Loosening FDA Restrictions

In an editorial on the Food and Drug Administration (June 8), The Times opines that Sen. Tom Daschle’s (D-S.D.) amendment is “worth considering, for the agency has been stubborn in loosening restrictions for the sickest of patients.” Huh?

One of the first protease drugs for treating AIDS was approved so fast the manufacturer wasn’t ready to supply it and had to sell its limited quantities through just one pharmacy. When it became clear that resistance to these drugs was developing rapidly, the slowpoke FDA took a whole week to approve clinical trials on an immunologic adjuvant we have for solving the problem. That was back in October, and we still haven’t done anything about it because it takes a lot longer to explain it all to the investment community.

Besides, Daschle’s proposal shouldn’t be to “let physicians prescribe non-FDA-approved drugs.” That’s none of Congress’ business; the practice of medicine is regulated by the states. Over the last three years, for instance, a couple of hundred AIDS patients have been treated with our immune therapy because California law defines the practice of medicine with insight and elegance. If the senator’s idea is to let drug companies sell drugs the FDA hasn’t approved, forget it. The prohibition against such sales is the way the multinational drug companies lock small, innovative competitors out of the market. In case you haven’t heard, the Congress works for the multinational companies that keep campaign war chests filled.

ALLEN D. ALLEN

President and Director of Research

CytoDyn of New Mexico

Studio City

* Excuse me, but did I miss something? In your editorial championing reauthorization of the Prescription Drug User Fee Act you use as part of the foundation for your argument the fact that “fees [will be] paid by the pharmaceutical companies” to fund expanded FDA “oversight.” Isn’t this a bit like having the airline industry fund government inspection of planes, or the auto makers paying the salaries of safety inspectors?

Come on, if there are potential dangers in the drugs these companies are producing, let’s keep them--and their expected biases--out of the process.

WILLIAM BRIGHAM

San Diego