[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3466 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 3466

    To allow sponsors of certain new drug applications to rely upon 
 investigations conducted in certain foreign countries, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 29, 2016

   Mr. Paul introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
    To allow sponsors of certain new drug applications to rely upon 
 investigations conducted in certain foreign countries, and for other 
                               purposes.

    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 ``Accelerating New Pharmaceutical 
Competition Act''.

SEC. 2. DRUGS APPROVED IN CERTAIN FOREIGN COUNTRIES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended--
            (1) in subsection (b), by adding at the end the following:
    ``(7) An application described in paragraph (2) may rely upon 
investigations conducted in a country listed under subparagraph (A) or 
designated under subparagraph (B) of section 802(b)(1), including 
premarket clinical and nonclinical investigations and postmarket 
surveillance studies, if the drug that is the subject of such 
application has been approved in such country.''; and
            (2) in subsection (c)--
                    (A) in paragraph (1), by striking ``Within'' and 
                inserting ``Except as provided in paragraph (5), 
                within''; and
                    (B) by adding at the end the following:
    ``(5) In the case of an application that relies on investigations 
conducted in a foreign country, as described in subsection (b)(7), 
within 90 days after the filing of such application under subsection 
(b), the Secretary shall approve the application if the Secretary finds 
that none of the grounds for denying approval specified in subsection 
(d) applies or take action described in paragraph (1)(B). If the 
Secretary does not approve the application or take such other action 
within such 90-day period, the application shall be considered approved 
under this subsection.''.

SEC. 3. APPROVAL OF GENERIC DRUGS.

    (a) Stays in the Case if Patent Infringement Lawsuits.--Section 
505(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)(B)(iii)) is amended by striking ``the expiration of 
the thirty-month period beginning on the date of the receipt of the 
notice provided under paragraph (2)(B)(i)'' and inserting ``the date 
upon final judgment is entered in such action''.
    (b) Expedited Generic Review.--Section 505(j)(5) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--
            (1) in subparagraph (A), by striking ``Within'' and 
        inserting ``Except as provided in subparagraph (G), within''; 
        and
            (2) by adding at the end the following:
    ``(G)(i) The Secretary shall prioritize the review, and act not 
later than 150 calendar days after the date of the submission of an 
application, or supplement to an application, in the case of an 
application or supplement to an application described in clause (ii).
    ``(ii) Clause (i) shall apply to an application or supplement to an 
application under this subsection with respect to which the applicable 
listed drug, or another drug approved under this subsection with 
reference to such listed drug--
            ``(I) has been introduced into interstate commerce by not 
        more than one manufacturer or sponsor in the 3-month period 
        immediately preceding the date of submission of such 
        application or supplement and with respect to which tentative 
        approval has been granted for not more than 2 applications 
        under this subsection; or
            ``(II) has been included on the drug shortage list under 
        section 506E.''.
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