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Under new chief, FDA gives signs of rediscovering watchdog role

THE BALTIMORE 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.

"One thing about him is that he is an extremely political animal. Everything that he does, there is calculation behind it," Mr. Leonard said. "That is not unusual. It is what this town thrives on.

"What he has done so far is essentially cosmetic," Mr. Leonard said. "It is important. Labeling is important, but that should never have been allowed to degenerate to the point where simply maintaining truthful labels looks like a great accomplishment." Mr. Leonard said.

Food manufacturers do not dismiss Dr. Kessler's crackdown so readily. They claim that he acted before specific guidelines, mandated by last year's Nutrition Education and Labeling Act, were drawn up. Most of those guidelines are to be announced by November. Dr. Kessler has cited the 1938 Federal Food, Drug and Cosmetic Act, which broadly bans false and misleading labeling, to justify his crackdown.

Sherwin Gardner, a senior vice president for science and technology of the Grocery Manufacturers of America, said, "Our view is until those standards are established, what they are doing is holding manufacturers accountable for a set of criteria that they are in the dark about."

Dr. Kessler's activism has not all been on the policing level. He also has promised to hasten approval of new drugs to combat life-threatening diseases such as acquired immune deficiency syndrome and Alzheimer's. He has cut the number of administrative steps in the regulatory process and put an in-house emphasis on efficiency and modernization.

"I think the challenge for Dr. Kessler in the short term is to restore the credibility of the agency to deal more effectively with the various constituencies," said Wayne Pines, former assistant FDA commissioner for public affairs and now executive vice president of Burson-Marsteller, a public relations operation specializing in health care.

The first challenge for the slightly built, bespectacled and bearded Dr. Kessler was to bolster morale in the agency's Rockville headquarters.

Today he likes to recount how he is frequently stopped by colleagues. He says: "They tell me that the agency is alive again. They say they have pride in the FDA. They report that they are happy to be doing the job they signed on for -- protecting and promoting the public health."

Friends describe him as an extremely focused and "directed" individual, a workaholic who combined his final year at law school with his medical studies, who drafted food and drug legislation for Sen. Orrin G. Hatch, R-Utah, while training as a pediatrician in the early 1980s at Johns Hopkins Hospital.

"It's the first time I've had only one job," he jokes of his FDA post.

Dr. Kessler has yet to rule on SmithKline Beecham's dinner program for the Baltimore doctors.

Several local doctors did attend the three dinners at Stouffer's given by the company last month "to examine and discuss the profile" of a new company product, Relafon, generically known as nabumetone. Last week's canceled sessions were to focus on an anti-depressant, paroxitine hcl. Both new drugs are still awaiting FDA approval.

Dr. Edward F. Ellerbeck, a fellow in Johns Hopkins Hospital's Department of Medicine, had complained to the Washington-based Public Citizen Health Research Group about the company's "promotional campaign" for unlicensed drugs. "There is the question that this is like a bribe, an attempt to get people to sit through a marketing program," he said.

SmithKline Beecham spokesman Jeremy Helmsfeld said the dinners were not designed to "prime the audience for when the drug was approved but rather to get information from the physicians." He said the company was cooperating with the FDA investigation but continued to believe the dinner program was ,, "appropriate."

David A. Kessler

Born: May 31, 1951, New York City.

Family: Married to attorney Paulette Steinberg Kessler, two children.

Education: B.A., Amherst College, 1973; J.D., University of Chicago law school, 1978; M.D., Harvard medical school, 1979; advanced professional certificate from New York Graduate School of Business Administration, 1986.

Medical background: Intern and resident with Department of Pediatrics, Johns Hopkins Hospital, 1979-1982; special assistant to president of Montefiore Medical Center, 1982-1984; medical director, Hospital of the Albert Einstein College of Medicine, 1984-1990.

Academic appointments: Assistant professor, Albert Einstein College of Medicine, 1982-1990; lecturer, Columbia University School of Law, 1986-1990.

Political career: Consultant to Sen. Orrin G. Hatch, R-Utah, then chairman of Senate Committee on Labor and Human Resources, 1982-1884.

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