FDA’s Gottlieb Suggests Corporate-Sponsored Prescription Opioid Monitoring

FDA Commissioner Scott Gottlieb has suggested corporate-sponsored prescription opioid monitoring.

The Commissioner of Food and Drugs, Scott Gottlieb, made remarks at a public workshop that suggested drug manufacturers and sellers might be required to help create a nationwide database for prescription opioid monitoring.

Gottlieb delivered the remarks on Monday, December 11, at a workshop in Silver Spring, Maryland entitled “Packaging, Storage, and Disposal Options to Enhance Opioid Safety – Exploring the Path Forward.”

After affirming his committed to ensuring the opioid crisis is his highest priority as FDA Commissioner, Gottlieb described a number of different programs being piloted by the agency as a method of deterring opioid abuse and addiction. In addition, Gottlieb announced that the FDA was publishing a Federal Register notice, and sought to incite those with relevant information and experience to provide comments on how the FDA might proceed in its efforts to combat the opioid crisis.

Much of the workshop was focused on the packaging used for prescription opioids, and how specific designs and warning labels can provide an effective deterrent for misuse. He also mentioned the utilization of packaging innovations in order to foster compliance with prescriber recommendations and facilitate the disposal of unused prescription opioids.

Gottlieb highlighted three areas that the FDA believes could offer the opportunity for improvement, thereby combating the opioid crisis.

The first of these three areas was the over-prescription of opioids, especially when non-opioid options were available. The next was long-term prescription of opioids, which Gottlieb emphasized must be curbed. And the final area Gottlieb cited was “pill mills,” which he characterized as “egregious prescribing” that may rise to the level of “criminal activity,” taking the time to praise the Drug Enforcement Agency for their efforts in combating the opioid crisis.

Among Gottlieb’s suggestions for additional programs moving forward was a national database for the prescription opioids. In his description of the proposed program, Gottlieb described a system that would require a prescribing doctor to enter the number of pills they wished to prescribe their patient, which would require doctors to provide additional medical justification for the prescription when certain conditions were triggered. Gottlieb also suggested a nationwide prescription opioid monitoring database, funded by drugmakers, which would provide real-time alerts about patients who had reached certain prescription limits.

In addition to requesting comments on the Federal Register, the FDA has scheduled a public hearing on January 30, 2018 to discuss the next steps the agency will take in combating the opioid crisis.