King Of Cave-In Saved FDA
Kessler dodged reforms; he bent but didn't break
Sunday Sun-Journal (Lewiston, Me.), December 22, 1996
David Kessler has resigned, and he will go down in bureaucratic history as the man who saved the Food and Drug
The New York Times glowingly described Kessler as "the commissioner of food and drugs who has fought for the
regulation of tobacco, worked to standardize nutritional labeling and taken steps to speed the federal drug-approval
For those who believe in FDA reform and consumer choice, however, Kessler will be remembered as the bureaucrat who,
through shrewd politicking, "saved" a fatally flawed agency.
A few years ago, the FDA was intensely disliked by large segments of American society, including small
medical-device firms, consumer-choice advocates and alternative medical-device practitioners.
The medical-device industry complained that the FDA maintained a "reference list" of noncompliant companies.
Companies could get on the list if they ran afoul of an FDA inspection. And, being on the list could make it
impossible to get any product appro ved.
The FDA's legal authority to hold product approvals hostage to inspection reports was suspect. Moreover, the list
was secret, so no company could actually protest its inclusion on the list. Observers called the list
"McCarthy-like" and "J. Edgar Hoover- like."
Under intense industry opposition, the FDA abandoned the reference list. A victory for FDA reform? Perhaps.
But what the FDA rescindeth, the FDA can reinstate. Losing lasting, systematic change by settling for piecemeal,
easily reversible change is a Pyrrhic victory.
And that's what happened to a host of other objections. Does market approval for medical devices take too long? By
selectively reviewing the easiest applications, FDA reviewers brought average review times down, blunting criticism.
Are news stories reporting on a European device denied to suffering Americans? Many of these high-profile devices
were suddenly awarded FDA treatment that other devices could scarcely dream of.
Are small-device firms moving abroad because of the FDA's regulatory burden? By announcing that it would ease up on
export controls and other regulatory requirements, the FDA got on the good side of many industry critics.
The practice of partially caving in to one's critics is not new at the FDA. Years ago, AIDS activists rallied
against the FDA to make the agency approve more anti-AIDS drugs.
Back then, the FDA caved in to AIDS activists, and AZT was approved with record-breaking speed. "You couldn't get
penicillin through that fast," one commentator quipped. AIDS patients are still benefiting from the FDA's cave-in
The FDA's more recent cave-ins have similar advantages for the critics.
The FDA today may be a better agency because of Congress' critiques. Desperately seeking to avoid an FDA reform
bill, it tempered many of its outrageous abuses of authority. But in bending rather than breaking, it effectively
killed lasting FDA reform.
This was David Kessler's genius. His FDA backed down just enough to forestall fundamental changing the FDA's
Meanwhile, Kessler pursued his pet projects, such as the scientifically shaky moratorium on silicone breast implants
and the legally shaky attack on tobacco advertising and marketing.
He also attempted to regulate dietary supplements used by millions of Americans and crusaded to prevent drug
companies from even talking about additional, not-yet-approved uses for their drugs at scientific conferences.
Health and Human Services Secretary Donna Shalala, accepting Kessler's resignation, said that "David is what you
hope for in a public servant. He actually improved public health."
If public health is defined as empowering people to make informed decisions about the best treatment for their
problems, given their specific circumstances, then Kessler's actions have consistently hindered public health.
The conflict between this definition of public health and Kessler's view has been at the heart of the FDA debate.
Suppose you've been diagnosed with a terminal illness, and given one year to live. A drug exists that could kill
you, but it could also save your life. Is it worth taking?
David Kessler, and the folks at the FDA, think they know. They know, even though they can not feel your
helplessness. They will not share your joy if you survive the treatment, nor will they share your pain if the drug
They do not know the quality of your life, what you could have done with your extra years, how tolerant you are of
risk or the thrill and fear of taking your life into your own hands.
But because the people at the FDA have studied medicine, they think they know what's best for you. They also dread
having to answer for their actions if you die because you took the drug.
Far better that you die silently, unknown, without television cameras, because you did not take the drug. And
because the people at the FDA work for the government, they can make you do what they say.
This is the essence of the FDA's legislative mission -- an inconvenient fact that the FDA-reform debate has
studiously avoided. Perhaps, with David Kessler gone, the FDA debate can continue in earnest.
Alexander Volokh is a policy analyst at the Reason Foundation, a public policy think tank based in Los Angeles, and
writes frequently on food and drug law.
(also appeared in BridgeNews, December 10, 1996;
Sunday Press Dispatch (Victorville, Ca.), December 15, 1996;
Asheville (N.C.) Citizen-Times, December 16, 1996;
High Point (N.C.) Enterprise, December 16, 1996)
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