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David A. Kessler is sending drugmakers a message: Follow the rules, or pay. They're listening.
In a Newark (N.J.) federal court on Aug. 16, the Food & Drug Administration forced Warner-Lambert Co. to temporarily halt production of its drugs and over-the-counter products that didn't meet FDA specifications. The tab for production shortcomings and withdrawn drugs: $150 million this year alone. With the extraordinary action, FDA chief Kessler put the industry on notice. "There's no doubt that there is an increase in compliance [activity]," says Lodewijk J.R. deVink, president of Warner-Lambert. "It has been ratcheted up in a hurry."
The FDA denies that this is a sudden--or even recent--crackdown. "We said two to three years ago that enforcement was a priority--and I think we have stuck with it," says Kessler. But now, the tough FDA campaign suddenly has gone very public. The agency is scrutinizing drug factories and industry marketing claims as never before, delivering manufacturers hundreds of tough-sounding "warning letters" and dispensing with "voluntary agreements" in favor of court-supervised consent decrees. Taken together, the agency's actions are turning up the level of anxiety in an industry already reeling from stock market shocks, health-care-reform threats, and the nastiest competition in years.
The actions also show how much weight Kessler's FDA can swing. The physician-lawyer made his mark in 1991 by restraining orange-juice makers from misusing the word "fresh." A year later, he pulled most breast implants off the market for safety reasons. He has been working on the drug industry, too, since taking over the FDA's top job in December, 1990, trying to reverse the agency's reputation for weak-kneed ineffectiveness by beefing up enforcement and criticizing industry promotional efforts.
The Warner-Lambert move, though, represents what some see as a quantum leap in regulation. Critics call it overkill. Under the court order, the company had to cease production for over a week on products, including Listerine and Benadryl, and make Rolaids antacid under review by independent consultants. It also had to temporarily shut down parts of six factories that turn out prescription medicines. The company has permanently discontinued at least three minor drug lines after running into manufacturing problems that caught the FDA's eye. In all, the cuts could trim sales growth this year by half, to about 5%, putting 1993 sales at about $5.9 billion.
WARNING LETTERS. The FDA forced such action even while conceding that none of the faults it found in two years of examining Warner-Lambert operations had yet compromised safety or efficacy. The FDA's complaint: The company's plants were out of sync with agency-defined "current good manufacturing practices"--production, quality control, and testing procedures.
Warner-Lambert's anti-anxiety drug Centrax, for example, didn't dissolve in tests as specified. Asthma medicine Tedral didn't meet sustained-release requirements, and the migraine drug Ergostat was subpar in potency tests. There was no health risk, but the manufacturing processes didn't meet standards that FDA Regional Director Richard J. Davis of Philadelphia says exist "to assure that drug products have the strength, purity, and quality that they are purported to have."
Industry experts say the agency has raised the bar since Kessler arrived. "It is not that industry practices have deteriorated, but the FDA has administratively adopted a more rigorous and demanding standard," says Peter Barton Hutt, a former FDA chief counsel who now advises drugmakers. "In companies that got no FDA objections two years ago, all of a sudden inspectors come in and complain about a number of problems."
Agency officials also are writing formal warning letters. Often addressed directly to chief executive officers, they admonish companies to make changes or face product seizures or court injunctions. Top execs at the likes of Merck, Sandoz Pharmaceuticals, and American Home Products, unaccustomed to such stiff regulatory attention, all have received at least one warning this year. The agency sent drugmakers 373 warnings in the year ended Sept. 30, 1992, up from 285 in fiscal 1991.
Drugmakers are acting fast to comply. Warner-Lambert's deVink now personally oversees his company's regulatory-compliance task force. He and others are well aware of the punishment meted out to KV Pharmaceutical Co., a Brentwood (Mo.) maker of generic drugs. Federal agents seized $5 million of KV's products in April after FDA officials said the company had failed to make previously mandated manufacturing changes. The company signed a consent order in June, promising improvements while not admitting violations.
The FDA's toughened oversight has its roots in the agency's problems with generic drugmakers in the late 1980s. The agency was embarrassed when some of its examiners took bribes from several generic outfits. It was appalled when two generic drugmakers submitted doctored brand-name drugs in new-product applications to the agency--a practice it had inadequate guards against.
HAUNTED. Such scandals led the U.S. Attorney in Baltimore to win convictions in prosecutions against 10 companies. One, Halsey Drug Co., pleaded guilty in July, paying $2.5 million, to charges that it added unapproved ingredients to its products. The same U.S. Attorney's office is now investigating the FDA's problems with Warner-Lambert, which says it is cooperating fully with the probe.
The generic scandals begot other strictures now haunting brand-name drugmakers. In 1990, the FDA initiated preapproval reviews, evaluating production lines' compliance with manufacturing rules prior to a new drug's approval. Inspectors now urge delays in about one in three reviews. Such actions were provided additional legal basis in February when a federal judge, ruling in the case of generic drugmaker Barr Laboratories Inc., upheld many of the FDA's complaints about manufacturing practices.
To some in the business, the FDA's continuing crackdown unfairly penalizes drugmakers that already are the world's safest. Commissioner Kessler doesn't see it that way. "We have to make sure what's on the label is what's in the bottle," he explains. If companies don't scrupulously follow the FDA's guidelines for manufacturing, carefully testing sample batches and production processes to prove that each tablet contains what it's supposed to, Kessler says, "I can't give assurances that the drugs are safe." That sentiment is hard to argue with. The question is, are Kessler's methods the best cure?Joseph Weber in Philadelphia and John Carey in Washington