Bill · H.R. 1843· House(119-HR-1843)
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
- Introduced
- 3/5/2025
- Last activity
- 3/5/2025 — Referred to the House Committee on Energy and Commerce.
- Sponsored by
- Neal Dunn
- Cosponsors
- - 0 - 1
- Introduced
- In Committee
What this bill would do
This bill aims to amend the Federal Food, Drug, and Cosmetic Act to increase transparency regarding generic drug applications. It requires the Secretary to inform applicants whether a drug is qualitatively and quantitatively the same as a listed drug upon request or on their own initiative. If a drug is found to be different, the Secretary must disclose the specific ingredients and any quantitative deviations. The bill also limits when the Secretary can change or rescind a determination that a drug is the same as the listed drug. Additionally, the Secretary is tasked with issuing guidance on how these determinations are made, including assessments of pH adjusters.
Yes· 3 of 5
Does this make what the government does easier for the public to see?+5
The bill mandates that the Secretary disclose specific ingredients and deviations when a drug is not the same as a listed drug.
Would business owners be better off under this?+4
The bill provides more predictable and transparent regulatory feedback for drug developers.
Does this make it easier to run a small business?+3
The bill provides greater regulatory certainty and transparency for drug application applicants.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Increased Transparency for Applicants: Under Section 1(a)(i), the Secretary must inform a person submitting an abbreviated application whether their drug is qualitatively and quantitatively the same as the listed drug. This provides clarity to those submitting applications.
-
Specific Disclosure of Differences: According to Section 1(a)(ii), if a drug is not the same, the Secretary is required to identify the specific ingredient causing the difference and the amount of any quantitative deviation. This provides exact details rather than vague findings.
-
Consistency in Determinations: Section 1(a)(iii) states that the Secretary shall not change or rescind a determination that a drug is the same as the listed drug unless the listed drug's formulation changed for safety/effectiveness or an error is identified. This prevents arbitrary changes to previous determinations.
-
Clear Process for Guidance: Section 1(b) requires the Secretary to publish draft guidance and allow at least 60 days for public comment before publishing final guidance. This ensures a structured process for how the Secretary determines if a drug is qualitatively and quantitatively the same.
Potential Negative Impacts for People
- No negative impacts or burdens are explicitly stated in the provided text.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Business Owners+4Good For Low Income Households+1
- Governance And Ideology
- Improves Government Transparency+5
- Economy And Finance
- Improves Small Business Support+3
- Healthcare
- Improves Healthcare Access+2
- 3/5/2025
- Referred to the House Committee on Energy and Commerce.
- 1 Cosponsor added.
- Introduced in House
4 bills Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Kevin MullinDemocrat · California