Leo’s Law

Bill Number

H.R. 7693

Origin Chamber

House

Congress

119th Congress, Session 2

Policy Area

Health

Status

Introduced

Latest Action

2026-02-25: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-04-06T21:13:11Z

AI-Generated Summary

Purpose

This legislation, titled "Leo's Law" (H.R. 7693), aims to counteract the disruptions caused by the COVID-19 pandemic on the development of orphan drugs—medications designed to treat rare diseases or conditions (those affecting fewer than 200,000 people in the U.S.). It does this by extending certain market exclusivity periods for qualifying orphan drugs, encouraging continued investment in research and development for these treatments despite pandemic-related delays.

Key Provisions

• Eligibility for Extensions: Applies to "covered orphan drugs," defined as drugs designated by the FDA as orphan drugs where:
• An investigational new drug (IND) application— an early-stage request to test a drug in humans—was submitted between December 1, 2019, and up to 120 days before the end of the COVID-19 emergency period (as defined under Social Security Act provisions).
• A full approval application (under sections 505(b) or 351(a) of relevant laws) is later approved based on that IND.
• The drug has no approved uses outside of rare diseases or conditions.
• Exclusivity Extensions: For eligible drugs, various exclusivity periods (times when competitors cannot market similar versions) are automatically extended by 180 days, if not already expired. These include:
• 12-year exclusivity for biologics against biosimilars (similar to generics for biological products).
• 5-year exclusivity for new chemical entities (novel drugs).
• 3-year exclusivity for new clinical studies on existing drugs.
• 7-year orphan drug exclusivity.
• Patent-related approval delays for drugs relying on certain certifications (e.g., under the Abbreviated New Drug Application process, which allows generics based on existing data).
• Conforming Extensions: Related periods, such as 4-year protections against certain approvals or 48-month/7.5-year timelines, are also extended by 180 days to maintain consistency.
• Effective Date: Takes effect immediately upon enactment, without needing FDA guidance or new regulations.

Significant Changes to Existing Law

• Amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Public Health Service Act by adding a one-time 180-day extension to multiple exclusivity periods specifically for orphan drugs impacted by the COVID-19 timeline.
• Introduces a new definition of "covered orphan drug" tied to the pandemic period, which did not exist before—this targets only drugs with IND submissions during the crisis, even if prior applications for the same drug existed for different rare conditions.
• Does not alter the core lengths of exclusivity periods (e.g., 7 years for orphans remains 7 years base) but provides a targeted "pandemic mitigation" extension, similar to prior COVID-related adjustments in other laws but unique to orphan incentives.

Potential Impacts

• On Government Agencies: The FDA will need to implement these extensions administratively during approval processes, potentially increasing workload for tracking eligible drugs but without requiring new rulemaking. This could streamline incentives without broad regulatory changes.
• On Citizens: Patients with rare diseases may benefit from sustained development and availability of specialized treatments, as extended exclusivity could encourage more orphan drug innovation. However, it might delay generic or lower-cost versions, potentially affecting affordability.
• On International Relations: Minimal direct impact, though U.S. extensions could influence global pharmaceutical markets by prolonging U.S.-based exclusivity, affecting international drug pricing and access for multinational companies.
• Broader Economy: Supports the biotech sector by offsetting pandemic delays (e.g., clinical trial disruptions), potentially leading to more orphan drugs reaching the market over time.

Main Stakeholders Affected

• Pharmaceutical and Biotech Companies: Developers of orphan drugs gain extended market protection, reducing financial risks from COVID-19 delays and incentivizing R&D for rare diseases.
• Patients and Advocacy Groups: Individuals with rare conditions (and groups like the National Organization for Rare Disorders) stand to gain from accelerated or protected drug availability.
• Generic and Biosimilar Manufacturers: Face delayed market entry due to extensions, which could postpone competition and lower prices.
• FDA and Regulators: Must apply these rules to approvals, affecting resource allocation for orphan drug reviews.
• Payers and Healthcare Systems: Insurers and government programs (e.g., Medicare) may see short-term higher costs from prolonged exclusivity.

Notable Legal, Constitutional, or Political Implications

• Legal: Reinforces the FD&C Act's framework for incentivizing rare disease treatments (via the Orphan Drug Act of 1983) without challenging patent or exclusivity basics; the extensions are narrowly tailored to pandemic effects, likely withstanding challenges as a rational legislative adjustment. No new enforcement mechanisms are added, relying on existing FDA authority.
• Constitutional: Aligns with Congress's commerce clause powers to regulate drugs and public health; no apparent free speech, due process, or equal protection issues, as it treats similarly situated drugs (pandemic-affected orphans) equally.
• Political: Bipartisan sponsorship (by Reps. Gottheimer and Bacon) highlights rare disease advocacy as a non-partisan issue; could set precedent for future crisis-related extensions in pharma law, potentially sparking debate on balancing innovation incentives with access to affordable drugs.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Gottheimer, Josh [D-NJ-5]

Cosponsors (1)

Rep. Bacon, Don [R-NE-2]

Recent Actions

• 2026-02-25: Referred to the House Committee on Energy and Commerce.
• 2026-02-25: Introduced in House
• 2026-02-25: Introduced in House

Bill Versions

• Leo’s Law — issued 2026-02-25 — PDF (5 pages)