and that there is reason to believe that such disclosure 
may result in— 
‘‘(1) furtherance of a potential violation under 
investigation; 
‘‘(2) endangerment to the life or physical safety 
of any person; 
‘‘(3) flight or other action to avoid prosecution 
or other enforcement remedies; 
‘‘(4) destruction of or tampering with evidence; 
or 
‘‘(5) intimidation of potential witnesses. 
An order under this subsection may be renewed for addi-
tional periods of up to 90 days upon a showing that any 
of the circumstances described in paragraphs (1) through 
(5) continue to exist. 
‘‘(g) RELATION TO OTHER PROVISIONS.—The sub-
poena authority vested in the Commissioner and the dis-
trict courts of the United States by this section is in addi-
tion to any such authority vested in the Commissioner or 
such courts by other provisions of law, or as is otherwise 
authorized by law. 
‘‘(h) NONDELEGATION.—The authority to issue a 
subpoena under this section is limited to the Commis-
sioner or an official designated by the Commissioner. An 
official may not be so designated unless the official is the 
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director of the district under this Act in which the drug 
is located, or is an official senior to such director.’’. 
(c) FAILURE TO OBEY SUBPOENA.—Section 801 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381), as amended, is further amended by adding at the 
end the following new subsection: 
‘‘(v)(1) A drug shall be refused admission if any per-
son who manufactures, processes, packs, holds, or ships 
such drug before it is imported or offered for import into 
the United States fails or refuses to obey a subpoena 
issued pursuant to section 312 and such subpoena was 
issued, in whole or in part, for the purpose of determining 
whether such drug is adulterated, misbranded, or an unap-
proved new drug. 
‘‘(2) No drug shall be refused admission under this 
section based on the failure or refusal to obey a subpoena 
that has been withdrawn by the Commissioner or quashed 
by a United States district court.’’. 
SEC. 405. WHISTLEBLOWER PROTECTIONS. 
Chapter X of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.), as amended, is further 
amended by adding at the end the following: 
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‘‘SEC. 1014. PROTECTIONS FOR EMPLOYEES WHO REFUSE 
TO VIOLATE, OR WHO DISCLOSE VIOLATIONS 
OF, THIS ACT. 
‘‘(a) IN GENERAL.—No person who submits or is re-
quired under this Act or the Public Health Service Act 
to submit any information related to a drug, or any offi-
cer, employee, contractor, subcontractor, or agent of such 
person, may discharge, demote, suspend, threaten, harass, 
or in any other manner discriminate against an employee 
in the terms and conditions of employment because of any 
lawful act done by the employee (including any lawful act 
that is within the ordinary course of the job duties of such 
employee)— 
‘‘(1) to provide information, cause information 
to be provided, or otherwise assist in any investiga-
tion regarding any conduct which the employee rea-
sonably believes constitutes a violation of this Act 
that is related to a drug, or any other provision of 
Federal law relating to the safety of a drug, if the 
information or assistance is provided to, or an inves-
tigation stemming from the provided information is 
conducted by— 
‘‘(A) a Federal regulatory or law enforce-
ment agency; 
‘‘(B) any Member of Congress or any com-
mittee of Congress; or 
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‘‘(C) a person with supervisory authority 
over the employee (or such other person work-
ing for the employer who has the authority to 
investigate, discover, or terminate the mis-
conduct); 
‘‘(2) to file, cause to be filed, testify, participate 
in, or otherwise assist in a proceeding filed, or about 
to be filed (with any knowledge of the employer), in 
any court or administrative forum relating to any 
such alleged violation; or 
‘‘(3) to refuse to commit or assist in any such 
violation. 
‘‘(b) ENFORCEMENT ACTION.— 
‘‘(1) IN GENERAL.—An employee who alleges 
discharge or other discrimination in violation of sub-
section (a) may seek relief in accordance with the 
provisions of subsection (c) by— 
‘‘(A) filing a complaint with the Secretary 
of Labor; or 
‘‘(B) if the Secretary of Labor has not 
issued a final decision within 210 days of the 
filing of the complaint and there is no showing 
that such delay is due to the bad faith of the 
claimant, or within 90 days after receiving a 
final decision or order from the Secretary, 
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bringing an action at law or equity for de novo 
review in the appropriate district court of the 
United States, which court shall have jurisdic-
tion over such action without regard to the 
amount in controversy, and which action shall, 
at the request of either party to such action, be 
tried by the court with a jury. 
‘‘(2) PROCEDURE.— 
‘‘(A) IN
GENERAL.—Any action under 
paragraph (1) shall be governed under the rules 
and procedures set forth in section 42121(b) of 
title 49, United States Code. 
‘‘(B) EXCEPTION.—Notification in an ac-
tion under paragraph (1) shall be made in ac-
cordance with section 42121(b)(1) of title 49, 
United States Code, except that such notifica-
tion shall be made to the person named in the 
complaint, the employer, and the Commissioner 
of Food and Drugs. 
‘‘(C) BURDENS
OF
PROOF.—An action 
brought under paragraph (1)(A) or (1)(B) shall 
be governed by the legal burdens of proof set 
forth in section 42121(b) of title 49, United 
States Code. 
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