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This article was originally published in The Tan Sheet

Executive Summary

KV PHARMACEUTICAL PRODUCTS SEIZED BY FDA INCLUDE ALL SOLID- DOSE OTCs, the agency said. Due to KV's noncompliance with good manufacturing practices, investigators from FDA's local branch office seized all solid-dose OTC and prescription products that were "on hand" at the company's St. Louis facility on April 21, including final dosage forms and in-process materials. The OTC products seized include phenylpropanolamine, buffered aspirin, enteric coated aspirin and antacid tablets; OTC vitamins are not among the confiscated products. Prescription products represent most of finished dosage forms seized, FDA said. The agency estimated the value of all the seized drugs at about $ 15 mil. FDA noted that KV has three options in response to the seizure: accept the seizure, contest the appropriateness of the action or enter into a consent decree. FDA investigators and a U.S. marshall entered KV's manufacturing facilities on April 21 with a seizure order based on a complaint filed by the agency in St. Louis district court on April 20. FDA said it asked the U.S. Attorney's office to seal the complaint in order to ensure that the seizure would proceed quickly and efficiently. However, while the complaint is sealed, the agency cannot disclose the specifics of KV's GMP problems. The government has filed a motion to make the complaint public on April 26. FDA pointed out that over the last year it has conducted several inspections at KV that unearthed GMP violations that the firm subsequently failed to adequately address. The most recent inspection spanned from mid-February to March 17. The resulting FD-483 observes that "neither biobatch data nor clinical batch data was provided or reviewed that justifies the commercial manufacturing process and specifications for" drugs marketed under ANDAs or drug master files including nitroglycerin ER caps and theophylline immediate-release caps. In 1992, there were at least two major inspections at KV: July 31-Nov. 3 and March 11-April 23. Also, four prior inspections -- in May-June 1990, March-April 1991, May 1991, and August-September 1991 -- found that "deficiencies existed between the production of the biobatches and the full-scale productions." GMP problems at KV also resulted in at least two recalls of Rx drug products in 1992. The issue of whether recalls will occur following the April 21 seizure will be discussed when the agency meets with KV, FDA said. In addition, a January 1992 FDA warning letter to the firm foreshadowed continuing compliance problems at the company. "You have a practice of correcting the specific deficiencies addressed by the investigators relating to a specific product but you do not follow through in correcting the deficiencies throughout the 'system' to cover all products," the warning letter asserts. St. Louis-based KV Pharmaceutical specializes in drug delivery technology and has a number of arrangements with major pharmaceutical firms to develop and manufacture products using its extended-release technologies. For example, KV's once-a-day oral technology, KV/24, is incorporated in Hismanal-D, which is a combination of Janssen's once-a-day antihistamine and KV's once- daily pseudoephedrine decongestant. Hismanal-D is pending approval at FDA; the combination product is currently marketed outside the U.S. KV also contract manufactures drugs and has product development arrangements with firms including Warner-Lambert. Through its Ethex subsidiary, KV also markets specialty generic products to wholesalers and drug store chains. Separately, generic manufacturer Circa (formerly called Bolar Pharmaceutical) paid $ 3 mil. to KV to settle a suit filed by KV in St. Louis federal court in February 1990. KV had sought $ 149 mil. in damages and terminated the firms' joint venture, citing Bolar's "impaired . . . reputation and trade prestige" due to a FDA audit of Bolar's ANDAs and related "substantial adverse publicity." Since the lawsuit was filed, the Justice Department has successfully prosecuted most of Bolar's former top management team for participating in a scheme to submit fraudulent data to FDA to support generic drug approvals.

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