shall preclude, delay,
or serve as the basis to stay the other course of action.
``(3) Other labeling changes.--If the Secretary makes a
determination that a pediatric assessment conducted under
this section does or does not demonstrate that the drug that
is the subject of such assessment is safe and effective,
including whether such assessment results are inconclusive,
in pediatric populations or subpopulations, the Secretary
shall order the labeling of such product to include
information about the results of the assessment and a
statement of the Secretary's determination.
``(h) Dissemination of Pediatric Information.--
``(1) In general.--Not later than 180 days after the date
of submission of a pediatric assessment under this section,
the Secretary shall make available to the public in an easily
accessible manner the medical, statistical, and clinical
pharmacology reviews of such pediatric assessments and shall
post such assessments on the website of the Food and Drug
Administration.
``(2) Dissemination of information regarding labeling
changes.--The Secretary shall require that the sponsors of
the assessments that result in labeling changes that are
reflected in the annual summary developed pursuant to
subsection (f)(4)(H) distribute such information to
physicians and other health care providers.
``(3) Effect of subsection.--Nothing in this subsection
shall alter or amend section 301(j) of this Act or section
552 of title 5, United States Code, or section 1905 of title
18, United States Code.
``(i) Adverse Event Reporting.--
``(1) Reporting in year 1.--During the 1-year period
beginning on the date a labeling change is made pursuant to
subsection (g), the Secretary shall ensure that all adverse
event reports that have been received for such drug
(regardless of when such report was received) are referred to
the Office of Pediatric Therapeutics. In considering such
reports, the Director of such Office shall provide for the
review of the report by the Pediatric Advisory Committee,
including obtaining any recommendations of such committee
[[Page S5359]]
regarding whether the Secretary should take action under this
Act in response to such report.
``(2) Reporting in subsequent years.--Following the 1-year
period described in paragraph (1), the Secretary shall, as
appropriate, refer to the Office of Pediatric Therapeutics
with all pediatric adverse event reports for a drug for which
a pediatric study was conducted under this section. In
considering such reports, the Director of such Office may
provide for the review of such reports by the Pediatric
Advisory Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should take
action in response to such report.
``(3) Effect.--The requirements of this subsection shall
supplement, not supplant, other review of such adverse event
reports by the Secretary.''.
SEC. 415. MEANINGFUL THERAPEUTIC BENEFIT.
Section 505B(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c) is amended--
(1) by striking ``estimates'' and inserting ``determines'';
and
(2) by striking ``would'' and inserting ``could''.
SEC. 416. REPORTS.
(a) Institute of Medicine Study.--
(1) In general.--Not later than 3 years after the date of
enactment of this subtitle, the Secretary shall contract with
the Institute of Medicine to conduct a study and report to
Congress regarding the pediatric studies conducted pursuant
to section 505B of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c) since 1997.
(2) Content of study.--The study under paragraph (1) shall
review and assess--
(A) pediatric studies conducted pursuant to section 505B of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c)
since 1997 and labeling changes made as a result of such
studies; and
(B) the use of extrapolation for pediatric subpopulations,
the use of alternative endpoints for pediatric populations,
neonatal assessment tools, number and type of pediatric
adverse events, and ethical issues in pediatric clinical
trials.
(3) Representative sample.--The Institute of Medicine may
devise an appropriate mechanism to review a representative
sample of studies conducted pursuant to section 505B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) from
each review division within the Center for Drug Evaluation
and Research and the Center for Biologics Evaluation and
Research in order to make the required assessment.
(b) GAO Report.--Not later than September 1, 2010, the
Comptroller General of the United States, in consultation
with the Secretary of Health and Human Services, shall submit
to Congress a report that addresses the effectiveness of
section 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a) in ensuring that medicines used by children are
tested and properly labeled, including--
(1) the number and importance of drugs for children that
are being tested as a result of this provision and the
importance for children, health care providers, parents, and
others of labeling changes made as a result of such testing;
(2) the number and importance of drugs for children that
are not being tested for their use notwithstanding the
provisions of such section 505B, and possible reasons for the
lack of testing; and
(3) the number of drugs for which testing is being done and
labeling changes required, including the date labeling
changes are made and which labeling changes required the use
of the dispute resolution process established under such
section 505B, together with a description of the outcomes of
such process, including a description of the disputes and the
recommendations of the Pediatric Advisory Committee.
SEC. 417. TECHNICAL CORRECTIONS.
Section 505B(a)(2)(B)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c(a)(2)(B)(ii)) is amended by
striking ``one'' and inserting ``1''.
Subtitle C--Pediatric Medical Devices
SEC. 421. SHORT TITLE.
This subtitle may be cited as the ``Pediatric Medical
Device Safety and Improvement Act of 2007''.
SEC. 422. TRACKING PEDIATRIC DEVICE APPROVALS.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section 515
the following:
``SEC. 515A. PEDIATRIC USES OF DEVICES.
``(a) New Devices.--
``(1) In general.--A person that submits to the Secretary
an application under section 520(m), or an application (or
supplement to an application) or a product development
protocol under section 515, shall include in the application
or protocol the information described in paragraph (2).
``(2) Required information.--The application or protocol
described in paragraph (1) shall include, with respect to the
device for which approval is sought and if readily
available--
``(A) a description of any pediatric subpopulations that
suffer from the disease or condition that the device is
intended to treat, diagnose, or cure; and
``(B) the number of affected pediatric patients.
``(3) Annual report.--Not later than 18 months after the
date of enactment of this section, and annually thereafter,
the Secretary shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report that includes--
``(A) the number of devices approved in the year preceding
the year in which the report is submitted, for which there is
a pediatric subpopulation that suffers from the disease or
condition that the device is intended to treat, diagnose, or
cure;
``(B) the number of devices approved in the year preceding
the year in which the report is submitted, labeled for use in
pediatric patients;
``(C) the number of pediatric devices approved in the year
preceding the year in which the report is submitted, exempted
from a fee pursuant to section 738(a)(2)(B)(v); and
``(D) the review time for each device described in
subparagraphs (A), (B), and (C).
``(b) Determination of Pediatric Effectiveness Based on
Similar Course of Disease or Condition or Similar Effect of
Device on Adults.--
``(1) In general.--If the course of the disease or
condition and the effects of the device are sufficiently
similar in adults and pediatric patients, the Secretary may
conclude that adult data may be used to support a
determination of a reasonable assurance of effectiveness in
pediatric populations, as appropriate.
``(2) Extrapolation between subpopulations.--A study may
not be needed in each pediatric subpopulation if data from
one subpopulation can be extrapolated to another
subpopulation.
``(c) Pediatric Subpopulation.--In this section, the term
`pediatric subpopulation' has the meaning given the term in
section 520(m)(6)(E)(ii).''.
SEC. 423. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.
(a) In General.--Section 520(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (3), by striking ``No'' and inserting
``Except as provided in paragraph (6), no'';
(2) in paragraph (5)--
(A) by inserting ``, if the Secretary has reason to believe
that the requirements of paragraph (6) are no longer met,''
after ``public health''; and
(B) by adding at the end the following: ``If the person
granted an exemption under paragraph (2) fails to demonstrate
continued compliance with the requirements of this
subsection, the Secretary may suspend or withdraw the
exemption from the effectiveness requirements of sections 514
and 515 for a humanitarian device only after providing notice
and an opportunity for an informal hearing.'';
(3) by striking paragraph (6) and inserting the following:
``(6)(A) Except as provided in subparagraph (D), the
prohibition in paragraph (3) shall not apply with respect to
a person granted an exemption under paragraph (2) if each of
the following conditions apply:
``(i)(I) The device with respect to which the exemption is
granted is intended for the treatment or diagnosis of a
disease or condition that occurs in pediatric patients or in
a pediatric subpopulation, and such device is labeled for use
in pediatric patients or in a pediatric subpopulation in
which the disease or condition occurs.
``(II) The device was not previously approved under this
subsection for the pediatric patients or the pediatric
subpopulation described in subclause (I) prior to the date of
enactment of the Pediatric Medical Device Safety and
Improvement Act of 2007.
``(ii) During any calendar year, the number of such devices
distributed during that year does not exceed the annual
distribution number specified by the Secretary when the
Secretary grants such exemption. The annual distribution
number shall be based on the number of individuals affected
by the disease or condition that such device is intended to
treat, diagnose, or cure, and of that number, the number of
individuals likely to use the device, and the number of
devices reasonably necessary to treat such individuals. In no
case shall the annual distribution number exceed the number
identified in paragraph (2)(A).
``(iii) Such person immediately notifies the Secretary if
the number of such devices distributed during any calendar
year exceeds the annual distribution number referred to in
clause (ii).
``(iv) The request for such exemption is submitted on or
before October 1, 2012.
``(B) The Secretary may inspect the records relating to the
number of devices distributed during any calendar year of a
person granted an exemption under paragraph (2) for which the
prohibition in paragraph (3) does not apply.
``(C) A person may petition the Secretary to modify the
annual distribution number specified by the Secretary under
subparagraph (A)(ii) with respect to a device if additional
information on the number of individuals affected by the
disease or condition arises, and the Secretary may modify
such number but in no case shall the annual distribution
number exceed the number identified in paragraph (2)(A).
``(D) If a person notifies the Secretary, or the Secretary
determines through an inspection under subparagraph (B), that
the number of devices distributed during any calendar year
exceeds the annual distribution
[[Page S5360]]
number, as required under subparagraph (A)(iii), and modified
under subparagraph (C), if applicable, then the prohibition
in paragraph (3) shall apply with respect to such person for
such device for any sales of such device after such
notification.
``(E)(i) In this subsection, the term `pediatric patients'
means patients who are 21 years of age or younger at the time
of the diagnosis or treatment.
``(ii) In this subsection, the term `pediatric
subpopulation' means 1 of the following populations:
``(I) Neonates.
``(II) Infants.
``(III) Children.
``(IV) Adolescents.''; and
(4) by adding at the end the following:
``(7) The Secretary shall refer any report of an adverse
event regarding a device for which the prohibition under
paragraph (3) does not apply pursuant to paragraph (6)(A)
that the Secretary receives to the Office of Pediatric
Therapeutics, established under section 6 of the Best
Pharmaceuticals for Children Act (Public Law 107-109)). In
considering the report, the Director of the Office of
Pediatric Therapeutics, in consultation with experts in the
Center for Devices and Radiological Health, shall provide for
periodic review of the report by the Pediatric Advisory
Committee, including obtaining any recommendations of such
committee regarding whether the Secretary should take action
under this Act in response to the report.''.
(b) Report.--Not later than January 1, 2012, the
Comptroller General of the United States shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives a report on the impact of allowing persons
granted an exemption under section 520(m)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with
respect to a device to profit from such device pursuant to
section 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as
amended by subsection (a)), including--
(1) an assessment of whether such section 520(m)(6) (as
amended by subsection (a)) has increased the availability of
pediatric devices for conditions that occur in small numbers
of children, including any increase or decrease in the number
of--
(A) exemptions granted under such section 520(m)(2) for
pediatric devices; and
(B) applications approved under section 515 of such Act (21
U.S.C. 360e) for devices intended to treat, diagnose, or cure
conditions that occur in pediatric patients or for devices
labeled for use in a pediatric population;
(2) the conditions or diseases the pediatric devices were
intended to treat or diagnose and the estimated size of the
pediatric patient population for each condition or disease;
(3) the costs of the pediatric devices, based on a survey
of children's hospitals;
(4) the extent to which the costs of such devices are
covered by health insurance;
(5) the impact, if any, of allowing profit on access to
such devices for patients;
(6) the profits made by manufacturers for each device that
receives an exemption;
(7) an estimate of the extent of the use of the pediatric
devices by both adults and pediatric populations for a
condition or disease other than the condition or disease on
the label of such devices;
(8) recommendations of the Comptroller General of the
United States regarding the effectiveness of such section
520(m)(6) (as amended by subsection (a)) and whether any
modifications to such section 520(m)(6) (as amended by
subsection (a)) should be made;
(9) existing obstacles to pediatric device development; and
(10) an evaluation of the demonstration grants described in
section 425, which shall include an evaluation of the number
of pediatric medical devices--
(A) that have been or are being studied in children; and
(B) that have been submitted to the Food and Drug
Administration for approval, clearance, or review under such
section 520(m) (as amended by this Act) and any regulatory
actions taken.
(c) Guidance.--Not later than 180 days after the date of
enactment of this subtitle, the Commissioner of Food and
Drugs shall issue guidance for institutional review
committees on how to evaluate requests for approval for
devices for which a humanitarian device exemption under
section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j(m)(2)) has been granted.
SEC. 424. CONTACT POINT FOR AVAILABLE FUNDING.
Section 402(b) of the Public Health Service Act (42 U.S.C.
282(b)) is amended--
(1) in paragraph (21), by striking ``and'' after the
semicolon at the end;
(2) in paragraph (22), by striking the period at the end
and inserting ``; and''; and
(3) by inserting after paragraph (22) the following:
``(23) shall designate a contact point or office to help
innovators and physicians identify sources of funding
available for pediatric medical device development.''.
SEC. 425. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE
AVAILABILITY.
(a) In General.--
(1) Request for proposals.--Not later than 90 days after
the date of enactment of this subtitle, the Secretary of
Health and Human Services shall issue a request for proposals
for 1 or more grants or contracts to nonprofit consortia for
demonstration projects to promote pediatric device
development.
(2) Determination on grants or contracts.--Not later than
180 days after the date the Secretary of Health and Human
Services issues a request for proposals under paragraph (1),
the Secretary shall make a determination on the grants or
contracts under this section.
(b) Application.--A nonprofit consortium that desires to
receive a grant or contract under this section shall submit
an application to the Secretary of Health and Human Services
at such time, in such manner, and containing such information
as the Secretary may require.
(c) Use of Funds.--A nonprofit consortium that receives a
grant or contract under this section shall facilitate the
development, production, and distribution of pediatric
medical devices by--
(1) encouraging innovation and connecting qualified
individuals with pediatric device ideas with potential
manufacturers;
(2) mentoring and managing pediatric device projects
through the development process, including product
identification, prototype design, device development, and
marketing;
(3) connecting innovators and physicians to existing
Federal and non-Federal resources, including resources from
the Food and Drug Administration, the National Institutes of
Health, the Small Business Administration, the Department of
Energy, the Department of Education, the National Science
Foundation, the Department of Veterans Affairs, the Agency
for Healthcare Research and Quality, and the National
Institute of Standards and Technology;
(4) assessing the scientific and medical merit of proposed
pediatric device projects; and
(5) providing assistance and advice as needed on business
development, personnel training, prototype development,
postmarket needs, and other activities consistent with the
purposes of this section.
(d) Coordination.--
(1) National institutes of health.--Each consortium that
receives a grant or contract under this section shall--
(A) coordinate with the National Institutes of Health's
pediatric device contact point or office, designated under
section 424; and
(B) provide to the National Institutes of Health any
identified pediatric device needs that the consortium lacks
sufficient capacity to address or those needs in which the
consortium has been unable to stimulate manufacturer
interest.
(2) Food and drug administration.--Each consortium that
receives a grant or contract under this section shall
coordinate with the Commissioner of Food and Drugs and device
companies to facilitate the application for approval or
clearance of devices labeled for pediatric use.
(3) Effectiveness and outcomes.--Each consortium that
receives a grant or contract under this section shall
annually report to the Secretary of Health and Human Services
on--
(A) the effectiveness of activities conducted under
subsection (c);
(B) the impact of activities conducted under subsection (c)
on pediatric device development; and
(C) the status of pediatric device development that has
been facilitated by the consortium.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $6,000,000 for
each of fiscal years 2008 through 2012.
SEC. 426. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND
PEDIATRIC ADVISORY COMMITTEE.
(a) In General.--
(1) Office of pediatric therapeutics.--Section 6(b) of the
Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is
amended by inserting ``, including increasing pediatric
access to medical devices'' after ``pediatric issues''.
(2) Plan for pediatric medical device research.--
(A) In general.--Not later than 270 days after the date of
enactment of this subtitle, the Office of Pediatric
Therapeutics, in collaboration with the Director of the
National Institutes of Health and the Director of the Agency
for Healthcare Research and Quality, shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives a plan for expanding pediatric medical
device research and development. In developing such plan, the
Commissioner of Food and Drugs shall consult with individuals
and organizations with appropriate expertise in pediatric
medical devices.
(B) Contents.--The plan under subparagraph (A) shall
include--
(i) the current status of federally funded pediatric
medical device research;
(ii) any gaps in such research, which may include a survey
of pediatric medical providers regarding unmet pediatric
medical device needs, as needed; and
(iii) a research agenda for improving pediatric medical
device development and Food and Drug Administration clearance
or approval of pediatric medical devices, and for evaluating
the short- and long-term safety and effectiveness of
pediatric medical devices.
(b) Pediatric Advisory Committee.--Section 14 of the Best
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is
amended--
[[Page S5361]]
(1) in subsection (a), by inserting ``(including drugs and
biological products) and medical devices'' after
``therapeutics''; and
(2) in subsection (b)--
(A) in paragraph (1), by inserting ``(including drugs and
biological products) and medical devices'' after
``therapeutics''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``and 505B'' and
inserting ``505B, 510(k), 515, and 520(m)'';
(ii) by striking subparagraph (B) and inserting the
following:
``(B) identification of research priorities related to
therapeutics (including drugs and biological products) and
medical devices for pediatric populations and the need for
additional diagnostics and treatments for specific pediatric
diseases or conditions; and''; and
(iii) in subparagraph (C), by inserting ``(including drugs
and biological products) and medical devices'' after
``therapeutics''.
SEC. 427. SURVEILLANCES.
(a) Postmarket Surveillances.--Section 522 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is amended--
(1) by striking subsection (a) and inserting the following:
``(a) Postmarket Surveillance.--
``(1) In general.--
``(A) Conduct.--The Secretary may by order require a
manufacturer to conduct postmarket surveillance for any
device of the manufacturer that is a class II or class III
device--
``(i) the failure of which would be reasonably likely to
have serious adverse health consequences;
``(ii) that is expected to have significant use in
pediatric populations; or
``(iii) that is intended to be implanted in the human body
for more than 1 year, or a life sustaining or life supporting
device used outside a device user facility.
``(B) Condition.--The Secretary may order a postmarket
surveillance under subparagraph (A) as a condition to
approval of an application (or a supplement to an
application) or a product development protocol under section
515 or as a condition to clearance of a premarket
notification under section 510(k) only for a device described
in subparagraph (A)(ii).
``(2) Rule of construction.--The provisions of paragraph
(1) shall have no effect on authorities otherwise provided
under the Act or regulations issued under this Act.''; and
(2) in subsection (b)--
(A) by striking ``(b) Surveillance Approval.--Each'' and
inserting the following:
``(b) Surveillance Approval.--
``(1) In general.--Each'';
(B) by striking ``The Secretary, in consultation'' and
inserting ``Except as provided in paragraph (2), the
Secretary, in consultation'';
(C) by striking ``Any determination'' and inserting
``Except as provided in paragraph (2), any determination'';
and
(D) by adding at the end the following:
``(2) Longer surveillances for pediatric devices.--The
Secretary may by order require a prospective surveillance
period of more than 36 months with respect to a device that
is expected to have significant use in pediatric populations
if such period of more than 36 months is necessary in order
to assess the impact of the device on growth and development,
or the effects of growth, development, activity level, or
other factors on the safety of the device.''.
TITLE V--OTHER PROVISIONS
SEC. 501. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC
ARTICLES PUBLISHED BY FDA EMPLOYEES.
Subchapter A of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.), as amended by section
241, is further amended by adding at the end the following:
``SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC
ARTICLES PUBLISHED BY FDA EMPLOYEES.
``(a) Definition.--In this section, the term `article'
means a paper, poster, abstract, book, book chapter, or other
published writing.
``(b) Policies.--The Secretary, through the Commissioner of
Food and Drugs, shall establish and make publicly available
clear written policies to implement this section and govern
the timely submission, review, clearance, and disclaimer
requirements for articles.
``(c) Timing of Submission for Review.--If an officer or
employee, including a Staff Fellow and a contractor who
performs staff work, of the Food and Drug Administration is
required by the policies established under subsection (b) to
submit an article to the supervisor of such officer or
employee, or to some other official of the Food and Drug
Administration, for review and clearance before such officer
or employee may seek to publish or present such an article at
a conference, such officer or employee shall submit such
article for such review and clearance not less than 30 days
before submitting the article for publication or
presentation.
``(d) Timing for Review and Clearance.--The supervisor or
other reviewing official shall review such article and
provide written clearance, or written clearance on the
condition of specified changes being made, to such officer or
employee not later than 30 days after such officer or
employee submitted such article for review.
``(e) Non-Timely Review.--If, 31 days after such submission
under subsection (c), the supervisor or other reviewing
official has not cleared or has not reviewed such article and
provided written clearance, such officer or employee may
consider such article not to have been cleared and may submit
the article for publication or presentation with an
appropriate disclaimer as specified in the policies
established under subsection (b).''.
SEC. 502. TECHNICAL AMENDMENTS.
The Public Health Service Act (42 U.S.C. 201 et seq.) is
amended--
(1) in section 319C-2(j)(3)(B), by striking ``section 319C-
1(h)'' and inserting ``section 319C-1(i)'';
(2) in section 402(b)(4), by inserting ``minority and
other'' after ``reducing'';
(3) in section 403(a)(4)(C)(iv)(III), by inserting ``and
post doctoral training funded through investigator-initiated
research grant awards'' before the semicolon; and
(4) in section 403C(a)--
(A) in the matter preceding paragraph (1), by inserting
``graduate students supported by NIH for'' after ``with
respect to'';
(B) in paragraph (1), by inserting ``such'' after
``percentage of''; and
(C) in paragraph (2), by inserting ``(not including any
leaves of absence)'' after ``average time''.
SEC. 503. SEVERABILITY CLAUSE.
If any provision of this Act, an amendment made this Act,
or the application of such provision or amendment to any
person or circumstance is held to be unconstitutional, the
remainder of this Act, the amendments made by this Act, and
the application of the provisions of such to any person or
circumstances shall not be affected thereby.
Amend the title so as to read: ``To amend the Federal Food,
Drug, and Cosmetic Act and the Public Health Service Act to
reauthorize drug and device user fees and ensure the safety
of medical products, and for other purposes.''.
Mr. KENNEDY. Mr. President, this basically incorporates a number of
the adjustments and changes that we had indicated during the course of
our markup. We had a number of amendments that were offered. We
indicated to the members we would try to work through some of the
points that were raised. I commend our staffs on both sides who have
been diligent in doing so.
These are alterations, changes that are known to the majority and the
minority and all the staff members. Later on in the discussion and
debate we can go into some in greater detail. Most of them are
clarifications. Some of them are simplifications. I think all of them
are worthy and justified, and I think they help to strengthen the
legislation. So we are very grateful to all of our colleagues on our
committee who offered the amendments, and, most particularly, we are
very grateful for their willingness to work with us to try to work
through these alterations and changes.
Mr. President, this legislation, as was pointed out in the excellent
statement made by our friend and colleague from Rhode Island, Mr. Reed,
and others, is complex, but it is incredibly important in terms of
American families, most precisely with regard to drug safety. We have
reviewed those provisions. Senator Enzi made an excellent presentation
yesterday. We tried to go through those in some detail yesterday
afternoon. I might go through some of those again this afternoon.
But we want our Members to know we are ready to consider amendments.
We know there are several that are just about ready to be offered. We
urge those who are considering bringing them to the floor, let's begin
the debate and discussion. We have one or two that are still being
worked on. So even though it does not appear like we are making
progress on this legislation at the moment, progress is being made in
making sure we are going to have strong FDA reauthorization
legislation. But we do hope we can get to the amendments very soon, and
we expect to be able to do so.
The PRESIDING OFFICER. The Senator from Wyoming.
Mr. ENZI. Mr. President, I rise at this moment to support the
substitute that has been put into S. 1082, the Food and Drug
Administration Revitalization Act. I have said a lot about this
important bill, and I do intend to say more. The most important thing I
can say right now is this is the product of a lot of bipartisan work by
members of the Senate Committee on Health, Education, Labor, and
Pensions. We have a great process that wound up with a work in
progress, which wound up with this substitute bill.
Now we do have one major outstanding issue to figure out; that is,
the direct consumer advertising for prescription drugs. I do believe we
will work something out, but we are not quite there yet. So I would ask
my colleagues' indulgence to work that out, and I hope I have the
assurance of the
[[Page S5362]]
chairman that we will engage in a serious dialog about the various
provisions that are included in that direct consumer issue. That will
be a real key to finishing up.
I congratulate the Senator from Massachusetts, Mr. Kennedy, for the
outstanding way he and his staff have worked with all the Members on
our side of the aisle to clear up. As he said, in some cases,
clarifications were needed, and in some cases it was the expansion of
wording; in some cases, a reduction in wording. But, at any rate, we
got it to where I think both sides understand and agree on many of the
issues that are included. I hope we can have other amendments brought
to the floor so we can debate them and get them worked out.
Of course, it would be nice if any Senator thinking about offering an
amendment would share their idea with us prior to filing it. We might
be able to save some time that way and make sure debate flows in an
orderly process. We are trying to keep the bill to relevant amendments.
The PRESIDING OFFICER. The Senator from Massachusetts.
Mr. KENNEDY. Mr. President, I am pleased to continue working with my
colleague from Kansas, Senator Roberts, and my colleague from Iowa,
Senator Harkin, on the important issue of direct-to-consumer
advertising.
We have to strike an important balance between seeing that consumers
get accurate information on drug safety and seeing that we do not
improperly restrain free speech.
Senator Harkin has a proposal to add safety information to drug ads.
Senator Roberts has an idea to allow FDA to impose fines for inaccurate
ads. Our bill includes a moratorium--only to be used in rare cases--on
DTC ads. The IOM went further and recommended a moratorium on DTC for
all new drugs. We rejected that recommendation due to the first
amendment concerns but included more limited authority that we believe
meets the constitutional test.
Still, some have raised concerns about our current proposal, and we
take those concerns seriously. We will continue to work on this
important issue with our colleagues and constitutional experts. I think
we are making progress through the afternoon and, hopefully, by
tomorrow we will have some recommendation.
I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The bill clerk proceeded to call the roll.
Ms. KLOBUCHAR. Madam President, I ask unanimous consent that the
order for the quorum call be rescinded.
The PRESIDING OFFICER (Mrs. McCaskill). Without objection, it is so
ordered.
Ms. KLOBUCHAR. Madam President, I ask unanimous consent to speak as
in morning business and that my remarks be printed at the appropriate
place in the Record.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________