Doxil supplies going further but J&J CMO uncertainty remains

Patient status and changes to prescribing decisions have left Johnson & Johnson (J&J) with enough Doxil (doxorubicin HCl liposome injection) to supply patients on its waiting list. However, the longer-term vision is bleaker.

“We do not anticipate new supply from our third-party manufacturer until late 2012​”, J&J said on its Doxil website. The news follows the decision by the CMO (contract manufacturing organisation) supplying Doxil, Ben Venue Laboratories, to extend the shutdown at its Ohio, US production plant.

After making the decision Ben Venue said some manufacturing could restart in the first quarter but products from the troubled North facility are unlikely to reach patients until the end of the year. J&J updated patients on the development and said it is working to find an alternative source.

“We continue to pursue a variety of options to bring a consistent supply of Doxil back to patients and physicians as quickly as possible​”, J&J said. In December J&J said it hoped to have an update about its search for a new supplier by early this year.

Substandard threat ​

The US Food and Drug Administration (FDA) has warned healthcare professionals that shortages of injectable cancer drugs, such as Doxil, could prompt “unscrupulous individuals​” to sell substandard products.

“FDA is aware of promotions and sales of unapproved injectable cancer medications direct-to clinics in the US, which most likely were administered to patients​”, the Agency said. Failure to transport the injectables under appropriate conditions could have affected quality and threatened patients’ health.

To cut the risk of prescribing substandard cancer drugs the FDA says healthcare professionals should only use approved medications bought directly from the manufacturer or distributors licensed in the US.