FDA, drugmakers say they've solved two drug shortages

The U.S. Food and Drug Administration and several pharmaceutical companies said Tuesday they have reached agreements to alleviate shortages for the drugs methotrexate and Doxil.

Methotrexate is used to treat children with a form of leukemia and others with tumors of the breast and lungs. Doxil is used to treat ovarian cancer and multiple myeloma.

“A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration,” FDA Commissioner Margaret A. Hamburg, M.D., said in a statement. “Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”

Hamburg appeared at a midday news conference at FDA headquarters in suburban Washington, D.C., with prominent cancer doctors and top executives from Hospira and APP Pharmaceuticals, two of the generic manufacturers involved.

The FDA delivered on Friday an expedited approval of APP's drug application for methotrexate.

Meanwhile, Hospira, which was already producing the drug, got rushed approval to bring ingredients from its overseas factories and suppliers.

"I’m thrilled to relay that, 24 hours ago, we began directly shipping 31,000 vials of new product — enough to address more than a month’s worth of demand — and it is being received in hundreds of our nation’s hospitals and treatment centers today," Hospira chief executive officer Michael Ball said at the news conference.

As for Doxil (doxorubicin hydrochloride liposome injection), the FDA said it temporarily relaxed rules and is allowing the importation of a replacement drug, Lipodox, which is expected to end the shortage and fully meet patient needs in the coming weeks. Lipodox is made by the Indian company Sun Pharma Global.

The shortages of both drugs were related to the shutdown because of manufacturing problems at the plant run by Ben Venue Laboratories, Inc., in Ohio. Ben Venue is a subsidiary of Boehringer Ingelheim GmbH. Doxil is a product of the Johnson & Johnson subsidiary Janssen Research & Development LLC., which in turn contracted with Ben Venue Laboratories to make Doxil.

It was unclear what costs would be incurred by APP or Hospira for the newly-announced production or what prices they will charge for the drug.