and feasible to verify and describe clinical benefit 
and to assess the product’s safety and effectiveness. 
‘‘(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 
five 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 a patient who— 
‘‘(i) according to a health care professional 
has previously benefitted from the product; and 
‘‘(ii) has signed a statement of informed 
consent that— 
‘‘(I) states that the patient has re-
ceived notice from the sponsor that the re-
sults of completed studies on the product 
have proven to be inconclusive or the risk- 
to-benefit profile cannot be positively es-
tablished; and 
‘‘(II) identifies the risks of continuing 
the product. 
Otherwise the product shall be unavailable except in 
a research setting until the product can meet the 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
same standard of safety and effectiveness that exists 
for full approval.’’. 
(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: 
‘‘(y) 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(y) 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. 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
‘‘(2) Any person who fails to act with due diligence 
to complete a postmarket study required under section 
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: 
‘‘(z) 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 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
reports released by the Food and Drug Administra-
tion, the National Institutes of Health, the Agency 
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 (21 U.S.C. 
355a); and 
(2) authorities under section 505B of such Act 
(21 U.S.C. 355b). 
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 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
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, 
other personnel action (or rejection of such action) that 
in any manner discriminates against any covered indi-
vidual, or other manner of discrimination if such action, 
discrimination, or recommendation is due, in whole or in 
part, to any lawful act done, perceived to have been done, 
or intended to be done by the covered individual— 
(1) to provide information, cause information to 
be provided, or otherwise assist in an investigation 
or proceeding regarding any conduct which the cov-
ered individual reasonably believes constitutes evi-
dence of a violation of any law, rule, or regulation, 
a substantial and specific threat to public health or 
safety, an abuse of authority, fraud, waste, or mis-
management of public funds, censorship, distortion, 
or suppression of scientific information, research, or 
analysis, or the willful disclosure of false, mis-
leading, or incomplete scientific information, if the 
information or assistance is provided to or the inves-
tigation or proceeding is conducted by— 
(A) a Federal, State, or local regulatory or 
law enforcement agency (including an office of 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
Inspector General under the Inspector General 
Act of 1978); 
(B) any Member of Congress, any com-
mittee of Congress, or the Government Ac-
countability Office; 
(C) any person with supervisory or mana-
gerial authority over the covered individual (or 
any other person who has the authority to in-
vestigate, discover, or terminate misconduct); or 
(D) a potential witness to or other person 
affected by or aware of the conduct described in 
this section who has the authority to inves-
tigate, discover, or terminate misconduct; 
(2) to file, cause to be filed, testify, participate 
in, or otherwise assist in a proceeding or action filed 
or about to be filed relating to an alleged violation 
of any law, rule, or regulation; or 
(3) to refuse to violate or assist in the violation 
of any law, rule, or regulation. 
(b) ENFORCEMENT ACTION.— 
(1) IN GENERAL.—A covered individual who al-
leges discharge or other discrimination by any per-
son in violation of subsection (a) may seek relief 
under paragraph (3) by— 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
(A) filing a complaint with the Secretary of 
Labor; or 
(B) if the Secretary has not issued a final 
decision within 180 days after the filing of the 
complaint and there is no showing that such 
delay is due to the bad faith of the claimant, 
bringing an action at law or equity for de novo 
review in the appropriate district court of the 
United States, which shall have jurisdiction 
over such an action without regard to the 
amount in controversy. 
(2) PROCEDURE.— 
(A) IN GENERAL.—An action under para-
graph (1)(A) shall be governed under the rules 
and procedures set forth in section 42121(b) of 
title 49, United States Code. 
(B) EXCEPTION.—Notification made under 
section 42121(b)(1) of title 49, United States 
Code, shall be made— 
(i) to the person named in the com-
plaint; and 
(ii) to the person’s employer. 
(C) BURDENS
OF
PROOF.—An action 
brought under paragraph (1)(B) shall be gov-
erned by the legal burdens of proof set forth in 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
section 42121(b) of title 49, United States 
Code. 
(D) STATUTE OF LIMITATIONS.—An action 
under paragraph (1) shall be commenced not 
later than 6 years after the date on which the 
violation occurs. 
(3) REMEDIES.— 
(A) IN
GENERAL.—A covered individual 
prevailing in any action under this subsection 
shall be entitled to all relief appropriate to 
make the covered individual whole. 
(B) DAMAGES.—Relief for any action 
under this subsection shall include— 
(i) reinstatement with the same se-
niority status and employment grade or 
pay level (or the equivalent) that the cov-
ered individual would have had, but for the 
discrimination; 
(ii) compensatory damages, including 
the amount of any back pay, with interest; 
(iii) compensation for any special 
damages sustained as a result of the dis-
crimination, including litigation costs, ex-
pert witness fees, and reasonable attorney 
fees; and 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
(iv) punitive damages in an amount 
not to exceed the greater of 3 times the 
amount of any monetary damages awarded 
under this section (apart from this para-
graph) or $5,000,000. 
(c) CRIMINAL PENALTIES.— 
(1) IN
GENERAL.—Any person who violates 
subsection (a) shall be fined under title 18 of the 
United States Code, imprisoned not more than 10 
years, or both. 
(2) REPORTING
REQUIREMENTS.—The Attor-
ney General of the United States shall (based on 
such periodic reports and other information from the 
Department of Labor as the Attorney General may 
require) submit to the Congress an annual report on 
the enforcement of paragraph (1). Each such report 
shall— 
(A) identify each case in which formal 
charges under paragraph (1) were brought; 
(B) describe the status or disposition of 
each such case; and 
(C) in any action under subsection (b) in 
which the covered individual was the prevailing 
party or the substantially prevailing party, indi-
cate whether or not any formal charges under 
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS
paragraph (1) have been brought and, if not, 
the reasons therefor. 
(d) RIGHTS RETAINED BY COVERED INDIVIDUAL.— 
Nothing in this section shall be deemed to diminish the 
rights, privileges, or remedies of any covered individual 
under any Federal or State law, or under any collective 
bargaining agreement. The rights and remedies in this 
section may not be waived by any agreement, policy, form, 
or condition of employment. 
(e) NOTIFICATION.—The provisions of this section 
shall be prominently posted in any place of employment 
to which this section applies. 
(f) DEFINITIONS.—For purposes of this section: 
(1) The term ‘‘covered individual’’ means an 
employee or a contractor or subcontractor of the 
Food and Drug Administration. 
(2) The term ‘‘lawful’’ means not specifically 
prohibited by law. 
SEC. 4. RIGHT TO PUBLISH. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 
amended by adding at the end the following section: 
‘‘SEC. 565. RIGHT TO PUBLISH. 
‘‘Officers and employees of the Food and Drug Ad-
ministration, and individuals sponsored by such Adminis-
VerDate Aug 31 2005 
03:50 Feb 22, 2007
Jkt 059200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H1165.IH
H1165
hmoore on PROD1PC68 with HMBILLS