Add three more drugs whose commercial availability is contingent on a risk evaluation and mitigation strategy: Aranesp, Epogen and Procrit. All three are erythropoiesis-stimulating agents (ESAs) made by Amgen and Centocor Ortho Biotech Products. We reported earlier this week that Auxilium's just-approved biologic for a progressive hand disease also requires one.
The FDA says ESAs can increase the risk of tumor growth and shorten survival in patients with cancer. They can also increase the risk of heart attack, heart failure, stroke or blood clots in those using the drugs to treat other conditions.
REMS development has become a "key commercial activity," says Heather Morel, VP/GM of McKesson's Specialty Care Solutions' business, via email. It often requires director-level involvement of the regulatory and safety teams, and typically such other functions as brand management, marketing, channel or trade, and legal.
The ESA REMS is more complicated than that of the Auxilium drug, which involves a communication plan and a medication guide. ESAs require a medication guide, prescriber and provider training on patient education, and enrollment in a program intended to document that such education takes place before ESA treatment begins.
- here's the Amgen release
- see the FDA safety note