Plain English summary not yet available
The full original text is available below. Check back soon as we process this bill.
II
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 Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Efficiency and Trans-
4
parency in Petitions Act’’.
5
SEC. 2. CITIZEN PETITION AMENDMENTS.
6
Section 505(q) of the Federal Food, Drug, and Cos-
7
metic Act (21 U.S.C. 355(q)) is amended—
8
(1) in paragraph (1)—
9
(A) in subparagraph (A)—
10
VerDate Sep 11 2014
02:14 Mar 14, 2019
Jkt 089200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\S660.IS
S660
kjohnson on DSK79L0C42 with BILLS
2
•S 660 IS
(i) in clause (i), by striking ‘‘; and’’
1
and inserting ‘‘;’’;
2
(ii) by redesignating clause (ii) as
3
clause (iii); and
4
(iii) by inserting after clause (i) the
5
following:
6
‘‘(ii)(I) the petition is submitted with-
7
in 1 year of the petitioner first discovering
8
the issue that is the basis for submission
9
of such petition; or
10
‘‘(II) the Secretary grants a waiver of
11
the 1-year period under subclause (I);
12
and’’; and
13
(B) in subparagraph (H), by adding at the
14
end the following: ‘‘Any subsequent petition or
15
amendment to a petition with respect to the
16
same application under subsection (b)(2) or (j)
17
of this section or section 351(k) of the Public
18
Health Service Act filed by the same person
19
shall include an explanation of why such person
20
did not include the information or allegations
21
contained in the subsequent petition or amend-
22
ment in the original petition.’’;
23
(2) in paragraph (3)—
24
VerDate Sep 11 2014
02:14 Mar 14, 2019
Jkt 089200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\S660.IS
S660
kjohnson on DSK79L0C42 with BILLS
3
•S 660 IS
(A) in subparagraph (C), by striking ‘‘;
1
and’’ and inserting ‘‘, and the basis for the de-
2
terminations of such number of days;’’;
3
(B) in subparagraph (D), by striking the
4
period and inserting a semicolon; and
5
(C) by adding at the end the following:
6
‘‘(E) as applicable, the timing of submis-
7
sion of the petition in relation to the expiration
8
of any patents listed under subsection (j)(7) for
9
a drug approved under subsection (c) of this
10
section that is referenced in the application
11
under subsection (b)(2) or (j); and
12
‘‘(F) the time the Food and Drug Admin-
13
istration expended on the petition.’’; and
14
(3) by adding at the end the following:
15
‘‘(6) PUBLICATION
OF
PETITIONS.—The Sec-
16
retary shall annually publish a list of all petitions
17
that were submitted during the preceding 12-month
18
period.’’.
19
Æ
VerDate Sep 11 2014
02:14 Mar 14, 2019
Jkt 089200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6301
E:\BILLS\S660.IS
S660
kjohnson on DSK79L0C42 with BILLS