Patients with ovarian cancer and other deadly tumors will regain access to an important chemotherapy drug, Food and Drug Administration officials told USA TODAY in an exclusive interview Monday.
The drug, Doxil, has been in short supply since last June. There are no generic versions of the drug, which is also used to treat multiple myeloma and AIDS-related Kaposi's sarcoma.
The agency says it will announce today that it has worked out a deal to temporarily import a replacement drug, called Lipodox, from an Indian company, says the FDA's Sandra Kweder. The FDA has previously inspected the company, Sun Pharma Global, which exports the drug to other companies.
"It's wonderful news," says Kweder, who says the deal will end the Doxil shortage "for the forseeable future."
Doxil is one of 287 drugs that have been in short supply this year, says the University of Utah's Drug Information Service, which has been monitoring the problem. That's up from 61 shortages in 2005, the FDA says.
The FDA announced last week that it had averted a much-feared shortage of a cancer drug called methotrexate. Preservative-free versions of that drug are used to treat children with acute lymphoblastic leukemia, or ALL. Because there are no substitutes, many doctors and patients were worried about a shortage after manufacturer Ben Venue Laboratories suddenly shut down its plant last November. Kweder says the FDA was able to avert that shortage by asking other makers of generic drugs to ramp up production. In a statement, Ben Venue said it will release a small amount of methotrexate from its inventory at the Ohio plant.
Laura Bredesen of Minneapolis, whose son Ben, 4, is being treated for ALL, says she's grateful he was able to get methotrexate last week. But, she says, she won't feel at ease until the next dose is "in the hospital's hands."
Given the growing number of drug shortages, Kweder acknowledges that "our work isn't done," and she says the drug industry needs to make broader changes to halt this cycle.
Because makers of generic drugs operate on thin profit margins, they often have no backup facilities to take over if one production line breaks down.
"The real solution is a shift in the industry to assuring good manufacturing practices to prevent finding themselves in a critical juncture where they have no choice but to shut down."
In some cases, when plants close, "the things they shut down to fix are not new," Kweder says. "They've been trying to patch things together for some time."
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