I 
110TH CONGRESS 
1ST SESSION H. R. 1165 
To amend the Federal Food, Drug, and Cosmetic Act to establish additional 
authorities to ensure the safe and effective use of drugs, to establish 
whistleblower protections for certain individuals, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 16, 2007 
Mr. MARKEY 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 
establish additional authorities to ensure the safe and 
effective use of drugs, to establish whistleblower protec-
tions for certain individuals, 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 ‘‘Swift Approval, Full 
Evaluation Drug Act’’ or the ‘‘SAFE Drug Act’’. 
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SEC. 2. POSTMARKET STUDIES REGARDING DRUG SAFETY; 
POSTMARKET LABELING CHANGES. 
(a) POSTMARKET ORDERS REGARDING STUDIES.— 
Chapter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351 et seq.) is amended by inserting after sec-
tion 505B the following section: 
‘‘SEC. 505C. POSTMARKET STUDIES REGARDING DRUG 
SAFETY. 
‘‘(a) POSTMARKET ORDERS.—Within 30 days after 
receiving evidence of a significant issue regarding the safe-
ty or lack of effectiveness of an approved drug, including 
reports of adverse events, studies conducted or reports re-
leased by the Food and Drug Administration, the National 
Institutes of Health, the Agency for Healthcare Research 
and Quality, or another relevant agency, actions or reports 
by regulatory agencies in foreign countries, or studies or 
case reports published in scientific or academic journals, 
the Secretary, after providing public notice of the signifi-
cant safety or effectiveness issue, may order the holder 
of the approved application to conduct a study or studies 
to address the issues involved. Each such notice and order 
shall be published in the Federal Register. 
‘‘(b) RESTRICTIONS ON USE.— 
‘‘(1) IN GENERAL.—An order under subsection 
(a) with respect to an approved drug may, during 
the period in which the study involved is conducted, 
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establish restrictions on the distribution or use of 
the drug if the Secretary determines that such re-
strictions are necessary to ensure the safe and effec-
tive use of the drug during such period. 
‘‘(2) CERTAIN AUTHORITIES.—Restrictions that 
may be established by the Secretary under para-
graph (1) with respect to a drug include the fol-
lowing: 
‘‘(A) Restricting distribution to certain fa-
cilities or physicians with special training or ex-
perience. 
‘‘(B) Conditioning distribution on the per-
formance of specified medical procedures. 
‘‘(C) Restricting direct-to-consumer adver-
tisements for the drug. 
‘‘(3) TERMINATION.—The Secretary may, on 
the basis of the results of a study ordered pursuant 
to subsection (a) or other evidence, continue the re-
strictions under paragraph (1), terminate restric-
tions established, or establish different restrictions, 
as necessary to ensure the safe use of the drug. The 
Secretary shall notify the sponsor of the decision to 
extend, terminate, or change the restrictions no later 
than 30 days after the date on which the results of 
the study involved are submitted to the Secretary. 
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‘‘(c) 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.’’. 
(b) NEW DRUG APPLICATIONS; POSTMARKET STUD-
IES PURSUANT TO ACCELERATED APPROVAL.—Section 
505 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) is amended by adding at the end the following 
subsection: 
‘‘(o)(1) The Secretary shall amend subpart H of part 
314 of title 21, Code of Federal Regulations, to establish 
the following policies: 
‘‘(A) As a condition of the approval under such 
subpart of a new drug on or after the date of the 
enactment of the SAFE Drug Act, the Secretary 
shall require that one or more postmarket studies of 
the drug be conducted. 
‘‘(B) The Secretary may not approve the appli-
cation involved unless— 
‘‘(i) the sponsor has submitted to the Sec-
retary the protocols for each such study; 
‘‘(ii) the Secretary has approved the proto-
cols; and 
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