I 

114TH CONGRESS 

1ST SESSION H. R. 2455 

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

medicine. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 19, 2015 

Mr. PITTS introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

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

respect to precision medicine. 

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

3 SECTION 1. PRECISION MEDICINE GUIDANCE AND OTHER 

4 PROGRAMS OF FOOD AND DRUG ADMINIS5 TRATION. 

6 Chapter V of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 351 et seq.) is amended by adding at the 

8 end the following: 


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1 ‘‘Subchapter J—Precision Medicine 

2 ‘‘SEC. 591. GENERAL AGENCY GUIDANCE ON PRECISION 

3 MEDICINE. 

4 ‘‘(a) IN GENERAL.—The Secretary shall issue and 

5 periodically update guidance to assist sponsors in the de6 velopment of a precision drug or biological product. Such 

7 guidance shall— 

8 ‘‘(1) define the term ‘precision drug or biologi9 cal product’; and 

10 ‘‘(2) address the topics described in subsection 

11 (b). 

12 ‘‘(b) CERTAIN ISSUES.—The topics to be addressed 

13 by guidance under subsection (a) are— 

14 ‘‘(1) the evidence needed to support the use of 

15 biomarkers (as defined in section 507(e)) that iden16 tify subsets of patients as likely responders to thera17 pies in order to streamline the conduct of clinical 

18 trials; 

19 ‘‘(2) recommendations for the design of studies 

20 to demonstrate the validity of a biomarker as a pre21 dictor of drug or biological product response; 

22 ‘‘(3) the manner and extent to which a benefit23 risk assessment may be affected when clinical trials 

24 are limited to patient population subsets that are 

25 identified using biomarkers; 


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1 ‘‘(4) the development of companion diagnostics 

2 in the context of a drug development program; and 

3 ‘‘(5) considerations for developing biomarkers 

4 that aid prescribing decisions for a drug or biological 

5 product, and when information regarding a bio6 marker may be included in the labeling for a drug 

7 or biological product approved under section 505 of 

8 this Act or section 351 of the Public Health Service 

9 Act. 

10 ‘‘(c) DATE CERTAIN FOR INITIAL GUIDANCE.—The 

11 Secretary shall issue guidance under subsection (a) not 

12 later than 18 months after the date of the enactment of 

13 the 21st Century Cures Act. 

14 ‘‘SEC. 592. PRECISION MEDICINE REGARDING ORPHAN15 DRUG AND EXPEDITED-APPROVAL PRO16 GRAMS. 

17 ‘‘In the case of an application for a precision drug 

18 or biological product under section 505(b)(1), or section 

19 351(a) of the Public Health Service Act, that has been 

20 designated under section 526 as a drug for a rare disease 

21 for a serious condition, the Secretary may— 

22 ‘‘(1) consistent with applicable standards for 

23 approval, rely upon data or information previously 

24 developed by the sponsor of the precision drug or bi25 ological product for a prior approved drug or indicaVerDate Sep 11 2014 04:11 May 27, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2455.IH H2455

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1 tion (or that of another sponsor, provided the spon2 sor of the precision drug or biological product has 

3 obtained a contractual right of reference to such 

4 other sponsor’s data and information) in order to ex5 pedite clinical development for a precision drug or 

6 indication that is using the same or similar approach 

7 as that of the prior approved drug or indication; and 

8 ‘‘(2) as appropriate under section 506, consider 

9 the application for approval of such precision drug 

10 or biological product to be eligible for expedited re11 view, including under section 506(c) (relating to ac12 celerated approval).’’. 

Æ 


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