FDA approves new supplies of drugs that are facing shortages

By Dr. Ananya Mandal, MDFeb 22 2012

The United States Food and Drugs Administration (FDA) have approved new suppliers for two crucial cancer drugs, easing critical shortages that had been concerning patients and families particularly of the children with leukemia. But there are currently 283 separate prescription drugs in short supply or unavailable nationwide, and regulators and manufacturers say shortages are a long-term problem that will continue to scare patients and doctors.

This Tuesday the FDA said it will temporarily allow importation of a replacement drug for Doxil, a drug for recurrent ovarian or bone marrow cancer. The Johnson & Johnson drug hasn’t been available for new patients for months because J&J’s contract manufacturer had to shut down production over serious quality lapses. The FDA also has approved a new supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL, for lymphomas and for the bone cancer osteosarcoma.

“We have made real progress ... We believe that (suppliers) will be able to meet the demands of patients in the U.S. market” for the two drugs indefinitely, FDA Dr. Commissioner Margaret A. Hamburg told The Associated Press in an exclusive interview. “It’s a huge relief for us.” Numerous medical and drugmaker groups, along with the White House, applauded the news but cautioned that much still must be done to resolve all the problems causing shortages.

President Barack Obama Oct. 31 directed U.S. regulators, through an executive order, to gather information from drug manufacturers about potential shortages. The FDA has prevented 114 drug shortages since Obama signed the executive order, FDA Commissioner Margaret Hamburg said today. The agency released draft guidelines today that attempt to help drugmakers understand when they should notify regulators of an impending shortage.

In the latest case, the FDA has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global FZE. The Indian drug maker already sells products in the U.S., and its factory has been inspected.

Hospira Inc. on Monday began shipping 31,000 vials of preservative-free methotrexate, more than enough to meet a month’s U.S. demand, to hundreds of hospitals and treatment centers, said its CEO, Mike Ball. He said the company will ship another 34,000 units next week and 55,000 more in mid-March to build a supply cushion. It’s also now transporting from around the world to its Australian factory about 100 kilograms of methotrexate’s active ingredient — enough to make about a three- to four-month supply. Two other companies, Mylan Inc. and Sandoz Inc., also are ramping up their production of preservative-free methotrexate.

Still, hundreds of other drugs remain in short supply, including at least six for cancer. “I don’t think we can ever close the book on drug shortages,” Hamburg told The AP. “I think we will always have to be vigilant.” Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs. They are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers. At least 15 deaths since 2010 have been blamed on the shortages.

So far this year, 27 new shortages have been reported, and about 215 that began in 2010 or 2011 remain unresolved, according to Erin R. Fox, manager of the University of Utah Drug Information Service, which tracks shortages. “At this time last year, we were on a pace of about one new shortage per day. Thanks to FDA’s hard work, that pace is cut in half for this first part of 2012,” Fox said. The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.

Meanwhile, some unscrupulous smaller distributors, dubbed “gray marketers,” have been exacerbating shortages by charging hospitals many times the normal price for drugs that can’t be acquired through normal suppliers. Several bills in Congress are pending that would establish penalties for drugmakers that don’t give notice of impending shortages, or by setting penalties for price gouging on prescription drugs.