I 
118TH CONGRESS 
1ST SESSION H. R. 1805 
To mitigate the effects of the COVID–19 pandemic on incentives under 
the Federal Food, Drug, and Cosmetic Act for the development of orphan 
drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 27, 2023 
Mr. GOTTHEIMER (for himself and Mr. BACON) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To mitigate the effects of the COVID–19 pandemic on incen-
tives under the Federal Food, Drug, and Cosmetic Act 
for the development of orphan drugs, and for other pur-
poses. 
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 ‘‘Leo’s Law’’. 
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SEC. 2. MITIGATION OF EFFECTS OF COVID–19 PANDEMIC 
ON ORPHAN-DRUG DEVELOPMENT INCEN-
TIVES. 
(a) IN GENERAL.—In the case of a covered orphan 
drug, each of the following exclusivity periods is deemed 
to be extended by 180 days, so long as such period is not 
expired: 
(1) The 12-year period referred to in subpara-
graph (A) of section 351(k)(7) of the Public Health 
Service Act (42 U.S.C. 262(k)(7)). 
(2) The 5-year period referred to in subsection 
(c)(3)(E)(ii) and subsection (j)(5)(F)(ii) of section 
505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355). 
(3) The 3-year period referred to in each of 
clauses (iii) and (iv) of subsection (c)(3)(E) and 
clauses (iii) and (iv) of subsection (j)(5)(F) of sec-
tion 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355). 
(4) The 7-year period referred to in section 
527(a) of the Federal, Food, Drug, and Cosmetic 
Act (21 U.S.C. 360cc). 
(5) In the case of a covered orphan drug with 
one or more certifications specified in clauses (ii), 
(iii), and (iv) of section 505(b)(2)(A) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
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355(b)(2)(A)), or in subclauses (II), (III), and (IV) 
of section 505(j)(2)(A)(vii) of such Act (21 U.S.C. 
355(j)(2)(A)(vii)), each corresponding patent-related 
approval-delay period (other than a patent for which 
the information required pursuant to subsection (b) 
or (c) of section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) has not been filed). 
(b) CONFORMING EXTENSIONS.—In addition to the 
periods extended under subsection (a) for a covered or-
phan drug, the following periods are each deemed to be 
extended by 180 days: 
(1) The 4-year period referred to in subpara-
graph (B) of section 351(k)(7) of the Public Health 
Service Act (42 U.S.C. 262(k)(7)). 
(2) The 4-year, 48-month, and 7 and one-half- 
year periods referred to in subsection (c)(3)(E)(ii) 
and subsection (j)(5)(F)(ii) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355). 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘covered orphan drug’’ means an 
orphan drug for which— 
(A) an application is submitted under sec-
tion 505(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)) during the 
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COVID–19 emergency period (without regard 
to whether the same applicant has submitted 
such applications for the same drug before De-
cember 1, 2019, for a different rare disease or 
condition); 
(B) an application under section 505(b) of 
the Federal Food, Drug, and Cosmetic Act or 
under section 351(a) of the Public Health Serv-
ice Act (or a supplemental application, as the 
case may be) is approved pursuant to the inves-
tigational new drug application referred to in 
paragraph (1); and 
(C) there is no approved indication that is 
not for a rare disease or condition. 
(2) The term ‘‘corresponding patent-related ap-
proval delay period’’, with respect to a covered or-
phan drug, means the period ending with the last 
applicable date for the approval of an application 
within the meaning of subparagraph (A), (B), or (C) 
of section 505(c)(3) of the Federal, Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(c)(3)), or clause (i), 
(ii), or (iii) of section 505(j)(5)(B) of such Act (21 
U.S.C. 355(j)(5)(B)), whichever applies pursuant to 
the applicable patent certification. 
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