FDA's Gottlieb suggests corporate-sponsored monitoring program could curb opioid epidemic
U.S. Food and Drug Administration Commissioner Scott Gottlieb, MD, presented the idea of creating a corporate-sponsored, nationwide prescription drug monitoring program as a way of curbing opioid abuse.
The proposal is just one of several made today at an FDA workshop on options that would enhance opioid safety.
If enacted, the FDA would require drug sponsors to form a national prescription drug monitoring program as part of the drug approval process. Gottlieb explained the agency believes it could be more effective in helping providers identify patients who may by abusing opioids and provide real-time alerts about potentially harmful drug combinations.
Currently, 49 states already operate statewide PDMPs, but each has its own rules and enforcement policies. Missouri has been in an ongoing battle to create a statewide database, but to no avail. A unified system potentially could eliminate the current patchwork system.
Gottlieb didn’t expand further on the idea or explain how in-depth the organization was in exploring the idea. However, the FDA announced today that it plans to hold a public hearing to bring together stakeholders to discuss this idea and the others introduced at today’s workshop.
The FDA is also considering working with medical professional societies on a framework to outline appropriate opioid prescribing and dispensing tailored to different medical needs, which will then be incorporated into product labeling.
As part of the labeling, Gottlieb said the FDA is looking into packaging certain opioids in units that align with this framework that could later be linked to quality metrics. The agency is also looking into educational requirements and changes to the opioid prescription process.
“While we recognize that some of the ideas we’re exploring are unprecedented, the tragic truth is that this crisis is so immense that we need to consider a range of more impactful options that we may not have considered before,” Gottlieb said.
“Ultimately we believe it’s our obligation to identify and explore every option available to us,” he continued. “We’re determined to make sure that, when combined with other efforts we and others are taking, new steps yield meaningful results.”