Speeding Access to Already Approved Pharmaceuticals Act of 2015

Bill: 114-hr-1455
Sponsor: full_name: Rep. Stivers, Steve [R-OH-15]
Introduced: 2015-03-18
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Europe

European Union

Food and Drug Administration (FDA)

Prescription drugs
Latest action: action_date: 2015-03-20
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-03-18
action_desc: Introduced in House
text: <p><b>Speeding Access to Already Approved Pharmaceuticals Act of 2015</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to facilitate the development and expedite the review of a new drug, biological product, or device that has been approved in the European Union.</p>

tv_txt: I 114th CONGRESS 1st Session H. R. 1455 IN THE HOUSE OF REPRESENTATIVES March 18, 2015 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 2015 . 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.