To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. BREAKTHROUGH THERAPIES.
(a) In General.--Section 506 (21 U.S.C. 356) is amended-- (1) by redesignating subsection (d) as subsection (f); (2) by redesignating subsections (a) through (c) as subsections (b) through (d), respectively; (3) by inserting before subsection (b), as so redesignated, the following: ``(a) Designation of a Drug as a Breakthrough Therapy.-- ``(1) In general.--The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a `breakthrough therapy'.) ``(2) Request for designation.--The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of the Public Health Service Act. ``(3) Designation.-- ``(A) In general.--Not...