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Ben Venue's consent decree was necessary says FDA; limited manufacturing to continue

By Dan Stanton, 04-Feb-2013

Related topics: Drug delivery, formulation, Regulatory affairs, Contract Manufacturing

The Consent decree was a necessary response to Ben Venue's long history of quality failures says the US FDA.

The consent decree  the US Food and Drug Administration (FDA) agreed with Ben Venue Laboratories last week followed a long running series of quality problems at the contract manufacturing organisation's (CMO's) manufacturing facility in Bedford, Ohio.

FDA spokeswoman, Sarah Clark-Lynn, told Outsoucing-Pharma.com that “Ben Venue Labs has a long history of not meeting quality requirements for drug manufacturing. The FDA felt legal action was necessary to ensure that Ben Venue Laboratories makes safe and effective drugs.”

Various hygiene and bad practice issues at Ben Venue’s plant were picked out by the FDA, including the detection of foreign particles in sterile products, poorly maintained equipment and failures in basic cleaning. The plant has been the source of various product recalls in the past which led to shortages in essential drugs and intervention from the FDA.

The decree, which was signed on January 31, cited the CEO, Vice President of Operations and Vice-President of Quality Operations at Ben Venue as defendants in failing to comply with cGMP requirements following recent FDA inspections.

“BVL is required to develop a plan with strict timelines to meet quality requirements,” said Clark-Lynn. “The firm faces financial penalties if it does not meet these timelines.”

Manufacturing to continue

Earlier today Bloomberg News  reported that manufacturing has ceased at the facility, However, Marjorie Moeling, a spokeswoman for the CMOs parent company Boehringer Ingelheim, told Outsourcing-Pharma.com that: ”The FDA is allowing Ben Venue to continue to manufacture and distribute safe and effective medicines while the site is undergoing remediation.”

This was confirmed by Clark-Lynn from the FDA, who told us that manufacture of more than 100 drugs will be allowed under the decree “to help address shortages of medically necessary drugs” thus avoiding previous problems arisen from the plant.

Drug Shortages

Previous withdrawals of essential drugs and shutdowns in manufacture have caused shortages and forced customers to shift production to other CMOs. Ovarian cancer therapy Doxil , marketed by J&J’s Janssen Products division, has only recently recovered following a turbulent 18 months of production complications due to Ben Venue.

Allowing Ben Venue to continue production, albeit with enhanced controls, is in keeping with procedures implemented by the FDA to keep drugs on the market following manufacturing malpractice.

Other actions by the FDA to avoid shortages include: Working with other manufacturing companies, expediting reviews of new production lines and raw material source approvals and utilizing overseas companies.