113 HR 4918 IH: Speeding Access to Already Approved Pharmaceuticals Act of 2014 U.S. House of Representatives 2014-06-19 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 113th CONGRESS 2d Session H. R. 4918 IN THE HOUSE OF REPRESENTATIVES June 19, 2014 Mr. Stivers (for himself and Mr. Ryan of Ohio) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require the Food and Drug Administration to expedite review of pharmaceuticals that are approved for marketing in the European Union.

1.

Short title

This Act may be cited as the Speeding Access to Already Approved Pharmaceuticals Act of 2014.

2.

Expedited review of EU-approved pharmaceuticals

(a)

In general

Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) is amended by adding at the end the following: (g)

EU-Approved pharmaceuticals

(1)

Expedited review

Beginning not later than 90 days after a new pharmaceutical is approved for marketing in the European Union, the Secretary shall, at the request of the sponsor of the pharmaceutical, facilitate the development and expedite the review of such new pharmaceutical under section 505 or 515 of this Act or section 351 of the Public Health Service Act, as appropriate. (2)

Definition

In this subsection, the term pharmaceutical means a drug (including a biological product) or a device.. (b)

Technical correction

Subsection (f) (relating to awareness efforts) of section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) is hereby moved so as to follow subsection (e) (relating to construction) of such section 506.