119:s:1040 — Drug Competition Enhancement Act

Sponsor

Introduced by

John Cornyn

R Republican · Senate · TX R+6

Chairman · United States Senate Caucus on International Narcotics Control

Latest action

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

Action timeline

Every recorded action on this bill, newest first. Stage badges color-code the legislative path.

Apr 10, 2025

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

Judiciary Committee

Apr 10, 2025

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

Apr 03, 2025

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

Judiciary Committee

Mar 13, 2025

introduced Introduced in Senate

Mar 13, 2025

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

Judiciary Committee

Text versions

Each stage of the bill — official text published by GPO. Click any format to read on congress.gov / govinfo.

Apr 10, 2025 Reported to Senate

XML

Mar 13, 2025 Introduced in Senate

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CRS summaries

Plain-English summaries written by the Congressional Research Service — neutral, nonpartisan staff who summarize bills as they advance through stages. The authoritative description of what each version of the bill does.

00 Introduced in Senate Mar 13, 2025

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.

via Congressional Research Service · published through congress.gov

Changelog

ⓘ

How a bill moves through Congress. Each stage produces a new official text. The diff between them shows what changed at that step.

`ih` / `is` — Introduced in House / Senate. First filed version.

`rfh` / `rfs` — Referred to a committee for review.

`rh` / `rs` — Reported back by the committee to the floor (often with amendments — this is where most language changes happen).

`pcs` / `pch` — Placed on Calendar for floor consideration.

`eh` / `es` — Engrossed. Passed by the originating chamber. Text is now what was actually voted on.

`rdh` / `rds` — Received by the other chamber.

`eah` / `eas` — Engrossed Amendment. The other chamber passed an amended version.

`ath` / `ats` — Agreed to. Both chambers settled on the same text.

`enr` — Enrolled. Final reconciled text, sent to the President.

`pl` — Public Law. Signed by the President. It's now law.

`pp` — Public Print. Official printing post-enactment.

Most bills die before `eh`/`es`. Going from `pcs` → `enr` is the full path through both chambers.

Line-level diff between text versions of this bill — what actually changed at each legislative stage.

+31 −6 28 unchanged

--- Introduced (Senate)

+++ Reported (Senate)

@@ -1,8 +1,9 @@

[From the U.S. Government Publishing Office]

-[S. 1040 Introduced in Senate (IS)]

+[S. 1040 Reported in Senate (RS)]

<DOC>

+Calendar No. 43

119th CONGRESS

1st Session

S. 1040

@@ -19,6 +20,11 @@

Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, and Mr. Durbin)

introduced the following bill; 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]

_______________________________________________________________________

@@ -82,7 +88,7 @@

section 505 of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 355) or an application under subsection (b)(2) of such

section 505 that seeks a therapeutic equivalence rating to the

-reference product.

+reference product abbreviated new drug application.

``(6) Listed drug.--The term `listed drug' means a drug

listed under section 505(j)(7) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 355(j)(7)).

@@ -185,9 +191,9 @@

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--

+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

@@ -336,4 +342,23 @@

section 27 of the Federal Trade Commission Act, as added by subsection

(a) (other than terms that are defined in subsection (a) of such

section 27).

-<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

Lobbying activity

Organizations whose LDA filings reference this bill, ranked by filing count. Position not disclosed — LDA does not require lobbyists to report support / oppose / monitor. Bill-number references can be stale (lobbyists sometimes copy text year-over-year), so verify against the filing description.

CAMBIA HEALTH SOLUTIONS

HCR

5

filings · 2026 Q3

AMERICA'S HEALTH INSURANCE PLANS INC (AHIP)

PHA

5

filings · 2026 Q3

BLUE CROSS AND BLUE SHIELD ASSOCIATION

PHA

5

filings · 2026 Q3

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

PHA

5

filings · 2026 Q3

PHARMACEUTICAL INDUSTRY LABOR MANAGEMENT ASSOCIATION

PHA

5

filings · 2026 Q3

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

HCR

5

filings · 2026 Q3

BLUE CROSS AND BLUE SHIELD OF FLORIDA INC

PHA

5

filings · 2026 Q3

BCBSM INC

PHA

5

filings · 2026 Q3

GUIDEWELL MUTUAL HOLDING CORPORATION

PHA

5

filings · 2026 Q3

THE CIGNA GROUP AND SUBSIDIARIES (FORMERLY CIGNA CORPORATION AND SUBSIDIARIES)

PHA

4

filings · 2025 Q3

via Senate LDA · self-reported quarterly. Filing count = filings mentioning this bill (no position required), not money spent on it. Click a client to see all bills they've filed on.

Cosponsors (3)

Members who signed on to support this bill.

Blumenthal D

Grassley R

Durbin D