Tuesday October 3 6:44 PM ET
Wyeth-Ayerst Pays for Violations

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON (AP) - A major vaccine manufacturer agreed Tuesday to pay a $30 million fine for repeatedly violating federal drug-quality rules at two of its manufacturing plants, including a flu-shot factory whose temporary closure contributed to this year's delay in flu vaccine.

Wyeth-Ayerst Laboratories signed the consent decree with the Food and Drug Administration (news - web sites), which also requires the Pennsylvania-based company to take specific steps to improve quality at the plants on a preset schedule or face up to $5 million more in fines.

The FDA said it never found contaminated Wyeth products and is aware of no illnesses. It nevertheless called the manufacturing problems serious violations of rules meant to ensure that drugs and vaccines are sterile and of high quality.

The consent decree was prompted because Wyeth did not correct violations despite repeated FDA inspections, warnings and even the seizure last June of hundreds of doses of prescription drugs and vaccines made at one of the substandard plants, FDA said.

The factories are in Marietta, Pa., and Pearl River, N.Y. The violations dated back to 1995.

``Thirty million dollars is substantial money to us, no doubt about that. It is clear that FDA did regard these problems as problems that needed more attention and a faster pace than we achieved,'' said Dr. Bruce Burlington, Wyeth's senior vice president, who formerly worked at the FDA.

``We've been working hard on those problems,'' Burlington said. Among other steps, Wyeth hired outside quality consultants to tell FDA how the violations were being corrected; the federal agency also must reinspect the factories.

Among products made at the problem plants is flu vaccine.

Shipments of flu shots to doctors' offices are being delayed this fall, which has prompted federal officials to urge that the first available vaccine be given to elderly and chronically ill. The reason: All vaccine makers had trouble producing the right influenza strain, plus FDA-discovered manufacturing problems caused some companies temporarily to stop production.

All Wyeth's flu vaccine-related problems have been fixed and production restarted, Burlington said. Wyeth should begin shipping flu shots by midmonth and expects to have produced 24 million doses by the middle of December.

To guard against health problems, the FDA does not allow flu or other vaccines to be sold until samples have passed safety tests. ``FDA is going to be closely monitoring the firm's compliance under the consent decree,'' said spokesman Lawrence Bachorik.

The consent decree is subject to federal court approval.

Although it is fairly rare for FDA to go to court over manufacturing violations, Wyeth's consent decree is not the agency's most severe: Abbott Laboratories last year paid a $100 million fine and stopped selling 100 products until violations were corrected.

But it is the latest in a string of problems for Wyeth and its parent company, New Jersey-based American Home Products. In recent years, the companies pulled off the market the childhood diarrhea vaccine RotaShield after infants suffered bowel obstruction; paid $4.83 billion to settle claims that the diet drug fenfluramine caused heart problems; withdrew the painkiller Duract because of fatal liver toxicity; and agreed to a multimillion-dollar settlement of lawsuits claiming the Norplant contraceptive caused side effects.

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