Leo’s Law

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