New Broom Sweeps Life into the FDA

DANIEL S. GREENBERG

March 12, 1991|By DANIEL S. GREENBERG

WASHINGTON. — The Reagan White House successfully directed much of its anti-regulatory fervor at the Food and Drug Administration, crimping its authority and battering its staff to the point where the FDA became a bureaucratic cripple. Its plight worsened when scandals involving fraudulent drug data rocked the agency. For anti-government zealots, the trashing of the Food and Drug Administration was a great ideological triumph, but at the price of lesser safeguards against faulty medicines, misleading drug advertising and contaminated foods.

Now, with the blessings of the President and Congress, a recuperative process is under way to restore authority and vigor to the government agency that has more to do with our individual well being than any other on the crowded bureaucratic landscape.

Though the Bush administration has been generally torpid in domestic matters, it has installed an unusually dynamic figure at the helm of the FDA. David Kessler, a 40-year-old pediatrician who is also a lawyer, comes to the agency from a department chairmanship at the Albert Einstein Medical School. He was once a member of the staff of Sen. Orrin Hatch, the Utah Republican with impeccable conservative credentials. Senator Hatch pushed for his nomination to fill a post vacant for over a year. When the nomination finally emerged from the White House late last year, Mr. Hatch helped speed it through the confirmation process in the frantic final days of the last Congress.

Perhaps excessively grand expectations have been raised by Dr. Kessler's initial months in office, but there's no doubt that the new commissioner of Food and Drugs is surrounded by admirers and well wishers across a broad political spectrum. In contrast to the timidity that was forced on the FDA during the Reagan years, Dr. Kessler is talking tough about scientific claims for drugs, the accuracy of drug advertising, and the protection of the nation's food supply.

Wednesday he returned to Capitol Hill for the first time since his confirmation and in clear terms spelled out his formula for the resurrection of his agency. Heretofore, drug companies were taken at their word when they reported on the safety and efficacy of new drugs. Most reports were trustworthy, but enough were faked to warrant change. ''Mr. Chairman,'' Dr. Kessler said, in addressing Sen. Edward Kennedy, D-Mass., ''the honor system at FDA is being replaced by a systematic pre-approval inspection program.''

Referring to recent episodes of fraudulent data on generic drugs, Dr. Kessler said the episodes occurred ''because people perceived the agency as not being strong in enforcement and surveillance.'' To counter that impression, he announced, the FDA was expanding its staff of criminal investigators. Drug advertising will also be subjected to closer surveillance. Referring to a surge in prescription-drug advertising directed at patients, Dr. Kessler noted that ''consumers are being misled by new public-relations initiatives. Unless we act swiftly to stop the escalation of these activities, they will almost certainly result in the kind of chaos that we saw recently with health claims on the food label.''

While assuring the validity of claims for new drugs, Dr. Kessler said, the FDA must eliminate delays for getting important new medications to market -- an issue that has been highlighted by protests over delays in releasing drugs for AIDS patients. ''We need to expand access to and give special priority for therapies to treat life-threatening diseases.''

The energy and openness that the new FDA commissioner has brought to his job is illustrated by his willingness to listen to the FDA's most persistent and knowledgeable critic, Sidney Wolfe, head of Ralph Nader's Health Research Group. Through publicity and court suits, Dr. Wolfe has repeatedly attacked the agency for letting hazardous drugs on the market.

For many years prior to the new commissioner's appointment, Dr. Wolfe was regarded as Enemy No. 1 at the FDA. Now there's a change. At Dr. Kessler's initiative, he and Dr. Wolfe get together once a month for a couple of hours of private discussions on matters of professional mutual interest.

Among bureaucracy watchers in Washington, Dr. Kessler's performance arouses two questions: Can he succeed? Can he last?

Daniel S. Greenberg publishes the newsletter Science & Government Report.

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