I 
117TH CONGRESS 
1ST SESSION H. R. 2853 
To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligi-
bility for approval of a subsequent generic drug, to remove the barrier 
to that approval posed by the 180-day exclusivity period afforded to 
a first generic applicant that has not yet received final approval, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 26, 2021 
Mr. SCHRADER 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 eligibility for approval of a subsequent generic 
drug, to remove the barrier to that approval posed by 
the 180-day exclusivity period afforded to a first generic 
applicant that has not yet received final approval, and 
for other purposes. 
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 ‘‘Bringing Low-cost Op-
tions and Competition while Keeping Incentives for New 
Generics Act of 2021’’ or the ‘‘BLOCKING Act of 2021’’. 
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SEC. 2. CHANGE CONDITIONS OF FIRST GENERIC EXCLU-
SIVITY TO SPUR ACCESS AND COMPETITION. 
Clause (iv) of section 505(j)(5)(B) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) 
is amended— 
(1) in subclause (I), after ‘‘180 days after the 
date of the first commercial marketing of the drug 
(including the commercial marketing of the listed 
drug) by any first applicant’’ by inserting ‘‘or by an 
applicant whose application is approved pursuant to 
subclause (III)’’; and 
(2) by adding at the end the following new sub-
clause: 
‘‘(III) APPLICANT APPROVAL.—An applica-
tion containing a certification described in para-
graph (2)(A)(vii)(IV) that is for a drug for 
which a first applicant has submitted an appli-
cation containing such a certification can be ap-
proved notwithstanding the eligibility of a first 
applicant for the 180-day exclusivity period de-
scribed in subclause (II)(aa) if each of the fol-
lowing conditions is met: 
‘‘(aa) The approval of such an appli-
cation could be made effective, but for the 
eligibility of a first applicant for 180-day 
exclusivity under this clause. 
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‘‘(bb) At least 30 months have passed 
since the date of submission of an applica-
tion for the drug by at least one first ap-
plicant. 
‘‘(cc) Approval of an application for 
the drug submitted by at least one first ap-
plicant is not precluded under clause (iii). 
‘‘(dd) No application for the drug 
submitted by any first applicant is ap-
proved at the time the conditions under 
items (aa), (bb), and (cc) are all met, re-
gardless of whether such an application is 
subsequently approved.’’. 
Æ 
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