Senators back FDA's plan to require mandatory prescriber education for opioids
Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.
While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.
“In light of the many available education programs and the lack of a nationwide standard, FDA is exploring the value of a single source for education on the appropriate use of opioids, on the risks of opioid abuse and misuse, and on the treatment of opioid use disorder to address multiple needs and reduce the burden on prescribers,” the agency said.
Cumulatively, from the end of February 2013 through May 15, 2021, FDA said more than 350,000 doctors have completed prior education courses, but that’s only about one-third of the approximately 1 million prescribers of opioid analgesics in 2019.
“In addition, although many public and private entities have independently implemented their own education programs and other interventions to encourage safe and effective prescribing practices for opioid analgesics, there is no nationwide standard. Therefore, these programs likely differ with regard to content, focus, and duration,” FDA said.
In offering their support for mandatory prescriber education on opioids, Democrat Sens. Richard Durbin of Illinois, Richard Blumenthal of Connecticut and Joe Manchin of West Virginia made clear that it’s the direction that they’d like to see FDA move in.
“Continuing a system of voluntary prescriber education for addictive opioids would ignore the reality of: the ongoing promotion by pharmaceutical sales representatives of prescription painkillers; how individuals get hooked on heroin and fentanyl; and the shortcomings of the current preventive regulatory framework,” they wrote in a comment submitted to the docket.