[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.
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IN THE HOUSE OF REPRESENTATIVES
May 19, 2015
Mr. Pitts introduced the following bill; which was referred to the
Committee on Energy and Commerce
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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).''.
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