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House bill · H.R. 6485 (119th Congress)

Skinny Labels, Big Savings Act

U.S. House of Representatives

Latest action Apr 20, 2026

Sponsor: Ben Cline (U.S. Representative, VA-6, Republican)

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From Congress.gov and official rosters. This record was last updated Jul 30, 2026. About our data

Summary

Skinny Labels, Big Savings Act This bill provides a statutory safe harbor from patent infringement claims for generic or biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs. Under current law, the Food and Drug Administration (FDA) may approve generic and biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. , a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics. The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act: submitting or seeking approval of a skinny label for a generic or biosimilar drug; promoting or commercially marketing a drug with skinny labeling approved by the FDA; or describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug. The bill also applies the safe harbor to similar actions under the Public Health Service Act.

Summary from the Congressional Research Service. How we handle summaries

Where it stands

Assigned to a committee for review.

  1. Introduced
  2. In committee
  3. Up for a vote
  4. Passed one chamber
  5. Passed
  6. Enacted

Committee

House Committee on the Judiciary · U.S. House of Representatives

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Cosponsors

6

Cosponsors listed on Congress.gov, shown A to Z.

  • Democratic3
  • Republican3

This bill has cosponsors from more than one party.

Shown in neutral colors by design; Agora is non-partisan.

Related bills

As identified by Congress.gov.

Full history

  1. Apr 20, 2026

    Introduced

    Introduced in U.S. House

    U.S. House

  2. Dec 5, 2025

    Introduced

    Introduced in House

    U.S. House of Representatives

  3. Dec 5, 2025

    In committee

    Referred to the House Committee on the Judiciary.

    U.S. House

  4. Dec 5, 2025

    Referred to committee

    Referred to the House Committee on the Judiciary.

    U.S. House of Representatives

Read the record