I 
109TH CONGRESS 
1ST SESSION H. R. 4429 
To amend the Federal Food, Drug, and Cosmetic Act with respect to drug 
safety, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 18, 2005 
Mr. TIERNEY (for himself and Mr. RAMSTAD) 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 with 
respect to drug safety, 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 Safety Act of 2005’’. 
SEC. 2. CENTER FOR POSTMARKET DRUG EVALUATION 
AND RESEARCH. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 506C the following:
‘‘SEC. 507. DRUG SAFETY. 
‘‘(a) 
ESTABLISHMENT
OF
THE
CENTER
FOR 
POSTMARKET DRUG EVALUATION
AND RESEARCH.— 
There is established within the Food and Drug Adminis-
tration a Center for Postmarket Drug Evaluation and Re-
search (referred to in the section as the ‘Center’). The 
Director of the Center shall report directly to the Commis-
sioner of Food and Drugs. 
‘‘(b) DUTIES OF THE CENTER FOR POSTMARKET 
DRUG EVALUATION AND RESEARCH.— 
‘‘(1) RESPONSIBILITIES
OF
DIRECTOR.—The 
Director of the Center shall— 
‘‘(A) conduct postmarket risk assessment 
of drugs approved under section 505 of this Act 
and of biological products licensed under section 
351 of the Public Health Service Act; 
‘‘(B) conduct and improve postmarket sur-
veillance of approved drugs and licensed biologi-
cal products using postmarket surveillance pro-
grams and activities (including MedWatch), 
risk-benefit analyses, adverse event reports, the 
scientific literature, any clinical or observational 
studies (including studies required under sub-
section (d) or (e)), and any other resources that 
the Director of the Center determines appro-
priate;
‘‘(C) determine whether a study is required 
under subsection (d) or (e) and consult with the 
sponsors of drugs and biological products to en-
sure that such studies are completed by the 
date, and according to the terms, specified by 
the Director of the Center; 
‘‘(D) contract, or require the sponsor of an 
application or the holder of an approved appli-
cation or license to contract, with the holders of 
domestic and international surveillance data-
bases to conduct epidemiologic and other obser-
vational studies; 
‘‘(E) determine, based on postmarket sur-
veillance programs and activities (including 
MedWatch), risk-benefit analyses, adverse event 
reports, the scientific literature, and any clinical 
or observational studies (including studies re-
quired under subsection (d) or (e)), and any 
other resources that the Director of the Center 
determines appropriate, whether a drug or bio-
logical product may present an unreasonable 
risk to the health of patients or the general 
public, and take corrective action if such an un-
reasonable risk may exist;
‘‘(F) make information about the safety 
and effectiveness of approved drugs and li-
censed biological products available to the pub-
lic and healthcare providers in a timely manner; 
and 
‘‘(G) conduct other activities as the Direc-
tor of the Center determines appropriate to en-
sure the safety and effectiveness of all drugs 
approved under section 505 and all biological 
products licensed under section 351 of the Pub-
lic Health Service Act. 
‘‘(2) 
DETERMINATION
OF
UNREASONABLE 
RISK.—In determining whether a drug or biological 
product may present an unreasonable risk to the 
health of patients or the general public, the Director 
of the Center shall consider the risk in relation to 
the known benefits of such drug or biological prod-
uct. 
‘‘(c) SECRETARIAL AUTHORITY.— 
‘‘(1) IN GENERAL.—Approval of a drug under 
section 505 of this Act or issuance of a license for 
a biological product under section 351 of the Public 
Health Service Act may be subject to the require-
ment that the sponsor conduct 1 or more postmarket 
studies as described in subsection (d) or (e) of this
section, or other postmarket studies as required by 
the Secretary, to validate the safety and effective-
ness of the drug or biological product. 
‘‘(2) DEFINITION.—For purposes of this sec-
tion, the term ‘postmarket’ means— 
‘‘(A) with respect to a drug, after approval 
of an application under section 505; and 
‘‘(B) with respect to a biological product, 
after licensure under section 351 of the Public 
Health Service Act. 
‘‘(d) PREAPPROVAL REVIEW.— 
‘‘(1) REVIEW OF APPLICATION.— 
‘‘(A) IN GENERAL.— 
‘‘(i) REVIEW.—At any time before a 
drug is approved under section 505 of this 
Act or a biological product is licensed 
under section 351 of the Public Health 
Service Act, the Director of the Center 
shall review the application (or supplement 
to the application), and any analyses asso-
ciated with the application, of such drug or 
biological product. 
‘‘(ii) EFFECT
OF
APPROVAL
OR
LI-
CENSURE.—The approval of a drug under 
section 505 or the licensure of a biological
product under such section 351 shall not 
affect the continuation and completion of a 
review under clause (i). 
‘‘(B) LIMITATION.—In no case shall the 
review under subparagraph (A) delay a decision 
with respect to an application for a drug under 
section 505 of this Act or for a biological prod-
uct under section 351 of the Public Health 
Service Act. 
‘‘(2) RESULT OF REVIEW.—The Director of the 
Center may, based on the review under paragraph 
(1)— 
‘‘(A) require that the sponsor of the appli-
cation agree to conduct 1 or more postmarket 
studies to determine the safety or effectiveness 
of a drug or biological product, including such 
safety or effectiveness as compared to other 
drugs or biological products, to be completed by 
a date, and according to the terms, specified by 
the Director of the Center; or 
‘‘(B) contract, or require the sponsor of 
the application to contract, with a holder of a 
domestic or an international patient database to 
conduct 1 or more epidemiologic or other obser-
vational studies.
‘‘(e) POSTMARKETING STUDIES OF DRUG SAFETY.— 
‘‘(1) IN GENERAL.—At any time after a drug is 
approved under section 505 of this Act or a biologi-
cal product is licensed under section 351 of the Pub-
lic Health Service Act, the Director of the Center, 
may— 
‘‘(A) require that the holder of an ap-
proved application or license conduct 1 or more 
studies to determine the safety or effectiveness 
of such drug or biological product, including 
such safety and effectiveness as compared to 
other drugs or biological products, to be com-
pleted by a date, and according to the terms, 
specified by such Director; or 
‘‘(B) contract, or require the holder of the 
approved application or license to contract, with 
a holder of a domestic or an international pa-
tient database to conduct 1 or more epidemio-
logic or other observational studies. 
‘‘(2) REVIEW OF OUTSTANDING STUDIES.—Not 
later than 90 days after the date of enactment of 
the Food and Drug Administration Safety Act of 
2005, the Director of the Center shall— 
‘‘(A) review and publish a list in the Fed-
eral Register of any postmarketing studies out-
standing on the date of enactment of the Food 
and Drug Administration Safety Act of 2005; 
and 
‘‘(B) as the Director determines appro-
priate, require the sponsor of a study described 
in subparagraph (A) to conduct such study 
under this subsection. 
‘‘(f) PUBLICATION
OF PROGRESS REPORTS
AND 
COMPLETED STUDIES.— 
‘‘(1) IN GENERAL.—The Director of the Center 
shall require that the sponsor of a study under sub-
section (d) or (e) submit to the Secretary— 
‘‘(A) not less frequently than every 90 
days, an up-to-date report describing the 
progress of such study; and 
‘‘(B) upon the completion date of such 
study, the results of such study. 
‘‘(2) COMPLETION DATE.—For purposes of this 
section, the completion date of such study shall be 
determined by the Director of the Center. 
‘‘(g) DETERMINATIONS BY DIRECTOR.— 
‘‘(1) RESULTS OF STUDY.—The Director of the 
Center shall determine, upon receipt of the results of 
a study required under subsection (d) or (e)—
‘‘(A) whether the drug or biological prod-
uct studied may present an unreasonable risk to 
the health of patients or the general public; and 
‘‘(B) what, if any, corrective action under 
subsection (k) shall be taken to protect patients 
and the public health. 
‘‘(2) RESULTS OF EVIDENCE.—The Director of 
the Center may, at any time, based on the empirical 
evidence from postmarket surveillance programs and 
activities (including MedWatch), risk-benefit anal-
yses, adverse event reports, the scientific literature, 
any clinical or observational studies (including stud-
ies required under subsection (d) or (e)), or any 
other resources that the Director of the Center de-
termines appropriate— 
‘‘(A) make a determination that a drug or 
biological product may present an unreasonable 
risk to the health of patients or the general 
public; and 
‘‘(B) order a corrective action under sub-
section (k) be taken to protect patients and the 
public health. 
‘‘(3) REQUIRED CONSULTATION AND CONSIDER-
ATIONS.—Before making a determination under 
paragraph (2), ordering a study under subsection
(d) or (e), or taking a corrective action under sub-
section (k), the Director of the Center shall— 
‘‘(A) consult with the Director of the Cen-
ter for Drug Evaluation and Research or the 
Director of the Center for Biologics Evaluation 
and Research, as appropriate; and 
‘‘(B) consider— 
‘‘(i) the benefit-to-risk profile of the 
drug or biological product; 
‘‘(ii) the effect that a corrective ac-
tion, or failure to take corrective action, 
will have on the patient population that re-
lies on the drug or biological product; and 
‘‘(iii) the extent to which the drug or 
biological product presents a meaningful 
therapeutic benefit as compared to other 
available treatments. 
‘‘(h) PUBLIC INFORMATION.—Periodically, but not 
less often than every 90 days, the Secretary shall make 
available to the public, by publication in the Federal Reg-
ister and posting on an Internet website, the following in-
formation: 
‘‘(1) Studies required under subsection (d) or 
(e) including— 
‘‘(A) the type of study;
‘‘(B) the nature of the study; 
‘‘(C) the primary and secondary outcomes 
of the study; 
‘‘(D) the date the study was required 
under subsection (d) or (e) or was agreed to by 
the sponsor; 
‘‘(E) the deadline for completion of the 
study; and 
‘‘(F) if the study has not been completed 
by the deadline under subparagraph (E), a 
statement that explains why. 
‘‘(2) The periodic progress reports and results 
of completed studies described under subsection (f). 
‘‘(3) Any determinations made by the Director 
of the Center under subsection (g), including— 
‘‘(A) reasons for the determination, includ-
ing factual basis for such determination; 
‘‘(B) reference to supporting empirical 
data; and 
‘‘(C) an explanation that describes why 
contrary data is insufficient. 
‘‘(i) DRUG ADVISORY COMMITTEE.—The Drug Safe-
ty and Risk Management Drugs Advisory Committee with-
in the Center of the Food and Drug Administration 
shall—