S 1197 · 104th Congress · Health

A bill to amend the Federal Food, Drug, and Cosmetic Act to facilitate the dissemination to physicians of scientific information about prescription drug therapies and devices, and for other purposes.

Introduced 1995-08-11· Sponsored by Sen. Mack, Connie, III [R-FL]· Senate

Bill Progress

Introduced
2
Committee
3
Senate Vote
4
House
5
Enacted
Latest: Read twice and referred to the Committee on Labor and Human Resources.(1995-08-11)

Plain Language Summary

[AI summary unavailable — showing source text] 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 restrictio…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (10)

10 Republicans