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Ben Venue Enters Consent Decree



By Gil Roth



Published January 23, 2013
Ben Venue Laboratories, a Boehringer Ingelheim subsidiary, has voluntarily entered into a consent decree with the FDA relating to its GMP requirements. Under the terms of the consent decree, BVL is permitted to continue to manufacture and distribute more than 100 "important drugs that are essential for patient care," according to a company statement. The company conducted both contract manufacturing and generics business (as Bedford Laboratories) through the Bedford, OH site.

Doxil, a key cancer drug from Johnson & Johnson that was manufactured by BVL is in the process of being transferred to another contract manufacturer. In its earnings call yesterday, a J&J spokesman, said that the company has "made significant progress to restore a reliably supply [of Doxil]. An alternate manufacturing approach consisting of a collaboration between [BVL] and another supplier to complete end-to-end production of Doxil was approved in the EU and Japan late in 2012 and in Canada earlier this month." The U.S. supply of Doxil, also manufactured by BVL and a second CMO, was restored fully in October 2012.

BVL is permitted to continue drug-development activities, and may file abbreviated new drug applications (ANDAs). If remediation progresses to the FDA’s satisfaction, it may receive ANDA approvals and manufacture other products. The consent decree is subject to approval by the U.S. District Court for the Northern District of Ohio.

So far, BVL has spent more than $300 million to upgrade its facilities, making improvements and changes to processes to address the manufacturing-related issues that resulted in the company’s decision to voluntarily halt manufacturing in November 2011. An FDA inspection in May 2011 resulted in a 33-page 483 Warning Letter, while the FDA's most recent inspection in November-December 2011, led to 10 separate cGMP deviations.

The company has worked steadily to improve its manufacturing processes, and announced in October 2012 that limited production had resumed. Since that time, production has resumed on additional manufacturing lines.


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