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04-06-2012 22:51:00

WSJ BLOG/Health: Cancer Doctors Say Some, Not All, Drug Shortages Have Eased

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(This story has been posted on The Wall Street Journal Online's Health Blog at http://blogs.wsj.com/health.)

By Jennifer Corbett Dooren

Doctors who treat cancer say a shortage of oncology drugs has eased, though shortages persist of some chemotherapy drugs that form the backbone of treatment for breast, colon, lung and some other cancers.

Hospitals have been struggling with shortages of mostly older, generic drugs for cancer and other ailments for about two years. There were a record 250 shortages in 2011. The American Society of Clinical Oncology, which is currently holding its annual meeting in Chicago, and other medical groups have been lobbying Congress and federal officials for a fix. ASCO held a press conference Monday to provide an update on the issue.

"The good news is the frequency of drug shortages has begun to decline," said Richard Schilsky, the head of ASCO's government relations committee and the deputy director of the University of Chicago Comprehensive Cancer Care Center.

With the exception of Johnson & Johnson's Doxil, all the other cancer-drug shortages are of generic drugs that in many cases have been used for decades for treat cancer. The shortages mostly stem from manufacturing problems at the companies who make the drugs.

The most recent trouble started in November when Ben Venue Laboratories, a division of Germany's Boehringer Ingelheim, shut down an Ohio plant to address manufacturing problems. Ben Venue makes Doxil and several other drugs including a preservative-free version of methotrexate, the only treatment for children with a certain type of leukemia. The FDA approved two new drug suppliers in February to address those shortages.

Although progress is being made on the cancer front, the overall shortage problem is far from being fully resolved. "With regard to oncology drugs we remain extremely concerned about the shortages," says Sandra Kweder, the deputy director of FDA's office of new drugs, who spoke at ASCO on Monday.

Dr. Kweder says voluntary notification from drug manufacturers about production and other problems has helped the agency avert 150 new shortages since November.

An FDA spokeswoman says there are 12 cancer drugs currently on FDA's drug-shortage list, but most of those issues are being resolved. There are also ongoing shortages of anesthesia, pain medicines and antibiotics. So far this year there have been about 90 drug shortages compared to 145 seen during the same period last year, the FDA says.

Both the Senate and House recently approved legislation renewing the FDA's ability to collect fees from drug and medical-device companies to help fund the agency's review of product applications. Included in those bills are provisions aimed at addressing drug shortages. Drug companies would be required to tell the FDA if they have a problem they think will result in a shortage of a critical drug within the next six months, such as a snag in obtaining enough of an active ingredient to make a particular medicine.

ASCO officials have been pushing for the legislation to include monetary penalties that would apply to companies that don't disclose problems, but, "frankly there's not been a lot of receptivity to that," Dr. Schilsky says.

-For continuously updated news from The Wall Street Journal, see WSJ.com at http://wsj.com.

(END) Dow Jones Newswires

June 04, 2012 16:51 ET (20:51 GMT)

Copyright (c) 2012 Dow Jones & Company, Inc.

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