Bill · H.R. 1051· House(119-HR-1051)
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.
- Introduced
- 2/6/2025
- Last activity
- 2/6/2025 — Referred to the House Committee on Energy and Commerce.
- Sponsored by
- Nikki Budzinski
- Cosponsors
- None
- Introduced
- In Committee
What this bill would do
This bill proposes amendments to the Federal Food, Drug, and Cosmetic Act. It seeks to allow the Secretary to approve an abbreviated new drug application for a drug even if a first applicant is eligible for a 180-day exclusivity period. This is applicable if certain conditions are met, such as the passage of at least 33 months since the first applicant's submission. The bill also establishes rules regarding the commencement of commercial marketing within 75 days of approval. It includes a special forfeiture rule if an applicant fails to start marketing the drug as intended.
Yes· 3 of 4
Does this lower the price of prescription medicines?+5
By accelerating the entry of subsequent applicants into the market, the bill encourages competition that can lower drug prices.
Does this make health care easier to get in general?+3
The bill aims to increase drug availability by allowing quicker market entry for subsequent applicants.
Would households on low incomes be better off under this?+3
Increased drug competition facilitated by this bill may lead to lower costs for essential medicines.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Earlier Access to Drugs: The Secretary may approve an application for a drug even while a first applicant is eligible for exclusivity, provided certain conditions are met (Section 1(a)(2)(III)). This could allow subsequent applicants to enter the market.
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Requirements for Market Readiness: An applicant must certify that no conditions prevent them from starting commercial marketing within 75 days of approval (Section 1(a)(2)(III)(bb)). This ensures that those receiving approval are actually prepared to bring the drug to the market.
Potential Negative Impacts for People
-
Loss of Approval Due to Marketing Delays: An application can lose its effective approval if the applicant fails to start commercial marketing within the required 75-day period (Section 1(b)(1)(I)).
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Strict Requirements for Unforeseen Events: If an applicant cannot market the drug within 75 days, they must prove that an unforeseen event prevented them from doing so and that all issues from that event are fully resolved to be eligible for subsequent approval (Section 1(b)(1)(II)(bb)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Reduces Prescription Drug Costs+5Improves Healthcare Access+3
- Demographic And Interest Groups
- Good For Low Income Households+3
- Economy And Finance
- Improves Small Business Support+3
- 2/6/2025
- Referred to the House Committee on Energy and Commerce.
- Introduced in House