FDA Fines Vaccine Maker for Manufacturing Violations

From the WebMD Archives

Oct. 3, 2000 (Washington) -- A maker of the flu vaccine has agreed to pay a $30 million fine for repeated violations of federal manufacturing rules -- violations that may have contributed to the recent delay in shipments of the flu vaccine to doctors' offices.

Wyeth-Ayerst Laboratories, a division of Madison, N.J.-based American Home Products, on Tuesday signed a consent decree with the FDA for manufacturing violations dating back to 1995 at its plants in Marietta, Pa., and Pearl River, N.Y. -- where among other things, the company manufactures a flu vaccine.

The FDA says no contaminated products were found at either plant, and no cases of illness are known to have resulted from the manufacturing violations. But the agency pursued the consent decree because manufacturing practices at those plants violated rules meant to ensure that drugs are kept sterile and are of the highest quality, FDA representatives said.

Wyeth-Ayerst did not correct these violations despite repeated warnings and even the seizure last June of numerous prescription drugs and vaccines made at one of the plants, the FDA said.

In the meantime, the company was forced to stop manufacturing the vaccine, which may have contributed in part to this year's shortage of the flu vaccine, an FDA spokeswoman confirms. But under the consent decree, Wyeth-Ayerst will be able to keep manufacturing the vaccine if it can provide assurances it will be manufactured in line with federal standards, she tells WebMD.

Until now, officials have said the primary reason shipments of the flu vaccine were being delayed was because manufacturers have had trouble producing the correct strain of influenza needed to make it.

Wyeth-Ayerst says it anticipates resuming shipment of the flu vaccine by mid-October and expects to manufacture and distribute approximately 24 million doses by late December.

"We have confidence in the purity, safety, and effectiveness of our products," says John Stafford, chairman and CEO of American Home Products. "We are in the business of protecting and improving people's health. Our commitment to this mission has never wavered. It is a tremendous responsibility, and I am confident we are effectively addressing all FDA concerns."

Under the consent decree, the company also agreed to hire expert consultants to help put things in order, and to pay a fine of $15,000 per day for failing to address any shortcomings seen by those experts within a certain period of time. The company also agreed to undergo a series of inspections by federal regulators to ensure all the violations have been addressed.

The consent decree, which was submitted to the U.S. District Court in Knoxville, Tenn., is awaiting court approval.

For more information from WebMD, see Flu Shots All Around?