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FDA authority over unapproved therapies would be compromised by S 1035, agency says.

This article was originally published in The Tan Sheet

Executive Summary

FDA ABILITY TO RESTRICT USE OF UNAPPROVED MEDICAL PRODUCTS WOULD BE COMPROMISED by Sen. Tom Daschle's (D-S.D.) Access to Medical Treatment Act (S 1035), FDA Executive Assistant to the Commissioner of Food and Drugs Jerold Mande asserted at a July 30 hearing of the Senate Labor and Human Resources Committee. The bi-partisan legislation, which Daschle introduced July 14, 1995 ("The Tan Sheet" July 17, 1995, p. 9), would allow health practitioners to administer unapproved drugs, devices, foods or dietary supplements to patients, as long as there is no evidence that the treatment causes harm and the patient is informed about the product and its possible side effects.

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