United States 119th Congress Status: In Committee Bipartisan · 2 D · 2 R cosponsors

S 43 — Skinny Labels, Big Savings Act

Last action — Read twice and referred to the Committee on the Judiciary.

  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed Senate
  4. 4
    Passed House
  5. 5
    To Executive
  6. 6
    Enacted

This bill is in committee in the Senate. Introduced January 09, 2025. It must pass committee before a floor vote.

Next likely step: a committee vote, then a floor vote in the Senate.

Odds of enactment

Low chance

Based on the sponsor, cosponsors, and committee posture, this bill has a low chance of becoming law.

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A statistical estimate from our own model of past outcomes — an insight, not a guarantee. Policymaking is volatile.

Prognosis

Advancing 38% · moderate confidence

  • In Committee

    Current position in the legislative process.

  • 4 sponsors

    1 primary, 3 co-sponsors signed on.

  • Bipartisan support

    Sponsored across 2 parties (2 D · 2 R) — cross-party backing.

Based on stage, sponsorship breadth, committee status, recorded votes, and cross-state momentum — a description of the observable signals, not a prediction.

Summary

Skinny Labels, Big Savings ActThis 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; ordescribing 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.

Bill Text

Action History

  1. Introduced in Senate

  2. Read twice and referred to the Committee on the Judiciary.

Sponsors

Sponsorship breakdown

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1 sponsors · 3 co-sponsors · 543 not signed on

Sponsors (1)

Co-sponsors (3)

Not signed on (543)

543 members have not signed on to this bill.

Show all 543 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

healthcare health-insurance
Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

What does S 43 do?
Skinny Labels, Big Savings ActThis 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; ordescribing 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.
Who sponsors S 43?
S 43 is sponsored by Hickenlooper, John W. (Democratic), Welch, Peter (Democratic), Cotton, Tom (Republican), and Collins, Susan M. (Republican).
What is the current status of S 43?
This bill is in committee in the Senate. Introduced January 09, 2025. It must pass committee before a floor vote.
Where can I track S 43?
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Last checked for changes 3 months ago · updated continuously

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