Cancer docs want penalties for drugmakers slow to report disruptions

Cancer docs used the American Society of Clinical Oncology meeting in Chicago on Monday to vent frustration over continuing shortages of cancer drugs. The society is suggesting fines for drugmakers that don't give the FDA an early heads up if they face anything that might lead to a shortage.

The FDA reauthorization bill, which has been passed by both chambers of Congress but must be merged into a single piece of legislation, would require early notification but has no penalties for companies that fail to do it.

"If there is no teeth in that legislation, some companies may not report as required," Bloomberg quoted Dr. Richard Schilsky as saying at the meeting. Schilsky, a gastrointestinal cancer specialist, is chairman of ASCO's government relations committee. He did say that shortages have eased some this year, reports The Wall Street Journal

An FDA deputy director, speaking at ASCO, pointed to quality and supply issues with generic drugmakers as the source of many of the shortages, Bloomberg reports. "If one company makes 30 products and they have a problem, suddenly 30 products are at risk of a shortage," said FDA's Sandra Kweder. "Early notification by a manufacturer of when they are having production difficulty makes a huge difference in our ability to prevent the public from bearing the burden of drug shortages."

Without naming names, Kweder said some generic drugmakers have failed to keep up with growing demand and need to upgrade plants to avoid problems and disruptions. She claimed that the agency has avoided 150 shortages since the president last year directed the FDA to seek early warning from manufacturers on supply disruptions. That has allowed the agency to find new sources to help with some shortages. Many shortages in the last 6 months, including for Johnson & Johnson's ($JNJ) cancer drug Doxil, are linked to a Ben Venue Laboratories plant that was idled in November to fix a myriad of problems.

The agency is temporarily allowing in some unapproved foreign drugs from India to help address the Doxil shortage. And Pfizer ($PFE) agreed to re-introduce several drugs--including paclitaxel, which is used in chemotherapy, and irinotecan, used to treat colon cancer--when supplies of those drugs became hard to get. Still, there have been 90 shortages so far this year, and there are 12 cancer drugs currently on the shortage list. All of the cancer drugs in short supply, except Doxil,  are generics that have been available for decades, WSJ says. 

- read the Bloomberg story
- here's the Wall Street Journal story