Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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T00-48 Print Media: 301-827-6242
October 3, 2000
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The consent decree was submitted to the U.S. District Court in Knoxville, Tennessee by the Department of Justice on behalf of FDA and is subject to approval by the court.
The government's action in this case follows inspections completed at the Marietta and Pearl River facilities earlier this year during which FDA found deviations from FDA's GMP regulations, including issues related to quality control.
In the months since FDA completed its inspection of the Marietta facility in February, FDA has been working with Wyeth to ensure that the firm's manufacturing problems are being corrected. Wyeth, on its own initiative, temporarily closed a portion of its Marietta facility to address the issues raised during the inspection and to make other facility improvements. Wyeth has made substantial commitments to the agency and has retained independent expert consultants to verify the remedial measures being implemented by the firm.
The consent decree signed today by Wyeth and three of its top corporate executives will ensure that Wyeth keeps its commitments to the agency. Under the consent decree, Wyeth will retain independent expert consultants to conduct comprehensive inspections of its Marietta and Pearl River operations. Their reports will be provided to FDA. The firm has agreed to address any observations made by the expert consultants in accordance with a schedule approved by FDA and to pay $15,000 per day for failure to meet the schedule (up to a $5,000,000 cap). FDA will re- inspect both facilities when the agency believes it is appropriate.
Wyeth also agreed to pay $30,000,000 to the U.S. Treasury within 15 days after the consent decree has been entered by the court. The government sought this money as the equitable remedy of disgorgement based on the firm's deviations from the GMP regulations.
Under the terms of the consent decree, the expert consultants retained by Wyeth will also evaluate Wyeth's quality assurance program at all of the firm's facilities, and review the manufacturing records for batches of products produced at the Marietta and Pearl River facilities after the consent decree is entered by the court. The expert consultants will also conduct yearly inspections of both facilities for a period of four years.
Flu vaccine is one of the products Wyeth makes at the Marietta facility, and the signing of the consent decree will not interrupt its production. The firm has reported to FDA that it anticipates beginning to ship the vaccine by mid-October and that it expects to manufacture and distribute approximately 24 million doses of flu vaccine this year.
The actions being taken by Wyeth and the provisions of the consent decree should ensure the continued quality of the firm's products, including flu vaccine.
The consent decree also resolves the disposition of certain products that were manufactured at the Marietta facility before FDA's November 1999 to February 2000 inspection and seized in June by the Department of Justice on behalf of FDA.
Previous FDA inspections of the Marietta facility in August- September 1995, June 1996, and September-October 1998 found GMP deviations that resulted in the issuance of two warning letters and a regulatory meeting between FDA and Wyeth.
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