House bill aims to prolong orphan drug exclusivity impacted by COVID-19

Legislation authored by U.S. Rep. Josh Gottheimer has been introduced in the House that would extend exclusivity periods for orphan drugs affected by the COVID-19 pandemic, the U.S. Congress reports.

Filed as H.R.7693 on Feb. 25, 2026, during the 2026 regular session of the 119th Congress, the bill is summarized here using details from the actual bill text, with clarifications provided where necessary for understanding.

Named “Leo’s Law,” the bill proposes a 180-day extension of exclusivity periods for specified orphan drugs under the Federal Food, Drug, and Cosmetic Act due to COVID-19-related disruptions. Coverage applies to drugs with applications submitted during the COVID-19 emergency and approved for rare disease indications. Additionally, the measure would extend some patent-related approval delays for these products. The bill’s provisions become effective upon enactment, irrespective of other guidance from the Secretary of Health and Human Services. Its aim is to facilitate orphan drug development that experienced interruptions due to the pandemic.

Rep. Josh Gottheimer (Democrat-NJ-5th District) introduced the bill, with Rep. Don Bacon (Republican-NJ-2nd District) serving as co-sponsor.

Rep. Gottheimer has introduced 56 other bills since the current session began.

Bills in Congress may originate in either the House of Representatives or the Senate, except revenue legislation, which begins in the House. After introduction, bills are referred to committees for review, hearings, amendment, and debate before possible chamber votes. Identical bills passed in both chambers go to the president, who may sign or veto the measure. Congress is organized in two-year terms, each split into two annual sessions. The legislative process and official bill data are tracked by the U.S. Congress through Congress.gov.

Josh S. Gottheimer serves as a Representative from New Jersey. He was elected as a Democrat to the One Hundred Fifteenth and the next four Congresses. He assumed office on Jan. 3, 2017, and earned a B.A. from the University of Pennsylvania in 1997 as well as a J.D. from Harvard Law School in 2004.

Information in this article was sourced from the U.S. Congress. The original data is available here.