In Washington, D.C., experts tracking the political shifting sands often advise you to watch what someone does, not what they say. Applying that to the FDA suggests the agency is starting to take risk management enforcement a bit more seriously.
Here’s a good example. Earlier this week (Feb. 16) the agency approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs) manufactured by Amgen Inc. The company’s risk management program or Risk Evaluation and Mitigation Strategy (REMS), requires health care professionals to provide their patients receiving an ESA with a Medication Guide that contains information for patients on how to safely use a drug.
And earlier this month, the agency requested a 23% hike in its budget to help it more aggressively pursue food, drug and device safety (plus its new tobacco initiative).
More action and more dollars could add up to a more active FDA in 2010.
Make sure to read our previous post: Risk Management Matures Beyond the Spreadsheet
