FDA moves to address cancer drug shortages

Agency allows temporary importation of chemo drug, issues draft guidance to manufacturers

SILVER SPRING, Md. — An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

The FDA announced that it would address a shortage of the injectable Doxil (doxorubicin hydrochloride liposome) by allowing importation of Lipodox, an identical drug, by India-based Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Labs. The FDA said the measure was temporary and that such temporary importation of unapproved foreign drugs was considered in rare cases when there was a shortage of a critical drug. The shortage resulted from the closing of a manufacturing plant in Bedford, Ohio, owned by drug maker Ben Venue.

The FDA also gave expedited review to APP Pharmaceuticals' preservative-free methotrexate, which it expects to become available in March. The drug is used to treat leukemia in children and osteosarcoma, as well as autoimmune disorders. In addition to the approval of APP's version, Hospira is releasing 31,000 vials of the drug, enough to last a month, and the agency said it was working with Mylan, Sandoz and other companies to increase production.

Doxil is used in several treatment regimens, such as for ovarian cancer after treatment with platinum-based chemotherapy has failed, and also in patients with AIDS-related Kaposi's sarcoma 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 Hamburg said. "Through the collaborative work of [the] 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."

The FDA's action is based on an executive order that President Obama made on Oct. 31, 2011, designed to address shortages of critical drugs. The FDA said the order and its own letter to manufacturers resulted in a six-fold increase in voluntary notifications of potential shortages by drug companies, with 114 shortages prevented since the order.

In addition to Tuesday's approvals, the agency released draft guidance to the industry on detailed requirements for mandatory and voluntary notifications to the FDA on issues that could result in shortages and supply disruptions.

 


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