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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2455 Introduced in House (IH)]

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.

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

SECTION 1. PRECISION MEDICINE GUIDANCE AND OTHER PROGRAMS OF FOOD AND 
              DRUG ADMINISTRATION.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by adding at the end the following:

                   ``Subchapter J--Precision Medicine

``SEC. 591. GENERAL AGENCY GUIDANCE ON PRECISION MEDICINE.

    ``(a) In General.--The Secretary shall issue and periodically 
update guidance to assist sponsors in the development of a precision 
drug or biological product. Such guidance shall--
            ``(1) define the term `precision drug or biological 
        product'; and
            ``(2) address the topics described in subsection (b).
    ``(b) Certain Issues.--The topics to be addressed by guidance under 
subsection (a) are--
            ``(1) the evidence needed to support the use of biomarkers 
        (as defined in section 507(e)) that identify subsets of 
        patients as likely responders to therapies in order to 
        streamline the conduct of clinical trials;
            ``(2) recommendations for the design of studies to 
        demonstrate the validity of a biomarker as a predictor of drug 
        or biological product response;
            ``(3) the manner and extent to which a benefit-risk 
        assessment may be affected when clinical trials are limited to 
        patient population subsets that are identified using 
        biomarkers;
            ``(4) the development of companion diagnostics in the 
        context of a drug development program; and
            ``(5) considerations for developing biomarkers that aid 
        prescribing decisions for a drug or biological product, and 
        when information regarding a biomarker may be included in the 
        labeling for a drug or biological product approved under 
        section 505 of this Act or section 351 of the Public Health 
        Service Act.
    ``(c) Date Certain for Initial Guidance.--The Secretary shall issue 
guidance under subsection (a) not later than 18 months after the date 
of the enactment of the 21st Century Cures Act.

``SEC. 592. PRECISION MEDICINE REGARDING ORPHAN-DRUG AND EXPEDITED-
              APPROVAL PROGRAMS.

    ``In the case of an application for a precision drug or biological 
product under section 505(b)(1), or section 351(a) of the Public Health 
Service Act, that has been designated under section 526 as a drug for a 
rare disease for a serious condition, the Secretary may--
            ``(1) consistent with applicable standards for approval, 
        rely upon data or information previously developed by the 
        sponsor of the precision drug or biological product for a prior 
        approved drug or indication (or that of another sponsor, 
        provided the sponsor of the precision drug or biological 
        product has obtained a contractual right of reference to such 
        other sponsor's data and information) in order to expedite 
        clinical development for a precision drug or indication that is 
        using the same or similar approach as that of the prior 
        approved drug or indication; and
            ``(2) as appropriate under section 506, consider the 
        application for approval of such precision drug or biological 
        product to be eligible for expedited review, including under 
        section 506(c) (relating to accelerated approval).''.
                                 <all>
```