Published November 20, 2014
A troubled contract manufacturer, whose problems caused a shortage of Johnson & Johnson's cancer drug Doxil, has suspended manufacturing and distribution of products from its Ohio plant, saying routine preventive maintenance and other required actions were overdue.
The action is likely to exacerbate a Doxil shortage that has persisted since the summer and has cut off treatment for many cancer patients, Dow Jones Newswires reported Saturday.
Ben Venue Laboratories Inc., the contract manufacturer, also is the sole-source supplier of other medically necessary drugs on behalf of several drug companies.
Ben Venue, a division of Boehringer Ingelheim GmbH, said in a statement Saturday, "A recent internal review of documentation indicated that routine preventive maintenance and requalification of some manufacturing equipment did not occur at the specified time interval, and is overdue."
The company is conducting a site-wide assessment at its Bedford, Ohio, plant to help determine potential corrective actions that may be needed immediately to restore production.
J&J spokeswoman Monica Neufang said the Ben Venue action will impact the production and release of Doxil. "We do not know when Ben Venue will begin manufacturing any drug product again," she said.
Ben Venue, which specializes in sterile, injectable products, has been grappling with several deficiencies identified by government regulators at its Bedford plant, including contamination issues. Earlier this year, equipment failures caused unplanned downtime, which led to the Doxil shortage.
Ben Venue said it notified global regulatory agencies of its voluntary manufacturing suspension. The company said it is assessing stock levels and anticipated demand to try to minimize impact to product supply in the marketplace.