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.

Summary

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.

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Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 11 August 1995

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 11 August 1995

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 11 August 1995

  Open at official source

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