BioCentury
ARTICLE | Politics & Policy

FDA approves classwide opioid REMS

July 10, 2012 1:20 AM UTC

FDA approved a final classwide REMS for extended-release and long-acting opioids that requires companies to make educational programs available to prescribers at no or nominal cost. The REMS does not require prescribers to participate in the training programs, though FDA said it is working with Congress to explore legislation to mandate prescriber training, including a prescriber education requirement as a condition of obtaining registration with the Drug Enforcement Agency. The final opioid REMS is in line with elements FDA detailed in letters sent to companies last April (see BioCentury Extra, April 19, 2011). ...