FDA Asks Drug Maker to Monitor ESA Prescribing

I have always heard that historically, FDA has pretty much just regulated the manufacture and marketing of the products it oversees (i.e., pharmaceuticals and medical devices, among others) but not the practice of medicine itself. Currently, though, FDA can mandate certain activities under a risk evaluation and mitigation strategy (REMS). A recent agency announcement shows that it can come pretty close to regulating practice—and in this instance it seems to be involving the drug manufacturer.

FDA is requiring Amgen, the manufacturer of certain Erythropoiesis-Stimulating Agents (ESAs), to develop a risk management program, which includes preparation of a medication guide explaining the risks and benefits of ESAs. Requirements for medication guides are increasing, so this is nothing new. (But it is a challenge for manufacturers to ensure that such guides are provided to all patients. Retail pharmacies have been known to miss a guide or two, especially when repackaging takes place.)

But FDA has also asked Amgen to develop the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program for healthcare professionals who prescribe ESAs to patients with cancer. FDA reports that under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program.

Is this unique? Is it realistic? Have other manufacturers had to work so closely with the practitioner environment to ensure safe product use?

Has packaging or labeling played a role in easing product use? It certainly can to ensure that medication guides are handy and available for dispensing to patients. Is that all that is needed, or can packaging and labeling play other roles?

I have put a call into Amgen to see what it may be doing with packaging and labeling. But I would love to hear from you, too, especially if you are being drawn into setting practice standards.

Daphne Allen