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