[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2113 Introduced in House (IH)]

<DOC>






115th CONGRESS
  1st Session
                                H. R. 2113

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 20, 2017

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 2017''.

SEC. 2. EXPEDITED REVIEW OF EU-APPROVED PHARMACEUTICALS.

    Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356) is amended by adding at the end the following:
    ``(i) 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.''.
                                 <all>