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This article was originally published in The Tan Sheet

Executive Summary

WARNER-LAMBERT CONSENT DECREE NOT EXPECTED TO AFFECT OTC SUPPLIES, the company is telling customers in a letter to explain an Aug. 16 consent decree with FDA covering manufacturing problems at six of the company's U.S. and Puerto Rico plants. The letter, sent to more than 350,000 pharmacists, physicians, retailers and wholesalers states: "While we don't expect any interruptions in supply for any our OTC products, spot shortages may occur." Under the consent decree, Warner-Lambert has suspended manufacturing of its prescription and OTC product lines with the exception of certain prescription drugs declared "medically necessary" and investigational drugs. Except for prescription drugs Dilantin and Nitrostat, the company is required by the consent decree to submit either manufacturing certifications from outside consultants or remedial action plans to FDA for each product" within 120 days of entry" of the decree, which was filed in Newark federal court. In an Aug. 16 "Dear Colleague" letter, Chairman and CEO Melvin Goodes said Warner-Lambert does "not anticipate any significant disruption in the marketplace" because the company has "substantially" completed "much of the certification work." Warner-Lambert said it will continue to ship OTC and Rx products manufactured at the company's mainland U.S. plants from inventory stocks while it conducts laboratory and product certifications. The anticipated consent decree covers Warner-Lambert's six drug manufacturing facilities in the mainland U.S. and Puerto Rico and requires the company to bring its manufacturing procedures into compliance with current good manufacturing practices ("The Tan Sheet" July 12, p. 16). The plants are located in Morris Plains, N.J., Lititz, Penn., Rochester and Holland, Mich. and Vega Baja and Fajardo, Puerto Rico. The decree does not prohibit the manufacturing and distribution of Benadryl 25 mg tablets and capsules, and solid oral dosage forms of maximum strength Sinutab and Rolaids, provided certain requirements are met. Warner-Lambert said that Rolaids is continuing to be manufactured and made available. In the next several days, the company expects to be producing new supplies of its OTC products, including Benadryl, Sinutab and Listerine. The consent decree does not affect the OTC products Efferdent, Replens, and EPT. A section of the consent decree dealing with the Vega Baja and Fajardo, P.R. facilities discusses the necessary requirements for continued manufacturing and distribution of Benadryl, Sinutab, and Rolaids as well as a number of the company's important prescription drugs. The degree does not prohibit the manufacture of the Benadryl and Sinutab products after the company has "submitted for the last 50 batches of product manufactured prior to entry of this decree": "a summary of all test data for the product including, but not limited to, all in-process testing, all release testing, and all stability testing; past validation studies relevant to the current manufacturing process; all failure investigations; and all test deviation reports." The company must also send a certification signed by a responsible employee saying that all test data and other data "are complete and accurate." Benadryl and Sinutab can be distributed after FDA notifies Warner-Lambert that "the manufacturing process appears to be validated"; an expert certifies that methods, facilities and controls used to produce the product are in conformity with regs; and "a qualified outside laboratory [performs] release testing on each batch of the product manufactured during the 180-day period prior to release of the product, [and] initiate the required stability testing." Rolaids can be manufactured and distributed "if a qualified outside laboratory performs release testing on each batch of product manufactured after entry of this decree." The lab must test each batch until FDA notifies the company that the facility appears to be in compliance. Prior to distribution, experts must certify the quality of each batch of Rolaids. Warner-Lambert cannot manufacture or distribute drugs at the Morris Plains, Lititz and Rochester facilities until an expert certifies each lab and FDA authorizes distribution of products, or an expert certifies the manufacturing processes and validations. Many Warner-Chilcott generics as well as some OTC drugs are made at the Lititz facility. FDA will continue to inspect the plants and examine manufacturing and testing records. Under the decree, the agency has the authority to have the company recall any product not meeting GMP standards. The consent decree follows a number of plant inspections and meetings with FDA. The agency became concerned about Warner- Lambert's stability program during 1991 inspections of the Puerto Rico plants. Compliance problems at the facilities included not reporting product stability problems to FDA until employees were confronted during inspection, repeated retesting as a means of obtaining passing stability results and conducting inadequate investigations into out-of-specification results and product complaints. Further evidence of these GMP problems and other problems were obtained during 1992 inspections by FDA. Early 1993 inspections cited continuing problems with the stability program. Agency inspections eventually spread to Warner-Lambert's mainland U.S. facilities. Since November 1992, the company has issued at least 17 drug recalls. Four of the recalls were for prescription Dilantin Kapseals that failed dissolution tests or had incorrect expiration dates. Although the consent decree was just issued, Warner-Lambert has been working with FDA on the agreement since February. Apparently, finalization of the decree was drawn out due to the number of GMP issues and continuing discussions. Warner-Lambert is being represented by Bruce Kuhlik and Peter Barton Hutt of Covington & Burling and by James Altieri of Shanley & Fisher, Morristown, N.J. The consent decree "requires Warner-Lambert to pay damages resulting from violations of the injunction and the agency's costs associated with this continuing oversight," FDA said. "The impact of the decree is expected to result in an aggregate loss of sales revenue of approximately $ 150 mil. in 1993," company President and Chief Operating Officer Lodewijk de Vink stated in a release. "The losses will result from discontinuation of certain lower- volume prescription products produced in Puerto Rico and losses associated with interruptions in product distribution. As a result, 1993 revenues should be in the range of $ 5.9 bil." Warner-Lambert also is the subject of a grand jury investigation into fraudulent activity. The company reported last autumn that FDA had discovered discrepancies in data submitted for products manufactured at the Puerto Rico facilities. The consent decree is significant not only in the extent of its reach and requirements, but also because it is the first court-approved agreement, in recent memory, requiring GMP compliance by a major pharmaceutical company. In October 1989, FDA reached a voluntary agreement with Lilly to correct extensive compliance problems at its Building 100 manufacturing facility in Indianapolis. The agreement permitted Lilly to distribute drugs from the facility on a product-by- product basis. The agreement came two months after issuance of a highly publicized inspection report. Similar to the Warner-Lambert case, Lilly was cited by FDA for lack of investigations into the reasons for recurrent product and process failures. Another FDA concern at Lilly was the recurrence of unapproved reprocessing due to the absence of a validation system. FDA publicly has stated that it is no longer accepting voluntary agreements by companies to correct serious GMP compliance problems and instead will use consent decrees ("The Tan Sheet" Aug. 2, p. 17). Consent decrees have been signed with companies including KV Pharmaceutical, Halsey Drug and Biopharmaceutics.

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