To amend the Federal Food, Drug, and Cosmetic Act to revise the requirements of that Act relating to the dissemination of scientific information on drugs.

Summary

Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved new drug application to distribute in any manner to a health professional (including insurers) a reprint of an article in an independent peer-reviewed medical textbook, journal, or medical compendium if the reprint is accompanied by a copy of the package insert and a statement that the reprint has not been approved by the Food and Drug Administration. Declares that the reprints shall not be regulated as advertising or labeling. Prohibits the Secretary of Health and Human Services from preventing advertising or labeling regarding an approved indication for a new drug, and for any pharmacoeconomic information relating to a drug, unless the Secretary determines in writing that the advertising or labeling is likely to cause unsafe or ineffective misuse.

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Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 1 February 1996

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• Introduced in House (PDF)

  Introduced in House · EN · 1 February 1996

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• Introduced in House

  summary · EN · 1 February 1996

  Open at official source

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