FDA Announces a New Class-Wide REMS

By William T. Koustas —

 The FDA has announced that it will require all drugs known as Erythropoiesis-Stimulating Agents (“ESAs”) to have a Risk Evaluation and Mitigation Strategy (“REMS”).  At the present time, this class of drugs is limited to three Amgen products: Procrit, Epogen (both epoetin alfa) and Aranesp (darbepoetin alfa).  FDA required Amgen to create a “risk management program,” or REMS, in April of 2008 for ESAs based on new safety information received from studies that showed ESAs caused tumors to grow faster, leading to premature death in some cancer patients.

 The REMS consists of a medication guide, communication plan, and elements to assure safe use (“ETASU”).  The medication guide is to be provided at retail/hospital outpatient pharmacies as well as in physician offices, clinics, hospital inpatient and in-clinic services and upon request.  The communication plan will consist of letters to Nephrology and Oncology related professional societies, “Dear Healthcare Provider” letters to hospital Directors of Pharmacy/Administrators and to those healthcare providers who directly purchase/prescribe ESAs and ensure access to communication materials online. 

 The most onerous part of this REMS is the required ETASU that includes certification for healthcare providers who both prescribe and dispense ESAs as well as the hospitals themselves.  Amgen has established Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs (“APPRISE”) which provides each eligible healthcare provider and/or hospital with an APPRISE enrollment number and ensures that they re-enroll in the APPRISE program every three years.  Failure to do so will result in that provider/hospital no longer having access to ESAs.  Further, the ETASU require that Amgen ensure that certified hospitals and healthcare providers only dispense ESAs after they have discussed the risks with the patient and the patient has signed an “Acknowledgment Form.” 

 We have previously discussed on this blog how FDA may expand its use of class-wide REMS as it continues to become more comfortable with its new powers under FDAAA, and this appears to further confirm that FDA is moving in that direction.