Nature Medicine | Spoonful of Medicine

FDA moves to fix drug shortages, but warns that the problem is not over

The latest twist in the saga of US drug shortages came today when the country’s Food and Drug Administration (FDA) announced that it had found alternative sources for the cancer drugs methotrexate and doxorubicin, two of the 220 drugs currently in short supply in the US.

Last week, the FDA announced that emergency supplies of an injectable, preservative-free form of methotrexate, which is used to treat the childhood blood cancer acute lymphoblastic leukemia, would be made available by the Ohio-based manufacturer Bed Venue Laboratories. And today, commissioner Margaret Hamburg reported that APP Pharmaceuticals, a drugmaker based near Chicago that specializes in injectable therapies, had received expedited approval to make a version of methotrexate that will be available next month.

Meanwhile, the agency is also importing shipments of both methotrexate and doxorubicin from abroad. An unapproved generic version of doxorubicin, which is marketed as Doxil by New Jersey’s Johnson&Johnson, will be temporarily imported from India by Caraco Pharmaceutical Laboratories of Detroit, and the Chicago area company Hospira is shipping 31,000 vials of preservative-free methotrexate—enough to last US patients for one month—from its plant in Australia. “We believe supplies will continue to increase in the coming weeks,” Hamburg said in a press briefing this afternoon. “This should resolve the shortage.”

But the two shortages addressed today are far from the whole story. In the past two years, the American Society of Health-System Pharmacists has documented an increasing number of shortages of other medications, many of them for cancer or rare fatal diseases. To remedy the situation, US President Barack Obama issued an executive order in October calling on the FDA to address drug shortages farther in advance and with greater urgency. Today, Hamburg insisted that the FDA had made strides since then, preventing 114 drug shortages since the President’s decree. And she pointed to a six-fold increase in voluntary reports to the FDA by drug manufacturers about potential shortages as evidence that the system is working better than it has in the past.

Voluntary reporting will not be sufficient long term, however, as many on the panel of patients, doctors and industry representatives convened for today’s press briefing pointed out. The most important piece missing from the battle against drug shortages is legislation outlining what information manufacturers must report to the FDA and when. A bill, called the Preserving Access to Lifesaving Medication Act, was introduced in February of last year. But it has been stalled in committee, frustrating many researchers as well as patient advocates. “Shortages today slow development of better treatments for tomorrow’s cancer patients,” said Michael Link, president of the American Society of Clinical Oncology. “We cannot continue to practice medicine from crisis to crisis.”

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