Maggie Hassan (D-NH)
Increasing Transparency in Generic Drug Applications Act
A Democratic bill with 4 Republican cosponsors · See all 6 cosponsors
Last activity — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
In committee
Introduced and handed to a committee in the chamber it started in.
The committee holds it, and most bills are never heard from again. A hearing or a committee vote would be news; silence is the usual outcome, and it kills the bill without anyone voting against it.
Its path through Congress
- Introduced
- In Committee
What this bill would do
The "Increasing Transparency in Generic Drug Applications Act" aims to provide more clarity regarding generic drug applications. It requires the Secretary to inform applicants whether a drug is qualitatively and quantitatively the same as the listed drug when requested or during review. If a drug is not the same, the Secretary must disclose the specific ingredients and the amount of any quantitative deviation. The Act also prevents the Secretary from changing a determination of being "the same" unless there is a change in the listed drug's formulation for safety or effectiveness, or an identified error. Additionally, the Secretary is tasked with issuing guidance on how these determinations are made.
Yes· 3 of 7
- Scored +5
Does this make what the government does easier for the public to see?
The bill specifically aims to increase transparency regarding how the Secretary determines if a drug is qualitatively and quantitatively the same as a listed drug.
- Scored +3
Would business owners be better off under this?
Drug manufacturers and applicants benefit from more predictable regulatory determinations and clearer guidance.
- Scored +3
Does this lower the price of prescription medicines?
By increasing transparency in the generic drug application process, this bill may facilitate smoother entry of generics into the market, potentially lowering costs.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Increased Certainty for Applicants: The Secretary must inform a person whether a drug is qualitatively and quantitatively the same as the listed drug upon request or during the review process (Section 2(a)(i)). This provides clarity for those submitting abbreviated applications.
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Detailed Disclosure of Discrepancies: If a drug is determined not to be the same as the listed drug, the Secretary is required to identify the specific ingredient causing the issue and the exact amount of any quantitative deviation (Section 2(a)(ii)). This ensures applicants know exactly why a drug does not match.
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Consistency in Determinations: The Secretary cannot change or rescind a determination that a drug is the same as the listed drug unless there is a specific reason, such as a change in the listed drug's formulation due to safety or effectiveness, or a corrected error (Section 2(a)(iii)). This creates a more stable regulatory environment.
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Standardized Guidance: The Secretary of Health and Human Services is required to issue guidance describing how they determine if a drug is qualitatively and quantitatively the same, including how to assess pH adjusters (Section 2(b)(1)).
Potential Negative Impacts for People
- No specific negative impacts are explicitly detailed in the provided text.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Tap or hover a score for the reason it gave.
- Demographic And Interest Groups
- Would business owners be better off under this? — Drug manufacturers and applicants benefit from more predictable regulatory determinations and clearer guidance. Would households on low incomes be better off under this? — Increased competition from generics may lead to lower costs for essential medications. Would middle-income households be better off under this? — Increased competition from generics may lead to lower costs for essential medications. Would retired people be better off under this? — Lower prescription drug costs can significantly assist retirees on fixed incomes.
- Governance And Ideology
- Does this make what the government does easier for the public to see? — The bill specifically aims to increase transparency regarding how the Secretary determines if a drug is qualitatively and quantitatively the same as a listed drug. Does this give the federal government more power? — The bill expands the regulatory transparency requirements and duties of the Secretary of Health and Human Services.
- Healthcare
- Does this lower the price of prescription medicines? — By increasing transparency in the generic drug application process, this bill may facilitate smoother entry of generics into the market, potentially lowering costs.
- 12/9/2025
- 2 Cosponsors added.
- 5/8/2025
- 1 Cosponsor added.
- 4/3/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 3 Cosponsors added.
- Introduced in Senate
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.
John HickenlooperDemocrat · Colorado
Jon HustedRepublican · Ohio
James LankfordRepublican · Oklahoma
Mike LeeRepublican · Utah
Jon OssoffDemocrat · Georgia
Rand PaulRepublican · Kentucky