Federal RuleAug 21
62
DOL Rewrites Disability Rules for 'Merit-Based Opportunity' Push
RuleLabor DepartmentFederal Contract Compliance Programs OfficeSignificant Wallet
119-hr-7693119th CongressWALLET
Leo’s Law
Sponsored By: Representative Gottheimer, Josh [D-NJ-5]
Introduced
Summary
This bill would extend orphan‑drug exclusivity by 180 days for covered drugs tied to COVID‑19 incentives. The 180‑day blocks apply only if an exclusivity period has not already expired. It covers five exclusivity types: the 12‑year biologics exclusivity, the 5‑year and 3‑year new‑drug exclusivities under the Food, Drug, and Cosmetic Act, the 7‑year exclusivity under section 527, and applicable patent‑related approval‑delay periods tied to certain 505(b)(2) or 505(j) certifications. Patents are excluded if the information required under section 505(b) or 505(c) was not filed.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
Longer exclusivity for some orphan drugs
This bill would add 180 days to certain orphan-drug market exclusivity and related patent delay periods. The extension would apply only if the listed exclusivity or approval-delay period is not expired. It would apply to drugs that had a 505(i) application filed during the COVID-19 emergency (beginning Dec 1, 2019), were later approved under 505(b) or 351(a) tied to that investigational new drug application, and have no approved non-rare-disease indication. The extension would not apply to patents missing the information required under section 505(b) or (c). The change would take effect upon enactment without waiting for agency guidance.
Sponsors & CoSponsors
Sponsor
Gottheimer, Josh [D-NJ-5]
NJ • D
Cosponsors
Rep. Bacon, Don [R-NE-2]
NE • R
Sponsored 2/25/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov