The chemotherapy drug Doxil may soon be in short supply. That’s bad news for women battling ovarian cancer, patients with cancer of the blood, and those suffering from AIDS-related Kaposi’s sarcoma. Ben Venue Laboratories Inc., the sole manufacturer of Johnson & Johnson’s cancer drug Doxil, announced they will be shutting their doors by the end of the year. UPDATE: (12/19/2013) J&J strikes deal to Manufacture Doxil itself at Ben Venue Plant
The announcement comes after years of warnings from the Food and Drug Administration, citing Ben Venue for “repeatedly failing to comply with good manufacturing practices.” Violations at the Bedford, Ohio drug manufacturing company included metal and plastic particles in sterile products and basic facility cleaning and maintenance issues. In 2011, an inspector famously discovered a 10-gallon barrel full of an “unknown substance” that was later determined to be urine. Soon after, the troubled company voluntarily shut down production.
In 2012, Johnson & Johnson petitioned the FDA to allow Ben Venue to resume production of Doxil due to a drug shortage and Ben Venue entered into a constant decree with the FDA. The provisions of the agreement allowed for the production of Doxil and other drugs in short supply if certain quality control measures were met.
Despite more than $300 million spent in upgrades to their facilities, the company, a subsidiary of German drugmaker Boehringer Ingelheim, released a statement that the company would be unable to return to a sustainable level of production. “The magnitude of continued investment and time required to overcome the systemic manufacturing challenges is not viable,” the company said.
Johnson & Johnson has filed suit against Ben Venue and Boehringer Ingelheim for failing to fulfill contractual obligations to produce Doxil.
“Boehringer Unit That Makes J&J Doxil and Other Drugs Will Shut Down” by Jonathan D. Rockoff, The Wall Street Journal, October 3, 2013.