I 
116TH CONGRESS 
1ST SESSION H. R. 2455 
To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen 
petitions. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 1, 2019 
Mr. JOYCE of Pennsylvania (for himself and Mr. BRINDISI) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Ensuring Timely Ac-
cess 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)— 
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(A) by striking ‘‘If the Secretary’’ and in-
serting the following: 
‘‘(i) IN GENERAL.—If the Secretary’’; 
(B) by striking the second sentence and in-
serting 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 con-
sider— 
‘‘(I) whether it appears, based on 
the date that relevant information re-
lied upon in the petition became 
known to the petitioner (or reasonably 
should have been known to the peti-
tioner), as certified by the petitioner 
in accordance with subparagraph (H), 
that the petitioner has taken an un-
reasonable 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 
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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 infor-
mation in support of the scientific po-
sitions 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 con-
cerns standards for approval of a drug 
for which the Secretary has provided 
an opportunity for public input, such 
as draft or final product-specific guid-
ance applicable to the drug, and the 
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petitioner has not provided comment 
other than through the petition; 
‘‘(VII) whether the petition re-
quests 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, ref-
erence product, or petitioner’s version 
of the same drug; 
‘‘(VIII) the history of the peti-
tioner with the Food and Drug Ad-
ministration, such as whether the pe-
titioner has a history of submitting 
petitions that the Secretary has deter-
mined were submitted with the pri-
mary purpose of delay; and 
‘‘(IX) other relevant consider-
ations, 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 Administra-
tion a list of any petitions that the Sec-
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retary 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 applica-
tion. Such procedures shall include notifi-
cation to the petitioner and an opportunity 
for the petitioner to respond to the Sec-
retary prior to referral to the Federal 
Trade Commission.’’; and 
(2) by adding at the end the following: 
‘‘(J) TIMELINE
FOR
SUBMITTING
PETI-
TIONS.—The Secretary may establish a time pe-
riod after the relevant information relied upon 
in a petition became known to the petitioner (or 
reasonably should have been known to a peti-
tioner), as certified by the petitioner in accord-
ance with subparagraph (H), and any petition 
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that is submitted after such time period has 
passed shall be summarily denied.’’. 
Æ 
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