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WARNER-LAMBERT CONSENT DECREE COVERING REVALIDATION AT ALL GMP FACILITIES

This article was originally published in The Tan Sheet

Executive Summary

WARNER-LAMBERT CONSENT DECREE COVERING REVALIDATION AT ALL GMP FACILITIES is expected to be implemented by a court order in the next several weeks, the company said. The consent agreement would cover Warner-Lambert's manufacturing operations in Vega Baja and Fajardo, Puerto Rico as well as the company's Morris Plains, N.J., Lititz, Penn., and Rochester, Mich. plants. In its 10Q filing with the Securities & Exchange Commission for the first quarter, Warner-Lambert reported that "discussions with the FDA are ongoing concerning the company's prescription and over-the-counter products and its Puerto Rico or other U.S. manufacturing facilities." The 10Q states that "a consent decree or other enforcement action is likely." The company would not discuss the terms of the consent decree. However, such an agreement could order cessation of production of certain or all products produced by the plants until manufacturing processes have been validated and the facilities have been brought into compliance with GMPs. In addition to the GMP problems, Warner-Lambert is being investigated for fraudulent activity. The 10Q states that "certain present and former employees have been served with subpoenas by the U.S. Attorney's office in Maryland to appear before a federal grand jury in Baltimore, which is conducting an inquiry relating to compliance with FDA regulations." The company reported last autumn that the agency had found some discrepancies in data submitted on products manufactured at the Puerto Rico facilities. The extensive compliance problems in Warner-Lambert's Puerto Rico manufacturing plants were revealed last fall in a series of FD-483 inspection reports. Compliance problems appear to persist in those facilities despite a complete revamping of the company's Puerto Rico quality assurance unit and statements by Warner- Lambert to FDA that the company would apply all the resources necessary to correct the problems. Warner-Lambert's compliance difficulties have spread well beyond Puerto Rico. Over the last few months, FDA officials have been conducting inspections at W-L's U.S. facilities and have uncovered GMP violations at each one. Since November 1992, Warner-Lambert has issued 17 recalls for products made at its U.S. and Puerto Rico facilities -- nearly all of which are prescription products. While the vast majority of the products recalled were from Warner-Lambert's Puerto Rico facilities, the company's Morris Plains and Lititz plants had two recalls each, of Dilantin and Benadryl. In the 10Q, Warner-Lambert notes that "depending on the terms and conditions of any such enforcement action, the effect upon the company's results of operations could be material." Warner-Lambert reported that the manufacturing difficulties in its Puerto Rico plants cost the company $ 50 mil. in the first half of this year. Cognex became "approvable" on May 10, but the agency has yet to approve the priority drug. Warner-Lambert has maintained that labeling issues are under discussion; however, in light of the pervasive compliance problems documented by FDA at the company's Puerto Rico facilities, manufacturing may also be an issue in the Cognex discussions. Recently, drug wholesalers were informed that Warner-Lambert may halt production temporarily of six additional products, reportedly in order to devote those production resources to the scale-up of Cognex for marketing. The products, which wholesalers were told would become unavailable for up to two months, include Anusol HC cream and suppositories.
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