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.
Sponsored By: Representative Budzinski
Introduced
Summary
This bill would let certain later generic drug applicants gain FDA approval even if an earlier filer is eligible for 180-day exclusivity. It sets tight checkpoints: applicants must be ready to market within 75 days of approval, wait at least 33 months after a first filing, and face forfeiture if they miss the marketing window.
Show full summary
- Patients and families: Could get generic drugs to market sooner when a later applicant meets the bill's conditions, which may speed access to lower-cost medicines.
- Later generic applicants: Would have a narrow path to approval if they certify readiness and no first filer is effectively approved, and they must begin commercial marketing within 75 days or their approval becomes tentative and they may lose eligibility for a later effective approval.
- First filers: May see their practical exclusivity reduced if they delay marketing because a subsequent applicant can obtain approval under the bill's conditions.
- FDA: Gains authority to approve subsequent abbreviated new drug applications (ANDAs) under specified conditions to balance first-to-file rights with faster generic entry.
Personalized for You
How does this bill affect your finances?
Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
New path for second generic filers
If enacted, FDA could approve a later generic filer even if a first filer has 180-day exclusivity. This would apply only if at least 33 months have passed since a first filer applied, no first filer is already effectively approved, and the first filer is not legally blocked from approval. The later filer would need to certify it can start selling within 75 days after approval, then actually start, and notify FDA within one business day of starting sales. If the filer fails or says it cannot start within 75 days, the approval would revert to tentative and it could lose use of this path unless it proves an unforeseeable issue is fixed. If a first filer becomes eligible the same day, the later filer would wait until 180 days after the first filer starts selling. These changes would only apply to ANDAs filed after enactment and only for drugs without a prior Paragraph IV patent challenge filed before enactment.
Sponsors & CoSponsors
Sponsor
Budzinski
IL • D
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov