Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of HHS (FDA) to inform an ANDA applicant, on request or on FDA initiative, whether a proposed generic drug’s inactive ingredients are qualitatively and quantitatively the same as the listed drug. If not the same, FDA must identify which ingredients differ and quantify deviations.
Left emphasizes consumer benefits and faster generics availability
Relative to its intended legislative type, this bill is a focused substantive amendment to the FD&C Act that creates a new, specific information-disclosure obligation for the Secretary of HHS (FDA) and mandates guidance development.
Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of HHS (FDA) to inform an ANDA applicant, on request or on FDA initiative, whether a proposed generic drug’s inactive ingredients are qualitatively and quantitatively the same as the listed drug.
If not the same, FDA must identify which ingredients differ and quantify deviations.
A finding that ingredients are the same generally cannot be rescinded after an ANDA is submitted except for narrow safety/error reasons.
Technocratic, limited-impact proposal with built-in safeguards increases viability, but possible pushback from brand manufacturers and agency resource concerns introduce uncertainty.
Relative to its intended legislative type, this bill is a focused substantive amendment to the FD&C Act that creates a new, specific information-disclosure obligation for the Secretary of HHS (FDA) and mandates guidance development. The statutory text is detailed about what must be disclosed and the conditions under which determinations may be changed.
Left emphasizes consumer benefits and faster generics availability
These are examples from the analysis, not a ranked list of the most-affected groups.
Left emphasizes consumer benefits and faster generics availability
Likely welcomes the bill as a consumer-friendly, pro-generic transparency measure that could lower drug costs by reducing uncertainty for generic makers.
Will view the non-rescind provision as protecting applicants from late surprises that delay competition.
May press for strong implementation and enforcement.
Generally supportive of clearer administrative rules that reduce regulatory ambiguity, while cautious about implementation details, agency capacity, and unintended consequences.
Wants measured safeguards for trade secrets and careful guidance drafting.
Mixed but leaning positive: appreciates measures that can increase generic competition and market-driven price pressure, but wary of additional federal mandates and potential rigidity or litigation triggered by new disclosure rules.
Concerned about federal overreach into regulatory processes.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Technocratic, limited-impact proposal with built-in safeguards increases viability, but possible pushback from brand manufacturers and agency resource concerns introduce uncertainty.
The bill has not accumulated any surfaced votes yet.
Left emphasizes consumer benefits and faster generics availability
Technocratic, limited-impact proposal with built-in safeguards increases viability, but possible pushback from brand manufacturers and agen…
Relative to its intended legislative type, this bill is a focused substantive amendment to the FD&C Act that creates a new, specific information-disclosure obligation for the Secretary of HHS (FDA) and mandates guidance…
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.