FDA moves to stem drug shortages

The Food and Drug Administration on Tuesday took action to address shortages of two cancer drugs.

The Food and Drug Administration on Tuesday took action to address shortages of two cancer drugs.

The agency also released new requirements and voluntary guidelines for how and when manufacturers should notify the agency of potential shortages or supply disruptions.

“Prevention of shortages must be a priority for all of us. And it is,” FDA Commissioner Margaret A. Hamburg said during a press conference this afternoon.

The drugs in question, Doxil and Methotrexate, both were manufactured at an Ohio Ben Venue Laboratories plant that was shut down in November due to manufacturing problems.

Doxil is part of Janssen Products LP‘s portfolio and is used to treat some forms of ovarian cancer and sarcoma, among other conditions. Janssen is a subsidiary of New Brunswick-based Johnson & Johnson.

Hamburg said the FDA would allow the importation of a Doxil substitute, Lipodox, even though Lipodox is not approved by the FDA for sale in the United States. She said her agency has the discretion to allow the drug to be sold on a temporary and limited basis.

“It’s one of the tools that we have to respond to shortages,” Hamburg said. “We use it in fairly rare circumstances when there is no FDA-approved drug that can address patient needs and a drug shortage.”

Lipodox is made by the Indian firm Sun Pharma Global FZE, and distributed by its Detroit-based subsidiary Caraco Pharmaceutical Laboratories Ltd.

Methotrexate is available in generic form and is used to treat a number of types of cancer. Hamburg said Tuesday her agency has approved a new manufacturer for the drug, APP Pharmaceuticals, which should have supplies of the preservative-free formulation of the drug by next month. Hamburg also announced that Hospira Inc. has stepped up its production of the drug, and is releasing more than 31,000 vials of it. She said other manufacturers, including Mylan Pharmaceuticals Inc. and Sandoz Inc., are stepping up production of the drug. Sandoz has its U.S. headquarters in Princeton.

“We now have available supplies and we will continue to see an increase in numbers over the weeks to come,” Hamburg said. “This should resolve the shortage.”

President Barack Obama in October issued an executive order calling for better reporting of potential drug shortages. The FDA said 195 drug shortages were prevented in 2011, and 114 drug shortages have been prevented since the Oct. 31 executive order.