Bill · S. 1040· Senate(119-S-1040)
Drug Competition Enhancement Act
- Introduced
- 3/13/2025
- Last activity
- 4/10/2025 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.
- Sponsored by
- John Cornyn
- Cosponsors
- - 1 - 2
- Introduced
- On Calendar
What this bill would do
This bill, titled the "Drug Competition Enhancement Act," aims to amend the Federal Trade Commission Act to prohibit "product hopping." It targets manufacturers of reference drugs or listed drugs who engage in "hard switches" or "soft switches" to impede competition from generic drugs or biosimilar biological products. The legislation defines these switches and establishes specific timeframes during which such actions are considered unfair methods of competition. It also provides manufacturers with specific justifications and defenses for their actions. Finally, the bill outlines enforcement powers for the Federal Trade Commission, including the ability to seek injunctions, restitution, and disgorgement.
Yes· 3 of 6
Does this lower the price of prescription medicines?+8
The bill facilitates lower drug costs by encouraging competition from generic and biosimilar products.
Does this give people more protection from unfair business practices?+7
The bill enhances consumer protection by preventing manufacturers from using unfair 'product hopping' tactics to block cheaper generic competition.
Would households on low incomes be better off under this?+5
Lower prescription drug prices benefit low-income households.
The opposite
Would business owners be better off under this?-5
Drug manufacturers may face increased regulatory scrutiny and litigation.
Who it would affect, and how
Potential Positive Impacts for People
-
Increased Competition: By prohibiting "hard switches" and "soft switches," the bill aims to prevent manufacturers from impeding competition from generic drugs or biosimilar biological products (Section 2, paragraph (b)(1)).
-
Protection Against Unfair Tactics: The bill targets "hard switches," such as when a manufacturer withdraws or destroys inventory of a listed drug to impede competition, and "soft switches," which involve actions that unfairly disadvantage a listed drug relative to a follow-on product (Section 2, paragraph (b)(1)(A) and (B)).
-
Accountability through Remedies: The Federal Trade Commission is empowered to seek restitution and disgorgement of any unjust enrichment obtained as a result of a violation (Section 2, paragraph (c)(3)(A) and (B)).
-
Judicial Oversight: The bill allows for judicial review of cease and desist orders through the United States Court of Appeals (Section 2, paragraph (c)(2)).
Potential Negative Impacts for People
-
Potential Disruptions in Supply: While there are exceptions, manufacturers may face restrictions when trying to manage product lifecycles, which could involve practical challenges if they are attempting to address supply disruptions (Section 2, paragraph (b)(3)(A)(ii)).
-
Legal and Regulatory Burdens for Manufacturers: Companies may face legal actions, including proceedings or lawsuits by the Commission, which can result in injunctions, restitution, or disgorgement (Section 2, paragraph (c)(1)).
-
Compliance Requirements: Manufacturers must navigate complex definitions and potential justifications to ensure their actions regarding product modification or withdrawal are not deemed unfair methods of competition (Section 2, paragraph (b)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Low Income Households+5Good For Middle Class Households+5Good For Retirees+5Good For Business Owners-5
- Healthcare
- Reduces Prescription Drug Costs+8
- Economy And Finance
- Improves Consumer Protection+7
- Governance And Ideology
- Increases Federal Power+5
- 4/10/2025
- Committee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.
- 4/3/2025
- Committee on the Judiciary. Ordered to be reported with an amendment favorably.
- 3/13/2025
- Read twice and referred to the Committee on the Judiciary.
- 3 Cosponsors added.
- Introduced in Senate
Richard BlumenthalDemocrat · Connecticut
Richard DurbinDemocrat · Illinois
Chuck GrassleyRepublican · Iowa