Quality problems have wreaked havoc on the U.S. drug supply, with most drug shortages tied to production halts after the FDA delivered warning letters to drugmakers. In fact, a survey of oncologists at a meeting this week in Chicago found that a majority have had to deal with a shortage for patients in the last 6 months. But the FDA has a good news for them and the patients who have had to miss treatments or switch drugs because their cancer medications are in short supply.
Valerie Jensen, the FDA's associate director, drug shortages, told Bloomberg that the agency has 25 employees working on each of the 133 medication shortages the FDA currently has listed. There are 10 cancer drugs on the list, and she said the FDA expects to resolve all of those shortages soon. "We aren't out of the woods yet," Jensen said about the shortage issue but said a new law passed last year requiring drugmakers to quickly report the possibility a shortage will arise has allowed the agency to work sooner to find alternative supplies.
The news comes even as surveys released this week at the American Society of Clinical Oncology (ASCO) meeting said 83% of cancer doctors dealt with a shortage in recent months. In nearly all cases, it affected the treatment of their patients, according to a release. Of those surveyed, 79% used a different drug and 77% had to switch drugs after treatment had already begun. More than 35% had to decide which patients to treat with a drug when it landed on the shortage list.
Much of the national shortage problem can be traced to production disruptions when drugmakers initiate improvements after the FDA has sent them warning letters about quality lapses. The FDA has traveled a variety of avenues to speed drugs back into the supply chain when that happens. Last year it allowed India's Sun Pharma to import an unapproved version of generic Doxil to ease a shortage of the Johnson & Johnson ($JNJ) cancer drug even as it fast-tracked Sun's version toward agency approval in February.
Some cancer patients have also been affected by shortages of total parenteral nutrition (TPN) products. They have made up most of the new shortages to the list after Daiichi Sankyo late last year temporarily halted production of TPN products at a plant operated by its American Regent unit while it made improvements. Last week, the FDA said that it would allow the U.S. division of Fresenius Kabi to import trace elements and phosphate injection for TPN from its Norway plant. Jensen said the tactic is expected to meet current demand for TPN products, which has affected cancer patients and pediatric uses for some weeks.
The FDA actions have been helping, agreed oncologist Keerthi Gogineni, who discussed the survey results at ASCO, but do not resolve the core issues. With fewer manufacturers making more essential drugs, a plant closure has a wider impact. There is some evidence that the market is self-adjusting, however, with shortages drawing new manufacturers into making sterile injectable drugs, the kinds of drugs that make up the largest portion of products in short supply.
- here's the Bloomberg story
- read more from the release