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FDA takes action to increase supply of mesothelioma drug, other cancer therapies


President Obama has ordered the Food and Drug Administration to increase the supply of key cancer-fighting drugs, including cisplatin, a chemotherapy agent vital to patients with inoperable mesothelioma.

 

To ease what health experts say is the most severe shortage of drugs for life-threatening conditions in decades, an Executive Order signed by the president Monday directs the agency to take several steps:

 

• require manufacturers to provide adequate advance notice of manufacturing discontinuances that could lead to shortages;

• expedite regulatory reviews of new drug suppliers and manufacturing sites;

• report any evidence of collusion or price-gouging in the supply chain to the Department of Justice for possible prosecution.

 

An FDA report issued in tandem with the president’s order says the number of drug shortages annually has tripled from 61 in 2005 to 178 in 2010. All of the chemotherapy drugs in short supply, including cisplatin, are known as sterile injectables. They accounted for 80 percent of the drug shortages, more than a quarter of which are oncology drugs.

 

The leading causes of shortages are quality-control problems at manufacturing facilities, delays in manufacturing or shipping and active ingredient shortages, the report said.

 

Earlier this year, Michael Link, a pediatric oncologist from the Stanford University School of Medicine and president-elect of the American Society of Clinical Oncology, said the shortage of chemotherapy drugs began several years ago and worsened in 2010.

 

“It’s the worst shortage we’ve experienced in three decades,” Link said. “In terms of scope, it’s huge.”

 

Cisplatin, a platinum-based chemotherapy, is the front-line treatment for inoperable pleural mesothelioma, a deadly cancer of the lung lining. A combination of cisplatin and pemetrexed is considered the most effective treatment for the disease, lengthening survival times in roughly 40 percent of patients, according to published studies.

 

Approved by the FDA in 1978, cisplatin is used to treat other cancers, as well, including sarcomas, lymphomas, germ cell tumors and certain carcinomas.

 

According to the Drug Information Center at the University of Utah, Bedford Laboratories, one of three manufacturers of cisplatin, stopped production in May 2011 to concentrate on other products. Teva Pharmaceuticals could not provide a reason for the shortage, according to the center, and the third manufacturer, APP Pharmaceuticals, said it was having trouble keeping up with demand.

 

While ordering the FDA action, President Obama reiterated his support for a bill that would require drug manufacturers to notify the agency six months in advance of any interruptions in supply. Stalled in Congress, the Preserving Access to Life-Saving Medications Act of 2011 would also require the Department of Health and Human Services to establish criteria for identifying potential drug shortages and report to Congress the actions taken to address the problem.

 

“Congress has been trying since February to do something about this,” Mr. Obama said today. “It has not yet been able to get it done. And it is the belief of this administration … that we can't wait for action on the Hill. We've got to go ahead and move forward.”