ASCO lobbies for fines to combat drug shortages

The American Society of Clinical Oncology meeting was a perfect forum for cancer doctors to lobby for relief from drug shortages. Although oncologists say shortages have eased a bit, some key chemo drugs are still scarce, most of them generics, The Wall Street Journal Health Blog reports.

"The good news is the frequency of drug shortages has begun to decline," ASCO's goverment relations chief, Richard Schilsky, said at a press conference. But, he said "[t]here is still unpredictable availability of many drugs. We are never exactly sure when a generic drug is going to go out of supply."

An FDA official told the Health Blog that 12 cancer drugs remain on the agency's list of shortages. "With regard to oncology drugs we remain extremely concerned about the shortages," said Sandra Kweder, the deputy director of the agency's office of new drugs.

New user-fee legislation recently approved in the Senate and House includes measures designed to ward off shortages. Companies would have to alert FDA to any production issues that might lead to a shortage within 6 months. With the help of voluntary notification, FDA has been able to avert 150 new shortages since November, Kweder told the WSJ.

But ASCO isn't sure mandating notifications will be enough to ward off shortages. The organization has been lobbying for monetary penalties for failure to disclose production problems. "If there is no teeth in that legislation some companies may not report as required," Schilsky said. But, he said, "[F]rankly there's not been a lot of receptivity to that."

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