To enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes.
Sponsors
Legislative Progress
ReportedReported by Mr. Grassley, without amendment
Ms. Klobuchar (for herself, Mr. Grassley, Mr. Durbin, Mr. Blumenthal, …
Summary
What This Bill Does
Makes filing sham citizen petitions to delay generic drug or biosimilar approvals an unfair method of competition enforceable by the FTC, including both individual objectively baseless petitions and series of petitions.
Who Benefits and How
Generic drug manufacturers gain protection from anticompetitive petition delays. Consumers benefit from faster generic drug access. FTC gains explicit authority over pharmaceutical petition abuse.
Who Bears the Burden and How
Brand-name drug companies face FTC liability for sham petitions. FTC must investigate and enforce against abusive petition practices. FDA petition process scrutinized for anticompetitive intent.
Key Provisions
- Defines sham as objectively baseless petition interfering with competitor
- Covers series of petitions even if individual petitions not baseless
- Applies to 505(b)(2), 505(j), and 351(k) applications
- FTC Act Section 5(a)(1) unfair competition liability
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
Enables FTC enforcement against sham citizen petitions that delay generic drug approvals
Policy Domains
Legislative Strategy
"Deter abuse of FDA petition process to block generic competition"
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_commission"
- → Federal Trade Commission
Key Definitions
Terms defined in this bill
Covered petition that is objectively baseless and attempts to use governmental process to interfere with competitor, or series of petitions attempting same
Petition or supplement filed under FDA section 505(q)
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