EMA pulls cancer meds made by troubled CMO
More bad news for customers of the contract manufacturer Ben Venue Laboratories: European authorities are recalling three cancer drugs made by the Boehringer Ingelheim unit and putting restrictions on use of a fourth, Outsourcing Pharma reports. The move by the European Medicines Agency comes after Ben Venue said it would halt production at its Ohio plant to handle overdue maintenance.
The recalled meds are all blood-cancer treatments--Johnson & Johnson's Velcade, Pierre Fabre's Busilvex, and Celgene's Vidaza--and have alternate suppliers. The restricted drug is an ovarian cancer treatment, Caelyx, marketed by J&J in the U.S. as Doxil; it's been running scarce for several months due to problems at the Ben Venue plant. It's because of that shortage the EMA decided to leave Caelyx on the market. J&J is now in the process of transitioning Caelyx/Doxil production to a new contract manufacturer.
Ben Venue officials decided to put the Ohio plant on idle during a joint inspection by regulators from U.K., U.S. and France, Outsourcing Pharma said, and this same inspection triggered the recalls. It's just the latest snafu for Ben Venue this year. Batches of other drugs were recalled. Health Canada restricted imports of the company's products. Equipment failures touched off the Doxil shortage. It's no wonder the company has decided to ease out of the CMO market over the next couple of years.