The Food and Drug Administration announced that Wyeth-Ayerst
Laboratories Division of American Home Products Corporation and Wyeth-
Ayerst Pharmaceuticals, Inc. (Wyeth) have signed a consent decree of
permanent injunction in which Wyeth agreed to a series of measures aimed
at ensuring that the products manufactured at Wyeth's Marietta, Pa. and
Pearl River, N.Y. facilities are made in compliance with FDA's good
manufacturing practice (GMP) regulations.
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
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.