In a statement last week the agency said production of the drugs – both of which are used to treat cancer – should be moved from Ben Venue’s plant in Bedford, Ohio, US to alternative facilities in light of concerns about manufacturing practices at the site.
Production of Caelyx – which is sold by J&J unit Janssen-Cilag International – will be moved to an as yet undisclosed alternative facility by September this year, while Ceplene – sold by Epicept – will be relocated by the end of 2013.
The problem is that Ben Venue’s Bedford facility is the only production site in the world authorised to make Caelyx and Ceplene for the European market, meaning that the two treatments could soon be in short supply.
As a result the US contract manufacturing Organisation (CMO) – which ceased all production operations in November - will continue to supply both drugs from existing stocks until the transfer is completed.
Ben Venue – which is part of privately-owned German drugmaker Boehringer Ingelheim –announced plans to get out of the business last August but has not said when it intends to wind up operations.
Sole supplier responsibilities
The EMA’s recommendation comes just a few weeks its US counterpart - the Food and Drug Administration (FDA) - set out drugmakers’ responsibilities in the event of potential shortages under section 506C of the Food Drug & Cosmetics Act.
In the document it says that: “Sole manufacturers [a firm which is the only producer of a particular drug] are required to report to FDA discontinuances of drug products that are life-supporting, life-sustaining, or intended for use in the prevention of a debilitating disease or condition.”
This rule applies to both drugs are produced in-house and those whose manufacture is outsourced to a third-party – as is the case with those made by Ben Venue.
In such circumstances the FDA explained that: “The application holder is responsible for establishing processes with contract manufacturers that ensure the application holder’s compliance.”