Under new chief, FDA gives signs of rediscovering watchdog role

September 29, 1991|By Gilbert A. Lewthwaite | Gilbert A. Lewthwaite,Washington Bureau of The Sun

WASHINGTON -- On three nights last week, small groups of Baltimore physicians were slated to be wined, dined and given $100 gift certificates by drug manufacturer SmithKline Beecham Pharmaceuticals at the Stouffer Harborplace Hotel in return for discussing one of the company's new products, but the dinners were canceled for lack of response.

One possible reason for the physicians' lack of appetite: The Philadelphia-based pharmaceutical company is being investigated by Dr. David A. Kessler, chief federal watchdog of the industry, for alleged "doctor-bribing" after organizing three similar Baltimore dinners last month.

Dr. Kessler, 40, a lawyer as well as a doctor, has established a reputation as a tough enforcer in his first months as commissioner of the U.S. Food and Drug Administration.

The drug industry is now waiting to see whether he will crack down on SmithKline Beecham the way he has lowered the boom on corporate giants such as Procter & Gamble Co. for breaches of federal regulations.

Until he took over last December, the agency was suffering from what detractors called the "Reagan deregulation syndrome," a political virus seen by some as weakening federal intervention in general and undermining FDA efforts in particular.

"The FDA nearly went bankrupt so far as public credibility was concerned," said Rod Leonard, executive director of the Community Nutrition Institute, a Washington-based consumer advocacy group.

After nine months of Dr. Kessler's leadership, all the signs are that the agency, which regulates products representing a quarter of all U.S. consumer spending and sets standards for everything from antiperspirants to vegetable oils, breast implants to hair restorers is back in the product-policing business in a big way.

In the first 10 months of fiscal 1991, the FDA referred 37 criminalallegations, 17 injunctions and 124 seizure cases to the Justice Department.

Sen. Joseph I. Lieberman, D-Conn., chairman of an ad hoc subcommittee on consumer and environmental affairs, told Dr. Kessler last week: "You have breathed some flesh and blood back into what had appeared to be a paper tiger. Your vigorous and visible law enforcement stance contrasts sharply with the not-so-benign neglect of the decade preceding."

Dr. Kessler has taken these initiatives:

* Ordered U.S. marshals to seize 2,000 cases of Procter & Gamble's Citrus Hill Fresh Choice Orange juice after the company ignored his demands that the word "fresh" be removed from the label of the product, made from concentrate. Two days later, the company agreed to make the change. Twenty other companies have followed suit.

* Forced companies to abandon potentially misleading "cholesterol free" and "fat free" claims that left the false impression their products were good for the heart. Among the targeted companies: Procter & Gamble, CPC International Inc. and Great Foods of America Inc. All companies approached by the FDA have fallen in line.

* Warned drug companies that they could be prosecuted if they promoted use of their products for treatments not approved by the FDA. He has taken particular exception to a recent beauty fad -- collagen injections for augmenting the lips. He has also opposed the use of Retin-A, a drug approved by the FDA only for the treatment of acne, for prevention of wrinkles.

He told the Food and Drug Law Institute earlier this year: "You can be sure that we will enforce the law vigorously and consistently, whenever public health or economic issues are at stake. . . . The time has come to end the din of mixed messages and partial truths on food labels in this country."

"For the first time in some time, the FDA is getting a positive image," said Dr. Charles C. Edwards, a former FDA commissioner and author of a recent report on the agency's problems.

However, Dr. Edwards, who now heads the Scripps Clinic and Research Foundation in La Jolla, Calif., added: "You run your string out, after a fashion, in terms of labeling orange juice and things like that. Then you have to tackle the tough issues."

Those issues, he said, include increasing FDA resources at a time of budget restraint and ensuring the independence of the agency. Another challenge is to improve research facilities to keep abreast of scientific advances, Dr. Edwards said.

Dr. Kessler has said he would target his limited resources on the most pressing issues. He has vowed to show the agency's independence by enforcing the law impartially and has committed himself to the technological improvements needed to make the FDA "an enlightened gatekeeper on the road to the market."

But Mr. Leonard of the Community Nutrition Institute is openly skeptical of Dr. Kessler's approach. He told The Sun that he viewed Dr. Kessler as deliberately seeking public approval with easy truth-in-labeling initiatives in advance of making major concessions to industry by approving controversial new food additives and substitutes.

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