H.R. 7693

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7693 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 7693

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

February 25, 2026

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 incentives under 
the Federal Food, Drug, and Cosmetic Act for the development of orphan 
drugs, and for other purposes.

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 ``Leo's Law''.

SEC. 2. MITIGATION OF EFFECTS OF COVID-19 PANDEMIC ON ORPHAN-DRUG 
DEVELOPMENT INCENTIVES.

(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 subparagraph (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 section 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. 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 orphan drug, the following periods 
are each deemed to be extended by 180 days:
(1) The 4-year period referred to in subparagraph (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 section 
505(i) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(i)) during the COVID-19 emergency period 
(without regard to whether the same applicant has 
submitted such application for the same drug before 
December 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 Service Act (or a 
supplemental application, as the case may be) is 
approved pursuant to the investigational 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 approval delay 
period'', with respect to a covered orphan 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.
(3) The term ``orphan drug'' means a drug that the 
Secretary has designated as a drug for a rare disease or 
condition under section 526(a) of the Federal, Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bb(a)).
(4) The term ``COVID-19 emergency period'' means the period 
beginning on December 1, 2019, and ending on the date that is 
not later than 120 days before the date on which the emergency 
period (as defined in section 1135(g)(1)(B) of the Social 
Security Act (42 U.S.C. 1320b-5(g)(1)(B))) terminates.
(5) The term ``rare disease or condition'' has the meaning 
given such term in section 526 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bb).
(d) Effective Date.--This section takes effect upon the date of the 
enactment of this Act, without regard to whether the Secretary has 
issued guidance or regulations regarding the implementation of this 
Act.
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