FDA Investigation Finds Serious Issues in Cancer Drug Factory

FDA Investigation Finds Serious Issues in Cancer Drug FactoryA recent inspection of a factory owned by a contract manufacturer for Johnson & Johnson’s cancer treatment drug Doxil found that the company has allegedly not been maintaining its equipment properly, has failed to investigate defective product claims in a timely manner and faced other serious problems at a Bedford, Ohio facility.

According to The Associated Press, the report details lax quality control, failure to follow standard procedures and one instance of a container of urine that was found in the Ben Venue Laboratories Inc. manufacturing plant, which develops sterile medicines.

According to the the National Library of Medicine, Doxorubicin, or Doxil, is used to treat several forms of cancer, including breast, ovarian, bronchogenic, thyroid and gastric. The medicine has already been known to decrease the number of blood cells found in a patient’s bone marrow, and prolonged use of the injected drug has also been linked to severe heart damage years after discontinuation.

The medication has been in short supply in 2011, creating a crisis that has been linked to 15 deaths, and has disrupted patient care and clinical testing of other drugs.

Currently, only 2,000 patients are receiving the drug due to the short supply, while another 2,240 are on a waiting list for the drug.

Ben Venue stated that it has temporarily stopped manufacturing and distribution of the products made at the Bedford plant. Company spokesman Jason Kurtz told the AP that now, the company is “working diligently to assess and implement the appropriate corrective actions to address the observations of the FDA investigators.”

“Our highest priority is the delivery of safe and effective products to patients,” he wrote in an email. “We are continuing to work closely with the FDA with the goal of bringing the products we make back to patients as quickly as possible.”

The report, posted on the FDA’s website, lists findings from visits between November 7 and December 2, and discussed several issues that were not quickly resolved or reported to the plant’s managing staff.

One investigation included a 10-gallon can, which was found in a storage area and contained urine, while another sought the source of microbial contaminants that were found in air samples taken from manufacturing areas.

J&J spokesman Lisa Vaga stated the company has no information on when Ben Venue will restart shipments of Doxil.