Ben Venue's manufacturing QA troubles, which prompted the voluntary closing of its Bedford, OH plant, have rippled across the Atlantic. The European Medicines Agency issued a precautionary recall of some cancer and antiviral drugs made at the plant. The EMA has also recommended that no new patients begin treatment with an ovarian cancer drug. The actions stem from risk of batch contamination.
The European regulator took the action last week. Earlier in the month, U.K. and French regulators joined the FDA in an inspection of the facility. Ben Venue, a unit of Boehringer Ingelheim, announced the plant shutdown Nov. 19.
The EMA cited "shortcomings in the quality management system, particularly in relation to the aseptic filling process," in an announcement. The site "has been the object of increased GMP surveillance."
Ben Venue said in a statement Saturday that preventive maintenance and the requalification of some manufacturing equipment had been overlooked and were past due. It discovered the oversight while reviewing internal records. The manufacturer now wants to check additional site documentation and begin whatever corrective actions may be necessary. The drugmaker announced in August it would exit the contract manufacturing business over the next several years. It plans to turn over the plant to its Bedford Labs unit for the manufacture of generic injectables.
The recalled oncology drugs are Pierre Fabre's Busilvex, Johnson & Johnson's ($JNJ) Velcade and Celgene's ($CELG) Vidaza. Vistide, from Gilead ($GILD), is the recalled antiviral. All were manufactured at Ben Venue's North Complex, according to the announcement, which is where the EMA said GMP issues pose the greatest risk.
Only those medicines that are "absolutely essential to meet patients' needs," and are unavailable from other sources will continue to be manufactured, according to the EMA statement. The agency considers Caelyx essential for patients already on treatment, and Ben Venue is the only source. Other manufacturers supply Europe with Busilvex, Velcade and Vidaza.
- here's the EMA announcement
- see the Ben Venue release
- here's more