PlainBillCongress, translated.Legislation. Context. Public interest.Read twice and referred to the Committee on Labor and Human Resources.
Congressional Research Service
Version 00 · Introduced in Senate · Aug 11, 1995
Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to allow, notwithstanding specified provisions of the Public Health Service Act (PHSA), dissemination to individuals and entities involved in health care (including practitioners, managed care organizations, insurers, and governmental agencies) written information (or an oral or written summary thereof) concerning: (1) a treatment use for an investigational new drug or an investigational biological product approved for that use; or (2) a use (whether or not the use is contained in the official labeling) of a new drug or a biological product for which a new drug application, an abbreviated new drug application, a certification of an antibiotic drug, or a product license issued under the PHSA has been approved. Sets forth restrictions and requirements. Allows, notwithstanding any other provision of law, dissemination to individuals and entities involved in health care (including practitioners, managed care organizations, insurers, and governmental agencies) written or oral information relating to a use (whether or not described in the official labeling) of a device registered under specified FDCA provisions. Sets forth restrictions and requirements. Declares that, notwithstanding any other provision of law, the dissemination shall not be construed as evidence of a new intended use or considered as labeling, adulteration, or misbranding of the device.
People & committees
Sen. Mack, Connie, III [R-FL] · R–FL
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Read twice and referred to the Committee on Labor and Human Resources.
Sponsor introductory remarks on measure. (CR S12401)
Introduced in Senate
Primary sources
Text links open the official source. We currently store references to these documents.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Apr 21, 2025. Consult Congress.gov for the current record.
AI Conversation Starters
Choose a perspective, copy a prompt, and paste it into your preferred AI. Each prompt includes the bill version and available official source links, and asks for counterarguments as well as supporting evidence.
Analyze S.1197 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.
Examine S.1197 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
Examine S.1197 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
Examine S.1197 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.