Title: Efficiency and Transparency in Petitions Act
Policy area: Health

Summary:
Efficiency and Transparency in Petitions Act
This bill requires a petition regarding a pending generic drug or biological product application to be submitted to the Food and Drug Administration (FDA)	within one year of when the petitioner discovers the issue that is the basis for the petition.
The FDA may grant a waiver of the one-year deadline.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 660 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                 S. 660

To address abuse of the Food and Drug Administration's citizen petition 
                  process by brand drug manufacturers.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 5, 2019

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

_______________________________________________________________________

                                 A BILL


 
To address abuse of the Food and Drug Administration's citizen petition 
                  process by brand drug manufacturers.

    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 ``Efficiency and Transparency in 
Petitions Act''.

SEC. 2. CITIZEN PETITION AMENDMENTS.

    Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(q)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) in clause (i), by striking ``; and'' 
                        and inserting ``;'';
                            (ii) by redesignating clause (ii) as clause 
                        (iii); and
                            (iii) by inserting after clause (i) the 
                        following:
                            ``(ii)(I) the petition is submitted within 
                        1 year of the petitioner first discovering the 
                        issue that is the basis for submission of such 
                        petition; or
                            ``(II) the Secretary grants a waiver of the 
                        1-year period under subclause (I); and''; and
                    (B) in subparagraph (H), by adding at the end the 
                following: ``Any subsequent petition or amendment to a 
                petition with respect to the same application under 
                subsection (b)(2) or (j) of this section or section 
                351(k) of the Public Health Service Act filed by the 
                same person shall include an explanation of why such 
                person did not include the information or allegations 
                contained in the subsequent petition or amendment in 
                the original petition.'';
            (2) in paragraph (3)--
                    (A) in subparagraph (C), by striking ``; and'' and 
                inserting ``, and the basis for the determinations of 
                such number of days;'';
                    (B) in subparagraph (D), by striking the period and 
                inserting a semicolon; and
                    (C) by adding at the end the following:
                    ``(E) as applicable, the timing of submission of 
                the petition in relation to the expiration of any 
                patents listed under subsection (j)(7) for a drug 
                approved under subsection (c) of this section that is 
                referenced in the application under subsection (b)(2) 
                or (j); and
                    ``(F) the time the Food and Drug Administration 
                expended on the petition.''; and
            (3) by adding at the end the following:
            ``(6) Publication of petitions.--The Secretary shall 
        annually publish a list of all petitions that were submitted 
        during the preceding 12-month period.''.
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