To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This bill, To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Trade, Criminal Justice.
Who Benefits and How
health care providers and patients may benefit from new authority, funding, eligibility, regulatory clarity, or reduced risk created by the bill.
Who Bears the Burden and How
federal implementing agencies, health care providers and patients may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.
Key Provisions
- Section H40466C315973402599A15CB39964ABA2: 1. Short title This Act may be cited as the Protecting Consumer Access to Generic Drugs Act of 2023.
- Section HD1DAB32EE54A41BFA06216729912F45A: 2. Unlawful agreements Subject to subsections (b) and (c), it shall be unlawful for an NDA or BLA holder and a subsequent filer (or for two subsequent filers)...
- Section H9A99350747024598942B1833573ECE00: 3. Notice and certification of agreements Section 1111(7) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 355 note) is...
- Section H6B45C4D269C34EE6AB5F76E98AC91C28: 4. Forfeiture of 180-day exclusivity period Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by...
- Section HDC02B3A7360E4B0397E53F56F29DED08: 5. Commission litigation authority Section 16(a)(2) of the Federal Trade Commission Act (15 U.S.C. 56(a)(2)) is amended— in subparagraph (D), by striking or...
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
This bill, To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Key Policy Areas
Healthcare, Trade, Criminal Justice
Primary Purpose
This bill, To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Policy Domains
Whole bill
Identified Gains
- health care providers and patients
Identified Costs
- federal implementing agencies
- health care providers and patients
Sponsors
Legislative Progress
IntroducedMs. Perez (for herself, Mr. Casten, and Mr. Connolly) introduced …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_commission"
- → The commission identified in the operative section
Key Definitions
Terms defined in this bill
any agreement that— resolves or settles a covered patent infringement claim
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology