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Access to Medical Treatment Act provisions questioned by FDA's Friedman at hearing.

This article was originally published in The Tan Sheet

Executive Summary

UNAPPROVED THERAPY SAFETY/EFFICACY BURDEN OF PROOF SHIFT TO FDA under the Access to Medical Treatment Act (HR 746) is one of several objections the agency has to the bill as drafted, FDA Lead Deputy Director Michael Friedman, MD, testified at a House Government Reform & Oversight Committee hearing April 22. In written comments to Chairman Dan Burton's (R-Ind.) committee, Friedman outlined a number of "significant concerns" the agency has with the bill.

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