United States 119th Congress Status: In Committee Bipartisan · 1 D · 1 R cosponsors

S 2658 — Medication Affordability and Patent Integrity Act

Last action — Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.

  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 August 01, 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 34% · moderate confidence

  • In Committee

    Current position in the legislative process.

  • 2 sponsors

    1 primary, 1 co-sponsors signed on.

  • Bipartisan support

    Sponsored across 2 parties (1 D · 1 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.

In plain language

This bill addresses medication affordability and patent integrity.

The Medication Affordability and Patent Integrity Act aims to improve access to affordable medications while ensuring patent protections are upheld. It tackles issues related to drug pricing and patent practices.

What this means for you
  • Families: Families may find it easier to afford necessary prescriptions.
  • Consumers: Consumers might benefit from more transparent pricing and increased competition in the pharmaceutical market.
  • Healthcare: This means potentially lower medication costs and improved access for patients.

Bill Text

How this bill changes current law

6 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill adds new disclosure requirements for sponsors of drug applications and holders of approved applications regarding patent information to be submitted to the FDA and PTO.

  • 21 U.S.C. 355(b)

    (7)(A) With respect to any application submitted under this subsection or approved under subsection (c), the sponsor of the application or holder of the approved application shall, for any applicable patent-- (i) certify to the Food and Drug Administration that the information described in subparagraph (B) that is submitted to the Secretary is, to the best knowledge of the sponsor or holder, consistent with the information such sponsor or holder provided to the United States Patent and Trademark Office and any communications such sponsor or holder had with the United States Patent and Trademark Office; and (ii)(I) submit to the United States Patent and Trademark Office any information material to patentability with respect to such applicable patent that the sponsor or holder submits to the Food and Drug Administration, and any information the Food and Drug Administration provided in response; and (II) certify to the United States Patent and Trademark Office that the submission under subclause (I), to the best knowledge of the sponsor or holder, includes all information material to patentability, and is consistent with the information such sponsor or holder provided to the Food and Drug Administration and any communications such sponsor or holder had with the Food and Drug Administration.

    This requires drug application sponsors to certify that their patent-related submissions are consistent with those made to the PTO.

  • 21 U.S.C. 355(b)(1)(A)

    and → and

    This change modifies the existing clause to accommodate new patent certification requirements.

  • 21 U.S.C. 355(b)(1)(A)

    . → ; and

    This change prepares the clause for the addition of new requirements regarding patent certifications.

  • 21 U.S.C. 355(b)(1)(A)

    (ix) with respect to each patent listed in the application pursuant to clause (viii) that is an applicable patent (as defined in paragraph (7)(C)), the certifications required under clauses (i) and (ii)(II) of paragraph (7)(A).

    This adds a new requirement for patent certification to the application process.

  • 42 U.S.C. 262(a)(2)

    (F)(i) With respect to any application submitted under this subsection or biological product licensed under this subsection, the sponsor of the application or holder of the licensure shall, for any applicable patent-- (I) certify to the Food and Drug Administration that the information described in clause (ii) that is submitted to the Secretary is, to the best knowledge of the sponsor or holder, consistent with the information such sponsor or holder provided to the United States Patent and Trademark Office and any communications such sponsor or holder had with the United States Patent and Trademark Office; and (II)(aa) submit to the United States Patent and Trademark Office any information material to patentability with respect to such applicable patent that the sponsor or holder submits to the Food and Drug Administration provided in response; and (bb) certify to the United States Patent and Trademark Office that the submission under item (aa), to the best knowledge of the sponsor or holder, includes all information material to patentability and is consistent with the information such sponsor or holder provided to the Food and Drug Administration and any communications such sponsor or holder had with the Food and Drug Administration.

    This introduces new disclosure requirements for biological product applications similar to those for drug applications.

  • 21 U.S.C. 331(q)(1)

    (D) to submit the certification required under section 505(b)(7) of this Act.

    This addition establishes a new regulatory violation for failing to submit the required patent certification.

Action History

  1. Introduced in Senate

  2. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  3. Committee on Health, Education, Labor, and Pensions. Hearings held.

  4. Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

  5. Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

  6. Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

  7. Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.

Sponsors

Sponsorship breakdown

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1 sponsors · 1 co-sponsors · 545 not signed on

Sponsors (1)

Co-sponsors (1)

Not signed on (545)

545 members have not signed on to this bill.

Show all 545 →

"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
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Frequently asked questions

Who sponsors S 2658?
S 2658 is sponsored by Hawley, Josh (Republican) and Hassan, Margaret Wood (Democratic).
What is the current status of S 2658?
This bill is in committee in the Senate. Introduced August 01, 2025. It must pass committee before a floor vote.
Where can I track S 2658?
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Last checked for changes 2 months ago · updated continuously

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