FDA Needs Better Patient Data to Regulate Stronger Opioids, Experts Say

The FDA needs more data on the likely impact on patients before it introduces tighter controls on high-strength opioids and doses for outpatient settings, the agency heard in a two-day public meeting.

“There’s so much we don’t know about the implications of [tighter regulations]. We need to track these patients…[and] track the data on what happens if we destabilize them,” Sean Mackey, chief of Stanford University’s Division of Pain Medicine, told the joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee.

There are many questions that can only be resolved with high quality real-world data, so the physical, social and psychological functioning of patients’ needs to be tracked, including how they fare after being taken off opioids, he said.

Joanna Katzman, a professor at the University of New Mexico’s Department of Neurosurgery, Psychiatry and Nursing, said there isn’t enough evidence that changes to clinician prescribing behavior has lowered the number of overdose deaths.