FDA says docs need training on Amgen ESA drugs, or no sale
The program, to be overseen by Amgen, will start registering physicians March 24, and will begin restricting distribution to non-compliant hospitals and oncologists after one year, said FDA officials during a media briefing.
“We're not doing this to make things more difficult for health care providers,” said Richard Pazdur, director of oncology drug products at FDA's Center for Drug Evaluation and Research. “We're doing it to make absolutely certain that patients are fully informed about the risks related to ESA drugs before receiving treatment.” ESA is shorthand for the class of drugs known as erythropoiesis-stimulating agents and are typically used as a supplemental therapy to treat anemia.Amgen is currently the sole manufacturer of FDA-approved ESAs, and Centocor Ortho Biotech is a marketing and distribution partner on Procrit.
The Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs (APPRISE) program was established as part of a Risk Evaluation and Mitigation Strategy (REMS) for ESAs, and will be overseen by Amgen.
Studies have shown that ESAs can increase the risk of tumor growth and shorten survival in cancer patients, among other risks. In addition to the APPRISE program for doctors, all patients will have to be provided with a medication guide explaining the risks and benefits of ESAs, Pazdur said in the briefing.
Despite serious safety concerns and declining sales over the last few years, Epogen and Aranesp still managed combined sales of over $5 billion for a 12-month period ending in September 2009. Those sales could be affected further by new Medicare rules that cap fees for kidney dialysis at around $250 per treatment, Bloomberg reported today. The cap would include ESA treatment used in conjunction with kidney dialysis patients.