Bill · H.R. 843· House(119-HR-843)
Prompt Approval of Safe Generic Drugs Act
- Introduced
- 1/31/2025
- Last activity
- 1/31/2025 — Referred to the House Committee on Energy and Commerce.
- Sponsored by
- Nanette Barragán
- Cosponsors
- None
- Introduced
- In Committee
What this bill would do
This bill, titled the "Prompt Approval of Safe Generic Drugs Act," seeks to amend the Federal Food, Drug, and Cosmetic Act. It aims to provide for the prompt approval of drugs when safety information is added to labeling. The legislation ensures that a drug application is not considered ineligible or misbranded because its labeling omits specific safety information. This omission applies when that information is protected by exclusivity or patents. Additionally, the Secretary is required to mandate certain safety statements in the drug's labeling.
Yes
Does this lower the price of prescription medicines?+5
The bill facilitates the prompt approval of drugs by allowing labeling omissions that are protected by patents or exclusivity, which can accelerate generic competition.
Would households on low incomes be better off under this?+4
Faster drug approval through these mechanisms can lead to earlier generic entry, potentially lowering costs for low-income households.
Does this make health care easier to get in general?+3
By streamlining the approval process for drugs through modified labeling requirements, the bill may increase the availability of necessary medications.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Prompt Drug Approval: The bill allows for drugs to be approved even if they omit certain safety information that is currently protected by exclusivity or patents, which may assist in the prompt approval process (Section 2, paragraph 1).
-
Ensuring Safe Use: The Secretary is required to ensure that the labeling of these drugs includes any appropriate safety information deemed necessary to assure safe use (Section 2, paragraph 2).
Potential Negative Impacts for People
- Omission of Safety Information: Under this act, a drug application may be considered eligible even if the labeling omits safety information such as contraindications, warnings, precautions, dosing, or administration, provided that information is protected by exclusivity or patent (Section 2, paragraph 1).
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+4
- 1/31/2025
- Referred to the House Committee on Energy and Commerce.
- Introduced in House