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

S 1040 — Drug Competition Enhancement Act

Last action — Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.

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  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 March 13, 2025. It must pass committee before a floor vote.

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

Prognosis

Advancing 38% · moderate confidence

Where this bill stands today.

Odds of enactment

Low

How often bills like it became law.

  • In Committee

    Current position in the legislative process.

  • 4 sponsors

    1 primary, 3 co-sponsors signed on.

  • Bipartisan support

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

Prognosis reads this bill's own signals — stage, sponsorship breadth, committee status, recorded votes and cross-state momentum. Odds come from a model trained on which bills have become law.

Summary

Drug Competition Enhancement Act This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission (FTC) to enforce this prohibition.Generally, product hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantively similar to an indication of the reference drug.The bill establishes a presumption that product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product.A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.The bill makes product hopping an unfair method of competition and provides for enforcement by the FTC. If the FTC has reason to believe a manufacturer has violated or is about to violate this prohibition on product hopping, the FTC may institute an administrative proceeding or bring suit in federal court to stop the manufacturer’s action and seek equitable remedies, including disgorgement of unjust profits or paying restitution to those harmed.

Bill Text

What changed in the latest version

12 added · 5 removed

Plain-language change summary

The amendment to Bill S. 1040 replaces the term "reference product" with "reference product abbreviated new drug application." This change clarifies the specific type of new drug application being referred to in legal actions initiated by the Commission under subsection (c)(1). This matters because it provides greater specificity, which could affect how the law is interpreted and applied in related proceedings.

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Latest
1040 Introduced in Senate (IS)] <DOC> 119th CONGRESS 1st Session S.
1040 Reported in Senate (RS)] <DOC> Calendar No.
43 119th CONGRESS 1st Session S.
which was read twice and referred to the Committee on the Judiciary _______________________________________________________________________ A BILL To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes.
which was read twice and referred to the Committee on the Judiciary April 10, 2025 Reported by Mr.
Grassley, with an amendment [Omit the part struck through and insert the part printed in italic] _______________________________________________________________________ A BILL To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes.
355) or an application under subsection (b)(2) of such section 505 that seeks a therapeutic equivalence rating to the reference product.
355) or an application under subsection (b)(2) of such section 505 that seeks a therapeutic equivalence rating to the reference product abbreviated new drug application.
``(3) Justification.-- ``(A) In general.--Subject to paragraph (4), the actions described in paragraph (1) by a manufacturer of a listed drug or reference product shall not be considered to be an unfair method of competition in or affecting commerce if the manufacturer demonstrates to the Commission or a district court of the United States, as applicable, in an action, suit or proceeding initiated by the Commission under subsection (c)(1) that-- ``(i) the manufacturer would have taken the actions regardless of whether a generic drug that references the listed drug or biosimilar biological product that references the reference product had already entered the market;
``(3) Justification.-- ``(A) In general.--Subject to paragraph (4), the actions described in paragraph (1) by a manufacturer of a listed drug or reference product shall not be considered to be an unfair method of competition in or affecting commerce if the manufacturer demonstrates to the Commission or a district court of the United States, as applicable, in an action, suit, or proceeding initiated by the Commission under subsection (c)(1) that-- ``(i) the manufacturer would have taken the actions regardless of whether a generic drug that references the listed drug or biosimilar biological product that references the reference product had already entered the market;
<all>
Calendar No.
43 119th CONGRESS 1st Session S.
1040 _______________________________________________________________________ A BILL To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes.
_______________________________________________________________________ April 10, 2025 Reported with an amendment
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Action History

  1. Committee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.

  2. Committee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.

  3. Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.

  4. Committee on the Judiciary. Ordered to be reported with an amendment favorably.

  5. Introduced in Senate

  6. 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 1040 do?
Drug Competition Enhancement Act This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission (FTC) to enforce this prohibition.Generally, product hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantively similar to an indication of the reference drug.The bill establishes a presumption that product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product.A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.The bill makes product hopping an unfair method of competition and provides for enforcement by the FTC. If the FTC has reason to believe a manufacturer has violated or is about to violate this prohibition on product hopping, the FTC may institute an administrative proceeding or bring suit in federal court to stop the manufacturer’s action and seek equitable remedies, including disgorgement of unjust profits or paying restitution to those harmed.
Who sponsors S 1040?
S 1040 is sponsored by Cornyn, John (Republican), Blumenthal, Richard (Democratic), Grassley, Chuck (Republican), and Durbin, Richard J. (Democratic).
What is the current status of S 1040?
This bill is in committee in the Senate. Introduced March 13, 2025. It must pass committee before a floor vote.
Where can I track S 1040?
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