To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, 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 fixes a problem in the generic drug approval process where companies can indefinitely block competitors from entering the market. Currently, the first generic drug company to challenge a patent gets a 180-day exclusive period to sell their generic version, but some companies obtain this right and then never actually launch their product, preventing other generics from entering the market. The bill allows the FDA to approve a second generic applicant's drug after 33 months if the first company still hasn't launched, provided the second company commits to launching within 75 days.
Who Benefits and How
Generic pharmaceutical manufacturers who are second or later to file applications (subsequent applicants) benefit by gaining a new pathway to market when first applicants fail to launch within 33 months, removing what was previously an indefinite barrier to entry. Consumers and health insurance companies benefit from faster access to lower-cost generic drugs, which can reduce prescription drug prices by bringing competition to market sooner rather than waiting indefinitely for a first applicant who may never launch.
Who Bears the Burden and How
First-to-file generic drug companies lose the ability to hold 180-day exclusivity rights indefinitely without launching their product; they must actually bring their drug to market within 33 months or face competition from subsequent applicants. Brand-name pharmaceutical manufacturers face generic competition sooner when first applicants fail to launch, potentially reducing their monopoly period. The FDA faces increased administrative burden tracking the new 33-month and 75-day deadlines, processing certifications, managing approvals, and enforcing forfeiture rules when companies fail to meet launch requirements.
Key Provisions
- Allows FDA to approve subsequent generic drug applications after 33 months if the first applicant hasn't effectively launched their product, notwithstanding the first applicant's 180-day exclusivity period
- Requires subsequent applicants to certify they can commence commercial marketing within 75 days of approval and actually intend to launch the drug
- Implements a forfeiture rule where subsequent applicants lose their approval if they fail to launch within the 75-day window
- Provides an "opportunity to cure" allowing subsequent applicants to regain approval only if an unforeseeable event prevented launch and the issue has been fully resolved
- Requires subsequent applicants to notify FDA within one business day of actually launching their product
- Applies only to applications filed after the bill's enactment for drugs where no prior patent challenge certification was made
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
Allows FDA to approve subsequent generic drug applications when first applicants fail to commence commercial marketing within 33 months, preventing indefinite delays in generic drug availability
Who Benefits
- Generic pharmaceutical manufacturers (subsequent applicants) - gain market access pathway after 33 months
- Consumers and healthcare system - faster access to generic drugs and lower drug prices
- Health insurance companies and government payers - reduced drug costs
Who Bears Costs
- First generic applicants - lose exclusivity monopoly if they fail to launch within 33 months
- Brand-name pharmaceutical companies - face competition sooner from subsequent generics
Key Policy Areas
Pharmaceuticals, FDA Regulation, Generic Drugs, Healthcare
Primary Purpose
Allows FDA to approve subsequent generic drug applications when first applicants fail to commence commercial marketing within 33 months, preventing indefinite delays in generic drug availability
Policy Domains
Legislative Strategy
"Address 'parking' problem where first generic applicants obtain exclusivity rights but fail to launch products, blocking subsequent generics and delaying consumer access to affordable medicines"
Identified Gains
- Generic pharmaceutical manufacturers (subsequent applicants) - gain market access pathway after 33 months
- Consumers and healthcare system - faster access to generic drugs and lower drug prices
- Health insurance companies and government payers - reduced drug costs
Identified Costs
- First generic applicants - lose exclusivity monopoly if they fail to launch within 33 months
- Brand-name pharmaceutical companies - face competition sooner from subsequent generics
Legislative Progress
IntroducedMs. Budzinski introduced the following bill; which was referred to …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Brand-name pharmaceutical manufacturers, First generic drug applicants (first-to-file generics), Generic pharmaceutical manufacturers (all)
Subsequent generic drug manufacturers (second-filer generics) faces effects in multiple directions
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of Health and Human Services (FDA Commissioner in practice)
Key Definitions
Terms defined in this bill
The first generic drug manufacturer to file an Abbreviated New Drug Application (ANDA) with a patent challenge certification under paragraph (2)(A)(vii)(IV), entitled to 180-day market exclusivity
The actual sale and distribution of the generic drug to the public (not just approval to market)
A later generic drug applicant who files an ANDA after the first applicant
An ANDA that meets all scientific and regulatory requirements but cannot receive final approval due to patent or exclusivity barriers
FDA application for approval of a generic drug, which relies on the safety and efficacy findings of the brand-name drug
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