• 06
  • January
    2012

According to a new inspection report by the U.S. Food and Drug Administration, multiple problems have been discovered at the Ben Venue Laboratories Inc. facility, which produces the cancer medication known as Doxil.

The issues are serious enough that they could produce a defective drug due to the lack of investigations of defective batches and from the lack of equipment maintenance. There has also apparently been a lack of follow-up procedure and failure to follow even standard procedures in manufacture of the drug.

Air sample monitoring has been incorrect, due to the facility not identifying their sources, and staff failed to have adequate training and technical expertise. Also, no data was found to have shown acceptable levels of sterility. Another offense involved the lack of a follow-up on a 10-gallon container holding a liquid later identified as urine.

The FDA's quality unit dubbed many of the issues as critical, though some were downgraded later. The full report was posted on the FDA's web site.

The company is Doxil's only supplier, and the drug has recently seen a large shortage in the U.S. More than 2,200 people are waiting to receive the drug, and about 2,000 are currently taking it. The drug has stopped being made at the facility in question, which is located in Bedford, Ohio, and is a manufacturer for Johnson and Johnson. About 15 of patient deaths have been blamed on the shortage.

A spokesperson for Ben Venue said the facility's highest goal is its products to be effective and safe. He added the company is cooperating with the FDA in order to continue making the drug.

Doxil has been used to treat cancers including multiple myeloma, Kaposi's sarcoma and ovarian cancer. It was first approved in 1995.

Consumers deserve to have assurance that medications they are taking for serious conditions like cancer are of high quality and effective. It is concerning when the FDA finds quality problems like those detailed in this report.

Source: Associated Press, "FDA finds serious problems in cancer drug factor," Linda A. Johnson, December 7, 2011.