HR 1051 · in committee · significant
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.
Show full title
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.
- healthcare
What this bill does
- The bill allows the FDA to approve a second generic drug application if the first applicant hasn't started selling their drug within 33 months.
- Generic drug manufacturers and the FDA are affected by changes to how market exclusivity periods work.
- The bill takes effect upon enactment and requires the second applicant to certify they can start selling within 75 days of approval.
Generated by claude-haiku-4-5
Community Threads
Started by Cosponsor
- 01
How would allowing a second generic applicant after 33 months affect drug prices and patient access compared to waiting for the first applicant?
- 02
What protections should exist to ensure the first applicant isn't unfairly disadvantaged by losing their exclusive period?
- 03
Why is the 33-month threshold and 75-day sales requirement the right timeline, rather than a different duration?
Cosponsor writes these to seed civic discussion — they aren't user posts. Sign in to reply.
Sponsor · D-IL-13
Nikki Budzinski
Citizen cosponsors
0
In Congress
0/ 435
House Reps cosponsoring
Introduced 2025-02-06
Legislative timeline
2025-02-06 · house · IntroReferral
Referred to the House Committee on Energy and Commerce.
2025-02-06 · IntroReferral
Introduced in House
2025-02-06 · IntroReferral
Introduced in House
Citizen comments
Sign in to comment on this bill.
No comments yet — be the first.