FDA Issues Final Rules On 'Fast Track' Drugs

WASHINGTON—The Food and Drug Administration has given final approval to a set of regulations that will give some patients with immediate life-threatening diseases quicker access to experimental drugs. The rules have been revised in an attempt to allay scientists' fears that such a "fast track" would abandon traditional safety requirements and jeopardize clinical trials, and drug companies' concerns that it might prolong the process of gaining final approval. Yet the final rules may not hav

Charles Marwick
Jun 14, 1987
WASHINGTON—The Food and Drug Administration has given final approval to a set of regulations that will give some patients with immediate life-threatening diseases quicker access to experimental drugs. The rules have been revised in an attempt to allay scientists' fears that such a "fast track" would abandon traditional safety requirements and jeopardize clinical trials, and drug companies' concerns that it might prolong the process of gaining final approval.

Yet the final rules may not have put those fears to rest. Charles Moertel, a cancer researcher at the Mayo Clinic, said the final version doesn't please him any better than the initial draft. "It fundamentally doesn't do anything but put a verbal smoke screen around the same reproposed rules," he said in a telephone interview. "In sum, it's a totally irresponsible regulatory act."

The new rules governing investigational new drugs (IND) will make it possible for AIDS victims and others to...

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