To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes.
Sponsors
Legislative Progress
ReportedReported by Mr. Grassley, with an amendment
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, and Mr. …
Summary
What This Bill Does
Amends the FTC Act to prohibit brand drug manufacturers from engaging in product hopping—making minor changes to drugs to delay generic or biosimilar competition through manipulation of approval pathways.
Who Benefits and How
Generic drug manufacturers gain protection from anticompetitive reformulation tactics. Consumers benefit from faster generic drug availability. Healthcare payers save money through earlier generic entry.
Who Bears the Burden and How
Brand-name drug companies prohibited from using follow-on product strategies to block generics. FTC gains explicit enforcement authority. Excludes changes requested by FDA or required by law.
Key Provisions
- Defines product hopping as changing formulation to delay generic competition
- Covers both drugs (505) and biologics (351)
- Excludes FDA-requested or legally required changes
- FTC enforcement authority established
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
Prohibits pharmaceutical product hopping to delay generic drug competition
Policy Domains
Legislative Strategy
"Close product hopping loophole to ensure generic competition"
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of HHS
Key Definitions
Terms defined in this bill
Drug or biologic approved for change or modification to same manufacturers previously approved product with identical or substantively similar indication
Application under 505(j) or 505(b)(2) seeking therapeutic equivalence rating
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