Title: Ensuring Timely Access to Generics Act of 2019
Policy area: Health

Summary:
Ensuring Timely Access to Generics Act of 2019
This bill requires the Food and Drug Administration (FDA) to consider certain factors in determining whether a petition is submitted for the primary purpose of delaying the approval of a drug application.
The FDA must (1) publish a list of petitions that were submitted with an intent to delay, and (2) establish procedures to refer such petitions to the Federal Trade Commission.
The FDA may establish a timeline for submitting petitions.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1169 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 1169

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                           citizen petitions.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 11, 2019

 Mr. Gardner (for himself, Mrs. Shaheen, Mr. Cassidy, and Mr. Bennet) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                           citizen petitions.

    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 ``Ensuring Timely Access to Generics 
Act of 2019''.

SEC. 2. CITIZEN PETITIONS.

    Section 505(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(q)(1)) is amended--
            (1) in subparagraph (E)--
                    (A) by striking ``If the Secretary'' and inserting 
                the following:
                            ``(i) In general.--If the Secretary'';
                    (B) by striking the second sentence and inserting 
                the following:
                            ``(ii) Factors.--In determining whether a 
                        petition was submitted with the primary purpose 
                        of delaying the approval of an application, the 
                        Secretary shall consider--
                                    ``(I) whether it appears, based on 
                                the date that relevant information 
                                relied upon in the petition became 
                                known to the petitioner (or reasonably 
                                should have been known to the 
                                petitioner), as certified by the 
                                petitioner in accordance with 
                                subparagraph (H), that the petitioner 
                                has taken an unreasonable length of 
                                time to submit the petition;
                                    ``(II) whether the petitioner has 
                                submitted multiple or serial petitions 
                                raising issues that reasonably could 
                                have been known to the petitioner at 
                                the time of submission of the earlier 
                                petition or petitions;
                                    ``(III) whether the petition was 
                                submitted close in time to a known, 
                                first date upon which an application 
                                under subsection (b)(2) of this section 
                                or section 351(k) of the Public Health 
                                Service Act could be approved;
                                    ``(IV) whether the petition was 
                                submitted without any data or 
                                information in support of the 
                                scientific positions set forth in the 
                                petition;
                                    ``(V) whether the petition raises 
                                the same or substantially similar 
                                issues as a prior petition to which the 
                                Secretary has responded substantively 
                                already, particularly if the subsequent 
                                submission follows the earlier response 
                                closely in time;
                                    ``(VI) whether the petition 
                                concerns standards for approval of a 
                                drug for which the Secretary has 
                                provided an opportunity for public 
                                input, such as draft or final product-
                                specific guidance applicable to the 
                                drug, and the petitioner has not 
                                provided comment other than through the 
                                petition;
                                    ``(VII) whether the petition 
                                requests that other applicants meet 
                                standards for testing, data, or 
                                labeling for a drug that are more 
                                onerous or rigorous than the standards 
                                applicable to, as applicable, the 
                                listed drug, reference product, or 
                                petitioner's version of the same drug;
                                    ``(VIII) the history of the 
                                petitioner with the Food and Drug 
                                Administration, such as whether the 
                                petitioner has a history of submitting 
                                petitions that the Secretary has 
                                determined were submitted with the 
                                primary purpose of delay; and
                                    ``(IX) other relevant 
                                considerations, as the Secretary may 
                                describe in guidance.''; and
                    (C) by adding at the end the following:
                            ``(iii) Public availability.--The Secretary 
                        shall publish on the internet website of the 
                        Food and Drug Administration a list of any 
                        petitions that the Secretary determines were 
                        submitted for the primary purpose of delaying 
                        the approval of an application.
                            ``(iv) Referral to the federal trade 
                        commission.--The Secretary shall establish 
                        procedures for referring to the Federal Trade 
                        Commission any petition or supplement to a 
                        petition that the Secretary determines was 
                        submitted with the primary purpose of delaying 
                        approval of an application. Such procedures 
                        shall include notification to the petitioner 
                        and an opportunity for the petitioner to 
                        respond to the Secretary prior to referral to 
                        the Federal Trade Commission.''; and
            (2) by adding at the end the following:
                    ``(J) Timeline for submitting petitions.--The 
                Secretary may establish a time period after the 
                relevant information relied upon in a petition became 
                known to the petitioner (or reasonably should have been 
                known to a petitioner), as certified by the petitioner 
                in accordance with subparagraph (H), and any petition 
                that is submitted after such time period has passed 
                shall be summarily denied.''.
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