Scott Gottlieb, the physician and entrepreneur who is President Trump’s nominee to head the Food and Drug Administration, told senators Wednesday that the nation’s opioid crisis is a “public health emergency on the order of Ebola and Zika” and requires dramatic action by the agency and the rest of government.
During his confirmation hearing before the Health, Education, Labor and Pensions Committee, Gottlieb described the FDA as “complicit, even if unwittingly,” in helping to fuel the opioid epidemic. Officials, he said, “didn’t fully recognize the scope of the emerging problem” several years ago and needed a new strategy to combat the issues involved.
Former FDA Associate Commissioner, Peter Pitts said that he was impressed by Gottlieb’s performance at the hearing.
“I think Scott is very much for good regulation, and very much against bad regulation,” Pitts said. “Importantly, he recognizes where FDA core mission stops, and where mission creep begins — and that’s an important finesse he’d bring to the commissioner’s chair.”
“It’s also important to remember that there is no such thing as an opioid that is 100 percent abuse-proof. The only abuse-proof medicine is one that is never prescribed – and for the hundreds of millions of Americans suffering from chronic pain that isn’t a viable option,” Pitts added.
But cutting the Gordian Knot of abuse means more than advancing the science and regulation of abuse deterrence, Pitts says. It means working with the providers of continuing medical education to develop better curricula. It means validated risk evaluation and mitigation strategies. And better REMS designs with more thoughtful purpose, using the tools of the 21st century century such as patient and physician apps. It means enhanced and validated reporting tools for post-marketing surveillance. And it means using real world data to provide real world advice.
It means using outcomes data for better social science tools that can assist prescribers in determining which patients are likely to abuse – and those for whom abuse is unlikely. The FDA can play an important role in working to develop and share (with a broad constituency) validated tools for physicians to use in determining which patients may be more prone to slide into abuse so they can choose their therapeutic recommendations more precisely.