Panel: Broaden Opioids Risk Plans, Require Prescriber Training
An FDA panel of expert advisers unanimously agreed the risk plans for opioids need to be significantly changed – with most calling for them to cover immediate-release products, rather than just the extended-release and long-acting drugs. Most on the committee also insisted prescriber training should be mandatory, rather than voluntary.
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At his first report as commissioner to the FDA's Science Board on March 1, Robert Califf has decided to focus on the scourge of opioid addiction in the US and the challenges the agency is up against in that spotlight of approving new pain management medicines.
It didn't take long for the accolades to come pouring in after the US Senate on Feb. 24 in an 89-4 vote confirmed Robert McKinnon Califf as the new permanent head of the FDA – coming just over a year after he joined the agency and his predecessor, Margaret Hamburg, announced her pending departure.
After coming under fire for failing to do enough to address the explosion in misuse, abuse and addiction to prescription opioids in the US, the FDA on Feb. 4 said it was overhauling its policies with the aim of "reversing the epidemic, while still providing patients in pain access to effective relief."