I 

113TH CONGRESS 

1ST SESSION H. R. 2090 

To amend chapter V of the Federal Food, Drug, and Cosmetic Act to 

permit provisional approval of fast track products. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 22, 2013 

Mr. GRIFFITH of Virginia (for himself, Mr. MCCAUL, and Mr. PETERS of 

California) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend chapter V of the Federal Food, Drug, and Cosmetic Act to permit provisional approval of fast track 

products. 

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 ‘‘Patient Choice Act 

5 of 2013’’. 


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1 SEC. 2. PROVISIONAL APPROVAL FOR FAST TRACK PROD2 UCTS. 

3 (a) IN GENERAL.—Section 506 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 356) is amended by 

5 adding at the end the following: 

6 ‘‘(f) PROVISIONAL APPROVAL.— 

7 ‘‘(1) PROVISIONAL APPROVAL FOR ADEQUATELY

8 SAFE FAST TRACK PRODUCTS.— 

9 ‘‘(A) IN GENERAL.—Subject to the re10 quirements of this subsection, if the Secretary 

11 determines that a drug that is designated as a 

12 fast track product under this section is ade13 quately safe (as such term is defined in para14 graph (2)), the Secretary shall grant provisional 

15 approval and the drug may be introduced into 

16 interstate commerce on or after the date such 

17 provisional approval is granted. 

18 ‘‘(B) TREATMENT OF PROVISIONAL AP19 PROVAL STATUS.—The provisional approval of a 

20 drug under subparagraph (A) shall be treated 

21 in the same manner as approval of a drug 

22 under section 505 of this Act or section 351 of 

23 the Public Health Service Act, except that such 

24 provisional approval shall be subject to the re25 quirements of this section, including the fol26 lowing: 


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1 ‘‘(i) The requirements under para2 graph (3), including requirements related 

3 to— 

4 ‘‘(I) informed consent; and 

5 ‘‘(II) continued pursuit of safety 

6 and efficacy data for purposes of 

7 gaining approval for such drug under 

8 section 505 of this Act or section 351 

9 of the Public Health Service Act. 

10 ‘‘(ii) The rules under paragraphs (4) 

11 and (5) relating to the length of the termi12 nation of the provisional approval and 

13 withdrawal of a drug subject to provisional 

14 approval. 

15 ‘‘(C) REQUEST FOR PROVISIONAL AP16 PROVAL.— 

17 ‘‘(i) IN GENERAL.—The sponsor of a 

18 drug that is designated as a fast track 

19 product under this section may request 

20 that the Secretary grant provisional ap21 proval for such drug under subparagraph 

22 (A). 

23 ‘‘(ii) RESPONSE TO REQUEST.—Not 

24 later than 90 days after receiving such a 

25 request, the Secretary shall either— 


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1 ‘‘(I) grant provisional approval 

2 for the drug under subparagraph (A); 

3 or 

4 ‘‘(II) provide notice to the spon5 sor of the drug that such request is 

6 denied. 

7 ‘‘(2) ADEQUATELY SAFE DEFINED.— 

8 ‘‘(A) IN GENERAL.—For purposes of this 

9 subsection, with respect to a drug, the term 

10 ‘adequately safe’ means that— 

11 ‘‘(i) for at least one population, the 

12 risk of death or morbidity caused directly 

13 by an adverse effect of the drug, as deter14 mined in one or more safety studies or 

15 through other data that the Secretary de16 termines are sufficient, is unlikely to be 

17 greater than the combined direct and sec18 ondary risks of death or morbidity, as es19 tablished in the literature or historical 

20 data, of— 

21 ‘‘(I) the disease that such drug is 

22 intended to treat; and 

23 ‘‘(II) existing therapies (includ24 ing infection) for such disease; or 


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1 ‘‘(ii) the drug has had a valid mar2 keting authorization, for a period of at 

3 least 4 years, by an authority in a country 

4 described in section 802(b)(1)(A), or des5 ignated by the Secretary under section 

6 802(b)(1)(B), and data adequate for the 

7 approval of such marketing authorization 

8 for such drug in such country have been 

9 submitted to the Secretary. 

10 ‘‘(B) LIMITATION.—The Secretary may 

11 not impose any requirements for purposes of 

12 the safety studies or data under subparagraph 

13 (A)(i) that are in addition to, or different than, 

14 the requirements for studies to establish safety 

15 for purposes of Phase 1 or Phase 2, as such 

16 terms are described in subsections (a) and (b), 

17 respectively, of section 312.21 of title 21, Code 

18 of Federal Regulations. 

19 ‘‘(3) REQUIREMENTS.—Provisional approval of 

20 a fast track product under this subsection shall be 

21 subject to the following requirements: 

22 ‘‘(A) INFORMED CONSENT.— 

23 ‘‘(i) IN GENERAL.—As a condition of 

24 provisional approval under paragraph (1), 

25 the sponsor of a drug shall ensure that, beVerDate Mar 15 2010 03:08 May 25, 2013 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2090.IH H2090

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1 fore such drug is dispensed to an indi2 vidual— 

3 ‘‘(I) the individual shall be in4 formed that the drug is subject to 

5 provisional approval based on limited 

6 safety data and that the efficacy of 

7 the drug has not been proven; 

8 ‘‘(II) the individual shall be in9 formed of the known risks of the drug 

10 and any unknown but reasonably pre11 dictable risks of the drug, including, 

12 as appropriate, potential risks of 

13 death, complications, or injury result14 ing from use of the drug, and risks 

15 related to the potential ineffectiveness 

16 of the drug, including progression of 

17 the disease that may result in death 

18 or morbidity, or the potential for the 

19 drug to accelerate or exacerbate the 

20 disease process; and 

21 ‘‘(III) the individual provides 

22 written informed consent acknowl23 edging that individual has been pro24 vided with and understands the infor25 mation under subclauses (I) or (II). 


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1 ‘‘(ii) REGULATIONS.—The Secretary 

2 shall issue regulations on the requirements 

3 for informed consent under clause (i). 

4 Such regulations shall be similar to the re5 quirements for informed consent for 

6 human subjects under subpart B of part 

7 50 of title 21, Code of Federal Regula8 tions, adjusted as appropriate for purposes 

9 of this subsection. 

10 ‘‘(B) PURSUIT OF FULL APPROVAL RE11 QUIRED.—A sponsor of a drug that receives a 

12 provisional approval under paragraph (1) shall 

13 continue to diligently conduct appropriate stud14 ies, after such provisional approval is granted, 

15 to— 

16 ‘‘(i) establish that the drug has an ef17 fect on a clinical endpoint or on a surro18 gate endpoint that is reasonably likely to 

19 predict clinical benefit; and 

20 ‘‘(ii) collect the data necessary to 

21 demonstrate that the drug is safe and ef22 fective (or, in the case of a biologic, safe 

23 and potent) for purpose of obtaining ap24 proval for such drug under section 505(c) 


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1 of this Act or section 351 of the Public 

2 Health Service Act. 

3 ‘‘(C) PROMOTIONAL MATERIALS.—During 

4 the period that provisional approval under para5 graph (1) applies to a drug, the sponsor of the 

6 drug shall submit copies of all promotional ma7 terials related to the drug at least 30 days prior 

8 to dissemination of the materials. 

9 ‘‘(D) RISK EVALUATION AND MITIGATION

10 STRATEGY.— 

11 ‘‘(i) IN GENERAL.—Section 505–1 

12 shall apply to a drug subject to provisional 

13 approval under this subsection in the same 

14 manner that such section applies to a drug 

15 approved under section 505 of this Act or 

16 section 351 of the Public Health Service 

17 Act. 

18 ‘‘(ii) RULE OF CONSTRUCTION.— 

19 Nothing in this subparagraph shall be con20 strued to limit the Secretary’s authority 

21 under section 505–1 to determine if a risk 

22 evaluation and mitigation strategy is nec23 essary. 


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1 ‘‘(E) INDICATION OF USE.—The provi2 sional approval under paragraph (1) shall only 

3 apply to the indication of use for the drug— 

4 ‘‘(i) which is related to the treatment 

5 of the condition with respect to which such 

6 drug was designated as a fast track prod7 uct; and 

8 ‘‘(ii) for which the drug is dem9 onstrated to be adequately safe. 

10 ‘‘(4) TERMINATION OF PROVISIONAL AP11 PROVAL.— 

12 ‘‘(A) IN GENERAL.—In the case of a drug 

13 that is not designated under section 526, the 

14 provisional approval of the drug under para15 graph (1) shall terminate on the earlier of the 

16 following: 

17 ‘‘(i) The date that the drug is ap18 proved under section 505(c) of this Act or 

19 section 351 of the Public Health Service 

20 Act. 

21 ‘‘(ii) At the end of the 5-year period 

22 beginning on the date on which provisional 

23 approval was granted for such drug, ex24 cept— 


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1 ‘‘(I) if the Secretary determines 

2 that the sponsor of the drug is dili3 gently engaging in actions (including 

4 conducting clinical trials) for the pur5 pose of seeking approval under section 

6 505(c) of this Act or section 351 of 

7 the Public Health Service Act (exclud8 ing provisional approval under para9 graph (1)) and the Secretary deter10 mines that the sponsor requires addi11 tional time to complete such actions 

12 and attain such approval, the Sec13 retary may extend such period for an 

14 appropriate length of time to allow 

15 the sponsor to complete such actions 

16 and attain such approval; or 

17 ‘‘(II) if the Secretary determines 

18 that the termination of the provisional 

19 approval is adverse to protecting or 

20 promoting the public health, the Sec21 retary may extend such period for an 

22 appropriate length of time to protect 

23 or promote the public health. 

24 ‘‘(B) SPECIAL RULE FOR ORPHAN

25 DRUGS.—In the case of a drug designated 


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1 under section 526, the provisional approval of 

2 the drug under paragraph (1) shall terminate 

3 on the date that the drug is approved under 

4 section 505(c) of this Act or section 351 of the 

5 Public Health Service Act. 

6 ‘‘(C) RULE OF CONSTRUCTION.—For pur7 poses of this paragraph, the phrase ‘approved 

8 under section 505(c) of this Act or section 351 

9 of the Public Health Service Act’ shall not be 

10 construed to include a provisional approval 

11 under paragraph (1). 

12 ‘‘(5) WITHDRAWAL.— 

13 ‘‘(A) IN GENERAL.—Subsection (b)(3) 

14 shall apply to a drug subject to a provisional 

15 approval under this subsection in the same 

16 manner as such subsection applies to any fast 

17 track product. 

18 ‘‘(B) ADDITIONAL WITHDRAWAL AUTHOR19 ITY.—In addition to subparagraph (A), the Sec20 retary may withdraw approval of a fast track 

21 product using the expedited procedures applied 

22 under subsection (b)(3) if the requirements of 

23 paragraph (3)(A) have not been met with re24 spect to the drug. 


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1 ‘‘(6) IMPACT ON MARKETING EXCLUSIVITY.— 

2 The rules related to marketing exclusivity under sec3 tions 505(c)(3)(E), 505(j)(5)(F), 505A, and 527 

4 shall apply to a drug subject to provisional approval 

5 under this subsection in the same manner that such 

6 rules apply to drugs approved under section 505 of 

7 this Act or section 351 of the Public Health Service 

8 Act, except that the period of provisional approval 

9 under this subsection for a drug shall be an addition 

10 to the applicable period of marketing exclusivity for 

11 such drug.’’. 

12 (b) MISBRANDING FOR MARKETING OF TERMINATED

13 DRUG.—Section 502 of the Federal Food, Drug, and Cos14 metic Act is amended by adding at the end the following: 

15 ‘‘(bb) If it is a drug that is introduced or delivered 

16 for introduction into interstate commerce after the date 

17 of the termination of the provisional approval for such 

18 drug under section 506(f), unless, on or before the date 

19 such drug is so introduced or delivered, such drug is ap20 proved under section 505(c) of this Act or section 351 of 

21 the Public Health Service Act.’’. 

22 (c) CONFORMING AMENDMENTS.—The chapter V of 

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

24 351) is further amended— 


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1 (1) in section 502(a), by inserting ‘‘(or an indi2 cation subject to a provisional approval under sec3 tion 506(f))’’ after ‘‘an indication approved under 

4 section 505 or under section 351(a) of the Public 

5 Health Service Act’’; 

6 (2) in section 506A— 

7 (A) in subsection (a), by inserting ‘‘(or a 

8 provisional approval under section 506(f))’’ 

9 after ‘‘a license under section 351 of the Public 

10 Health Service Act’’; and 

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

12 ‘‘(e) SPECIAL RULE FOR DRUGS SUBJECT TO PROVI13 SIONAL APPROVAL.—In the case of a drug subject to a 

14 provisional approval under section 506(f), any reference 

15 to safety and efficacy under this section shall be treated 

16 as a reference to adequate safety, as such term is defined 

17 for purposes of such section 506(f).’’; 

18 (3) in section 506B(a), by adding at the end 

19 the following: 

20 ‘‘(3) SPECIAL RULE FOR PROVISIONAL AP21 PROVAL.—A sponsor of a drug that is subject to a 

22 provisional approval under section 506(f) shall sub23 mit the reports required under this section on the 

24 studies conducted on such drug that are described in 

25 section 506(f)(3)(B). For purposes of this section, 


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1 such reports shall be treated as reports on post2 marketing studies described in paragraph (1).’’; and 

3 (4) in section 551(b)(1)(A) by inserting ‘‘(or a 

4 provisional approval under section 506(f))’’ after 

5 ‘‘Public Health Service Act’’. 

Æ 


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