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 receive experimental drugs when there is no comparable or alternative drug or other therapy available. Under the rules, manufacturers can make experimental drugs available to physicians with less testing than in the past. Administration officials acknowledge that the impetus behind the rule change—a proposal that has languished since it was first suggested in 1983—comes from a growing demand to help those with AIDS.
The FDA received more than ...
