I 
109TH CONGRESS 
2D SESSION 
H. R. 5922 
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 
JULY 27, 2006 
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 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 the study or other evi-
dence, continue the restrictions under paragraph (1), 
terminate restrictions established or establish dif-
ferent restrictions, as necessary to ensure the safe 
use of the drug. The Secretary shall notify the spon-
sor 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 sub-
mitted 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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‘‘(iii) the Secretary and the sponsor have 
agreed on a timeframe, including designated 
milestones, for the prompt completion of the 
study, which timeframe assumes due diligence 
by the sponsor in conducting the study. 
‘‘(C) The Secretary shall require that, after the 
application is approved under such subpart and the 
drug enters commercial distribution, the drug be 
marketed in accordance with the following: 
‘‘(i) The distribution and use of the drug 
shall be restricted in accordance with such sub-
part. 
‘‘(ii) Until the Secretary determines that 
the sponsor has fulfilled its commitments under 
subparagraphs (A) and (B), the labeling of the 
drug shall bear— 
‘‘(I) a statement that the Food and 
Administration is requiring a study or 
studies to confirm the safety and effective-
ness of the drug; and 
‘‘(II) a statement providing a clear 
and concise summary of the outstanding 
issues or questions to be addressed in such 
required studies. 
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‘‘(iii) Until the Secretary determines that 
the sponsor has fulfilled its commitments under 
subparagraphs (A) and (B), the label of the 
drug shall bear a statement providing as fol-
lows: ‘This product received conditional ap-
proval from the FDA under its accelerated ap-
proval process. It will not receive full approval 
until completion of further testing to confirm 
safety and/or efficacy. For further information 
please contact your physician.’. 
‘‘(iv) Direct-to-consumer advertisements 
for the drug shall be restricted until— 
‘‘(I) the Secretary determines that the 
sponsor has fulfilled its commitments 
under subparagraphs (A) and (B); and 
‘‘(II) the drug has been approved 
under such part 314 independently of sub-
part H of such part. 
‘‘(2) The Secretary shall amend part 314 of title 21, 
Code of Federal Regulations, to establish the following 
policies regarding postmarket studies that, on or after the 
date of the enactment of the SAFE Drug Act, are required 
pursuant to approval of a new drug under subpart H of 
such part or under section 506(b)(2) of this Act: 
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‘‘(A) If a required study is not completed by 
two years after the date on which the new drug was 
so approved, the Secretary shall, promptly after the 
expiration of such period, convene a public meeting 
of the appropriate advisory committee to review the 
progress of the study. Such review shall include the 
assessment of compliance with the timeframe for 
prompt completion of the study as agreed to by the 
company and the Secretary under paragraph 
(1)(B)(iii) or under section 506(b)(2) (as the case 
may be), the quality of study conduct, rates of en-
rollment overall and by institution, the barriers to 
progress, and whether the sponsor is acting with due 
diligence. At the meeting, the advisory committee 
shall determine whether it is in the best interest of 
the public to allow the sponsor to continue mar-
keting the drug until the study is completed or 
whether it is in the best interest of the public to sus-
pend the commercial marketing of the drug until the 
study is completed. 
‘‘(B) If the drug was approved on the basis of 
animal efficacy data because human efficacy studies 
are not ethical or feasible, the holder of the ap-
proved application shall conduct studies when ethical 
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and feasible to verify and describe clinical benefit 
and to assess the product’s safety. 
‘‘(C) If the results of a completed study that 
was so required are inconclusive or the risk-to-ben-
efit profile cannot be positively established, the Sec-
retary shall withdraw the product for commercial 
distribution. If a required study is not completed by 
eight years after the date of approval, the results of 
the study are presumed to be inconclusive. The prod-
uct may only be made available to patients who— 
‘‘(i) according to a health care professional 
have previously benefitted from the product; 
and 
‘‘(ii) have signed a statement of informed 
consent stating that they have received notice 
from the sponsor that the results of completed 
studies on the product have proven to be incon-
clusive and/or the risk to benefit profile can not 
be positively established. The document shall in-
clude the risks of continuing the product. 
Otherwise the product shall be unavailable except in 
a research setting until the product can meet the 
same standard of safety and effectiveness that exists 
for full approval.’’. 
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(c) ENFORCEMENT REGARDING POSTMARKET STUD-
IES.— 
(1) 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 with respect to which there is 
a failure to comply with a requirement under section 
505(o)(1), an order under section 505C, or a requirement 
under section 506(b)(2).’’. 
(2) CIVIL PENALTIES.—Section 303 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331) 
is amended by adding at the end the following: 
‘‘(g)(1)(A) Any person who violates section 301(a), 
301(b), or 301(c) by reason of section 502(x) shall be sub-
ject to a civil penalty of not more than 100 percent of 
the gross profits received by the sponsor from sales of the 
drug, or $1,000,000, whichever is greater, subject to sub-
paragraph (B). 
‘‘(B) If any harm to a consumer occurs as a result 
of a violation referred to in subparagraph (A), the person 
involved may be subject to a civil penalty of not more than 
an amount equal to 300 percent of the gross profits re-
ceived by the person, or $3,000,000, whichever is greater. 
‘‘(2) Any person who fails to act with due diligence 
to complete a postmarket study required under section 
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506(b)(2), or under subpart H of part 314 of title 21, 
Code of Federal Regulations, shall be subject to a civil 
penalty of not more than the amount that applies under 
subparagraph (A) or subparagraph (B) of paragraph (1) 
(as the case may be) for a violation referred to in such 
paragraph. The Secretary shall by regulation define the 
term ‘due diligence’ for purposes of this paragraph. 
‘‘(3) The provisions of paragraphs (3) through (5) 
of subsection (f) apply to a civil penalty under subpara-
graph (A) or (B) of paragraph (1) or under paragraph 
(2) to the same extent and in the same manner as such 
provisions apply to a civil penalty under paragraph (1) or 
(2) of such subsection.’’. 
(d) POSTMARKET
LABELING
CHANGES.—Section 
502 of the Federal Food, Drug, and Cosmetic Act, as 
amended by subsection (c)(1) of this section, is amended 
by adding at the end the following: 
‘‘(y) If it is a drug and the manufacturer of the 
drug or product fails to make changes to a product’s 
labeling in compliance with an order of the Sec-
retary, issued on the basis of clinical evidence (in-
cluding studies submitted to the Secretary, an anal-
ysis of adverse events reports, studies conducted or 
reports released by the Food and Drug Administra-
tion, the National Institutes of Health, the Agency 
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for Healthcare Research and Quality or another rel-
evant agency, actions or reports by regulatory agen-
cies in foreign countries, or studies published in sci-
entific or academic journals), that the labeling of the 
drug be modified to include specific wording re-
quired by the Secretary to ensure the safe and effec-
tive use of the drug.’’. 
(e) RULE OF CONSTRUCTION REGARDING CERTAIN 
PEDIATRIC STUDIES.—The amendments made by this 
section establish authorities in addition to, and not in lieu 
of— 
(1) the program under section 505A of the 
Federal Food, Drug, and Cosmetic Act; and 
(2) authorities under section 505B of such Act. 
SEC. 3. WHISTLEBLOWER PROTECTIONS. 
(a) PROHIBITION.—It shall be unlawful for any per-
son to discharge, demote, suspend, reprimand, investigate, 
or take or fail to take any other personnel action that in 
any manner discriminates against any covered individual, 
or in any other manner discriminate against any covered 
individual (including by a denial, suspension, or revocation 
of a security clearance or by any other security access de-
termination, or by denial of award of a Federal contract 
or subcontract), or to threaten or recommend the dis-
charge, demotion, suspension, reprimand, investigation, 
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