Fallout from the closing of a Ben Venue Laboratories' manufacturing facility over quality issues could prove deadly.
The Bedford, OH, facility was the primary source of methotrexate, which is used in the treatment of childhood leukemia. Shortages are now so severe, that within two weeks thousands of children could begin dying from a curable disease, The New York Times reports. The FDA has turned to foreign suppliers and other domestic makers of the treatment in a desperate attempt to avert a tragedy.
"This is dire," Valerie Jensen, associate director of the FDA's drug shortages program, told the Times. "Supplies are just not meeting demand."
Boehringer Ingelheim's Ben Venue Laboratories ceased most operations at the facility in November because of quality concerns. In fact, the problems there were so severe, Canada had banned 17 drugs from the facility. The company tried to maintain some operations while working to remedy problems raised in FDA inspections, but it said in late December that work on the facility required its closure. Officials said at the time that one facility at the campus needs "major reconstruction" that may stretch 9 months. "We anticipate that no products manufactured in the North facility will be available ... before the fourth quarter of 2012," the statement said.
"For a variety of reasons, I cannot disclose manufacturing information or timelines for specific products," Ben Venue spokesman Jason Kurtz said in an email Monday. "Because our highest priority is to deliver safe and effective products to patients, we are working diligently to resume manufacturing of this and other medicines as quickly as possible."
A Feb. 8 FDA update of the availability of Bedford Laboratories drugs listed "Methotrexate 50mg Inj SDV 2 mL BDF 10s and Methotrexate Inj Lyo 1g SDV 30 mL BDF 1s," pending release, and four other sizes as being out of stock.
The preservative-free drug is injected into the spine of patients to fight acute lymphoblastic leukemia, a cancer that most often strikes children between the ages 2 and 5, but which can be curable with treatment. Methotrexate is also used to treat rheumatoid arthritis.
Jensen told the Times the four other U.S. manufacturers of methotrexate were working to expand production, and the FDA is seeking a foreign supplier to provide emergency imports until the approved domestic supplies can meet demand.
"We're working on many fronts, and will keep this a priority," Jensen said.
The Ben Venue plant also was the sole manufacturer of the cancer drug Doxil for Johnson & Johnson ($JNJ). Several thousand patients have been put on a waiting list, as new supplies are not expected until the end of the year at the earliest.
Ben Venue has said it would get out of contract manufacturing over the next several years and dedicate operations of the Bedford plant to manufacturing of generic injectables for Boehringer Ingelheim's Bedford Laboratories.
- here's The New York Times story
Ben Venue shutdown strains J&J drug supply
Ben Venue lengthens remediation timeline