What does Preamble of HR 7693 do?

This bill, formally titled '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,' aims to address the impact of the COVID-19 pandemic on incentives related to orphan drug development. The bill intends to mitigate the effects of the COVID-19 pandemic on incentives under the Federal Food, Drug, and Cosmetic Act.

What does SHORT TITLE. of HR 7693 do?

This Act is formally titled Leo's Law.

What does MITIGATION OF EFFECTS OF COVID-19 PANDEMIC ON ORPHAN-DRUG of HR 7693 do?

This section extends certain exclusivity periods for covered orphan drugs by 180 days. The extended periods include those under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, specifically sections 351(k)(7), 505, and 527. A 'covered orphan drug' is defined as one with an application submitted during the COVID-19 emergency period, approved based on an investigational new drug application, and lacking approved indications outside of rare diseases or conditions. The 'COVID-19 emergency period' begins December 1, 2019, and ends 120 days before the termination of the emergency period as defined in the Social Security Act. This section takes effect upon enactment of the Act, regardless of whether guidance or regulations have been issued.

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Leo’s Law — HR. 7693

Last updated: 2/25/2026 · Introduced: 2/25/2026

Author: Josh Gottheimer (D-NJ)

TL;DR (AI)

The bill extends exclusivity periods for certain orphan drugs by 180 days to account for pandemic-related delays.
To qualify, an orphan drug must have an application submitted during the COVID-19 emergency period (December 1, 2019, to 120 days before the emergency’s termination) and be approved based on an investigational new drug application.
The extension applies to exclusivity periods under both the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.

119th Congressin committeeOfficial page

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Includes provisions on preamble, short title., and 1 more.

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