Ben Venue Laboratories has another black eye. We've heard a lot about the ongoing shortages of Johnson & Johnson's ($JNJ) cancer treatment Doxil, the supply of which is suffering from manufacturing snafus at the contract drugmaker. Now, the Ben Venue trouble has spawned a cancer-drug shortage so extreme that U.S. supplies may run out within two weeks.
The scarce drug is methotrexate, used to treat blood cancers and rheumatoid arthritis, The New York Times reports. Ben Venue made an injectable, preservative-free version used to treat acute lymphoblastic leukemia, or ALL, which is most commonly found in very small children. But because of manufacturing shortfalls and quality-control problems, Ben Venue halted work at the Ohio plant where methotrexate was produced.
Ben Venue wasn't the only drugmaker supplying the ALL treatment, but until the plant went on idle, it was among the biggest. As the NYT reports, supplies of the injectable have shrunk so much, oncologists fear they'll run out. "This is dire," FDA Associate Director Valerie Jensen told the newspaper. "Supplies are just not meeting demand."
The four other methotrexate manufacturers are trying to ramp up production, Jensen told the NYT, and the agency is looking for a foreign supplier to ship emergency imports until the FDA-approved ones produced domestically can meet demand. "This is a crisis that I hope the FDA's hard work can help to avert," American Society of Clinical Oncology President Michael Link told the newspaper.
- read the NYT piece