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Patient Safety and Generic Labeling Improvement Act

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2498)

Official summary

Version 00 · Introduced in Senate · Apr 18, 2012

Patient Safety and Generic Labeling Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved abbreviated new drug application (generic drug approval) to change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application.

Allows conforming changes to be ordered to the labeling of the equivalent listed drug and each drug approved under the abbreviated new drug application process that corresponds to such listed drug.

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Who introduced it

Sen. Leahy, Patrick J. [D-VT] · D–VT

Committees

  • Health, Education, Labor, and Pensions Committee
7 cosponsorship records, including any withdrawals

Actions

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  1. Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2498)

  2. Sponsor introductory remarks on measure. (CR S2497-2498, S2499-2500)

  3. Introduced in Senate

Bill text & related measures

Text links open the official source. We currently store references to these documents.

Related bills identified by Congress.gov

Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.

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Neutral evidence review

Objective

Analyze S.2295 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.

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Fairness and public impact

Progressive lens

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Institutions and government scope

Conservative lens

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Individual rights and government power

Liberty lens

Examine S.2295 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.

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