[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4918 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 4918

   To require the Food and Drug Administration to expedite review of 
 pharmaceuticals that are approved for marketing in the European Union.


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                    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.

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

SECTION 1. SHORT TITLE.

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

SEC. 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.
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