Saturday, March 10, 2007
Article in the Wall Street Journal -- FDA Warning Is a Blow to Amgen: 'Black Box' Label On Anemia Drugs Also Hits J&J, by Marilyn Chase and Anna Wilde Matthews. Here's an excerpt:
The Food and Drug Administration issued a sweeping safety warning about heart and cancer risks that arise from overuse of a family of anemia treatments that is the biotech industry's biggest drug class with $7.3 billion in U.S. sales in 2006.
The agency's safety advisory -- a so-called "black box warning" on the labels of all drugs in the class, called Erythropoiesis Stimulating Agents -- came sooner than analysts expected, two months ahead of a scheduled FDA advisory meeting to discuss risks on May 10. The move comes as the FDA is under pressure from Congress to show that it is focusing on drug safety, in the wake of a series of incidents including the market withdrawal of the painkiller Vioxx.
Hardest hit by the new warning is Amgen Inc., Thousand Oaks, Calif. The biotech giant alone accounted for $5.3 billion in U.S. sales from its best-selling products Aranesp and Epogen in 2006. Johnson & Johnson's Procrit fetched another $2 billion in U.S. sales. Roche Group AG, Basel, Switzerland, plans to launch its rival product, Cera, this spring despite a bitter patent battle with Amgen that has divided the onetime partners.
FDA officials said the black box was sparked by recent studies that have pointed to risks tied to the drugs, particularly when doctors used them for very aggressive treatments. Karen Weiss, deputy director of the agency's office of oncology drug products, said the "bulk of the data that has raised concerns" came when patients were given higher-than-recommended doses, whether they were suffering from anemia tied to kidney problems or cancer treatment. The evidence is that "this type of strategy is not beneficial and in fact has some evidence of harm," she said.
Plaintiffs attorneys are already looking into possible suits. "When you have a corrective action by this FDA, it's not just smoke," says plaintiffs' attorney Mike Papantonio of Levin Papantonio Thomas Mitchell Echsner & Proctor, in Pensacola, Fla.
The New York Times also has an article, F.D.A. Warning Is Issued on Anemia Drugs’ Overuse, by Andrew Pollack.