Ben Venue consent decree softened to account for drug shortages

Boehringer Ingelheim unit allowed to manufacture 100 'essential' drugs
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Ben Venue Laboratories' Bedford, Ohio, plant became the poster child of poor-quality manufacturing after FDA inspectors brought the hammer down on Boehringer Ingelheim's contract manufacturing arm in 2011. The enduring image from the whole debacle may very well end up being the 10-gallon container of urine inspectors found, ostensibly used by employees to avoid bathroom breaks.

But the consent decree that Ben Venue just announced with the agency clearly illustrates the fine line the FDA finds itself walking between company accountability and drug accessibility. The decree bars the plant from manufacturing some drugs until the agency is satisfied that problems at the plant have been rectified. But the FDA also is allowing it to continue to manufacture 100 drugs considered "essential for patient care."

The 483 reports from the inspection showed deep problems at the plant. Investigators found more than 100 basic preventative maintenance activities that hadn't been taken care of for at least a month. Fox News reports that court filings made with the consent decree, which still must be approved by a court, said Ben Venue issued 40 product recalls from 2002 until the plant voluntarily closed in November 2011. The closing, however, immediately led to shortages of important drugs such as Johnson & Johnson's ($JNJ) cancer drug Doxil, as well as drugs made by Pfizer ($PFE), Takeda and Bristol-Myers Squibb ($BMY).

The FDA worked to find substitutions and solutions for the shortages, but patients and doctors were unhappy. A U.S. House committee criticized the agency's regulatory aggressiveness, blaming it for four plant closings in which production interruptions created or exacerbated shortages of many drugs. The agency defended its actions as necessary to preserve patient safety but also found itself scrambling to try to deal with the shortages. It even allowed a substitute for Doxil made by India's Sun Pharma. The alternative treatment, Lipodox, was allowed in a "temporary, limited arrangement" until J&J can secure its own Doxil supplies. Through a number of avenues, J&J has gotten Doxil supplies replenished and back into the market.

Ben Venue said this week that it has invested more than $300 million to upgrade the plant since its 2011 closing. It began limited production in October and since then has brought on more lines. The company says it is working with the FDA to meet its expectations and to address shortages. It points out that even under the consent decree, the FDA is allowing it to do drug development and file abbreviated new drug applications that could lead to it taking on new products.

- here's the company release
- read the Fox News story

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