‘‘SEC. 505C. CENTER FOR POSTMARKET DRUG SAFETY AND 
EFFECTIVENESS. 
‘‘(a) ESTABLISHMENT.—Not later than 180 days 
after the date of the enactment of the Food and Drug 
Administration Improvement Act of 2007, the Secretary 
shall establish within the Food and Drug Administration 
a center to be known as the Center for Postmarket Drug 
Safety and Effectiveness (referred to in this section as the 
‘Center’), which shall be headed by a director appointed 
by the Secretary (without regard to the delegation to the 
Commissioner of Food and Drugs under section 
903(d)(2)). The Center shall be established as a separate 
center at the organizational level immediately below the 
Office of the Commissioner. The Director of the Center 
shall report directly to the Commissioner. 
‘‘(b) DUTIES.— 
‘‘(1) IN GENERAL.—The Director of the Center 
shall have the principal responsibility within the 
Food and Drug Administration, below the Office of 
the Commissioner, for assisting the Commissioner in 
regulating approved drugs, other than with respect 
to section 501. Such assistance includes assistance 
with the following: 
‘‘(A) Administering enforcement authori-
ties under chapter III, including civil penalties 
under section 303(f). 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
‘‘(B) Administering section 502. 
‘‘(C) Administering requirements for stud-
ies that were required as conditions for the ap-
proval of applications under section 505 (which 
studies are conducted after such approval). 
‘‘(D) Administering authorities under sec-
tions 505D and 505E. 
‘‘(E) Monitoring approved drugs to deter-
mine whether there are any issues regarding 
safety and effectiveness. 
‘‘(F) With respect to issues identified 
under subparagraph (E), taking action under 
the provisions referred to in subparagraphs (A) 
through (D), including as appropriate the fol-
lowing: 
‘‘(i) Establishing requirements for ad-
vertising under section 502(n). 
‘‘(ii) Establishing requirements for 
modifications in labeling under section 
502(x), including the specification of a 
date by which the modifications are re-
quired to be made. 
‘‘(iii) Withdrawing the approval of 
drugs under section 505(e). 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
‘‘(iv) Requiring reports under section 
505(k) on clinical experience with approved 
drugs, including reports on the number of 
individuals using the drugs as indicated by 
sales of the drugs at retail and reports on 
information possessed by manufacturers on 
usage of the drugs. 
‘‘(v) Requiring notifications under sec-
tion 505D(a)(1) to eliminate unreasonable 
risks of substantial harm to the public 
health. 
‘‘(vi) Establishing restrictions under 
section 505D(a)(2) to ensure the safe use 
of approved drugs, including requirements 
for— 
‘‘(I) the specific manner of ob-
taining the informed consent of pa-
tients to undergo treatment with the 
drugs; 
‘‘(II) providing education to phy-
sicians; 
‘‘(III) providing education to pa-
tients; and 
‘‘(IV) the establishment of risk- 
management plans by manufacturers. 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
‘‘(vii) Requiring the conduct of studies 
under section 505E. 
‘‘(2) TRANSFERS.—The Secretary shall transfer 
to the Center all responsibilities for the matters re-
ferred to in paragraph (1) that, on the day before 
the date of the enactment of the Food and Drug Ad-
ministration Improvement Act of 2007, were vested 
in the Center for Drug Evaluation and Research and 
the Center for Biologics Evaluation and Research. 
‘‘(c) INTERACTIONS WITH OTHER CENTERS.— 
‘‘(1) CONSULTATION.—The Director of the 
Center shall carry out this section in consultation 
with the Directors of the Centers referred to in sub-
section (b)(2). 
‘‘(2) ACCESS TO INFORMATION.—The Secretary 
shall ensure that the Director of the Center has full 
access to all information possessed by the Food and 
Drug Administration that relates to the safety and 
effectiveness of approved drugs, including informa-
tion possessed by the Centers referred to in sub-
section (b)(2). 
‘‘(d) DEFINITION.—For purposes of this section, the 
term ‘approved drug’ means a drug for which an approved 
application under section 505 is in effect or for which a 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
biologics license under section 351 of the Public Health 
Service Act is in effect. 
‘‘(e) FUNDING.—For the purpose of carrying out this 
section, the Secretary shall make available for a fiscal 
year, from the amount appropriated for the Food and 
Drug Administration for such year, the following amount, 
as applicable to such year: 
‘‘(1) For fiscal year 2008, $100,000,000. 
‘‘(2) For fiscal year 2009, $125,000,000. 
‘‘(3) For fiscal year 2010, $150,000,000. 
‘‘(4) For fiscal year 2011, $175,000,000. 
‘‘(5) For fiscal year 2012, $200,000,000. 
‘‘SEC. 505D. CERTAIN POSTMARKET AUTHORITIES. 
‘‘(a) IN GENERAL.—Effective on and after the date 
of the enactment of the Food and Drug Administration 
Improvement Act of 2007, the Secretary has with respect 
to approved drugs the same authorities as the Secretary 
has with respect to devices under the following provisions: 
‘‘(1) Section 518(a) (relating to notifications to 
eliminate an unreasonable risk of substantial harm 
to the public health). 
‘‘(2) Section 520(e)(1)(B) (relating to restric-
tions on sale, distribution, or use). 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
‘‘(3) Section 520(h) (relating to making avail-
able to the public summaries of information respect-
ing safety and effectiveness). 
‘‘(b) DEFINITION.—For purposes of this section, the 
term ‘approved drug’ has the meaning given such term 
in section 505C(d). 
‘‘SEC. 505E. POSTMARKET STUDIES REGARDING SAFETY OF 
DRUGS. 
‘‘(a) PHASE 4 STUDIES.—The Secretary may require 
that the manufacturer of an approved drug conduct one 
or more studies to confirm or refute an empirical or theo-
retical hypothesis of a significant safety issue with the 
drug (whether raised with respect to the product directly 
or with respect to the class of the product) that has been 
identified pursuant to— 
‘‘(1) the MedWatch postmarket surveillance 
system; 
‘‘(2) a clinical or epidemiological study; 
‘‘(3) the scientific literature; 
‘‘(4) a foreign government that regulates drugs 
or devices; 
‘‘(5) an international organization concerned 
with the safety or effectiveness of drugs or devices; 
or 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
‘‘(6) such other sources as the Secretary deter-
mines to be appropriate. 
‘‘(b) APPROVAL
OF PROTOCOL; TIMEFRAME.—A 
study under subsection (a) shall be conducted in accord-
ance with a protocol approved by the Secretary. In requir-
ing such a study, the Secretary shall specify a timeframe 
for completing the study. 
‘‘(c) PUBLIC DISCLOSURE.— 
‘‘(1) INTERNET SITE.—Notwithstanding section 
506B, the Secretary shall maintain on the Internet 
site of the Food and Drug Administration a data-
base that provides information on each study re-
quired under subsection (a), including a description 
of and the reason for the study, the required comple-
tion date, and whether the study has been com-
pleted. The Secretary shall update the database not 
less frequently than once each quarter. 
‘‘(2) FEDERAL REGISTER.—Not later than 30 
days after first establishing the database under 
paragraph (1), the Secretary shall, with respect to 
studies required under subsection (a), publish in the 
Federal Register the same information as is included 
in such database as of the date of such publication. 
Thereafter, the Secretary shall publish in the Fed-
eral Register, not less frequently than once each 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
quarter, updates that reflect the updates made 
under paragraph (1). 
‘‘(d) DEFINITION.—For purposes of this section, the 
term ‘approved drug’ has the meaning given such term 
in section 505C(d).’’. 
(b) CERTAIN STUDIES.— 
(1) IN
GENERAL.—With respect to section 
505E(c) of the Federal Food, Drug, and Cosmetic 
Act (as added by subsection (a) of this section), each 
study described in paragraph (2) is deemed to be a 
study to which such section applies. 
(2) RELEVANT
STUDIES.—For purposes of 
paragraph (1), a study described in this paragraph 
is a study that— 
(A) relates to the safety or effectiveness of 
a drug; 
(B) was in progress as of the date of the 
enactment of this Act; and 
(C) was conducted pursuant to an agree-
ment that, on or after January 1, 2003, was 
entered into with the Secretary of Health and 
Human Services, acting through the Commis-
sioner of Food and Drugs. 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
SEC. 4. ORDER REGARDING POSTMARKET LABELING. 
Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended by adding at the end the 
following: 
‘‘(y) If it is a drug and the Secretary deter-
mines that its labeling fails to provide information, 
including specific wording, required by the Secretary 
by order on the basis that the information is nec-
essary to ensure its safe and effective use.’’. 
SEC. 5. ADDITIONAL ENFORCEMENT PROVISIONS. 
(a) POSTMARKET AUTHORITIES.—Section 502 of the 
Federal Food, Drug, and Cosmetic Act, as amended by 
section 4 of this Act, is amended by adding at the end 
the following: 
‘‘(y) If it is a drug with respect to which there is 
a failure to comply with any requirement under section 
505D or 505E.’’. 
(b) CIVIL PENALTIES FOR VIOLATIONS OF REQUIRE-
MENTS RELATING TO DRUGS.—Section 303(f) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is 
amended— 
(1) by redesignating paragraphs (3) through 
(5) as paragraphs (4) through (6), respectively; 
(2) by inserting after paragraph (2) the fol-
lowing paragraph: 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
‘‘(3) Any person who violates a requirement of 
this Act which relates to drugs shall be liable to the 
United States for a civil penalty in an amount not 
exceeding $50,000 per day for each such violation, 
not to exceed $50,000,000 for all such violations ad-
judicated in a single proceeding.’’; 
(3) in paragraph (4) (as so redesignated) by 
striking ‘‘paragraph (1) or (2)’’ each place such 
term appears and inserting ‘‘paragraph (1), (2), or 
(3)’’; 
(4) in paragraph (5) (as so redesignated), by 
striking ‘‘paragraph (3)(A)’’ and inserting ‘‘para-
graph (4)(A)’’; and 
(5) in paragraph (6) (as so redesignated), by 
striking ‘‘paragraph (4)’’ each place such term ap-
pears and inserting ‘‘paragraph (5)’’. 
SEC. 6. PREEMPTION. 
(a) IN GENERAL.—With respect to the issue of 
whether a provision of chapter V of the Federal Food, 
Drug, and Cosmetic Act or of section 351 of the Public 
Health Service Act (or regulations or orders under such 
a provision) supersedes the law of a State, the Secretary 
of Health and Human Services (referred to in this section 
as the ‘‘Secretary’’) shall follow, without change, the inter-
pretation that was followed by the Food and Drug Admin-
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
istration in 1999, including the interpretation that such 
Administration ‘‘does not believe that the evolution of 
state tort law will cause the development of standards that 
would be at odds with the agency’s regulations’’ and that 
such regulations ‘‘establish minimal standards’’ but are 
not intended to preclude the States from imposing addi-
tional requirements (63 FR 66384). 
(b) PRODUCT LIABILITY CASES.—In the case of civil 
actions regarding product liability that are brought in 
State courts against manufacturers of drugs or devices, 
policies of the Secretary required under subsection (a) in-
clude the policy that the Secretary cease intervening in 
such actions to argue any interpretation contrary to such 
subsection. 
SEC. 7. ADDITIONAL PROVISIONS. 
(a) REQUIREMENTS REGARDING MEMBERSHIP
OF 
ADVISORY COMMITTEES.—Subchapter A of 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 
section: 
‘‘SEC. 712. REQUIREMENTS REGARDING MEMBERSHIP OF 
ADVISORY COMMITTEES. 
‘‘(a) IN GENERAL.—Notwithstanding any other pro-
vision of law, the Secretary shall comply with the following 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
with respect to any meeting of an advisory committee con-
vened by the Secretary under this Act: 
‘‘(1) Not later than 30 days before such meet-
ing, the Secretary shall post on the Internet site of 
the Food and Drug Administration the agenda for 
the meeting and the tentative list of all proposed ad-
visory committee members, together with a short bi-
ography of each such prospective member. 
‘‘(2) After compliance with paragraph (1), the 
Secretary shall provide the public not fewer than 20 
days to submit to the Secretary comments on the 
proposed membership of the advisory committee. 
‘‘(3) The Secretary shall consider the public 
comments to determine whether any adjustment to 
the roster of the advisory committee is necessary to 
make the committee fairly balanced. 
‘‘(4) Not later than three days before the start 
of the meeting, the Secretary shall post on such 
Internet site the final membership of the advisory 
committee. 
‘‘(b) CONFLICTS
OF INTEREST.—Notwithstanding 
any other provision of law, a member of an advisory com-
mittee under this Act may not, with respect to service on 
such committee, be granted an exemption under section 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
208(b) of title 18, United States Code (relating to per-
sonal financial interests). 
‘‘(c) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘advisory committee’ has the 
same meaning given such term in section 3(2) of the 
Federal Advisory Committee Act. 
‘‘(2) The term ‘fairly balanced’ has the same 
meaning as applies to such term under section 
5(b)(2) of the Federal Advisory Committee Act.’’. 
(b) CERTAIN USES OF APPROVED DRUGS.—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 section: 
‘‘SEC. 910. REQUIREMENT REGARDING INFORMED CON-
SENT FOR CERTAIN TREATMENTS. 
‘‘With respect to the prescribing of a drug for a use 
not included in the approved labeling for the drug under 
section 505 or under section 351 of the Public Health 
Service Act, the Secretary shall promulgate regulations re-
quiring that, before prescribing the drug— 
‘‘(1) the physician inform the patient that the 
use for which the physician intends to prescribe the 
drug has not been approved by the Food and Drug 
Administration; and 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
‘‘(2) the physician obtain from the patient an 
acknowledgment of such fact and the consent of the 
patient to use the drug for such use notwithstanding 
such fact.’’. 
Æ 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6301
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS