Quality deficiencies at the Boehringer Ingelheim-owned CMO (contract manufacturing organisation) placed it at the centre of the drug shortage problem earlier this year. These shortages are expected to worsen after an internal review prompted Ben Venue to suspended manufacture.
“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”, Ben Venue said in statement on Saturday.
Ben Venue is assessing the potential impact of the overdue tasks and will fix problems “as quickly as possible”. The CMO is working with regulators and taking other steps to minimise drug shortages but is yet to predict when production will resume.
The shortage problem
Shortages may worsen while manufacturing is suspended. Earlier problems at the Ohio site led to shortages of Doxil (doxorubicin HCI liposome injection), a cancer drug Ben Venue manufactures for Johnson & Johnson (J&J). In the third quarter sales of Doxil dropped by 87 per cent to $10m (€7m).
Earlier this month Rob Bazemore, president, of J&J-subsidiary Janssen Products, updated patients on the current shortage, which reportedly created a 2,700 person waiting list, but said options to fix the problem are limited. J&J will transition to another manufacturer but the process takes time.
Other clients of Ben Venue, such as Teva, Pfizer and Hospira, must also find alternatives. In August Ben Venue said it will exit the CMO market over the next few years and use the Ohio plant to serve its generic injectables business, Bedford Laboratories.
Suspension of manufacture comes months after Health Canada restricted import of products from the Bedford, Ohio plant. Health Canada acted after an inspection found good manufacturing practice (GMP) deficiencies at the facility.
Since then the US Food and Drug Administration has published a 483 it sent to Ben Venue after an inspection in May. The 33 page letter lists 48 quality concerns raised by FDA inspectors.