Ben Venue Laboratories, based in Bedford, OH, is ceasing all operations of its generic sterile injectables business by the end of 2013. The company has had ongoing support from the FDA for the production of Johnson & Johnson's cancer drug Doxil, which has suffered shortages, and invested more than $350 million in facility upgrades, but maintains it is unable to sustain production. The closure impacts all of Ben Venue’s 1,100 employees.
Interim controls were effectively put in place to assure product quality after manufacturing issues were found in 2011, however, according to the company, continued investment and time required to overcome the manufacturing challenges is not viable. According to third-party current cGMP experts and ongoing remediation efforts, Ben Venue projects additional operating losses of approximately $700 million in the next five years.
Ben Venue has notified the FDA and is working to help minimize the potential impacts of this decision and ensure that the critical medicines produced at the facility continue to reach patients. Parent company, Boehringer Ingelheim, is exploring strategic options to try to continue the supply of these products.