Kudos to the behind-the-scenes work of the FDA and the industry’s Opioids Working Group (OWG).
The FDA has approved a final class-wide 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 required educational programs must cover the content of an FDA-developed blueprint, which includes the dangers of misuse and abuse, directions for patient selection and how to recognize evidence of misuse and abuse. FDA expects the first educational program will be offered by March 2013. Companies will be required to track the number of prescribers completing the program and whether the program is adversely affecting patient access to medications.
In other news, the President signed PDUFA. The law reauthorizes both PDUFA and MDUFA and creates new user fee programs for biosimilars and generics along with a slew of other important codicils.
Strange that the White House is silent on this important piece of bi-partisan legislation. As Veep Biden once said, "It's a big, f--king deal."