The Food and Drug Administration has ordered Amgen to change the labels for its flagship anemia drugs in a way that could further restrict its use in treating patients with cancer. This move by the FDA is the first time the agency has invoked its authority granted under a 2007 law that empowered it to order changes in a drug’s prescribing information. Previously, the FDA could only negotiate with a drug’s manufacturer to change the label. I could never understand why that situation was allowed to exist since it made the FDA powerless in its ability to require needed label changes. Sales of the drugs, Aranesp and Procrit, fell in the last year because of studies suggesting that their use to treat the anemia caused by chemotherapy could actually make cancer worse or shorten lives.
Procrit is manufactured by Amgen but sold under license by Johnson & Johnson. Sales of Aranesp, generally considered Amgen’s flagship product, fell 13% in the second quarter from a year earlier, to $825 million. In the United States alone, sales plunged 26%, to $427 million. It’s estimated that the new label could reduce the use of Aranesp for cancer patients in this country — the drug is also used by people with kidney disease — by an additional 40%.
The labels for the drugs have already been changed a few times since new safety concerns arose early last year. The FDA and Amgen have been negotiating the latest changes since the advisory committee in March recommended further restrictions on use of the drugs. While the company and the agency agreed on most of the language changes, there were some points on which they could not reach agreement. Apparently, only then did the FDA invoke its new authority to order the changes. Amgen had wanted a much weaker label.
Source: New York Times
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