I 
109TH CONGRESS 
1ST SESSION H. R. 2090 
To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
deposit in the general fund of the Treasury of fees that are collected 
from manufacturers of drugs and devices under chapter VII of such 
Act, to terminate the authority of the Food and Drug Administration 
to negotiate with the manufacturers on particular uses of the fees, 
to establish a Center for Postmarket Drug Safety and Effectiveness, 
to establish additional authorities to ensure the safe and effective use 
of drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 4, 2005 
Mr. HINCHEY (for himself, Ms. DELAURO, and Mr. STUPAK) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide for the deposit in the general fund of the Treas-
ury of fees that are collected from manufacturers of 
drugs and devices under chapter VII of such Act, to 
terminate the authority of the Food and Drug Adminis-
tration to negotiate with the manufacturers on particular 
uses of the fees, to establish a Center for Postmarket 
Drug Safety and Effectiveness, to establish additional 
authorities to ensure the safe and effective use of drugs, 
and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug Ad-
ministration Improvement Act of 2005’’. 
SEC. 2. FEES PAID BY MANUFACTURERS TO FOOD AND 
DRUG ADMINISTRATION; DEPOSIT IN GEN-
ERAL FUND OF TREASURY; DIRECT SPEND-
ING. 
(a) IN GENERAL.—Subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379f et seq.) is amended by adding at the end the fol-
lowing part: 
‘‘PART 5—MODIFICATIONS REGARDING USER-FEE 
PROGRAMS 
‘‘SEC. 740A. DEPOSIT OF FEES IN GENERAL FUND OF 
TREASURY; DIRECT SPENDING. 
‘‘(a) DEPOSIT IN GENERAL FUND.—Notwithstanding 
part 2, part 3, and part 4, all fees collected under such 
parts shall be deposited in the general fund of the Treas-
ury. 
‘‘(b) DIRECT SPENDING.— 
‘‘(1) IN
GENERAL.—Notwithstanding part 2, 
part 3, and part 4, amounts are available to the Sec-
retary for obligation in accordance with the fol-
lowing: 
‘‘(A) The amount specified in section 
736(g)(3) for a fiscal year is, to the extent de-
scribed in section 736(g)(2)(A)(ii), available to 
the Secretary for obligation solely for the proc-
ess for the review of human drug applications 
(as defined in section 735). 
‘‘(B) The amount specified in section 
738(h)(3) for a fiscal year is, to the extent de-
scribed in section 738(h)(2)(A)(ii), available to 
the Secretary for obligation solely for the proc-
ess for the review of device applications (as de-
fined in section 737). 
‘‘(C) The amount specified in section 
740(g)(3) for a fiscal year is, to the extent de-
scribed in section 740(g)(2)(A)(ii), available to 
the Secretary for obligation solely for the proc-
ess for the review of animal drug applications 
(as defined in section 739). 
‘‘(2) LIST OF MANDATORY APPROPRIATIONS.— 
The program of spending established in paragraph 
(1) shall be considered entitlement authority within 
the meaning of section 250(17) of the Balanced 
Budget and Emergency Deficit Control Act of 1985.
‘‘SEC. 740B. TERMINATION OF AUTHORITY FOR NEGOTIA-
TIONS WITH MANUFACTURERS ON USE OF 
FEES. 
‘‘(a) IN GENERAL.—With respect to persons from 
whom fees are collected under part 2, part 3, or part 4: 
‘‘(1) Notwithstanding such parts, the following 
applies on and after the date of the enactment of the 
Food and Drug Administration Improvement Act of 
2005: 
‘‘(A) The Secretary may not enter into 
agreements with such persons on particular 
uses of the fees, including agreements on prior-
ities, performance goals, or other commitments 
relating to— 
‘‘(i) review times for human drug ap-
plications or supplements within the mean-
ing of part 2; 
‘‘(ii) review times for premarket appli-
cations, premarket reports, premarket noti-
fication submissions, or supplements within 
the meaning of part 3; or 
‘‘(iii) review times for animal drug ap-
plications or supplements within the mean-
ing of part 4.
‘‘(B) The Secretary may not otherwise ne-
gotiate understandings with such persons on 
particular uses of the fees. 
‘‘(2) Notwithstanding such parts, the following 
applies on and after October 1, 2005: 
‘‘(A) Any such agreement or under-
standing that was in effect on the day before 
the date of the Food and Drug Administration 
Improvement Act of 2005 is terminated, includ-
ing agreements or understandings pursuant to 
letters referred to in section 502(4) of Public 
Law 107–188 (116 Stat. 688), section 101(3) 
of Public Law 107–250 (116 Stat. 1589), and 
section 2(3) of Public Law 108–130 (117 Stat. 
1361). 
‘‘(B) The Secretary is relieved of responsi-
bility for meeting any particular goals con-
cerning such review times that were established 
in such letters. 
‘‘(b) RULES
OF CONSTRUCTION.—Subsection (a) 
may not be construed— 
‘‘(1) as affecting the responsibility of the Sec-
retary to work toward the general goal of admin-
istering this Act efficiently, including the review of
applications, reports, supplements and other submis-
sions referred to in subsection (a)(1)(A); or 
‘‘(2) as terminating requirements for the collec-
tion of fees under part 2, part 3, and part 4.’’. 
(b) APPLICABILITY.—Section 740A of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a) of this section, applies with respect to fiscal year 2006 
and subsequent fiscal years. 
SEC. 3. ESTABLISHMENT OF CENTER FOR POSTMARKET 
DRUG SAFETY AND EFFECTIVENESS. 
(a) IN GENERAL.—Chapter V of the the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 
is amended by inserting after section 505B the following 
sections: 
‘‘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 2005, 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). 
‘‘(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). 
‘‘(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. 
‘‘(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 2005, 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 
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 2006, $100,000,000. 
‘‘(2) For fiscal year 2007, $125,000,000. 
‘‘(3) For fiscal year 2008, $150,000,000. 
‘‘(4) For fiscal year 2009, $175,000,000.
‘‘(5) For fiscal year 2010, $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 2005, 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). 
‘‘(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 
‘‘(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 506B, 
the Secretary shall maintain on the Internet site of 
the Food and Drug Administration a database that 
provides information on each study required under 
subsection (a), including a description of and the 
reason for the study, the required completion date,
and whether the study has been completed. The Sec-
retary shall update the database not less frequently 
than once each quarter. 
‘‘(2) FEDERAL REGISTER.—Not later than 30 
days after first establishing the databank 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 
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, or or after January 1, 2003, was en-
tered into with the Secretary of Health and 
Human Services, acting through the Commis-
sioner of Food and Drugs. 
SEC. 4. ORDER REGARDING POSTMARKET LABELING. 
Section 502 of the the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352) is amended by adding at the 
end the following: 
‘‘(x) 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 
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 the 
Federal 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: 
‘‘(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)’’; and 
(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-
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