Boehringer Ingelheim has given up on its troubled sterile injectables plant in Bedford, OH, which may forever be remembered for the bucket of urine that FDA inspectors found in the production area. It is closing the plant, ceasing production by the end of the year and laying off 1,100 employees beginning this month.
The company said interim steps to maintain quality have been effective, but given the age of the plant, the "magnitude of continued investment and time required to overcome the systemic manufacturing challenges is not viable." It said it had already spent $350 million on upgrades but projected $700 million in operating losses over the next 5 years to keep it open. It had previously said it would close the older parts of the facility, which is operated by its Ben Venue Laboratories unit, and lay off about 400 workers at the end of the year.
While the company had entered into a consent decree with the FDA this year to insure improvements at the plant, it was allowed to continue to manufacture about 100 essential drugs, like Johnson & Johnson's ($JNJ) ovarian cancer drug Doxil. J&J has been struggling to overcome shortages of Doxil since the contract manufacturing facility ran into issues with the FDA and had to be closed temporarily in 2011. J&J hinted at what was coming with the facility earlier this month when it notified doctors that new shortages of Doxil would start in mid-October. J&J said it was attempting to get new producers qualified by the FDA but in court filings said it would be the end of next year before that happens. J&J has sued Ben Venue over the problems.
Ben Venue, for its part, said it understood the plant closure would be a blow to clients. In a release, it said, "Boehringer Ingelheim recognizes the importance of Bedford Laboratories, Ben Venue's generic sterile injectables business, and is exploring strategic options to try to continue the supply of these products to patients."
- here's the announcement