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, abuse of authority, or fraud, waste, or mis-
management of public funds, if the information or 
assistance is provided to or the investigation or pro-
ceeding is conducted by— 
(A) a Federal, State, or local regulatory or 
law enforcement agency (including an office of 
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 
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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 subsection (c) by— 
(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 
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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 
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. 
(c) REMEDIES.— 
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(1) IN
GENERAL.—A covered individual pre-
vailing in any action under subsection (b) shall be 
entitled to all relief appropriate to make the covered 
individual whole. 
(2) DAMAGES.—Relief for any action under 
subsection (b) shall include— 
(A) reinstatement with the same seniority 
status and employment grade or pay level (or 
the equivalent) that the covered individual 
would have had, but for the discrimination; 
(B) compensatory damages, including the 
amount of any back pay, with interest; 
(C) compensation for any special damages 
sustained as a result of the discrimination, in-
cluding litigation costs, expert witness fees, and 
reasonable attorney fees; and 
(D) 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 paragraph) or $5,000,000. 
(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 
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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 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-
tration, may publish in peer-reviewed journals and other 
scientific publications, and make oral presentations at pro-
fessional society meetings and other meetings of their 
peers, unless publication or presentation of the data is 
subject to Federal export control or national security laws 
or regulations, or is proprietary information. The right to 
publish or present such data cannot be waived by any 
agreement, policy, form or condition of employment.’’. 
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SEC. 5. BIENNIAL REPORTS ON APPROVED APPLICATIONS 
SUPPORTED BY NON-INFERIORITY STUDIES. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 2(b) of this Act, is amended 
by adding at the end the following subsection: 
‘‘(p) BIENNIAL REPORTS ON APPROVED APPLICA-
TIONS SUPPORTED BY NON-INFERIORITY STUDIES.—The 
Secretary shall submit to the Congress biennial reports on 
approved applications under subsection (b) (including sup-
plemental applications) that have been supported by data 
from one or more non-inferiority studies. For each such 
application, the report shall include the following informa-
tion: 
‘‘(1) The name of the drug listed in application. 
‘‘(2) The name of the sponsor. 
‘‘(3) The date of the approval. 
‘‘(4) The name of each drug used as an active 
control in the non-inferiority studies used to support 
the application. 
‘‘(5) The indication studied. 
‘‘(6) The primary and secondary endpoints of 
the non-inferiority studies. 
‘‘(7) The margins used in such studies. 
‘‘(8) The explanation required by section 
314.l26(b)(2)(iv) of title 21, Code of Federal Regu-
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lations, as to why the drugs should be considered ef-
fective in the study.’’. 
SEC. 6. BIANNUAL REPORTS REGARDING POSTMARKET 
STUDIES. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 5 of this Act, is amended by 
adding at the end the following subsection: 
‘‘(q) BIANNUAL REPORTS REGARDING POSTMARKET 
STUDIES.—The Secretary shall submit to the Congress bi-
annual reports that provide the following information: 
‘‘(1) The number of enforcement actions taken 
to ensure that sponsors are complying with the re-
quirements to complete postmarketing studies under 
subsection (o) and sections 505C and 506(b)(2), to-
gether with a description of each such action. 
‘‘(2) The measures taken by the Secretary to 
establish a system to ensure effective monitoring of 
the status of all such postmarketing studies, to-
gether with a description of the status of that sys-
tem. 
‘‘(3) The measures taken by the Secretary to 
develop a system to track information about ongoing 
postmarketing safety issues, together with a descrip-
tion of the status of that system.’’. 
Æ 
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