Boehringer Ingelheim's Ben Venue unit signed a consent decree with the FDA in January over the Bedford, OH, operations, a facility that had become the poster child for drug manufacturing and quality lapses. But that agreement did not end the company's legal entanglements over the plant, whose run-in with the FDA led to supply disruptions for a host of drugmakers.
Johnson & Johnson's ($JNJ) ovarian cancer drug Doxil was among those, and J&J has sued a unit of Germany's Boehringer, Bloomberg reports, saying the company breached its 2009 agreement to make Doxil. The action seeks to force Boehringer Ingelheim into arbitration. "BI's breach of the agreement cannot be seriously disputed," J&J said in the lawsuit, according to Bloomberg, which was unable to get a comment from Boehringer.
Manufacturing and sterility problems at Ben Venue Laboratories, the unit of Boehringer Ingelheim that makes Doxil, forced the contractor to suspend operations in November 2011. By February 2012, FDA Commissioner Margaret Hamburg had turned to India's Sun Pharma to temporarily import Lipodox, a Doxil substitute that the FDA had not approved. Earlier this year, the FDA approved a generic version of Sun's drug for the U.S. market to help ease the shortage. Still, J&J's suit says, "Although sales of most brand drugs rapidly diminish when a generic version is introduced, utilization of Doxil has remained high."
The Bedford plant manufactured so many drugs for so many companies that the FDA found itself walking a fine line between accountability and availability when it drew up the consent decree. It bars the plant from manufacturing some drugs until upgrades are made, but it also allowed the company to continue to produce 100 drugs during remediation because they were considered "essential for patient care." J&J looked for an alternate supplier for Doxil but also devised a multi-step process in which Boehringer did some of the production, but the drug was finished at another facility. The steps paid off and shortages abated.
Ben Venue has said it intends to get out of contract manufacturing and concentrate on its own generic sterile injectables business. The company has invested more than $300 million on improvements at the Bedford, OH, plant since the 2011 citation. But it also decided to close down some of its older facilities and said in June it "will concentrate production in the company's newer, more commercially sustainable facilities." It is laying off up to 400 workers by the end of this year. About 800 people will continue working at the manufacturing complex.
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