II 

109TH CONGRESS 

1ST SESSION S. 930 

To amend the Federal Food, Drug, and Cosmetic Act with respect to drug 

safety, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 27, 2005 

Mr. GRASSLEY (for himself and Mr. DODD) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to drug safety, and for other purposes. 

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 ‘‘Food and Drug Ad5 ministration Safety Act of 2005’’. 

6 SEC. 2. CENTER FOR POSTMARKET DRUG EVALUATION 

7 AND RESEARCH. 

8 (a) IN GENERAL.—Chapter V of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend10 ed by inserting after section 506C the following: 
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1 ‘‘SEC. 507. DRUG SAFETY. 

2 ‘‘(a) ESTABLISHMENT OF THE CENTER FOR

3 POSTMARKET DRUG EVALUATION AND RESEARCH.— 

4 There is established within the Food and Drug Adminis5 tration a Center for Postmarket Drug Evaluation and Re6 search (referred to in the section as the ‘Center’). The 

7 Director of the Center shall report directly to the Commis8 sioner of Food and Drugs. 

9 ‘‘(b) DUTIES OF THE CENTER FOR POSTMARKET

10 DRUG EVALUATION AND RESEARCH.— 

11 ‘‘(1) RESPONSIBILITIES OF DIRECTOR.—The 

12 Director of the Center shall— 

13 ‘‘(A) conduct postmarket risk assessment 

14 of drugs approved under section 505 of this Act 

15 and of biological products licensed under section 

16 351 of the Public Health Service Act; 

17 ‘‘(B) conduct and improve postmarket sur18 veillance of approved drugs and licensed biologi19 cal products using postmarket surveillance pro20 grams and activities (including MedWatch), 

21 risk-benefit analyses, adverse event reports, the 

22 scientific literature, any clinical or observational 

23 studies (including studies required under sub24 section (d) or (e)), and any other resources that 

25 the Director of the Center determines appro26 priate; 
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1 ‘‘(C) determine whether a study is required 

2 under subsection (d) or (e) and consult with the 

3 sponsors of drugs and biological products to en4 sure that such studies are completed by the 

5 date, and according to the terms, specified by 

6 the Director of the Center; 

7 ‘‘(D) contract, or require the sponsor of an 

8 application or the holder of an approved appli9 cation or license to contract, with the holders of 

10 domestic and international surveillance data11 bases to conduct epidemiologic and other obser12 vational studies; 

13 ‘‘(E) determine, based on postmarket sur14 veillance programs and activities (including 

15 MedWatch), risk-benefit analyses, adverse event 

16 reports, the scientific literature, and any clinical 

17 or observational studies (including studies re18 quired under subsection (d) or (e)), and any 

19 other resources that the Director of the Center 

20 determines appropriate, whether a drug or bio21 logical product may present an unreasonable 

22 risk to the health of patients or the general 

23 public, and take corrective action if such an un24 reasonable risk may exist; 
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1 ‘‘(F) make information about the safety 

2 and effectiveness of approved drugs and li3 censed biological products available to the pub4 lic and healthcare providers in a timely manner; 

5 and 

6 ‘‘(G) conduct other activities as the Direc7 tor of the Center determines appropriate to en8 sure the safety and effectiveness of all drugs 

9 approved under section 505 and all biological 

10 products licensed under section 351 of the Pub11 lic Health Service Act. 

12 ‘‘(2) DETERMINATION OF UNREASONABLE

13 RISK.—In determining whether a drug or biological 

14 product may present an unreasonable risk to the 

15 health of patients or the general public, the Director 

16 of the Center shall consider the risk in relation to 

17 the known benefits of such drug or biological prod18 uct. 

19 ‘‘(c) SECRETARIAL AUTHORITY.— 

20 ‘‘(1) IN GENERAL.—Approval of a drug under 

21 section 505 of this Act or issuance of a license for 

22 a biological product under section 351 of the Public 

23 Health Service Act may be subject to the require24 ment that the sponsor conduct 1 or more postmarket 

25 studies as described in subsection (d) or (e) of this 
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1 section, or other postmarket studies as required by 

2 the Secretary, to validate the safety and effective3 ness of the drug or biological product. 

4 ‘‘(2) DEFINITION.—For purposes of this sec5 tion, the term ‘postmarket’ means— 

6 ‘‘(A) with respect to a drug, after approval 

7 of an application under section 505; and 

8 ‘‘(B) with respect to a biological product, 

9 after licensure under section 351 of the Public 

10 Health Service Act. 

11 ‘‘(d) PREAPPROVAL REVIEW.— 

12 ‘‘(1) REVIEW OF APPLICATION.— 

13 ‘‘(A) IN GENERAL.— 

14 ‘‘(i) REVIEW.—At any time before a 

15 drug is approved under section 505 of this 

16 Act or a biological product is licensed 

17 under section 351 of the Public Health 

18 Service Act, the Director of the Center 

19 shall review the application (or supplement 

20 to the application), and any analyses asso21 ciated with the application, of such drug or 

22 biological product. 

23 ‘‘(ii) EFFECT OF APPROVAL OR LI24 CENSURE.—The approval of a drug under 

25 section 505 or the licensure of a biological 
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1 product under such section 351 shall not 

2 affect the continuation and completion of a 

3 review under clause (i). 

4 ‘‘(B) LIMITATION.—In no case shall the 

5 review under subparagraph (A) delay a decision 

6 with respect to an application for a drug under 

7 section 505 of this Act or for a biological prod8 uct under section 351 of the Public Health 

9 Service Act. 

10 ‘‘(2) RESULT OF REVIEW.—The Director of the 

11 Center may, based on the review under paragraph 

12 (1)— 

13 ‘‘(A) require that the sponsor of the appli14 cation agree to conduct 1 or more postmarket 

15 studies to determine the safety or effectiveness 

16 of a drug or biological product, including such 

17 safety or effectiveness as compared to other 

18 drugs or biological products, to be completed by 

19 a date, and according to the terms, specified by 

20 the Director of the Center; or 

21 ‘‘(B) contract, or require the sponsor of 

22 the application to contract, with a holder of a 

23 domestic or an international patient database to 

24 conduct 1 or more epidemiologic or other obser25 vational studies. 
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1 ‘‘(e) POSTMARKETING STUDIES OF DRUG SAFETY.— 

2 ‘‘(1) IN GENERAL.—At any time after a drug is 

3 approved under section 505 of this Act or a biologi4 cal product is licensed under section 351 of the Pub5 lic Health Service Act, the Director of the Center, 

6 may— 

7 ‘‘(A) require that the holder of an ap8 proved application or license conduct 1 or more 

9 studies to determine the safety or effectiveness 

10 of such drug or biological product, including 

11 such safety and effectiveness as compared to 

12 other drugs or biological products, to be com13 pleted by a date, and according to the terms, 

14 specified by such Director; or 

15 ‘‘(B) contract, or require the holder of the 

16 approved application or license to contract, with 

17 a holder of a domestic or an international pa18 tient database to conduct 1 or more epidemio19 logic or other observational studies. 

20 ‘‘(2) REVIEW OF OUTSTANDING STUDIES.—Not 

21 later than 90 days after the date of enactment of 

22 the Food and Drug Administration Safety Act of 

23 2005, the Director of the Center shall— 

24 ‘‘(A) review and publish a list in the Fed25 eral Register of any postmarketing studies out-
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1 standing on the date of enactment of the Food 

2 and Drug Administration Safety Act of 2005; 

3 and 

4 ‘‘(B) as the Director determines appro5 priate, require the sponsor of a study described 

6 in subparagraph (A) to conduct such study 

7 under this subsection. 

8 ‘‘(f) PUBLICATION OF PROGRESS REPORTS AND

9 COMPLETED STUDIES.— 

10 ‘‘(1) IN GENERAL.—The Director of the Center 

11 shall require that the sponsor of a study under sub12 section (d) or (e) submit to the Secretary— 

13 ‘‘(A) not less frequently than every 90 

14 days, an up-to-date report describing the 

15 progress of such study; and 

16 ‘‘(B) upon the completion date of such 

17 study, the results of such study. 

18 ‘‘(2) COMPLETION DATE.—For purposes of this 

19 section, the completion date of such study shall be 

20 determined by the Director of the Center. 

21 ‘‘(g) DETERMINATIONS BY DIRECTOR.— 

22 ‘‘(1) RESULTS OF STUDY.—The Director of the 

23 Center shall determine, upon receipt of the results of 

24 a study required under subsection (d) or (e)— 
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1 ‘‘(A) whether the drug or biological prod2 uct studied may present an unreasonable risk to 

3 the health of patients or the general public; and 

4 ‘‘(B) what, if any, corrective action under 

5 subsection (k) shall be taken to protect patients 

6 and the public health. 

7 ‘‘(2) RESULTS OF EVIDENCE.—The Director of 

8 the Center may, at any time, based on the empirical 

9 evidence from postmarket surveillance programs and 

10 activities (including MedWatch), risk-benefit anal11 yses, adverse event reports, the scientific literature, 

12 any clinical or observational studies (including stud13 ies required under subsection (d) or (e)), or any 

14 other resources that the Director of the Center de15 termines appropriate— 

16 ‘‘(A) make a determination that a drug or 

17 biological product may present an unreasonable 

18 risk to the health of patients or the general 

19 public; and 

20 ‘‘(B) order a corrective action under sub21 section (k) be taken to protect patients and the 

22 public health. 

23 ‘‘(3) REQUIRED CONSULTATION AND CONSIDER24 ATIONS.—Before making a determination under 

25 paragraph (2), ordering a study under subsection 
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1 (d) or (e), or taking a corrective action under sub2 section (k), the Director of the Center shall— 

3 ‘‘(A) consult with the Director of the Cen4 ter for Drug Evaluation and Research or the 

5 Director of the Center for Biologics Evaluation 

6 and Research, as appropriate; and 

7 ‘‘(B) consider— 

8 ‘‘(i) the benefit-to-risk profile of the 

9 drug or biological product; 

10 ‘‘(ii) the effect that a corrective ac11 tion, or failure to take corrective action, 

12 will have on the patient population that re13 lies on the drug or biological product; and 

14 ‘‘(iii) the extent to which the drug or 

15 biological product presents a meaningful 

16 therapeutic benefit as compared to other 

17 available treatments. 

18 ‘‘(h) PUBLIC INFORMATION.—Periodically, but not 

19 less often than every 90 days, the Secretary shall make 

20 available to the public, by publication in the Federal Reg21 ister and posting on an Internet website, the following in22 formation: 

23 ‘‘(1) Studies required under subsection (d) or 

24 (e) including— 

25 ‘‘(A) the type of study; 
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1 ‘‘(B) the nature of the study; 

2 ‘‘(C) the primary and secondary outcomes 

3 of the study; 

4 ‘‘(D) the date the study was required 

5 under subsection (d) or (e) or was agreed to by 

6 the sponsor; 

7 ‘‘(E) the deadline for completion of the 

8 study; and 

9 ‘‘(F) if the study has not been completed 

10 by the deadline under subparagraph (E), a 

11 statement that explains why. 

12 ‘‘(2) The periodic progress reports and results 

13 of completed studies described under subsection (f). 

14 ‘‘(3) Any determinations made by the Director 

15 of the Center under subsection (g), including— 

16 ‘‘(A) reasons for the determination, includ17 ing factual basis for such determination; 

18 ‘‘(B) reference to supporting empirical 

19 data; and 

20 ‘‘(C) an explanation that describes why 

21 contrary data is insufficient. 

22 ‘‘(i) DRUG ADVISORY COMMITTEE.—The Drug Safe23 ty and Risk Management Drugs Advisory Committee with24 in the Center of the Food and Drug Administration 

25 shall— 
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1 ‘‘(1) meet not less frequently than every 180 

2 days; and 

3 ‘‘(2) make recommendations to the Director of 

4 the Center with respect to— 

5 ‘‘(A) which drugs and biological products 

6 should be the subject of a study under sub7 section (d) or (e); 

8 ‘‘(B) the design and duration for studies 

9 under subsection (d) or (e); 

10 ‘‘(C) which drugs and biological products 

11 may present an unreasonable risk to the health 

12 of patients or the general public; and 

13 ‘‘(D) appropriate corrective actions under 

14 subsection (k). 

15 ‘‘(j) PENALTIES.— 

16 ‘‘(1) IN GENERAL.—If the Secretary deter17 mines, after notice and opportunity for an informal 

18 hearing, that a sponsor of a drug or biological prod19 uct or other entity has failed to complete a study re20 quired under subsection (d) or (e) by the date or to 

21 the terms specified by the Secretary under such sub22 section, the Secretary may order such sponsor or 

23 other entity to— 

24 ‘‘(A) complete the study in a specified 

25 time; 
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1 ‘‘(B) revise the study to comply with the 

2 terms specified by the Secretary under sub3 section (d) or (e); or 

4 ‘‘(C) pay a civil penalty. 

5 ‘‘(2) AMOUNT OF PENALTIES.— 

6 ‘‘(A) IN GENERAL.—The civil penalty or7 dered under paragraph (1) shall be $250,000 

8 for the first 30-day period after the date speci9 fied by the Secretary that the study is not com10 pleted, and shall double in amount for every 30- 

11 day period thereafter that the study is not com12 pleted. 

13 ‘‘(B) LIMITATION.—In no case shall a pen14 alty under subparagraph (A) exceed $2,000,000 

15 for any 30-day period. 

16 ‘‘(3) NOTIFICATION OF PENALTY.—The Sec17 retary shall publish in the Federal Register any civil 

18 penalty ordered under this subsection. 

19 ‘‘(k) RESULT OF DETERMINATION.— 

20 ‘‘(1) IN GENERAL.—If the Director of the Cen21 ter makes a determination that a drug or biological 

22 product may present an unreasonable risk to the 

23 health of patients or the general public under sub24 section (g), such Director shall order a corrective ac25 tion, as described under paragraph (2). 
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1 ‘‘(2) CORRECTIVE ACTIONS.—The corrective ac2 tion described under subsection (g)— 

3 ‘‘(A) may include— 

4 ‘‘(i) requiring a change to the drug or 

5 biological product label by a date specified 

6 by the Director of the Center; 

7 ‘‘(ii) modifying the approved indica8 tion of the drug or biological product to re9 strict use to certain patients; 

10 ‘‘(iii) placing restriction on the dis11 tribution of the drug or biological product 

12 to ensure safe use; 

13 ‘‘(iv) requiring the sponsor of the 

14 drug or biological product or license to es15 tablish a patient registry; 

16 ‘‘(v) requiring patients to sign a con17 sent form prior to receiving a prescription 

18 of the drug or biological product; 

19 ‘‘(vi) requiring the sponsor to monitor 

20 sales and usage of the drug or biological 

21 product to detect unsafe use; 

22 ‘‘(vii) requiring patient or physician 

23 education; and 
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1 ‘‘(viii) requiring the establishment of 

2 a risk management plan by the sponsor; 

3 and 

4 ‘‘(B) shall include the requirements with 

5 respect to promotional material under sub6 section (l)(1). 

7 ‘‘(3) PENALTIES.— 

8 ‘‘(A) IN GENERAL.—If the Secretary deter9 mines, after notice and opportunity for an in10 formal hearing, that a sponsor of a drug or bio11 logical product has failed to take the corrective 

12 action ordered by the Director of the Center 

13 under this subsection or has failed to comply 

14 with subsection (l)(2), the Secretary may order 

15 such sponsor to pay a civil penalty. 

16 ‘‘(B) AMOUNT OF PENALTIES.— 

17 ‘‘(i) IN GENERAL.—The civil penalty 

18 order under subparagraph (A) shall be 

19 $250,000 for the first 30-day period that 

20 the sponsor does not comply with the order 

21 under paragraph (1), and shall double in 

22 amount for every 30-day period thereafter 

23 that the order is not complied with. 
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1 ‘‘(ii) LIMITATION.—In no case shall a 

2 penalty under clause (i) exceed $2,000,000 

3 for any 30-day period. 

4 ‘‘(C) NOTIFICATION OF PENALTY.—The 

5 Secretary shall publish in the Federal Register 

6 any civil penalty ordered under this paragraph. 

7 ‘‘(l) PROMOTION MATERIAL.— 

8 ‘‘(1) SAFETY ISSUE.—If the Director of the 

9 Center makes a determination that a drug or bio10 logical product may present an unreasonable risk to 

11 the health of patients or the general public under 

12 subsection (g), such Director, in consultation with 

13 the Division of Drug Marketing, Advertising, and 

14 Communications of the Food and Drug Administra15 tion, shall— 

16 ‘‘(A) notwithstanding section 502(n), re17 quire that the sponsor of such drug or biologi18 cal product submit to the Director of the Cen19 ter copies of all promotional material with re20 spect to the drug or biological product not less 

21 than 30 days prior to the dissemination of such 

22 material; and 

23 ‘‘(B) require that all promotional material 

24 with respect to the drug or biological product 

25 include certain disclosures, which shall be dis-
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1 played prominently and in a manner easily un2 derstood by the general public, including— 

3 ‘‘(i) a statement that describes the 

4 unreasonable risk to the health of patients 

5 or the general public as determined by the 

6 Director of the Center; 

7 ‘‘(ii) a statement that encourages pa8 tients to discuss potential risks and bene9 fits with their healthcare provider; 

10 ‘‘(iii) a description of the corrective 

11 actions required under subsection (k); 

12 ‘‘(iv) where appropriate, a statement 

13 explaining that there may be products 

14 available to treat the same disease or con15 dition that present a more favorable ben16 efit-to-risk profile, and that patients should 

17 talk to their healthcare provider about the 

18 risks and benefits of alternative treat19 ments; 

20 ‘‘(v) a description of any requirements 

21 of outstanding clinical and observational 

22 studies, including the purpose of each 

23 study; and 

24 ‘‘(vi) contact information to report a 

25 suspected adverse reaction. 
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1 ‘‘(2) NEW PRODUCTS; OUTSTANDING STUD2 IES.—For the first 2-year period after a drug is ap3 proved under section 505 of this Act or a biological 

4 product is licensed under section 351 of the Public 

5 Health Service Act, and with respect to drugs and 

6 biological products for which there are outstanding 

7 study requirements under subsection (d) or (e), the 

8 Director of the Center, in consultation with the Divi9 sion of Drug Marketing, Advertising, and Commu10 nications of the Food and Drug Administration, 

11 shall— 

12 ‘‘(A) notwithstanding section 502(n), re13 quire that the sponsor of such drug or biologi14 cal product submit to the Director of the Cen15 ter copies of all promotional material with re16 spect to the drug or biological product not less 

17 than 30 days prior to the dissemination of such 

18 material; and 

19 ‘‘(B) require that all promotional material 

20 with respect to the drug or biological product 

21 include certain disclosures, which shall be dis22 played prominently and in a manner easily un23 derstood by the general public, including— 

24 ‘‘(i) a statement explaining that the 

25 drug or biological product is newly ap-
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1 proved or licensed or the subject of out2 standing clinical or observational studies, 

3 as the case may be, and, as a result, not 

4 all side effects or drug interactions may be 

5 known; 

6 ‘‘(ii) the number of people in which 

7 the drug or biological product has been 

8 studied and the duration of time during 

9 which the drug or biological product has 

10 been studied; 

11 ‘‘(iii) a statement that encourages pa12 tients to discuss the potential risks and 

13 benefits of treatment with their healthcare 

14 provider; 

15 ‘‘(iv) a description of any require16 ments of outstanding clinical and observa17 tional studies, including the purpose of 

18 each study; and 

19 ‘‘(v) contact information to report a 

20 suspected adverse reaction. 

21 ‘‘(3) EFFECT OF VOLUNTARY SUBMISSION.— 

22 Paragraphs (1)(A) and (2)(A) shall not apply to the 

23 sponsor of a drug or biological product if such spon24 sor has voluntarily submitted to the Division of 

25 Drug Marketing, Advertising, and Communications 
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1 of the Food and Drug Administration all pro2 motional material with respect the drug or biological 

3 product prior to the dissemination of such material. 

4 ‘‘(m) WITHDRAWAL OR SUSPENSION OF APPROVAL

5 OR LICENSURE.— 

6 ‘‘(1) IN GENERAL.—The Director of the Center, 

7 may withdraw or suspend approval of a drug or li8 cense of a biological product using expedited proce9 dures (as prescribed by the Secretary in regulations 

10 promulgated not later than 1 year after the date of 

11 enactment of the Food and Drug Administration 

12 Safety Act of 2005, which shall include an oppor13 tunity for an informal hearing) after consultation 

14 with the Director of Center for Drug Evaluation and 

15 Research or the Director of the Center for Biologics 

16 Evaluation and Research, as appropriate, and any 

17 other person as determined appropriate by the Di18 rector of the Center, if— 

19 ‘‘(A) the Director of the Center makes a 

20 determination that the drug or biological prod21 uct may present an unreasonable risk to the 

22 health of patients or the general public, and 

23 that risk cannot be satisfactorily alleviated by a 

24 corrective action under subsection (k); or 
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1 ‘‘(B) the sponsor fails to comply with an 

2 order or requirement under this section. 

3 ‘‘(2) PUBLIC INFORMATION.—The Secretary 

4 shall make available to the public, by publication in 

5 the Federal Register and posting on an Internet 

6 website, the details of the consultation described in 

7 paragraph (1), including— 

8 ‘‘(A) the reason for the determination to 

9 withdraw, suspend, or failure to withdraw or 

10 suspend, approval for the drug or licensure for 

11 the biological product; 

12 ‘‘(B) the factual basis for such determina13 tion; 

14 ‘‘(C) reference to supporting empirical 

15 data; 

16 ‘‘(D) an explanation that describes why 

17 contrary data is insufficient; and 

18 ‘‘(E) the position taken by each individual 

19 consulted. 

20 ‘‘(n) EFFECT OF SECTION.—The authorities con21 ferred by this section shall be separate from and in addi22 tion to the authorities conferred by section 505B. 

23 ‘‘(o) ADMINISTRATION OF SECTION.—The provisions 

24 of this section shall be carried out by the Secretary, acting 

25 through the Director of the Center.’’. 
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1 (b) MISBRANDING.—Section 502 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend3 ed by inserting after subsection (j) the following: 

4 ‘‘(k) If it is a drug or biological product for which 

5 the sponsor of an application or holder of an approved ap6 plication or license has not complied with an order or re7 quirement under section 507.’’. 

8 (c) REPORT ON DEVICES.—Not later than 6 months 

9 after the date of enactment of this Act, the Secretary of 

10 Health and Human Services, in consultation with the 

11 Commissioner of Food and Drugs, the Director of the 

12 Center for Postmarket Drug Evaluation and Research, 

13 and the Director of the Center for Devices and Radio14 logical Health, shall submit to Congress a report that— 

15 (1) identifies deficiencies in the current process 

16 of postmarket surveillance of devices approved under 

17 the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 321 et seq.); 

19 (2) includes recommendations on ways to im20 prove deficiencies of postmarket surveillance of de21 vices; and 

22 (3) identifies the changes in authority needed to 

23 make those improvements, recognizing the legitimate 

24 differences between devices and other medical prod-
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1 ucts regulated by the Food and Drug Administra2 tion. 

3 (d) TRANSFER OF FUNCTIONS.—The functions and 

4 duties of the Office of Drug Safety, including the Drug 

5 Safety and Risk Management Drugs Advisory Committee, 

6 of the Food and Drug Administration on the day before 

7 the date of enactment of this Act shall be transferred to 

8 the Center for Postmarket Drug Evaluation and Research 

9 established under section 507 of the Federal Food, Drug, 

10 and Cosmetic Act (as added by this section). The Center 

11 for Postmarket Drug Evaluation and Research shall be 

12 a separate entity within the Food and Drug Administra13 tion and shall not be an administrative office of the Center 

14 for Drug Evaluation and Research or the Center for Bio15 logics Evaluation and Research. 

16 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

17 are authorized to be appropriated to carry out this Act 

18 (and the amendments made by this Act)— 

19 (1) $50,000,000 for fiscal year 2006; 

20 (2) $75,000,000 for fiscal year 2007; 

21 (3) $100,000,000 for fiscal year 2008; 

22 (4) $125,000,000 for fiscal year 2009; and 

23 (5) $150,000,000 for fiscal year 2010. 

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