Washington (H24N). Drug manufacturer Wyeth-Ayerst was slapped Wendesday with a $30 million fine for failing to abide by Food and Drug Administration (FDA) good manufacturing practice regulations at production facilities in Marietta, Pa., and Pearl River, N.Y.

The Marietta plant manufactures flu vaccine, and its closure due to these violations added to the national shortage of the vaccine.

Under the settlement, Wyeth-Ayerst, which is a subsidiary of $72 billion drug-maker American Home Products, not only must pay the $30 million fine but must have outside consultants inspect and monitor its facilities. The company must also create a schedule that addresses and corrects any problems found by the independent consultants. Failure to comply will result in further fines against Wyeth-Ayerst, $15,000 a day up to $5 million.

John R. Stafford, Wyeth-Ayerst chairman and chief executive officer, commenting on the FDA-Wyeth agreement in a company news release, expressed optimism that the company would resolve the problems: "We have confidence in the purity, safety and effectiveness of our products. The company is committed to ensuring that its manufacturing processes at these two sites conform to the FDA's current good manufacturing practices. 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."

The company's facilities, after signing this agreement with FDA, will reopen, and Wyeth intends to begin shipment of the long-awaited flu vaccine by mid-October. The release of the vaccine has been hampered by not only the closing of Wyeth's Marietta facility but also difficulty developing the flu strain from which to make the vaccine.

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