Scott Gottlieb, MD, is still in his first months as FDA commissioner, but he’s already following up on pledges to take a harder line in addressing the ongoing epidemic of opioid addiction. In the opening remarks at a two-day meeting on opioid abuse, Gottlieb said that companies that make immediate-release opioids will now be required to offer stepped-up training for prescribers.
According to a report in The Washington Post, approximately 90 percent of the opioids in current circulation are immediate release. The remaining 10 percent are extended-release opioids, which already have mandated training attached to them.
Even though awareness campaigns have contributed to the number of opioid prescriptions finally starting to decline after a decade of skyrocketing growth, Gottlieb notes that the pills are still far too prevalent.
“America is simply awash in immediate-release opioid products,” Gottlieb said, according to the Post.
For now, the training requirements are entirely on the manufacturers’ side. There is no corresponding rule insisting those who hold prescription pads go through an educational process. Gottlieb warns that make be on the horizon.
“Based on the feedback we’ve received from two public meetings over the past year, we’re actively exploring the question of whether, in the future, there should be mandatory provider education, and how we’d operationalize such a condition,” said Gottlieb.
The announcement comes just one week after Endo International agreed to pull the opioid painkiller Opana ER off the market at the request of the FDA. That request was itself a first and seen as evidence of the agency’s intensified commitment to confronting the public health dilemma.
Filed Under: Industry regulations