II 

112TH CONGRESS 

1ST SESSION S. 1584 

To provide for additional quality control of drugs. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 20, 2011 

Mr. BENNET introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for additional quality control of drugs. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Drug Safety and Ac5 countability Act of 2011’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 

8 (1) Recent manufacturing quality problems re9 sulting in drug recalls and warnings from the Food 

10 and Drug Administration have exposed gaps in qual11 ity systems to ensure drugs in the United States are 

12 safe and free from contamination. 

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1 (2) Adherence to quality standards is the most 

2 effective way to ensure drug quality and integrity. It 

3 is impossible to test every pharmaceutical item that 

4 is produced. 

5 (3) More than 1,300,000 over-the-counter chil6 dren’s medicines were recalled in 2010 for quality 

7 issues that presented possible risk to patient health, 

8 and the quality standards at many other over-the9 counter manufacturers are unknown. 

10 (4) Up to 149 Americans died in 2007 and 

11 2008 after taking heparin, a blood thinner, contami12 nated during the manufacturing process in China. 

13 (5) Up to 80 percent of the active ingredients 

14 in drugs used in the United States are made over15 seas, many in countries where regulatory oversight 

16 does not meet the standards of the United States. 

17 SEC. 3. QUALITY CONTROL OF DRUGS. 

18 (a) ADULTERATION.—Section 501 of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend20 ed by adding at the end the following: 

21 ‘‘(j) If it is a drug that was manufactured, prepared, 

22 propagated, compounded, or processed by an establish23 ment that is, or was at the time of such manufacture, 

24 preparation, propagation, compounding, or processing, in 

25 violation of subsection (q) or (r) of section 510.’’. 

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1 (b) ADDITIONAL REQUIREMENTS OF PRODUCERS OF

2 DRUGS.—Section 510 of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 360) is amended by adding at 

4 the end the following: 

5 ‘‘(q) QUALITY MANAGEMENT PLANS.— 

6 ‘‘(1) SCOPE.—Each person required to register 

7 under subsection (b), (c), (d), or (i), with respect to 

8 the manufacture, preparation, propagation, com9 pounding, or processing of a drug shall have in ef10 fect and implement a quality management plan to 

11 ensure the quality and safety of— 

12 ‘‘(A) each such drug, including when such 

13 drug is prepared, propagated, compounded, or 

14 processed by another person; 

15 ‘‘(B) each active and inactive ingredient of 

16 such drug, including when such ingredient is 

17 prepared, propagated, compounded, processed, 

18 or held by another person; and 

19 ‘‘(C) materials used in the manufacture of 

20 the active ingredient, based on a risk assess21 ment that gives additional consideration to ma22 terials extracted or derived from plants, mi23 crobes, animal tissue, or other biological 

24 sources. 

25 ‘‘(2) PROVISIONS.— 

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1 ‘‘(A) IN GENERAL.—Each quality manage2 ment plan required under paragraph (1) shall— 

3 ‘‘(i) address risk assessment, risk con4 trol, risk communication, and risk review; 

5 ‘‘(ii) provide for an assessment, prior 

6 to contracting with a person to supply in7 gredients or to undertake any aspect of the 

8 manufacturing of a drug, of the suitability 

9 and competence of such person to carry 

10 out such activity, using audits, material 

11 evaluations, or qualification, as appro12 priate; 

13 ‘‘(iii) define responsibilities and com14 munication processes for manufacturing, 

15 quality control, and quality assurance ac16 tivities of any person described in clause 

17 (ii); 

18 ‘‘(iv) provide for the monitoring and 

19 review through periodic on-site audits of 

20 the facility conditions, controls, and prac21 tices of any person described in clause (ii) 

22 and ensure the implementation of appro23 priate measures to improve such condi24 tions, controls, and practices; 

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1 ‘‘(v) provide for the monitoring of in2 coming materials to ensure that such ma3 terials are from a person who meets the re4 quirements under clauses (ii) through (iv); 

5 ‘‘(vi) provide for implementation of ef6 fective systems, including appropriate spec7 ifications and test methods and verification 

8 of the identity, quality, strength, and pu9 rity of drug ingredients, to detect any haz10 ard that has been, or is reasonably likely 

11 to be, present in or on the drug during 

12 production, manufacturing, processing, 

13 packing, holding, or transporting; and 

14 ‘‘(vii) provide for adequate assessment 

15 of materials used in the manufacture of 

16 the active ingredient. 

17 ‘‘(B) ADDITIONAL PROVISIONS.—If the 

18 Secretary determines that provisions in addition 

19 to those described in subparagraph (A) would 

20 be appropriate to include in quality risk man21 agement plans for the protection of the public 

22 health, including provisions for the prevention 

23 of intentional adulteration of a drug or class of 

24 drugs, the Secretary may by regulation require 

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1 that such provisions be included in quality risk 

2 management plans. 

3 ‘‘(3) REVIEW AND UPDATING.—Each person re4 quired to implement a quality management plan 

5 under this subsection shall periodically review such 

6 plan and update such plan as necessary. 

7 ‘‘(4) APPLICATION OF SPECIFICATIONS OR TEST

8 METHODS BY ORDER OF THE SECRETARY.—If the 

9 Secretary finds that there is a significant threat to 

10 public health, the Secretary may order an establish11 ment— 

12 ‘‘(A) to promptly revise its quality risk 

13 management plan to include new or modified 

14 specifications or test methods for a drug; and 

15 ‘‘(B) to promptly implement such specifica16 tions or test methods. 

17 ‘‘(5) INSPECTION OF QUALITY MANAGEMENT

18 PLAN.—The Secretary shall, in the course of an in19 spection under section 704 of an establishment sub20 ject to this subsection or upon request by the Sec21 retary, conduct a review of the quality management 

22 plan of the establishment. 

23 ‘‘(r) DOCUMENTATION OF SUPPLY CHAIN.—Each 

24 person required to register under subsection (b), (c), (d), 

25 or (i), with respect to the manufacture, preparation, propmstockstill on DSK4VPTVN1PROD with BILLS

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1 agation, compounding, or processing of a drug shall pro2 vide, at the request of the Secretary, documentation of the 

3 names, addresses, phone numbers, and Global Positioning 

4 System coordinates of each producer, manufacturer, dis5 tributor, and shipper involved in the production of a drug 

6 or the production or transport of the active ingredients 

7 of a drug, and, where the assessment of materials de8 scribed in subsection (q)(2)(A)(vii) is required, each pro9 ducer, manufacturer, distributor, and shipper involved in 

10 the production or transport of such materials. Such docu11 mentation shall show that the drug and the ingredients 

12 of the drug were manufactured, prepared, propagated, 

13 compounded, processed, and handled in a manner ensur14 ing the identity, safety, quality, purity, and strength of 

15 such drug. 

16 ‘‘(s) TRACKING SYSTEMS.—Not later than 1 year 

17 after the date of enactment of the Drug Safety and Ac18 countability Act of 2011, the Secretary shall develop and 

19 maintain information systems to track and assess every 

20 establishment that is involved in the manufacturing, prep21 aration, propagation, compounding, or processing of a 

22 drug or active ingredient of a drug. The Secretary shall 

23 ensure the interoperability of all databases relevant to the 

24 tracking and assessment of such establishments and in25 clude in each such database the D–U–N–S number of each 

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1 such establishment required under subsection (b) to pro2 vide a D–U–N–S number. 

3 ‘‘(t) OVER-THE-COUNTER DRUGS.—In determining, 

4 for purposes of inspection, the risk associated with a per5 son required to register under this section, the Secretary 

6 shall not consider whether the drugs manufactured, pre7 pared, propagated, compounded, or processed by such per8 son are drugs described in section 503(b).’’. 

9 (c) UNIQUE REGISTRATION NUMBERS.—Section 510 

10 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 360) is amended— 

12 (1) in subsection (b)— 

13 (A) in paragraph (1), by striking ‘‘and all 

14 such establishments’’ and inserting ‘‘all such es15 tablishments, and the D–U–N–S number of 

16 each such establishment’’; and 

17 (B) in paragraph (2), by striking ‘‘and all 

18 such establishments’’ and inserting ‘‘all such es19 tablishments, and the D–U–N–S number of 

20 each such establishment’’; 

21 (2) in subsection (c), by striking ‘‘such estab22 lishment’’ and inserting ‘‘such establishment, and 

23 the D–U–N–S number of such establishment’’; 

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1 (3) in subsection (d), by inserting ‘‘, and the 

2 D–U–N–S number of such establishment’’ after ‘‘de3 vices’’; and 

4 (4) in subsection (i)(1)(A), by inserting ‘‘the 

5 D–U–N–S number of each such establishment,’’ 

6 after ‘‘place of business of the establishment,’’. 

7 (d) FACTORY INSPECTION.—Section 704(a)(1) of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 374(a)(1)) is amended, in the first sentence, by inserting 

10 ‘‘in the United States or for import into the United 

11 States,’’ after ‘‘to enter, at reasonable times, any factory, 

12 warehouse, or establishment in which food, drugs, devices, 

13 tobacco products, or cosmetics are manufactured, proc14 essed, packed, or held,’’. 

15 (e) MUTUAL RECOGNITION AGREEMENT PROGRESS

16 REPORT.—The Secretary of Health and Human Services 

17 shall, not later than 1 year after the date of enactment 

18 of this Act, issue a report that describes the progress on 

19 implementing cooperative arrangements and mutual rec20 ognition agreements relating to the regulation of drugs 

21 and good manufacturing practices entered into under sec22 tion 510(i)(3) or section 803 of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 360(i)(3), 383). 

24 (f) MANDATORY RECALL AUTHORITY FOR DRUGS.— 

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1 (1) IN GENERAL.—Chapter V of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 

3 seq.) is amended by inserting after section 506C the 

4 following: 

5 ‘‘SEC. 507. MANDATORY RECALL AUTHORITY FOR DRUGS. 

6 ‘‘(a) ORDER TO CEASE DISTRIBUTION; NOTIFICA7 TION; PROCESS.— 

8 ‘‘(1) ORDER TO CEASE DISTRIBUTION; NOTIFI9 CATION.—If the Secretary finds that there is a rea10 sonable probability that a drug intended for human 

11 use would cause serious, adverse health con12 sequences or death, the Secretary shall issue an 

13 order requiring the appropriate person (including 

14 the manufacturers, importers, distributors, or retail15 ers of the drug)— 

16 ‘‘(A) to immediately cease distribution of 

17 such drug; and 

18 ‘‘(B) to immediately notify health profes19 sionals and hospitals and other health care fa20 cilities of the order and to instruct such profes21 sionals and facilities to cease use of such drug. 

22 ‘‘(2) PROCESS.—The order under paragraph 

23 (1) shall provide the person subject to the order with 

24 an opportunity for an informal hearing, to be held 

25 not later than 10 days after the date of the issuance 

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1 of the order, on the actions required by the order 

2 and on whether the order should be amended to re3 quire a recall of such drug. If, after providing an op4 portunity for such a hearing, the Secretary deter5 mines that inadequate grounds exist to support the 

6 actions required by the order, the Secretary shall va7 cate the order. 

8 ‘‘(b) ORDER TO RECALL.— 

9 ‘‘(1) IN GENERAL.—If, after providing an op10 portunity for an informal hearing under subsection 

11 (a), the Secretary determines that the order should 

12 be amended to include a recall of the drug with re13 spect to which the order was issued, the Secretary 

14 shall, except as provided in paragraph (2), amend 

15 the order to require a recall. The Secretary shall 

16 specify a timetable in which the drug recall will 

17 occur and shall require periodic reports to the Sec18 retary describing the progress of the recall. 

19 ‘‘(2) AMENDED ORDER.—An amended order 

20 under paragraph (1)— 

21 ‘‘(A) shall— 

22 ‘‘(i) not include recall of a drug from 

23 individuals; and 

24 ‘‘(ii) not include recall of a drug from 

25 hospitals and other health care facilities if 

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1 the Secretary determines that the risk of 

2 recalling such drug from the facilities pre3 sents a greater health risk than the health 

4 risk of not recalling the drug from use; 

5 and 

6 ‘‘(B) shall provide for notice to individuals 

7 subject to the risks associated with the use of 

8 such drug. 

9 ‘‘(3) ASSISTANCE.—In providing the notice re10 quired by paragraph (2), the Secretary may use the 

11 assistance of health professionals who prescribed or 

12 used such a drug for individuals. If a significant 

13 number of such individuals cannot be identified, the 

14 Secretary shall notify such individuals pursuant to 

15 section 705(b).’’. 

16 (2) REGULATIONS.—Until the date that the 

17 Secretary of Health and Human Services issues a 

18 final regulation to implement section 507 of the 

19 Federal Food, Drug, and Cosmetic Act (as added by 

20 paragraph (1)), the regulations on medical device re21 call authority in part 810 of title 21, Code of Fed22 eral Regulations, shall apply to any recall of a drug 

23 under such section 507. 

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1 (3) PROHIBITED ACTS.—Section 301 of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 331) is amended by adding at the end the following: 

4 ‘‘(aaa) The failure to comply with an order issued 

5 under section 507.’’. 

6 (g) SUBPOENA AUTHORITY.—Section 702 of the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 372) 

8 is amended by adding at the end the following: 

9 ‘‘(f)(1) The Secretary may conduct investigations as 

10 the Secretary deems necessary— 

11 ‘‘(A) to carry out the authority of the Secretary 

12 under this Act or section 351 of the Public Health 

13 Service Act; or 

14 ‘‘(B) to determine whether any person has en15 gaged or is about to engage in any act that con16 stitutes or will constitute a violation of this Act or 

17 such section 351. 

18 ‘‘(2) For the purpose of any investigation conducted 

19 under paragraph (1), the Secretary may administer oaths 

20 and affirmations, subpoena witnesses, compel the attend21 ance of such witnesses, take evidence, and require the pro22 duction of any books, papers, documents, or other mate23 rials that are relevant to the investigation. 

24 ‘‘(3)(A) In case of contumacy or refusal to obey a 

25 subpoena issued under paragraph (2), the district court 

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1 of the United States for the judicial district in which such 

2 investigation or proceeding is conducted, or in which the 

3 subpoenaed person resides or conducts business, may issue 

4 an order requiring such person to appear before the Sec5 retary, testify, or produce books, papers, documents, or 

6 other materials that are relevant to the investigation. All 

7 process in any such case may be served in the judicial dis8 trict in which such person resides or may be found. 

9 ‘‘(B) Any failure to obey an order issued under sub10 paragraph (A) may be punished by the court as contempt 

11 of court.’’. 

12 (h) CIVIL PENALTIES.— 

13 (1) IN GENERAL.—Section 303(f) of the Fed14 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

15 333(f)) is amended— 

16 (A) in paragraph (4), by striking ‘‘or 505– 

17 1’’ each place it appears and inserting ‘‘505–1, 

18 or 505A’’; 

19 (B) by adding at the end the following: 

20 ‘‘(10)(A)(i) Any manufacturer, distributor, im21 porter, broker, or filer that violates a requirement of 

22 this Act that relates to drugs for human use (except 

23 a requirement referred to in paragraph (4) or sub24 section (g)) shall be liable to the United States for 

25 a civil penalty not to exceed $100,000 per violation. 

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1 ‘‘(ii) Each day during which a violation con2 tinues shall be considered a separate violation under 

3 clause (i). 

4 ‘‘(B)(i) Any manufacturer, distributor, im5 porter, broker, or filer that knowingly reports or en6 ters false or misleading data on documents related 

7 to the importation of a drug shall be liable to the 

8 United States for a civil penalty not to exceed 

9 $150,000. 

10 ‘‘(ii) Each act of reporting or entering false 

11 data shall be considered a separate violation under 

12 clause (i).’’; and 

13 (C) in paragraph (5) by striking ‘‘, or (9)’’ 

14 each place it appears and inserting ‘‘(9), or 

15 (10)’’. 

16 (2) APPLICABILITY.—Section 303(f)(10) of the 

17 Federal Food, Drug, and Cosmetic Act, as added by 

18 paragraph (1), shall apply to violations described in 

19 such section that occur after the date of enactment 

20 of this Act. 

21 (i) EXCHANGE OF INFORMATION.— 

22 (1) IN GENERAL.—Section 708 of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 379) is 

24 amended— 

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1 (A) by striking ‘‘The Secretary’’ and in2 serting ‘‘(a) The Secretary’’; and 

3 (B) by adding at the end the following: 

4 ‘‘(b)(1)(A) The Secretary may provide to any Federal 

5 agency acting within the scope of its jurisdiction any infor6 mation relating to drugs that is exempt from disclosure 

7 pursuant to subsection (a) of section 552 of title 5, United 

8 States Code, by reason of subsection (b)(4) of such sec9 tion, or that is referred to in section 301(j). 

10 ‘‘(B) Any such information provided to another Fed11 eral agency shall not be disclosed by such agency except 

12 in any action or proceeding under the laws of the United 

13 States to which the receiving agency or the United States 

14 is a party. 

15 ‘‘(2)(A) In carrying out this Act, the Secretary may 

16 provide to a State or local government agency any infor17 mation relating to drugs that is exempt from disclosure 

18 pursuant to section 552(a) of title 5, United States Code, 

19 by reason of subsection (b)(4) of such section, or that is 

20 referred to in section 301(j). 

21 ‘‘(B) Any such information provided to a State or 

22 local government agency shall not be disclosed by such 

23 agency. 

24 ‘‘(3) In carrying out this Act, the Secretary may pro25 vide to any person any information relating to drugs that 

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1 is exempt from disclosure pursuant to section 552(a) of 

2 title 5, United States Code, by reason of subsection (b)(4) 

3 of such section, if the Secretary determines that providing 

4 the information to the person is appropriate under the cir5 cumstances and the recipient provides adequate assur6 ances to the Secretary that the recipient will preserve the 

7 confidentiality of the information. 

8 ‘‘(4) In carrying out this Act, the Secretary may pro9 vide any information relating to drugs that is exempt from 

10 disclosure pursuant to section 552(a) of title 5, United 

11 States Code, by reason of subsection (b)(4) of such sec12 tion, or that is referred to in section 301(j)— 

13 ‘‘(A) to any foreign government agency; or 

14 ‘‘(B) any international organization established 

15 by law, treaty, or other governmental action and 

16 having responsibility— 

17 ‘‘(i) to facilitate global or regional harmo18 nization of standards and requirements in an 

19 area of responsibility of the Food and Drug Ad20 ministration; or 

21 ‘‘(ii) to promote and coordinate public 

22 health efforts, 

23 if the agency or organization provides adequate as24 surances to the Secretary that the agency or organimstockstill on DSK4VPTVN1PROD with BILLS

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1 zation will preserve the confidentiality of the infor2 mation. 

3 ‘‘(c) Except where specifically prohibited by statute, 

4 the Secretary may disclose to the public any information 

5 relating to drugs that is exempt from disclosure pursuant 

6 to section 552(a) of title 5, United States Code, by reason 

7 of subsection (b)(4) of such section, if the Secretary deter8 mines that such disclosure is necessary to protect the pub9 lic health. 

10 ‘‘(d) Except as provided in subsection (e), the Sec11 retary shall not be required to disclose under section 552 

12 of title 5, United States Code, or any other provision of 

13 law any information relating to drugs obtained from a 

14 Federal, State, or local government agency, or from a for15 eign government agency, or from an international organi16 zation described in subsection (b)(4), if the agency or or17 ganization has requested that the information be kept con18 fidential, or has precluded such disclosure under other use 

19 limitations, as a condition of providing the information. 

20 ‘‘(e) Nothing in subsection (d) authorizes the Sec21 retary to withhold information from the Congress or pre22 vents the Secretary from complying with an order of a 

23 court of the United States. 

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1 ‘‘(f) This section shall not affect the authority of the 

2 Secretary to provide or disclose information under any 

3 other provision of law.’’. 

4 (2) CONFORMING AMENDMENT.—Section 301(j) 

5 (21 U.S.C. 331(j)) is amended by striking ‘‘or to the 

6 courts when relevant in any judicial proceeding 

7 under this Act,’’ and inserting ‘‘to the courts when 

8 relevant in any judicial proceeding under this Act, or 

9 as specified in section 708,’’. 

10 (j) WHISTLEBLOWER PROTECTION.—Chapter X of 

11 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 

12 et seq.) is amended by adding at the end the following: 

13 ‘‘SEC. 1013. PROTECTIONS FOR EMPLOYEES WHO REFUSE 

14 TO VIOLATE, OR WHO DISCLOSE VIOLATIONS 

15 OF, THIS ACT OR SECTION 351 OF THE PUB16 LIC HEALTH SERVICE ACT. 

17 ‘‘(a) IN GENERAL.— 

18 ‘‘(1) PROTECTIONS FOR EMPLOYEES.—No per19 son that submits, or is required to submit to the 

20 Secretary a submission described in paragraph (2), 

21 or any officer, employee, contractor, subcontractor, 

22 or agent of such a person, may discharge, demote, 

23 suspend, threaten, harass, or in any other manner 

24 discriminate against an employee in the terms and 

25 conditions of employment because of any lawful act 

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1 done by the employee, including within the ordinary 

2 course of the job duties of such employee— 

3 ‘‘(A) to provide information, cause infor4 mation to be provided, or otherwise assist in 

5 any investigation regarding any conduct which 

6 the employee reasonably believes constitutes a 

7 violation of any section of this Act or the Public 

8 Health Service Act described under paragraph 

9 (2), any other provision of Federal law relating 

10 to the safety or effectiveness of a drug, biologi11 cal product, or device, or any provision of Fed12 eral law prohibiting fraud against the Food and 

13 Drug Administration, if the information or as14 sistance is provided to, or an investigation 

15 stemming from the provided information is con16 ducted by— 

17 ‘‘(i) a Federal regulatory or law en18 forcement agency; 

19 ‘‘(ii) any Member of Congress or any 

20 committee of Congress; or 

21 ‘‘(iii) a person with supervisory au22 thority over the employee (or such other 

23 person working for the employer who has 

24 the authority to investigate, discover, or 

25 terminate the misconduct); 

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1 ‘‘(B) to file, cause to be filed, testify, par2 ticipate in, or otherwise assist in a proceeding 

3 filed or about to be filed (with any knowledge 

4 of the employer) relating to an alleged violation 

5 of any section of this Act or the Public Health 

6 Service Act described under paragraph (2), any 

7 other provision of Federal law relating to the 

8 safety or effectiveness of a drug, biological 

9 product, or device, or any provision of Federal 

10 law prohibiting fraud against the Food and 

11 Drug Administration; or 

12 ‘‘(C) to refuse to violate or assist in the 

13 violation of any section of this Act or the Public 

14 Health Service Act listed described paragraph 

15 (2), any other provision of Federal law relating 

16 to the safety or effectiveness of a drug, biologi17 cal product, or device, or any provision of Fed18 eral law prohibiting fraud against the Food and 

19 Drug Administration. 

20 ‘‘(2) SUBMISSION.—A submission described in 

21 this paragraph is— 

22 ‘‘(A) a new drug application under section 

23 505(b); 

24 ‘‘(B) an abbreviated new drug application 

25 under section 505(j); 

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1 ‘‘(C) a biologics license application under 

2 section 351 of the Public Health Service Act; 

3 ‘‘(D) an application for an investigational 

4 new drug exemption under section 505(i); 

5 ‘‘(E) a new animal drug application under 

6 section 512(b); 

7 ‘‘(F) an abbreviated new animal drug ap8 plication under section 512(b); 

9 ‘‘(G) an application under section 571; 

10 ‘‘(H) a request under section 572; 

11 ‘‘(I) an application or report for premarket 

12 approval under section 515; 

13 ‘‘(J) an application for an investigational 

14 device exemption under section 520(g); 

15 ‘‘(K) a report under section 510(k); 

16 ‘‘(L) an application for a humanitarian de17 vice exemption under section 520(m); 

18 ‘‘(M) an amendment, supplement, or other 

19 submission with respect to any such application 

20 or report described in subparagraphs (A) 

21 through (L); or 

22 ‘‘(N) a record or report related to an ad23 verse event, a postapproval study, a post24 approval clinical trial, a report, or postmarket 

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1 surveillance under section 505(k), 505(o), 519, 

2 522, or 760. 

3 ‘‘(b) ENFORCEMENT ACTION.— 

4 ‘‘(1) IN GENERAL.—An employee who alleges 

5 discharge, or other discrimination in violation of 

6 subsection (a), may seek relief in accordance with 

7 the provisions of subsection (c), by— 

8 ‘‘(A) filing a complaint with the Secretary 

9 of Labor; or 

10 ‘‘(B) if the Secretary of Labor has not 

11 issued a final decision within 210 days of the 

12 filing of the complaint and there is no showing 

13 that such delay is due to the bad faith of the 

14 claimant, bringing an action at law or equity 

15 for de novo review in the appropriate district 

16 court of the United States, which shall have ju17 risdiction over such an action without regard to 

18 the amount in controversy. 

19 ‘‘(2) PROCEDURE.— 

20 ‘‘(A) IN GENERAL.—Any action under 

21 paragraph (1) shall be governed under the rules 

22 and procedures set forth in section 42121(b) of 

23 title 49, United States Code. 

24 ‘‘(B) EXCEPTION.—Notification in an ac25 tion under paragraph (1) shall be made in acmstockstill on DSK4VPTVN1PROD with BILLS

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1 cordance with section 42121(b)(1) of title 49, 

2 United States Code, except that such notifica3 tion shall be made to the person named in the 

4 complaint and to the employer. 

5 ‘‘(C) BURDENS OF PROOF.—An action 

6 brought under paragraph (1)(B) shall be gov7 erned by the legal burdens of proof set forth in 

8 section 42121(b) of title 49, United States 

9 Code. 

10 ‘‘(D) STATUTE OF LIMITATIONS.—An ac11 tion under paragraph (1) shall be commenced 

12 not later than 180 days after the date on which 

13 the violation occurs. 

14 ‘‘(c) REMEDIES.— 

15 ‘‘(1) IN GENERAL.—An employee prevailing in 

16 any action under subsection (b)(1) shall be entitled 

17 to all relief necessary to make the employee whole. 

18 ‘‘(2) COMPENSATORY DAMAGES.—Relief in an 

19 action under subsection (b) shall include— 

20 ‘‘(A) reinstatement with the same seniority 

21 status that the employee would have had, but 

22 for the discrimination; 

23 ‘‘(B) the amount of backpay owed to the 

24 employee, with interest; and 

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25 

•S 1584 IS

1 ‘‘(C) compensation for any special damages 

2 sustained as a result of the discrimination, in3 cluding litigation costs, expert witness fees, and 

4 reasonable attorney fees. 

5 ‘‘(d) RIGHTS RETAINED BY EMPLOYEE.—Nothing in 

6 this section shall be deemed to diminish the rights, privi7 leges, or remedies of any employee under any Federal or 

8 State law or under any collective bargaining agreement. 

9 The rights and remedies in this section may not be waived 

10 by any agreement, policy, form, or condition of employ11 ment.’’. 

Æ 

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