[Congressional Record Volume 153, Number 69 (Monday, April 30, 2007)]
[Senate]
[Pages S5270-S5303]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
The PRESIDING OFFICER. Under the previous order, the Senate will
proceed to the consideration of S. 1082, which the clerk will report by
title.
The assistant legislative clerk read as follows:
A bill (S. 1082) to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug
user fee provisions, and for other purposes.
The Senate proceeded to consider the bill, which had been reported
from the Committee on Health, Education, Labor, and Pensions, with an
amendment to strike all after the enacting clause and insert in lieu
thereof 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.''.
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
[[Page S5271]]
(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-quarter 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
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
[[Page S5272]]
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.
``(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
[[Page S5273]]
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. RISK EVALUATION.
(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) Risk identification and assessment.--
``(A) Routine active safety monitoring.--The Secretary
shall facilitate a public-private partnership to-
``(i) implement a routine active monitoring system for
postmarket drug safety; and
``(ii) 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 use of a drug.
``(B) Public-private partnership.--The public-private
partnership described in subparagraph (A) shall--
``(i) develop a mechanism for the pooling of relevant data
from Federal and private electronic health care population
databases that--
``(I) includes, in aggregate--
``(aa) at least 25,000,000 patients by January 1, 2009; and
``(bb) at least 100,000,000 patients by January 1, 2012;
``(II) allows access to full-text medical records, where
available;
``(III) takes into consideration the need for data
completeness, coding, cleansing, and transmission;
``(IV) may, on a temporary or permanent basis, implement
systems or products developed by private entities; and
``(V) complies with the requirements of the Health
Insurance Portability and Accountability Act of 1996;
``(ii) support the routine and systematic collection and
analysis of utilization and safety data from such pooled
databases and from the Food and Drug Administration with
respect to prescription drugs; and
``(iii) allow for prompt investigation of priority drug
safety questions, including--
``(I) unresolved safety questions for drugs or classes of
drugs; and
``(II) for a newly-approved drug--
``(aa) safety signals from clinical trials used to approve
the drug and from other preapproval trials;
``(bb) rare, serious drug adverse events; and
``(cc) 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).
``(C) Other approaches.--
``(i) In general.--The Secretary shall develop, support,
and participate in other approaches, including in other
public-private partnerships, to gather and analyze data and
information relevant to priority drug safety questions,
including--
``(I) approaches that are complimentary to the routine
active safety monitoring described in subparagraphs (A) and
(B), especially 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.
``(ii) Best practices.--With respect to such other
approaches, the Secretary shall develop and implement best
practices in epidemiology and the use of improved analytic
tools.
``(D) 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--
[[Page S5274]]
``(i) priority drug safety questions; and
``(ii) mechanisms for answering such questions, including
through--
``(I) routine active safety monitoring; and
``(II) when such monitoring is not sufficient, postmarket
studies under subsection (o)(4)(B) and postapproval clinical
trials under subsection (o)(4)(C).
``(E) Analysis of drug safety data.--The Secretary shall
engage independent private research groups, including through
the Centers for Education and Research on Therapeutics
provided for under section 905 of the Public Health Service
Act, to conduct analyses of data relating to priority drug
safety questions.
``(F) Use of analyses.--The Secretary shall provide the
analyses described under subparagraph (E), including the
methods and results of such analyses, about a drug to the
sponsor or sponsors of such drug.
``(G) Public availability of analyses.--The Secretary shall
make the analyses described under subparagraph (E), including
the methods and results of such analyses, available to the
public for review and comment.
``(H) 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) Qualifications.--The Secretary shall enter into a
contract with an entity under clause (i) only if the
Secretary determines that the entity--
``(I) has the research capability and expertise to conduct
and complete the activities under this paragraph;
``(II) has in place an information technology
infrastructure to support adverse event surveillance data and
operational standards to provide security for such data;
``(III) has experience with, and expertise in, the
development of drug safety and effectiveness research using
electronic population data;
``(IV) has an understanding of drug development and risk/
benefit balancing in a clinical setting; and
``(V) has a significant business presence in the United
States.
``(I) 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--
``(I) the Federal regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996 (concerning the privacy of individually-
identifiable beneficiary health information); or
``(II) 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--
``(I) 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
``(II) 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 under
this paragraph is terminated or not renewed, the following
requirements shall apply:
``(I) Confidentiality and privacy regulations.--The entity
shall continue to comply with the confidentiality and privacy
requirements under this paragraph with respect to all data
disclosed to the entity.
``(II) 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.
``(J) 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
subparagraph (H).
``(K) Review of contract in the event 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 paragraph will continue to be
met.''.
(b) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $30,000,000 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 safety monitoring 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
safety monitoring as available under subsection (k)(3)
(including available other approaches under subsection
(k)(3)(C)) are not sufficient to--
``(i) assess a signal of a serious risk with use of a drug;
or
``(ii) identify unexpected serious risks in a domestic
population who use the drug, including a population not
included in trials used to approve the drug (such as 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 safety monitoring as available under subsection (k)(3)
(including available other approaches under subsection
(k)(3)(C)), 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,
[[Page S5275]]
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 (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, 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 that the existing information may not
have identified or allowed for full assessment of all serious
risks of using the drug is necessary to protect public health
and safety, 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.--To the extent consistent with
the Constitution, if the Secretary determines that disclosure
under subparagraph (E)(ii) is inadequate to protect public
health and safety, and that a prohibition of direct-to-
consumer advertisements of the drug for a fixed period after
initial approval of the drug, not to exceed 2 years, is
necessary to protect public health and safety while
additional information about serious risks of the drug is
collected using the reports under subsection (k)(1) and the
routine active safety monitoring as available under
subsection (k)(3) (including available other approaches under
subsection (k)(3)(C)), the risk evaluation and mitigation
strategy for the drug may require that the applicant not
issue or cause to be issued direct-to-consumer advertisements
of the drug for such fixed period. In making such
determination, 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;
``(iii) the serious risks listed in the labeling of the
drug;
``(iv) the extent to which patients have access to other
approved drugs in the pharmacological class of the drug and
with the same intended use as the drug; and
``(v) the extent to which 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.
``(6) Restrictions on distribution or use for drugs with
known unusual, serious risks.--
``(A) In general.--When a risk evaluation and mitigation
strategy for a drug is required, and considering the adequacy
of the labeling of the drug and 1 or more communication
elements under paragraph (5) to mitigate a specific serious
risk listed in the labeling of the drug, if the Secretary
determines that the drug, which has been shown to be
effective, can be safely used only if distribution or use of
such drug is restricted, the Secretary may require as
elements of such strategy such restrictions on distribution
or use as are needed to assure safe use of the drug.
``(B) Limits on restrictions to assure access and minimize
burden.--Such restrictions under subparagraph (A) shall--
``(i) be commensurate with the specific, serious risk
presented by the drug;
``(ii) 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 (such as patients in rural areas) who have
difficulty accessing health care; and
``(iii) to the extent practicable, so as to minimize the
burden on the health care delivery system--
``(I) conform with restrictions on distribution or 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 protect patient safety.--The restrictions
on distribution or use described under subparagraph (A) shall
include 1 or more goals to evaluate or 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;
``(ii) pharmacies, practitioners, or health care settings
that dispense the drug are specially certified;
``(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 restrictions on
distribution or use described under subparagraph (A) that
employ elements 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 restrictions.--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 restrictions on
distribution or 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 restrictions on distribution or use of such drug to
assess whether the restrictions--
``(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 restrictions under this paragraph for 1 or
more drugs as appropriate.
``(7) Submission and review of risk evaluation and
mitigation strategy.--
``(A) Proposed risk evaluation and mitigation strategy.--
``(i) Voluntary proposal.--An applicant may include a
proposed risk evaluation and mitigation strategy for a drug
in an application, including in a supplemental application,
under subsection (b) or section 351 of the Public Health
Service Act for the drug.
``(ii) Required proposal.--The applicant shall submit a
proposed risk evaluation and mitigation strategy for a drug--
``(I) within a timeframe specified by the Secretary, not to
be less than 45 days, when ordered by the Secretary (acting
through the office responsible for reviewing the drug and the
office responsible for postapproval safety with respect to
the drug), 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
``(II) 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 order.--An order under subclauses (I) or
(II) of clause (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.
``(iv) Content of proposal.--A proposed risk evaluation and
mitigation strategy--
``(I) shall include a timetable as described under
paragraph (3)(B); and
[[Page S5276]]
``(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 restrictions
on distribution or use are meeting the goal or whether the
goal or such restrictions 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 a restriction on
advertising under subparagraph (D), (E), or (F) of paragraph
(5);
``(V) adding, modifying, or removing a restriction on
distribution or 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)(i), 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) 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)(I) 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) 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 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 subparagraph
(A)(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) in an application for initial
approval of a drug and 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) 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) 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 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 subparagraph (A)(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
[[Page S5277]]
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 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 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) Restrictions on distribution or use, if required
under subsection (o)(6) for the applicable listed drug,
except that such drug may use a different, comparable aspect
of such restrictions on distribution or use as are needed to
assure safe use of such drug if --
``(aa) the corresponding aspect of the restrictions on
distribution or 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 restrictions on distribution or
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;
[[Page S5278]]
``(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 restrictions on distribution or
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 restrictions on distribution or 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, is 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) Workload Adjustment.--Subparagraph (A) of section
736(c)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379h(c)(2)), as amended by section 103, is amended in
the first sentence by striking ``and manufacturing changes
submitted to the Secretary, and'' and inserting
``manufacturing changes, and assessments of risk evaluation
and mitigation strategies submitted to the Secretary, uses of
dispute resolution under the process for reviewing and
assessing risk evaluation and mitigation strategies, and''.
(c) 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) $50,000,000; 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.''.
(d) 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; and
(D) implement routine active safety monitoring under
section 505(k)(3) (including other approaches under
subsection (c) of such section) of the Federal Food, Drug,
and Cosmetic Act, as added by section 201 of this Act;
(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 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;
[[Page S5279]]
``(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. DRUG LABELING.
(a) Accessible Repository of Drug Labeling.--Not later than
the effective date of this subtitle, the Secretary, through
the Commissioner of Food and Drugs, and the Director of the
National Institutes of Health, shall establish a searchable
repository of structured, electronic product information,
including the approved professional labeling and any required
patient labeling of each drug approved under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
licensed under section 351 of the Public Health Service Act
(42 U.S.C. 262) in order to improve patient safety through
accessible product information, support initiatives to
improve patient care by better management of health care
information, and provide standards for drug information. Such
repository shall be made publicly accessible on the Internet
website of the National Library of Medicine and through a
link on the homepage of the Internet website of the Food and
Drug Administration.
(b) Posting Upon Approval.--The Secretary shall post in the
repository under subsection (a) the approved professional
labeling and any required patient labeling of a drug approved
under such section 505 or licensed under such section 351 not
later than 21 days after the date the drug is approved,
including in a supplemental application with respect to a
labeling change.
(c) Report.--The Secretary shall report annually to the
Committee on Health, Education, Labor and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives on the status of the repository under
subsection (a), and on progress in posting structured
electronic product information, including posting of
information regarding drugs approved prior to the effective
date of this subtitle.
(d) Medication Guides.--Not later than the effective date
of this subtitle, the Secretary, through the Commissioner of
Food and Drugs, shall establish on the Internet website for
the repository under subsection (a), a link to a list of each
drug, whether approved under such section 505 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.
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. ADVISORY COMMITTEE ON RISK COMMUNICATION.
``(a) 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').
``(b) 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.
``(c) 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.
``(d) Permanence of Committee.--Section 14 of the Federal
Advisory Committee Act shall not apply to the Committee
established under this section.''.
SEC. 212. REFERRAL TO ADVISORY COMMITTEE.
Section 505 of the Federal Food, Drug, and Cosmetic Act, as
amended by this 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--
[[Page S5280]]
(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.
(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).
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 strict
limits on the ability of donors to include stipulations or
restrictions on the use 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;
[[Page S5281]]
``(viii) establish policies for the execution of memoranda
of understanding and cooperative agreements between the
Foundation and other entities, including the Food and Drug
Administration;
``(ix) establish policies for funding training fellowships,
whether at the Foundation, academic or scientific
institutions, or the Food and Drug Administration, for
scientists, doctors, and other professionals who are not
employees of regulated industry, to foster greater
understanding of and expertise in new scientific tools,
diagnostics, manufacturing techniques, and potential barriers
to translating basic research into clinical and regulatory
practice;
``(x) specify a process for annual Board review of the
operations of the Foundation; and
``(xi) establish specific duties of the Executive Director;
``(B) prioritize and provide overall direction to the
activities of the Foundation;
``(C) evaluate the performance of the Executive Director;
and
``(D) carry out any other necessary activities regarding
the functioning of the Foundation.
``(3) Terms and vacancies.--
``(A) Term.--The term of office of each member of the Board
appointed under paragraph (1)(C) shall be 4 years, except
that the terms of offices for the initial appointed members
of the Board shall expire on a staggered basis as determined
by the ex officio members.
``(B) Vacancy.--Any vacancy in the membership of the
Board--
``(i) shall not affect the power of the remaining members
to execute the duties of the Board; and
``(ii) shall be filled by appointment by the appointed
members described in paragraph (1)(C) by majority vote.
``(C) Partial term.--If a member of the Board does not
serve the full term applicable under subparagraph (A), the
individual appointed under subparagraph (B) to fill the
resulting vacancy shall be appointed for the remainder of the
term of the predecessor of the individual.
``(D) Serving past term.--A member of the Board may
continue to serve after the expiration of the term of the
member until a successor is appointed.
``(4) Compensation.--Members of the Board may not receive
compensation for service on the Board. Such members may be
reimbursed for travel, subsistence, and other necessary
expenses incurred in carrying out the duties of the Board, as
set forth in the bylaws issued by the Board.
``(e) Incorporation.--The ex officio members of the Board
shall serve as incorporators and shall take whatever actions
necessary to incorporate the Foundation.
``(f) Nonprofit Status.--The Foundation shall be considered
to be a corporation under section 501(c) of the Internal
Revenue Code of 1986, and shall be subject to the provisions
of such section.
``(g) Executive Director.--
``(1) In general.--The Board shall appoint an Executive
Director who shall serve at the pleasure of the Board. The
Executive Director shall be responsible for the day-to-day
operations of the Foundation and shall have such specific
duties and responsibilities as the Board shall prescribe.
``(2) Compensation.--The compensation of the Executive
Director shall be fixed by the Board but shall not be greater
than the compensation of the Commissioner.
``(h) Administrative Powers.--In carrying out this
subchapter, the Board, acting through the Executive Director,
may--
``(1) adopt, alter, and use a corporate seal, which shall
be judicially noticed;
``(2) hire, promote, compensate, and discharge 1 or more
officers, employees, and agents, as may be necessary, and
define their duties;
``(3) prescribe the manner in which--
``(A) real or personal property of the Foundation is
acquired, held, and transferred;
``(B) general operations of the Foundation are to be
conducted; and
``(C) the privileges granted to the Board by law are
exercised and enjoyed;
``(4) with the consent of the applicable executive
department or independent agency, use the information,
services, and facilities of such department or agencies in
carrying out this section;
``(5) enter into contracts with public and private
organizations for the writing, editing, printing, and
publishing of books and other material;
``(6) hold, administer, invest, and spend any gift, devise,
or bequest of real or personal property made to the
Foundation under subsection (i);
``(7) enter into such other contracts, leases, cooperative
agreements, and other transactions as the Board considers
appropriate to conduct the activities of the Foundation;
``(8) modify or consent to the modification of any contract
or agreement to which it is a party or in which it has an
interest under this subchapter;
``(9) take such action as may be necessary to obtain
patents and licenses for devices and procedures developed by
the Foundation and its employees;
``(10) sue and be sued in its corporate name, and complain
and defend in courts of competent jurisdiction;
``(11) appoint other groups of advisors as may be
determined necessary to carry out the functions of the
Foundation; and
``(12) exercise other powers as set forth in this section,
and such other incidental powers as are necessary to carry
out its powers, duties, and functions in accordance with this
subchapter.
``(i) Acceptance of Funds From Other Sources.--The
Executive Director may solicit and accept on behalf of the
Foundation, any funds, gifts, grants, devises, or bequests of
real or personal property made to the Foundation, including
from private entities, for the purposes of carrying out the
duties of the Foundation.
``(j) Service of Federal Employees.--Federal Government
employees may serve on committees advisory to the Foundation
and otherwise cooperate with and assist the Foundation in
carrying out its functions, so long as such employees do not
direct or control Foundation activities.
``(k) Detail of Government Employees; Fellowships.--
``(1) Detail from federal agencies.--Federal Government
employees may be detailed from Federal agencies with or
without reimbursement to those agencies to the Foundation at
any time, and such detail shall be without interruption or
loss of civil service status or privilege. Each such employee
shall abide by the statutory, regulatory, ethical, and
procedural standards applicable to the employees of the
agency from which such employee is detailed and those of the
Foundation.
``(2) Voluntary service; acceptance of federal employees.--
``(A) Foundation.--The Executive Director of the Foundation
may accept the services of employees detailed from Federal
agencies with or without reimbursement to those agencies.
``(B) Food and drug administration.--The Commissioner may
accept the uncompensated services of Foundation fellows or
trainees. Such services shall be considered to be undertaking
an activity under contract with the Secretary as described in
section 708.
``(l) Annual Reports.--
``(1) Reports to foundation.--Any recipient of a grant,
contract, fellowship, memorandum of understanding, or
cooperative agreement from the Foundation under this section
shall submit to the Foundation a report on an annual basis
for the duration of such grant, contract, fellowship,
memorandum of understanding, or cooperative agreement, that
describes the activities carried out under such grant,
contract, fellowship, memorandum of understanding, or
cooperative agreement.
``(2) Report to congress and the fda.--Beginning with
fiscal year 2009, the Executive Director shall submit to
Congress and the Commissioner an annual report that--
``(A) describes the activities of the Foundation and the
progress of the Foundation in furthering the goals and
priorities established under subsection (c)(2), including the
practical impact of the Foundation on regulated product
development;
``(B) provides a specific accounting of the source and use
of all funds used by the Foundation to carry out such
activities; and
``(C) provides information on how the results of Foundation
activities could be incorporated into the regulatory and
product review activities of the Food and Drug
Administration.
``(m) Separation of Funds.--The Executive Director shall
ensure that the funds received from the Treasury are held in
separate accounts from funds received from entities under
subsection (i).
``(n) Funding.--From amounts appropriated to the Food and
Drug Administration for each fiscal year, the Commissioner
shall transfer not less than $500,000 and not more than
$1,250,000, to the Foundation to carry out subsections (a),
(b), and (d) through (m).''.
(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:
``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.
[[Page S5282]]
``(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.
``(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:
[[Page S5283]]
``(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).
``(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
[[Page S5284]]
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:
``(d) 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.--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).
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--
``(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
[[Page S5285]]
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. 301. SHORT TITLE; REFERENCES.
(a) Short Title.--This title may be cited as the ``Medical
Device User Fee Amendments of 2007''.
(b) 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. 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 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;
[[Page S5286]]
(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.
``(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:
----------------------------------------------------------------------------------------------------------------
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:
[[Page S5287]]
``(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--
``(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
the date of the enactment of this subtitle.
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 (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 manufacturer 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).'';
(3) by amending paragraph (6) to read as follows:
``(6) A device establishment is eligible for inspections by
persons accredited under paragraph (2) if the following
conditions are met:
``(A) With respect to inspections to be conducted by an
accredited person--
``(i) the owner or operator of the establishment submits to
the Secretary a notice indicating the intent to use such a
person to conduct the inspection, and the date on which the
inspection is scheduled to begin; and
``(ii) the accredited person whom the establishment selects
to conduct the inspection is listed on the Internet site of
the Food and Drug Administration referred to in paragraph
(4).
``(B) As requested by the Secretary, the establishment or
the accredited person identified in the notice under
subparagraph (A) provides information concerning the
relationship between the establishment and such accredited
person.'';
(4) 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, 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 new subparagraph:
``(F) The Secretary shall accept reports of audits
assessing conformance with an appropriate quality systems
standard set by the International Organization for
Standardization (ISO) identified by the Secretary in public
notice for the purpose of setting risk-based inspectional
priorities.''.
[[Page S5288]]
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 striking ``(b) On or before'' and inserting ``(b)(1)
On or before'';
(2) in paragraph (1), 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 striking ``(1) On or before'' and inserting ``(1)(A)
On or before'';
(2) in subparagraph (A)--
(A) by striking ``processing of a drug or a device that is
imported'' and inserting ``processing of a drug that is
imported'';
(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 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
[[Page S5289]]
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.'';
(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.'';
[[Page S5290]]
(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.
``(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
[[Page S5291]]
(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.
``(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)'';
[[Page S5292]]
(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
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
[[Page S5293]]
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 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
[[Page S5294]]
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--
(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.''.
SEC. 428. 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.
=========================== NOTE ===========================
On Page S5294, April 30, 2007, the following appears: ``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.' ''
The online version has been corrected by deleting the sentence
========================= END NOTE =========================
The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
Mr. KENNEDY. Madam President, this week the Senate has the
opportunity to set a new and better direction for the safety of the
prescription drugs and medical devices that make such a profound
difference in the lives of our people.
Every day, families across America rely on the Food and Drug
Administration in ways they barely realize. When they put dinner on the
table, they are counting on the FDA to see that the food is free from
contamination. They trust the FDA to make sure the drugs they take are
safe and effective. From prescription drugs, to pacemakers, to
chemotherapy, to the food we eat, the FDA protects the health of
hundreds of millions of Americans and monitors products that account
for a quarter of the Nation's economy.
[[Page S5295]]
The FDA should be the ``gold standard'' for safety, but its luster
has been tarnished in recent years for failure to protect the American
people from unsafe drugs. The public was shocked that the arthritis
drug Vioxx was able to stay on the market for 5 years, even though it
nearly doubled the risk of heart attack and stroke. Antidepressants
used by millions were found to increase the risk of suicide in
adolescents. Millions of Americans have needlessly been put at risk,
and they want action by Congress to reform and strengthen the agency.
We are responding now with bipartisan legislation that is the product
of months of work in our committee. I commend my colleague and friend
in this effort, Senator Enzi, for his work on this proposal that will
improve the way FDA oversees the safety of drugs. Almost half of all
Americans take at least one pill a day, so this legislation will make a
difference in the lives of every American family. Our proposals were
strengthened by our colleague from New Hampshire, Senator Gregg.
Safety is at the core. Our legislation was guided by the
recommendations of the impressive report by the Institute of Medicine
on the ``Future of Drug Safety.'' Its major recommendations for reform
are included in this legislation.
This chart I have in the Chamber gives the major recommendations for
the Food and Drug Administration: Build the internal epidemiology and
informatics capacity in order to improve the postmarket assessment of
drugs, have postclinical trial results in a public database, have
regularly analyzed postmarket study results. This aspect about
postmarketing surveillance is a key in terms of drug safety. We have
included their recommendations. Another is: Give the FDA better
enforcement tools. I am going to refer to that in a moment. Another is:
Conduct regular evaluation of new drug safety profiles. We have
included that. I will expand on that point in a few moments. Another
is: Substantially increase drug safety resources available to the FDA.
We have also included those.
So those were recommendations from the Institute of Medicine. We have
reviewed the same subject matter. We evaluated those very carefully and
we have taken the major recommendations in terms of safety and included
them in this legislation.
A small number of health systems in America--now referring to
postmarketing surveillance and the use of electronic records--
effectively links the surveillance of various kinds of prescription
drugs to safety databases. These systems--Kaiser Permanente, Mayo
Clinic, Veterans' Administration--have the means to examine whether
Vioxx and other drugs were being used effectively. They found these
drugs were being prescribed inappropriately, and they took steps to
curb their overuse. As a result, they approved the use of these
medications only for patients who had no other options. Overuse went
down and safety improved.
The use of these databases should not be limited to the few health
systems that currently use them. FDA should make use of every aspect of
modern health care technology to safeguard the public's health. Mark
McClellan, the former FDA Commissioner, calls these kinds of systems
health IT for drug safety. Our proposal includes his recommendations.
Surveillance is essential, but effective action is needed when a
safety problem is detected. Each drug has unique risks and benefits.
There can be no one-size-fits-all approach to drug safety. That is why
our legislation includes a flexible but effective program for safety.
We call it a risk evaluation and management system. It can be tailored
to the unique characteristics of each drug. It gives the FDA the
authority to act when action is needed to protect public health, but it
also contains safeguards to prevent such action from being imposed when
there is no reason to do so.
For some drugs, it is essential to require postmarket studies, yet
FDA today lacks the basic authority to require such trials to be
conducted. FDA can request them but it cannot require them, and has few
ways to see they are completed. As a result, companies routinely
promise to conduct studies that are never even started, much less
completed.
This chart I have in the Chamber shows how, under current law,
postmarket studies are not completed. These are the studies that have
been requested by the FDA because they are for sound safety reasons.
Yet 71 percent of them were not even started. Our legislation says when
they are required and recommended by the company, they must move ahead.
In its recent report on drug safety, GAO pointed out the failure of
the current system. Its report states:
In the absence of specific authority, FDA often relies on
drug sponsors voluntarily agreeing to conduct such
postmarketing studies. But the postmarketing studies that
drug sponsors agree to conduct have not consistently been
completed. The FDA has little leverage to ensure that the
studies are carried out by imposing administrative penalties.
Our legislation solves this problem. It gives the FDA clear authority
to require the conduct of the postmarketing studies when there is a
public health need to do so, and it gives the FDA the ability to assess
fines on those who ignore their responsibilities.
Databases and postmarketing studies help detect problems, but the FDA
needs the ability to take other action to protect the public health.
Here, too, the current law is inadequate. FDA lacks clear authority to
require measures to protect public health. When lives are on the line,
doctors are making the critical decisions. But because FDA's authority
is so unclear, it must first call the lawyers for their opinion as to
whether the agency can act. The Institute of Medicine identified this
major weakness of current law and called on Congress to give FDA the
authority to require risk management programs when needed to protect
health. These programs can be as simple as new information on a drug
label or an advisory notice to doctors or as sophisticated as special
monitoring of programs for patients who use a particular drug. The
legislation does not make the decision about which measures should be
taken for which drugs, but it does give the FDA the authority to make
the right choice for the public health. This authority has been lacking
in the past.
For Vioxx, it took 14 months to change the drug's label to warn
doctors and patients of the danger. Because FDA had weak authority, it
had to ask the manufacturer to change the label voluntarily, and the
manufacturer stalled and stalled. When patients are in danger, FDA
should not have to wait to get legal opinions to decide how to protect
health. It should be able to act immediately, and our bill gives them
that authority.
In many cases, companies have hidden evidence of safety problems. Our
bill addresses this abuse by including a public database of all
clinical trials and their results. Listen to that: all clinical trials
and their results. We protect the trademark aspects of the particular
item but require the publication of all clinical trials and their
results. A company will no longer be able to hide the results if they
do not show what the company wanted.
Some would say any increase in drug safety will inevitably decrease
access to needed drugs, but that is a false argument. Consider the
situation now. When the FDA is confronted with a new drug that may
impose safety risks, or where additional study may be required, with
little expectations that those risks will be mitigated by a voluntary
approach--and with no ability to ensure that the studies are going to
be conducted--FDA might reasonably conclude the risks of approving the
drug are too great and, therefore, not approve it.
Under our legislation, the calculation is reversed. With this bill in
place, FDA could allow patients to have access to the drug, secure in
the knowledge that effective safety measures were in place. That is not
my judgment; it is the judgment of a coalition of advocacy
organizations representing over 30 million patients. This coalition,
the Alliance for Drug Safety and Access, wrote Congress a letter
saying:
[T]his legislation gives the FDA the ability to continue to
study the safety of drugs after approval, flexible
enforcement tools necessary to ensure compliance with these
new safety protections, and additional funding to support
these new activities. Allowing the agency to act on clear
safety signals could actually allow the FDA to approve drugs
more quickly, knowing it will have the ability to respond on
behalf of patients if safety concerns appear postmarket.
[[Page S5296]]
That is support from the organization that has been put together that
is protecting safety for the consumers. That is the balance our
legislation strikes: greater safety, hand in hand with better access.
As our debate continues, I will discuss additional aspects of the
legislation, especially its new ideas for accelerating drug
development, its renewal of our commitment to safe and effective drugs
for children, and its provisions to improve drug science, and increase
the transparency of the FDA.
We are also working with our colleagues from Iowa and Kansas, Senator
Harkin and Senator Roberts, on ways to refine our provisions on direct-
to-consumer advertising, to make certain they are consistent with the
Constitution. We are working with Senator Durbin and other colleagues
on the committee on proposals for food safety on pet food. These
bipartisan proposals are being readied for floor action shortly. I look
forward to further discussions on them.
Our committee will continue to work to improve the ways FDA can
monitor and improve food safety. In this new era of life sciences,
medical advances will continue to bring immense benefit for our
citizens. To fulfil the potential of that bright future, we need not
only brilliant researchers to develop the drugs of tomorrow but also
strong and vigilant watchdogs for public health to guarantee that new
drugs and medical devices are safe and beneficial, and that they
actually reach the patients who urgently need them.
Congress has ample power to restore the luster the FDA has lost in
recent years. The legislation we are now considering represents a
bipartisan consensus on the best way to get the job done.
I want to mention a few additional items. I am quoting now from the
FDA's report brief on 2006:
The Food and Drug Administration's authorities must be
clarified and strengthened to empower the agency to take
rapid, decisive action when necessary and appropriate. FDA
lacks the clear, unambiguous authority needed to enforce
sponsor compliance with regulatory requirements and, instead,
relies on the process of productive negotiations with the
industry.
We have taken that. That is their No. 1 statement.
Included in that we have--this is the IOM committee.
The committee recommends that the FDA ensure that the FDA
has the ability to require postmarketing risk assessment and
to monitor and ensure the safe use of drugs.
We have done it.
These conditions may be imposed both before and after
approval of a new drug, a new indication or a new dosage.
We have incorporated those concepts, as well as the identification of
some new contraindications or patterns of adverse effects.
It talks about the distribution, conditioned on compliance, with
agency-initiated changes and drug labels. We have achieved that.
Conditioned on specific warnings, proposal materials, distribution
conditioned on a moratorium, on direct consumer advertising. We have at
least addressed that.
It also includes distribution of restrictions for special training,
if need be, for pharmacists and physicians. It also has distribution
conditions on the performance of specific medical procedures. It talks
about clinical trials. FDA needs increased enforcement authority,
better enforcement tools directed at drug sponsors which should include
fines and injunctions and withdrawal of drug approval.
We haven't taken every one of these recommendations--not every one
precisely--but we have taken the essence of these recommendations, and
we have included those that are as a result of our extensive hearings.
I could go on with this, and will later on perhaps, but I won't today.
I wish to mention, finally, the various groups.
We mentioned the Alliance for Drug Safety and Access. I will include
these letters of support. This is to Senators Kennedy and Enzi:
On behalf of the Alliance for Drug Safety and Access, we
write today to express our support for the goals of titles I
and II of S. 1082, the Food and Drug Administration
Revitalization Act.
It will continue the timely access of patients to new
therapies and will improve the ability of the Food and Drug
Administration to ensure safety of drugs already on the
market.
S. 1082 takes a life-cycle approach to the risk-benefit
assessment of drugs and biologics--
This is so, though we have not included biologics in this proposal
with regard to drugs as endorsed by the Alliance and recommended by the
Institute.
We are pleased that this legislation gives the FDA the
ability to continue to study the safety of drugs after
approval, flexible enforcement tools necessary to ensure
compliance with the new safety protections, and additional
funding to support these new activities.
It allows the FDA to approve drugs more quickly, knowing it will have
the ability to respond to the patients if safety concerns appear
afterwards.
This represents a group of at least 30 different health organizations
that have followed this most closely.
We have a letter that has been sent to Senator Enzi and myself,
Senator Dodd and Senator Clinton, talking about how this legislation
impacts children and giving special recognition, as they should, to our
colleagues and friends, Senator Dodd, who has been such a leader in
this area, and Senator Clinton as well, who has been so thoughtful in
this area.
It points out the Pediatric Medical Device Safety Improvement Act of
2000 provides a comprehensive approach to ensure that children are not
left behind in cutting-edge research and revolutionary technologies for
medical devices. It talks about swift action and passage.
The American Psychiatric Association talks about how the provisions
of this bill will ensure the Food and Drug Administration is equipped
with the necessary tools to enhance its consistency, transparency, and
accountability in ensuring the safety of drugs postapproval.
The American Psychiatric Association advocates for patient safety and
supports further postmarket research of medications to ensure the
safety and efficacy of medications used to treat mental illnesses. The
letter says:
We look forward to working with you to rebuild the
Administration's reputation and creating a universal drug
safety monitoring system that is reliable and dependable.
They indicate their strong support for the legislation.
Again, another letter of support from the American College of
Pharmacy, and it talks about the particular emphasis we have placed on
improving science knowledge, which improves their decisionmaking
regulatory oversight. Science knowledge grows on a daily basis. We know
we are in the life science century. We want that agency, the FDA, to
have the best in terms of science and science knowledge, and we have
included special provisions to enhance that particular effort, and this
association has recognized that.
We also have a letter from the Consumers Union, and they talk about
their strong support for this legislation. They oppose any weakening
amendments of this important legislation. It also has some reference to
some of the recent polls which point out that 96 percent of Americans
agree that Government should have the power to require warning labels
if safety problems are identified, with 80 percent of those strongly
agreeing to that authority. Right now the FDA has to negotiate safety
warnings.
It also talks about the strong support the American people have for
the FDA, which doesn't have the authority to provide studies to be
performed once the drug is on the market. The American people are way
ahead of us. They also show strong support to make public the clinical
trial studies. This bill does that. Sixty-eight percent of the American
people strongly agree the drug studies should be made public.
Eighty-four percent of the American people believe advertising for
prescription drugs with safety concerns should be prohibited. Then it
continues: Three-quarters of consumers agree that drug ads lead to
overprescribing, with 38 percent strongly agreeing and 59 percent
agreeing that the Government should restrict advertising by
pharmaceutical companies altogether. We haven't gone that route, but we
have taken safety considerations to heart.
Then the other letters from the Cardiovascular Association that talk
about the particular provisions dealing with children, the pediatric
provisions in here which are enormously important, and other letters. I
ask unanimous consent that the appropriate representative group of
letters be printed
[[Page S5297]]
in the Record and the references to some of the editorials from across
the country--I am not going to ask that they all be printed, but I will
ask that selected ones be printed in the Record and that other
newspapers be referenced showing strong support.
There being no objection, the material was ordered to be printed in
the Record, as follows:
The Alliance for Drug
Safety and Access,
April 17, 2007.
Hon. Edward M. Kennedy,
Chairman, Senate Health, Education, Labor, and Pensions
Committee, U.S. Senate, Washington, DC.
Hon. Michael B. Enzi,
Ranking Member, Senate Health, Education, Labor, and Pensions
Committee, U.S. Senate, Washington, DC.
Dear Senators Kennedy and Enzi: On behalf of the Alliance
for Drug Safety and Access (ADSA), we write today to express
our support for the goals of Titles I and II of S. 1082, the
``Food and Drug Administration Revitalization Act''. We
appreciate your leadership in introducing this bipartisan
legislation, which will both continue the timely access of
patients to new therapies and improve the ability of the Food
and Drug Administration (FDA) to ensure the safety of drugs
already on the market. While we would appreciate the
opportunity to continue to work with you on strengthening
this legislation as it moves forward, we urge the Committee
on Health, Education, Labor and Pensions to report out this
legislation for consideration by the full Senate.
ADSA members advocate on behalf of over 31 million
patients, including those suffering from HIV/AIDS,
Parkinson's disease, spinal cord injuries, paralysis,
multiple sclerosis, leukodystrophies, Tourette syndrome, and
over 6,000 known rare diseases. Our members also represent
over 100,000 providers of care to pediatric patients and
individuals with mental illnesses.
S. 1082 takes a life-cycle approach to the risk-benefit
assessment of drugs and biologics, as endorsed by ADSA and
recommended by the Institute of Medicine. We are pleased that
this legislation gives the FDA the ability to continue to
study the safety of drugs after approval, flexible
enforcement tools necessary to ensure compliance with these
new safety protections, and additional funding to support
these new activities. Allowing the agency to act on clear
safety signals could actually allow the FDA to approve drugs
more quickly, knowing it will have the ability to respond on
behalf of patients if safety concerns appear post-market.
We know that you share our interest in both speeding life-
saving drugs to patients while also strengthening oversight
of drugs post-market. And, we believe that with sufficient
resources both goals are achievable through the legislation
you have authored. ADSA looks forward to working with you
toward these goals and toward strengthening provisions of
your legislation related to patient access to clinical trial
information and the FDA's enforcement authorities.
Thank you again for your leadership on this critical issue
and the opportunity to share our views.
AIDS Treatment Action Coalition
American Academy of Pediatrics
American Academy of Child and Adolescent Psychiatry
American Psychiatric Association
Christopher and Dana Reeve Foundation
Elizabeth Glaser Pediatric AIDS Foundation
National Multiple Sclerosis Society
National Organization for Rare Disorders (NORD)
Parkinson's Action Network
Tourette Sydrome Association.
____
April 17, 2007.
Hon. Edward Kennedy,
U.S. Senate, Washington, DC.
Hon. Michael B. Enzi,
U.S. Senate, Washington, DC.
Hon. Christopher J. Dodd,
U.S. Senate, Washington, DC.
Hon. Hillary Rodham Clinton,
U.S. Senate, Washington, DC.
Dear Senators Kennedy, Enzi, Dodd and Clinton: As
organizations working to ensure better health care for the
nation's children, we write to thank you for your long-
standing commitment to children's health and to express our
support for legislation to reauthorize the Best
Pharmaceuticals for Children Act (BPCA) and the Pediatric
Research Equity Act (PREA) and to improve children's access
to safe medical devices. We are very pleased that BPCA and
PREA reauthorization language and S. 830, the Pediatric
Medical Device Safety and Improvement Act, have been included
in the Chairman's mark of S. 1082, the ``Food and Drug
Administration Revitalization Act,'' for consideration by the
Senate Health, Education, Labor and Pensions Committee
tomorrow.
Over the past decade, Congress has enacted bipartisan
legislation that has dramatically increased the number of
drugs tested and labeled for children. The results from BPCA
are extraordinary--over 336 requests have been generated for
over 780 pediatric studies, resulting in over 115 new drug
labels for children. Sen. Dodd's BPCA reauthorization
language strengthens this very successful existing program in
several important ways, including ensuring prompt label
changes, requiring that all study protocols and results be
made public, improving adverse events reporting for children,
and identifying and addressing important gaps in treatments
for children's diseases, In addition, the BPCA language
includes a reasoned approach to address the small percentage
of drugs for which the exclusivity provision has far exceeded
the incentive it was intended to provide pharmaceutical
companies.
S. 993, the Pediatric Research Improvement Act (PRIA),
introduced by Sen. Clinton and included in the Chairman's
mark, reauthorizes the Pediatric Research Equity Act of 2003
(PREA), which requires drug manufacturers to test their
products for use in children. This law ensures that children
are not a therapeutic afterthought and has generated
impressive and invaluable safety and dosing information for
children. Since the 2003 passage of PREA, 55 drugs have new
or improved pediatric labeling. These drugs range from
treatment of ear infections to the prevention of rejection of
organ transplants. S. 993 places children on equal
therapeutic footing with adults by creating the presumption
that medicines coming onto the market for illnesses and
conditions that occur in children will be labeled for
pediatric use and be available in formulations (e.g.,
liquids, chewable tablets) that children can take.
The Pediatric Medical Device Safety and Improvement Act of
2007 provides a comprehensive approach to ensuring that
children are not left behind as cutting-edge research and
revolutionary technologies for medical devices advance. Like
drugs, where for too long children were treated like small
adults, many essential medical devices used extensively by
pediatricians are not designed or sized for children.
According to pediatricians, the development of new medical
devices suitable for children's smaller and growing bodies
can lag 5-10 years behind those for adults. S. 830 improves
incentives for devices for small markets--while still
preserving the ability to ensure the safety of new products
once on the market. It provides assistance to innovators,
streamlines regulatory processes, and elevates pediatric
device issues at the Food and Drug Administration (FDA) and
the National Institutes of Health.
Despite our support for the Chairman's mark, we are
disappointed that a key provision to make PRIA permanent has
been omitted. As this legislation moves to the floor of the
Senate, we urge you to restore the permanent authority of the
FDA to ensure that children have properly studied medications
as a matter of fact, not chance.
We are grateful for your long-standing leadership and
commitment to improving the health of our nation's children
and look forward to working with you toward swift Committee
action and passage of these pediatric therapeutic bills by
the full Senate.
Sincerely,
American Academy of Pediatrics.
Elizabeth Glaser Pediatric AIDS Foundation.
AIDS Alliance for Children, Youth & Families.
American Academy of Child and Adolescent Psychiatry.
American Brain Coalition.
American Pediatric Society.
American Psychiatric Association.
American Thoracic Society.
Arthritis Foundation.
Association of Medical School Pediatric Department Chairs.
Children's Cause for Cancer Advocacy.
National Association of Children's Hospitals (N.A.C.H.).
National Organization for Rare Disorders.
National Research Center for Women and Families.
Society for Pediatric Research.
____
American Psychiatric
Association,
Arlington, VA, February 6, 2007.
The American Psychiatric Association (APA) would like to
thank Senators Edward Kennedy and Mike Enzi for their
introduction of the bipartisan bill, ``Enhancing Drug Safety
and Innovation Act of 2007'' (S.484). The provisions of the
bill will help ensure that the Food and Drug Administration
is equipped with the necessary tools to enhance its
consistency, transparency and accountability in assuring the
safety of drugs post approval.
The APA is the national medical specialty society
representing more than 37,000 psychiatric physicians
nationwide who specialize in the diagnosis and treatment of
mental and emotional illnesses and substance use disorders.
APA advocates for patient safety and supports further post-
market research of medications to ensure the safety and
efficacy of medications used to treat mental illnesses.
The APA thanks you again for your dedication and commitment
to enhance the nation's drug safety monitoring system. We
look forward to working with you to rebuild the
Administration's reputation and creating a universal drug
safety monitoring system that is reliable and dependable in
order for patients to make well informed decisions. As your
staff move forward with further action on legislation, Lizbet
Boroughs, Deputy Director, Government Relations for the APA
or Chatrane Birbal, Federal Legislative Coordinator.
Sincerely,
James H. Scully, Jr., M.D., Sc.D.
CEO and Medical Director,
American Psychiatric Association.
____
Consumers Union,
Washington, DC, April 26, 2007.
Senator XXXXX,
U.S. Senate,
Washington, DC.
Dear Senator: Consumers Union, the nonprofit, independent
publisher of Consumer
[[Page S5298]]
Reports, urges you to support S. 1082, the Food and Drug
Administration Revitalization Act, when it comes to the
Senate floor, and oppose any weakening amendments to this
important patient-safety legislation.
S. 1082 will save countless lives in the years to come by
giving the FDA more funding and flexible tools to ensure the
safety of prescription drugs and medical devices in the
marketplace. It also will help return public trust in an
agency that has been severely damaged by Vioxx, Paxil and
other recent drug safety disasters.
There is nothing in this legislation that would slow down
the approval of important, life-saving drugs. Rather, it
gives the FDA effective authority to ensure safety once drugs
come to market by improving the surveillance of post-market
adverse events and communicating possible risks to doctors
and patients.
Americans are extremely concerned about prescription drug
safety and support Congressional action on the issue. A
national poll recently conducted by the Consumer Reports
National Research Center found that more than 60 percent of
Americans agree that the FDA and Congress have failed to
adequately protect consumers from harmful prescription drugs.
It also found that 84 percent agree the government should
``have the authority to take any action necessary'' to ensure
drug safety.
Please support S. 1082. We also urge you to oppose any
attempts to weaken its drug safety sections, such as
amendments making it much harder to trigger a quick safety
action when there are signs of danger, or blocking the FDA--
in very rare cases--from moderating the mass marketing of a
new drug which has indications of safety problems. We also
hope that as the Senate considers FDA-related legislation, a
pro-consumer biogenerics bill can be added, and the FDA's
advisory committee conflict-of-interest provisions
strengthened.
We know that you share our interest in both speeding life-
saving drugs to patients while also strengthening oversight
of drugs post-market. We believe that with sufficient
resources and authority, both goals are achievable through
this legislation.
If you have any questions or concerns as to why the public
and the FDA need this legislation, please contact William
Vaughan.
Sincerely,
Jim Guest,
President and CEO, Headquarters Office.
____
Poll: Consumers Say Govt Failed To Protect Them From Dangerous
Prescription Drugs; Americans Back Host of Drug Safety Reforms
Washington, DC.--As Congress prepares to vote on the most
significant prescription drug safety legislation in 45 years,
a new Consumer Reports poll finds that the American public
strongly backs a host of key safety reforms. Nine out of 10
agree that all clinical drug trial results should be made
public, and that the government should have the power to
require warning labels and follow-up studies on drugs with
safety problems.
In general, the survey found consumers support the
government taking whatever steps necessary to ensure the
safety of prescription drugs--84 percent agree that the
government should ``have the authority to take any action
necessary'' to ensure drug safety, with 50 percent strongly
agreeing.
Also, more than 60 percent of Americans agree that the Food
and Drug Administration and Congress have failed to
adequately protect consumers from harmful prescription drugs.
``The message we're hearing from consumers couldn't be
clearer--they want strong laws to ensure our prescription
drugs are as safe and effective as possible,'' said Jim
Guest, CEO of Consumers Union, publisher of Consumer Reports.
``Right now drug companies can game the system by touting
the positive results from their drug studies, while
downplaying information about harmful side effects,'' Guest
added. ``Americans are fed up with being kept in the dark
about critical health and safety information, and they
overwhelmingly want change.''
The telephone survey of 1,026 randomly selected adults,
conducted March 15-18 by the Consumer Reports National
Research Center, asked about reforms that would strengthen
the nation's drug safety system. The margin of error is +/
-3.1 percent. Among the responses:
96 percent agree that the government should have the power
to require warning labels if safety problems are identified--
with 80 percent of those ``strongly agreeing'' to that
authority. Right now, the Food and Drug Administration must
negotiate safety warning labels with a drug maker.
93 percent agree that the FDA should have the power to
order follow-up safety studies, with 65 percent ``strongly
agreeing'' to that authority. Today, the FDA generally does
not have the authority to require safety studies be performed
once a drug is on the market.
92 percent of Americans agree that pharmaceutical companies
should make public the results of all of their clinical trial
studies, which reveal a drug's effectiveness as well as
possible hazardous side effects. Of those, 68 percent
``strongly agreed'' that drug studies should be made public.
Such studies are used to get a drug approved and generally
are conducted on human subjects. The makers of Vioxx and
Paxil had studies that indicated safety problems for years,
but failed to release those results to the public. Vioxx
eventually was removed from the market after being linked to
increased risk of heart attack and stroke; antidepressants in
the class of Paxil now carry black-box warnings about
increased suicide risk in adolescents and adults under 25.
84 percent agree that advertisements for a prescription
drug with safety concerns should be prohibited; with 59
percent ``strongly agreeing'' to such limits.
``Consumers expect Congress to take their concerns about
drug safety seriously, and deliver legislation that will
prevent future Vioxx-type disasters,'' said Bill Vaughan,
Consumers Union senior policy analyst.
``Failure to act this year on the strongest possible bill,
when more than 80 percent of Americans agree that Congress
should do whatever is necessary to ensure drug safety, would
equate to gross legislative malpractice,'' Vaughan added.
The Senate Health Committee is expected to vote Wednesday
on a bill that includes important drug safety measures, as
well as reauthorizing pharmaceutical industry user fees to
support the FDA drug-approval and safety process (S. 1082).
The last significant drug safety legislation in 1962 required
manufacturers to prove their drugs had some positive effect,
but failed to give the FDA power to quickly protect the
public when safety questions were raised.
Consumers Union and other patient and safety organizations
are working to further strengthen the drug safety legislation
to require the public release of all clinical trial data,
make safety disputes open to public scrutiny, and raise the
profile of drug safety and science in the FDA.
Conflict-of-interests between Pharma and FDA also a top concern
The survey found that 84 percent of consumers agree that
drug companies have too much influence over the government
officials who regulate them. More than two-thirds (67
percent) are concerned that much of the FDA's funding comes
from the pharmaceutical industry, with more than half--54
percent--``very concerned'' about that funding situation.
Congress is expected this summer to reauthorize the
Prescription Drug User Fee Act, first passed in 1992 to speed
up drug approvals by having the industry help fund the FDA
approval process. The original act has been extended twice
and is slated to expire this fall unless Congress
reauthorizes it. The FDA-industry proposal calls for industry
to pay $393 million annually to the FDA, an increase of $87
million over the previous PDUFA agreement. S. 1082 adds
additional user fees for safety.
Consumers also were concerned about conflicts of interest
on advisory boards that approve drugs for market. Six in 10
disapproved of allowing doctors and scientists with a
conflicting financial interest to participate on advisory
boards.
More than half of consumers say they currently take a
prescription drug, which translates to 124 million adults. A
significant number--40 percent--say they had experienced an
adverse reaction to a medication.
``Four out of 10 Americans say they've had a bad reaction
to a prescription drug, yet the FDA only receives about half
a million adverse-event reports a year,'' Vaughan said.
``Clearly, the FDA needs to do a better job fielding
consumers'' experiences with side effects. ``
Prescription drug advertising influences prescribing; should be limited
Americans are very aware of prescription drug advertising,
with nine out of 10 Americans (91 percent) reporting they had
seen a drug ad on television or in print, or heard one on
radio. More than a quarter of those (26 percent) said they
asked for a specific medication they learned about in an ad.
Three-quarters of consumers (75 percent) agreed that drug
ads lead to over-prescribing, with 38 percent ``strongly
agreeing.'' And 59 percent agreed the government should
restrict advertising by pharmaceutical companies, with 26
percent strongly agreeing to such restrictions.
Yet some consumers find drug ads useful in talking to their
doctor (63 percent agree, 24 percent strongly agree) and
others agreed they help consumers take charge of their health
care (54 percent agree, 14 percent strongly agree).
``Consumers are very concerned that advertising drives up
the prescription drug use and health-care costs, and they'd
like to see restrictions on those ads,'' Vaughan said.
____
The Society for Cardiovascular
Angiography and Interventions,
Washington, DC, April 17, 2007.
Hon. Edward Kennedy,
U.S. Senate,
Washington, DC.
Hon. Christopher J. Dodd,
U.S. Senate,
Washington, DC.
Hon. Hillary Clinton,
U.S. Senate,
Washington, DC.
Dear Senators Kennedy, Dodd and Clinton: I am writing to
express our support for your long-standing commitment to
children's health and to express our support for your efforts
to improve children's access to safe medical devices. We are
very pleased that the Pediatric Medical Device Safety and
Improvement Act has been included in the Chairman's mark of
S. 1082, the ``Food and Drug Administration Revitalization
Act,'' for consideration by the Senate Health, Education,
Labor and Pensions Committee tomorrow. Your proposal is an
important step forward.
[[Page S5299]]
The Society for Cardiovascular Angiography and
Interventions is a professional association representing over
3,700 invasive and interventional cardiologists. SCAI
promotes excellence in cardiac catheterization, angiography,
and interventional cardiology through physician education and
representation, and quality initiatives to enhance patient
care.
Fortunately, cardiovascular disease is far less common in
the pediatric population than it is in the adult population.
This good fortune does however frequently lead to unique
challenges for the pediatric interventional cardiologist who
treats these patients. Some of the challenges are clinical
and we are more frequently solving those problems, saving
children's lives and avoiding the trauma of surgery. Other
challenges, and perhaps the most frustrating ones are related
to obtaining the safe medical devices necessary to treat
these patients. Devices that are available to our colleagues
in Europe are not available in America. We support the FDA's
efforts to ensure that only safe and effective medical
devices are used on patients in our country, but when the
entry barriers into the American markets are so high that
manufactures refuse to enter--some patients suffer and die
needlessly. Required is an appropriate balance between the
sometimes mutually exclusive goals of safety and
availability.
We are especially pleased that your legislation will
require the FDA to issue guidance to institutional review
committees (IRCs) on how to appropriately consider the use of
the humanitarian device exemption (HDE) at their institution.
When HDE devices are not part of an ongoing trial, IRC's
(which focus on reviewing the care of patients in trials) are
sometimes confused.
We believe that giving the FDA explicit statutory authority
to extrapolate from adult to pediatric patients in
appropriate situations could help FDA officials expedite
their review of some pediatric medical devices.
We applaud the provision that allows companies to make a
profit on HDE devices designed for children. This change will
encourage the development of more devices by providing an
opportunity for profit and also by reducing concerns about
audits, specifically those using different assumptions which
could determine a profit was made when a manufacturer
calculated their financial situation differently. We note
that the 4,000 cap is arbitrary and far below the patient
limit that is placed on orphan drugs. We believe that more
devices will be available to pediatric patients and those
with congenital heart disease if that cap is raised. We
encourage you to consider such an increase either as a part
of this legislation or broader FDA reform legislation.
We look forward to working with you and your staff to
support passage of this legislation and thank you once again
for your efforts. Our contact person for this effort is Wayne
Powell and he may be reached at (202) 375-6341 or
[email protected].
Sincerely,
Gregory J. Dehmer, M.D., FSCAI,
President.
____
Heart Rhythm Society,
Washington, DC, April 3, 2007.
Hon. Christopher J. Dodd,
Chair, Subcommittee on Education and Early Childhood
Development,
Senate Committee on Health, Education, Labor and Pensions,
Russell Senate Office Building, Washington, DC.
Dear Chairman Dodd: I am writing to express the Heart
Rhythm Society's support for passage of the Pediatric Medical
Device Safety Act of 2007. We greatly appreciate your efforts
to expand pediatric patients' access to safe medical devices.
Your proposal is an important step forward.
The Heart Rhythm Society is the international leader in
science, education and advocacy for cardiac arrhythmia
professionals and patients, and the primary information
resource on heart rhythm disorders. Our mission is to improve
the care of patients by promoting research, education and
optimal health care policies and standards. We represent over
4300 specialists in cardiac pacing and electrophysiology.
We believe the Pediatric Medical Device Safety Act of 2007
would help promote needed innovation and focus efforts on
defining and then attempting to meet the unique needs of the
pediatric population. In our area this would translate into
improved medical device treatments for arrhythmias, such as
use of pacemakers and Internal Cardioverter Defibrillators
(ICDs) tailored to pediatric patients.
Also of great interest to the field of pediatric
electrophysiology are the proposed grants for research and
the crafting of an agenda for evaluation of ``long-term
safety and effectiveness of pediatric medical devices.''
Additional funds could potentially be utilized to create a
pediatric version of the ICD RegistryTM a database
registry which captures implant and outcomes data ICDs used
in patients at risk for sudden cardiac arrest. This project
would go a long way to achieve the goal outlined in Section
7(b)2, to ``assess the impact of growth, development,
activity level and other factors on the safety and efficacy
of the devices.''
We look forward to supporting you and your staff in
securing passage of this legislation and we thank you for
your efforts to enable the youngest of our patients life-
saving access to safe and effective medical devices. Amy
Melnick, Vice President, Health Policy will coordinate the
Heart Rhythm Society efforts to support this bill. She can be
reached at (202) 464-3434 or [email protected]. Please
do not hesitate to contact us and thank you for accepting our
endorsement.
Sincerely,
Dwight Reynolds, MD, FHRS,
President,
Heart Rhythm Society.
____
Washington, DC, April 19, 2007.
Hon. Edward Kennedy,
Chairman, Senate Committee on Health, Education, Labor, and
Pensions.
Hon. Mike Enzi,
Ranking Member, Senate Committee on Health, Education, Labor,
and Pensions.
Dear Chairman Kennedy and Ranking Member Enzi: On behalf of
the American Association of Colleges of Pharmacy (AACP) and
our nation's 97 accredited colleges and schools of pharmacy
we thank you for your efforts to protect the public's health
through the introduction of the ``Food and Drug
Administration Revitalization Act of 2007.'' AACP, the
national organization representing and supporting colleges
and schools of pharmacy and their faculties, is committed to
education and scholarship for improving drug therapy.
In particular we appreciate the legislation's provisions
that will support the Food and Drug Administration's (FDA)
publicly stated need to improve the science knowledge which
supports and improves their decision making and regulatory
oversight. Science knowledge grows on a daily basis and the
academic community, including academic pharmacy, is the best
place to look for individuals whose research is creating that
new knowledge. Your legislation helps the FDA increase its
science knowledge in partnership with academic pharmacy
through:
Opportunities to engage in extramural research; Influencing
FDA directly through nominations from academic pharmacy to
advisory committees, and the Reagan-Udall Foundation Board of
Directors; and actively engaging in the multiple
opportunities for public comment on the implementation of
many of the legislation's provisions.
Your recognition that the academic biomedical research
community is a cutting-edge knowledge resource recognizes the
important trend of translational research. AACP members are
already engaged with the Agency for Healthcare Research and
Quality (AHRQ) Centers for Education and Research on
Therapeutics (CERTs) program and the DEcIDE Network. This
provides the FDA with an excellent network of researchers
prepared to analyze drug safety data. Our members are in the
initial stages of developing practice-based research networks
(PBRN) that can further assist the Committee and the FDA in
reaching the goal of improved risk evaluation and mitigation.
This broad research capacity extends to medical devices,
pediatric care, and manufacturing.
The members of AACP appreciate your commitment to
protecting the public's health and stand ready to assist you
as your legislation continues the process of congressional
action. Please do not hesitate to contact me should you need
additional information regarding the role of academic
pharmacy in revitalizing the FDA.
Sincerely,
William G. Lang IV,
VP Policy and Advocacy.
Mr. KENNEDY. Madam President, we have very solid legislation that is
going to make a very important difference--very important difference in
protecting the American consumer. We now have in place leadership at
the Food and Drug Administration; for 5 of the last 6 years that has
not been so. We have in place leadership, and we are going to give that
agency the kind of tools necessary for protection the American people
are entitled to and to restore the kind of luster that should go with
the Food and Drug Administration, which is so important to the health
and well-being of American families.
The PRESIDING OFFICER. The Senator from Wyoming is recognized.
Mr. ENZI. Madam President, I wish to thank the Senator from
Massachusetts, Senator Kennedy, for his outstanding presentation on
what is in the bill.
I rise to speak about S. 1082 as well. It is a comprehensive bill to
enhance drug safety and provide key resources to the Food and Drug
Administration--the FDA--for the review of new drugs, for the review of
medical devices, and to ensure that drugs and devices for children are
safe and effective. It has been a long and careful road for this bill.
The Senate Committee on Health, Education, Labor and Pensions
embarked on a top-to-bottom review of the FDA's drug safety and
approval process over 2 years ago. This bill is the culmination of our
review and the input of hundreds of stakeholders. I wish to speak for a
few minutes discussing why the drug safety components and the changes
that are being made are so critical to restoring the
[[Page S5300]]
peace of mind to Americans who want to be assured the drugs they
purchase to address illnesses and chronic medical conditions can be
relied on and trusted.
``Bipartisan'' is a word that is kind of thrown around in this
Chamber a lot, and sometimes it means that one person from one party
joins several people from the other party. For Senator Kennedy and me,
bipartisan means you actually work together to find out what the
problem is, what the potential solutions are, and how you can meet
those needs. I mentioned it has been a long process--over 2 years--and
it is still a work in progress--and we are making progress.
We held hearings on the FDA. A lot of those hearings were held in the
heat of the moment, when certain drugs were having problems, and we
recognize that is a problem. One of the problems with Congress is we
usually see that if it is worth reacting to, it is worth overreacting
to. We have always taken a very careful view in our committee to make
sure that was not the case.
Other committees held hearings on the FDA, even though the FDA is
under the jurisdiction of our committee, and we have no problem with
that. We have taken the suggestions we have gotten through those
hearings and considered them for this legislation. Then we drew up a
list of principles, and we took that to the stakeholders to see what
all the people involved thought about the principles we had. Then we
did the tough part. We drafted the details. It is easy to sell
concepts, but details are tough. Until you have those details put down
in writing and have people look at every word that is in them, you
can't tell whether you have a bill. But we went through that process.
We took it back to the stakeholders. We redrafted. We filed the bill.
We had more hearings. This year, we have had more hearings on FDA, and
we have had a markup. That is when all the Committee Members are
offered a chance to request or suggest amendments to the bill.
We probably had about 50 amendments and we worked on the 12 major
categories of amendments. Some of those were worked into the bill as
part of the markup. Some of them have been put into the manager's
amendment. I mentioned this is a work in progress. We are still looking
at some of those, figuring out what is needed and how to get there. I
appreciate the cooperation we have had from the Members with their
suggestions and the staffs of the Members with their suggestions,
because throughout the last weekend, there were hours and hours and
hours spent by Senator Kennedy's staff and my staff and the interested
Senators and their staffs to arrive at the best possible solution. We
are not there yet. We are close. That is the way we work on bills--a
long process with decisions being made up to the last possible moment
so that we can have the best possible solution for the people of this
country. That is bipartisan.
It was mentioned there have been some hearings on food safety.
Recently, there has been some real criticism of the FDA on food safety.
We held hearings on food safety. I don't want the people of this
country to think it is all bad. In fact, I was amazed that three
Federal agencies have to work together on a food problem. The CDC, the
Department of Agriculture, and the Food and Drug Administration have to
work together because each of them has a role in discovering whether
there is a problem. I was amazed to find out that with as few as 50
cases spread out across the whole United States, they can diagnose and
determine there is a problem and get products off the market. If you
are not amazed with that, you are not paying attention. We have
agencies that work together, and they work together in critical times
to solve problems for the people of America. They can notice, with a
real small sampling--when you consider the millions of people in this
country, the millions of people who are being fed every day,--they can
recognize a problem with the food supply and get the harmful product
off the market. It would be nice if they could prevent that. They are
working on that.
But when you consider the number of producers in this country and
other countries, they have a tremendous job, and we have to be sure
they have the tools to do that job as well. But that is a job that is
in addition to the drug approvals. This bill concentrates on the drug
approvals.
Vioxx was one of the triggers of these discussions. As we saw with
Vioxx, the FDA doesn't have enough tools to deal with newly identified
risks when those risks become evident after a drug has been on the
market for some time. Most of the FDA's current authority is based on
information and plans available at the time of approval. They have a
massive job determining if a drug is ready to go to market. What is
amazing is that once they have given that approval, their options are
very limited. Now, that creates a little bit of a dilemma for them.
They don't know everything that will happen with that drug. Yes, it has
been through clinical trials. What is a clinical trial? It is a
controlled study of people taking the drug, and sometimes people who
are not taking the drug--a controlled study. Once that drug is
approved, it goes out to the whole market--not controlled people, not
people that we know what other drugs they are taking or what other
kinds of things they are doing. That can have a different result than
under a controlled situation.
The FDA's choice has been to take the information and approve the
drug and then monitor the drug, but have relatively few tools after
that point. What can be the result of that? The FDA can say let's
really be careful before we approve this because we will have expended
our toolbox. They have said: If you will give us a bigger toolbox for
after the approval, we can approve the drugs quicker. We can have some
assurance that because of the controlled study things will be fine. But
we won't have to worry quite as much about preapproval because we will
have tools after approval--tools for quick recognition of additional
problems as it goes out to the major markets.
We need to have that happen if we are going to have safe drugs in
this country. We have always relied on that, and we expect that. The
FDA, for the most part, has delivered.
So much more needs to be done to clarify the FDA's authority, to give
them the bigger toolbox so that FDA can proactively react to additional
safety information whenever that safety information is discovered. That
is the purpose of this underlying legislation. The FDA does have some
authority to manage the risks of drugs--for drugs such as novel cancer
therapies approved under subpart H for accelerated approval. Is that
faster approval? The FDA has the authority to apply restrictions on
distribution and use for those drugs at the time of approval to provide
further safeguards against misuse and adverse reactions. However, if
such a risk is determined after the drug is on the market, the only
option FDA has now is to pull the drug from the market, disrupting
patient care.
Some of the people who have that drug are deriving a tremendous
benefit from it and are not having the adverse reaction and would feel
hurt if it is pulled away from them as the only option that the FDA
has. The FDA does not want to disrupt patient care. The FDA just wants
to protect patients. Those who need the protection they want to help;
those who don't need the protection ought to be able to get the
continuing patient care. The option now, I repeat, is to pull the drug
from everybody. Then, of course, they can put it back on the market so
it can apply those special risk management tools. We have chosen to
give the FDA in this bill the authority to impose those restrictions
after a drug comes on the market, too, so there is no disruption in
patient care.
The bill also makes several key improvements to how patients get
their information through advertising and labeling. The changes ensure
that patients get access to new and changing information in a timely
manner. As Vioxx made clear, FDA has very little authority to require
labeling changes postmarket. Those changes are primarily negotiated and
they don't have any time limits on the two parties coming to agreement
to the labeling change.
Now, we have included provisions that ensure that those discussions
between the FDA and a drug manufacturer come to a close, rather than
relying on the FDA's ``nuclear option,''
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which is pulling the drug from the market. It hurts a lot of patients
and disrupts their care.
Imagine a system that gives the FDA, through sound science and
remarkable innovation, the tools to get drugs to the market quickly and
efficiently, especially when lives are on the line and people need new
drugs and therapies. Imagine a system that gives the FDA new authority
to take swift, appropriate, and decisive action to ensure patient
safety and protect consumers when new information comes to light to
expose unexpected risks. We can make this a reality with the passage of
this bill.
FDA doesn't have a current mechanism for active, routine surveillance
of potential safety problems. Thus, it cannot as readily detect safety
problems after a drug has been put on the market--short of a
catastrophe. FDA has minimal authority to require additional
observational studies or clinical trials after the product is already
on the market. FDA cannot even make companies finish studies they have
agreed to pursue concerning safety impacts on patients.
Given the current FDA limitations, I strongly felt it was necessary
to correct those problems and ensure that FDA has the right tools and
toolbox to address drug safety after the drug is on the market. That is
why this bill creates the risk evaluation and mitigation strategy, or
REMS. The REMS gives FDA a full toolbox of options for dealing with
potential safety problems, even if they are discovered after a drug is
first marketed. I hope you are noticing a trend.
With this new toolbox, FDA has the ability to identify side effects
after the drug is marketed through active surveillance. FDA also has
the authority to request a separate study or clinical trial to learn
more about a particular potential safety problem. FDA can also obtain
timely label changes for the first time under the new REMS system.
How does this all work together? A house cannot be built without a
foundation. Routine, active safety monitoring using large linked
databases--what I like to call ``health IT for drug safety''--is the
foundation. Risk evaluation and mitigation strategy, or REMS, is the
house.
I thank the Senator from New Hampshire, Mr. Gregg, for all of his
work on health IT for drug safety and his emphasis on being able to
have the right surveillance and the right triggers to be able to put
these things into place at an appropriate time. In designing that
house, you can have a small, simple house, or you can have a big
fancy house. The size and complexity of your house should match your
needs. The REMS is customizable, buildable to address whatever risks
are present for the drug in question. The REMS allows you to build an
addition for your house if your family grows, for example. You can also
move into a smaller home if you find you don't need so much space.
Let's talk about how this would work. Let's say drug A treats high
blood pressure, has very few side effects. Therefore, the label and use
of routine, active safety monitoring will be enough to manage the risk.
Drug A doesn't need a REMS. However, drug B, which also treats high
blood pressure, has serious side effects, including occasional liver
failure. The label and use of routine, active safety monitoring is not
enough to manage the risk. Therefore, drug B needs REMS.
The REMS will include extra warnings on the label, perhaps periodic
letters to doctors to remind them of the risks, and require testing and
a system to test patients for liver enzyme levels before they are
allowed to fill a prescription. As I said, not every drug needs a REMS.
However, every drug will need a very active FDA with all of the
necessary tools to identify and quickly manage additional risks.
Like everyone else, when I purchase a product for myself, my
children, or my grandchildren, I want the assurance that the product is
safe and beneficial. This bill gives the FDA the necessary resources
and tools so that moms and dads are able to trust that product at the
pharmacy counter and know that it is safe and effective.
As I mentioned, this bill is still a work in progress. There are a
dozen amendments, several of which have been in the managers'
amendment, and several are still being worked on. We do want faster
drug approval, but we want assurances that as the whole population
becomes a clinical trial, connections can be made quickly to any
problems without the need to pull the drug off the market and away from
those who could benefit. I will have more to say about other potential
things that will not be in this bill that I think would complicate the
bill or maybe be adverse to what we are trying to do in the bill, and
some of them that have not had enough study yet. I will comment on
those as they come up, if they come up.
At this point, I yield the floor.
The PRESIDING OFFICER. The Senator from Ohio is recognized.
Mr. BROWN. Madam President, I appreciate the words of my colleague,
the Senator from Wyoming, Mr. Enzi. S. 1082 is a major piece of
legislation that aims to--and will--achieve a profoundly important
goal. It will improve the public health.
When it is riskier to take a drug than to skip it, the public health
is compromised. When a lifesaving prescription drug or medical device
languishes at the FDA because of backlogs in the approval process, the
public health is compromised.
When pediatricians are forced to fly by the seat of their pants
because there is no data to guide the use of a drug or medical device
in children specifically, the public health is compromised.
When FDA has the responsibility but lacks the tools to assess the
safety or effectiveness of a new drug or device, the public health is
compromised.
S. 1082 tackles each of these problems. It gives FDA more authority
and drugmakers a greater incentive to assure the safety of medicines
before and after drug approval.
It reauthorizes user fees, an additional source of funding that
enables FDA to speed up the approval of new prescription drugs and
medical devices.
It reauthorizes financial incentives to encourage drugmakers to test
their products for use in children, and it establishes similar
incentives for medical device manufacturers.
At the same time, it puts more teeth in FDA's authority to require
studies when the health or safety of children is clearly at risk.
S. 1082 creates a new institute charged with developing up-to-date
methods of assessing the safety and effectiveness of cutting-edge
medical interventions.
You are no doubt going to hear complaints about this bill. Some
Members will tell you that it is overly bureaucratic. Coincidentally,
that is exactly what the brand-name drug industry says about it.
Nobody can accuse the drugmakers of inconsistency. They consistently
place their own self-interest ahead of health care safety, access, and
affordability.
The drug industry doesn't want FDA to take additional steps to
prevent prescription-drug-related injury or death, although the drug
industry is open to being shielded from liability when those tragedies
happen. When Members of this body stand up and claim this bill is too
bureaucratic, don't buy into it.
This is a carefully crafted bipartisan bill. It is less stringent
than consumer groups want and more stringent than the drug industry
wants. In other words, it is a compromise--a compromise that will
improve the public health. There will be amendments to this bill. As
Members on both sides of the aisle review them, I urge them to remember
this: Amendments that improve drug safety will benefit consumers and
reduce health care costs. Amendments that increase price competition in
the prescription drug market will benefit consumers and reduce health
care costs. And amendments that weaken this bill or block price
competition in the marketplace will benefit--who else--the brand-name
drug industry.
The drug industry has more than 3,000 lobbyists here and in the House
of Representatives. Last year alone, the drug industry spent more than
$150 million lobbying at the Federal level. That is quite a home court
advantage. As one might imagine, people who have lost loved ones to
unsafe drugs and people who cannot afford to fill their prescriptions
don't have quite as deep pockets as the drug industry. Still, this is a
drug safety bill, this is a drug access bill, this is not a drug
industry bill.
I hope every Member will consider the bill and every amendment in
that
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context because in that context, when we vote on the final bill, if we
vote yes, we will be voting to improve the public health.
Madam President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. KENNEDY. Madam President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. KENNEDY. Madam President, I was necessarily absent from the
Senate at the conclusion of Senator Enzi's remarks. I again thank him
for an excellent presentation, with the emphasis on the safety aspects
of this legislation.
I think all of us are reassured we are on the right track, not only
as a result of the extensive hearings we held but the very extensive
review the Institute of Medicine gave, a highly regarded, highly
respected agency. During the course of the hearings, we had very good
attendance and exchange of the representatives of the Institute of
Medicine, and we have worked with them subsequently in terms of the
language and refinements.
As we said, we didn't just copy everything, but the essential aspect
of the safety provisions in our legislation is, quite frankly,
preferable.
I look forward to working closely with Senator Enzi as well on the
other areas of public policy in terms of food safety and the follow-on
biologics which we are very much involved in as well.
I thank the Senator from Ohio for his comments. We know him for being
someone who has spent a great deal of time making sure safe drugs are
going to get to people who need them. There are many dimensions to this
debate. He has certainly been one whom, over the course of time, on the
Health Committee in the House of Representatives, I have had an
opportunity to work with on a number of health issues. He has been very
active and involved with this issue on our committee and also on making
sure we are going to have not only safe drugs but also have access to
them.
I will take a moment, because I think it is probably worthwhile in
the opening presentation, to go through one of the real safety crises
we had with prescription drugs and look at what existing authority was
there and then how that could have been handled under that legislation.
People will look through this legislation--it is not all that long,
but it is complex. The results are enormously important and very basic
and very fundamental. I use Vioxx as a point of illustration, which I
think most Americans remember the circumstances where hundreds of
thousands of Americans with heart needs were put at risk.
This was really the question--this is the FDA Reauthorization Act--
how we could have averted the Vioxx disaster. I think people are
beginning to study this legislation, and also our colleagues who are
reviewing the record ask about how this legislation can make a
difference on a particular drug. This chart is very useful in
understanding that point.
Can the FDA quickly detect safety problems with a drug? Vioxx, no.
Under our legislation, the answer is yes. Senator Enzi gave an
excellent presentation about how that can be done using the most modern
technology, using the greatest availability of public and private
collections of adverse reactions, and bringing those together within
the agency. We know all of that is going to gradually expand in the
future, so that agency will have the best of science. They will be able
to protect safety. The answer with this legislation is yes.
Can the FDA require label changes to warn of safety problems? The
answer with Vioxx was no. They spent 14 months trying to negotiate the
issue of the labels. Under our legislation, they would be able to do
that.
I mention that as one of the things they will be able to do. They can
either take the drug off the market--they have the power to do it. It
is not done because you don't want to take the chance that there may be
some people in the public, given the health risks, who are justified in
taking that particular medication, but for the great mass of people, it
might not be. Can we put label changes on? They would be able to do it
very quickly.
Are companies stopped from hiding safety problems? This comes back to
what both Senator Enzi and I referenced in making public clinical
trials. That is enormously important. Senator Mikulski has been very
involved in the transparency parts of this legislation. I hope those in
the Senate who are interested and concerned about the issues of
transparency might take a moment and talk with Senator Mikulski.
Hopefully, she will speak on these issues because she has made a very
important contribution.
Part of this transparency is that these clinical trials will be
available, to understand the significance of any safety problems, which
hasn't been the case, but they will also be available to people who may
want to enroll in a clinical trial, who have a particular illness, a
particular disease and know there is a particular trial that is going
to take place and say: I think I want to enroll in that particular
trial because it is taking place. People don't know that now. That is
enormously important and valuable to people. Whoever becomes part of a
clinical trial and finds out a particular drug can be lifesaving, it is
of enormous importance and consequence.
We have the knowledge of the clinical trial in terms of safety but
also in terms of the opportunities that are coming up, particularly in
this period of life sciences, with these extraordinary breakthroughs we
are seeing now--the mapping of the human genome, sequencing of the
gene, and I think before long in stem cell research we are going to see
incredible possibilities, and people are going to want to become part
of clinical trials.
But with regard to responding to this--are companies stopped from
hiding safety problems, yes; does FDA have flexible tools to enforce
safety decisions--it was expressed very well by Senator Enzi. He was
talking about the big toolbox. That is the way we should look at it.
There is a variety of tools in that toolbox. He explained that. There
are a number of different ways that those who are committed to safety
can titrate these different availabilities to ensure safety. Some may
require a heavier hand than others. What we want, obviously, is to do
enough to provide protection but not enough to discourage use where it
is necessary.
Finally, is FDA the gold standard for protecting public health and
assuring access? We are strongly committed to making sure it is. We
believe that with the safety protections we have put in the bill and
also the inclusions, working with the pharmaceutical industry in terms
of PDUFA and MDUFA to try to always find ways of expediting the
consideration of these lifesaving drugs--that was one of the very
important purposes, giving emphasis for research of many of the areas
of health that are of such concern to the American people: cancer,
cardiovascular issues, Parkinson's disease, Alzheimer's disease,
juvenile diabetes disease, the AIDS virus, and many others--we can try
to move toward a better relationship between the companies and FDA, in
the sense that we can move this process, move more quickly, but do it
more safely. That is what we are attempting to do, to ensure, in this
life science century, that these breakthrough opportunities are going
to be available and also do it in a way that will be safe. This is an
example of one of the challenges the country has been facing recently,
between the old and the new.
We have tried this afternoon to describe in greater detail the
various provisions of the legislation. We have not spent a great deal
of time on the provisions which were supported by the Senator from
Wyoming and myself with regard to children. Our committee has
recognized, through the good work of Senator Dodd and Senator Clinton,
the fact that children are not just little grownups; they are children.
Many of these substances have different reactions, different impacts in
terms of their development. It has taken special kinds of focus and
attention to try to be more responsive to those needs. Our committee
has done that. As a result, we see strong support from the American
Pediatric Society and others for the way we have addressed those issues
and modernized provisions to encourage greater research but also to
protect the interests of children. We have
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strong support from the various groups that have spent their lifetime
speaking for children.
We will probably have an opportunity to get into some greater detail
in discussion of those provisions. As I mentioned briefly in our
comments, we have recognized the importance of developing and upgrading
the science function in this agency. We think the FDA--at a time we are
having breakthroughs in knowledge, in science, in so many areas, we
want to make sure the FDA is out there on the cutting edge with respect
to these breakthroughs and know where they are going. We have paid
particular attention to those as well.
Then the Udall-Reagan Foundation is to try to look longer term at
ways in which the agency functions and take a longer look to make
recommendations to the private sector and to the public sector about
how it can be more effective generally. That kind of idea has not been
included in the past. It can very well be enormously valuable and
helpful to legislators in the future.
We have tried to get legislation that will provide the protection
presently, help and assist breakthrough technologies, and provide a
faster track for the American people in the future, but to do it with
greater safety protections for all families, and to recognize we are at
a time of breakthrough science, which that agency has to have, and
there are going to be breakthroughs in different modalities in that
agency working in the future. We have tried to build into this an
agency that can give us advice so we can be more effective in the
future.
I hope we will be able to move ahead. I know we have gone through, in
careful detail, the administration's positions over the weekend. We
certainly respect those. We have had a good exchange with the
administration.
For those who are interested, if they read through the letter they
sent to Senator Enzi and myself, and then if they look at the
recommendation of the Institute of Medicine, they will find we are much
closer to the recommendations of the Institute of Medicine. We may face
some amendments in those areas. We look forward to having a good
discussion and debate and the opportunity to expand some of the points
we have made this evening.
Mr. ENZI. I thank particularly Secretary Leavitt and those people on
his staff. We had discussions over the weekend. They had some
suggestions for changes. We asked for more detail on those changes. We
also asked for them to be prioritized. I was pleased they were
delivered within a matter of a very short period of time. That shows
people in Government can work together and that they do work on the
weekends to get these things done. A lot of people think when we go
into recess for a weekend, all work around here stops. But there are
dedicated staff who put their best effort into getting together and
working together, sometimes in very tense situations and long hours,
mostly through the night--last night. Then they have to draft what has
actually been decided. It is a very difficult process. We owe them a
great deal of credit. I want the American people to know that, too.
I yield the floor.
The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
Mr. KENNEDY. Madam President, we have the legislation before us. We
hope those who have an interest and have some ideas, have some
amendments, will be in touch with Senator Enzi and ourselves through
this late afternoon, early evening, or first thing in the morning. We
want to try to address those amendments early in the day, as early as
we can. We understand both parties have their lunches and have
important matters to discuss, and I am sure this will be among them.
But we are ready for any of the amendments, as I underline what Senator
Enzi has said. We had great participation in our markup with the
members of our committee. As he mentioned as well, we have had enormous
involvement of our committee members and many others over the period
since the legislation was reported out of our committee until now.
We are still in the process of trying to do business because we think
this legislation is so important. We hope those who do have amendments
will be in touch with us at the earliest possible time.
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