FDA unveils risk-management plan for Amgen anti-anemia drugs
Physicians who want to prescribe Amgen Inc.’s anti-anemia drugs for cancer patients will have to register and undergo special training under a risk-management plan unveiled Tuesday by the Food and Drug Administration.
Amgen also will require physicians to collect signed statements from patients attesting that they have been informed about the dangers of the drugs.
Studies have shown that the drugs can cause tumors to grow faster and shorten the lives of some cancer patients. They may also increase risk of heart failure, blood clots and stroke.
The risk-management plan had been under discussion since April 2008.
The drugs, which sell under the trade names Epogen, Aranesp and Procrit, are widely used by dialysis patients, but the safety plan applies only to use with cancer patients.
Two of the drugs, Epogen and Aranesp, are manufactured and sold by Amgen of Thousand Oaks. The company also manufactures Procrit, which is marketed by Johnson & Johnson.
Physicians can begin registering for the safety program March 24. Those who fail to sign up and take a 10- to 15-minute online training course within a year will lose prescribing privileges for the drugs.
The drugs form a class called Erythropoiesis-Stimulating Agents and work by stimulating bone marrow to make red blood cells. Beyond safety issues, ESAs have repeatedly come under scrutiny by congressional overseers after concerns about overprescription of the drugs.
They are among the costliest drugs paid for by Medicare, a fact that may have given regulators added incentive to focus on safety, said Ruben Mesa, a hematologist at the Mayo Clinic in Scottsdale, Ariz.
Richard Pazdur, director of the FDA’s Office of Oncology Products, said the agency hoped the added burden on physicians would be offset by fewer adverse events.
Amgen is to oversee physician and patient compliance with the program and report to the FDA.
In terms of the program’s effect on the companies, Eric Schmidt, an analyst with investment firm Cowen & Co., said, “What matters to investors is whether or not something new happens and this really isn’t new or unexpected . . . and the market seems to be largely unaffected by it. Both J&J and Amgen shares closed up today.”
“Each of these drugs have been plagued with safety issues and really had a tough go of it the last few years,” Schmidt said. “This might hurt sales more, but they’ve all been on a downward slope and there’s no reason to think that would change.”
Nathan Olivarez-Giles in Los Angeles contributed to this report.