FDA Commissioner Will Set Stricter Prescriber Education Standards for Opioid Manufacturers

In response to the opioid epidemic in the United States, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb plans to implement stricter standards for the education and training that opioid manufacturers provide to physicians and other health-care professionals who prescribe opioids.

The FDA announced this decision following a two-day meeting regarding drug abuse and addiction. It will require manufacturers of immediate-release opioids – which make up 90 percent of opioid prescriptions – to provide more extensive training for prescribers. Current regulations only require makers of extended-release products to provide such training.

Drug manufacturers also will be required to provide prescribers with more information regarding non-opioid pain management treatments and detail non-medication therapies.

The new requirements aim to “[make] sure providers who write prescriptions for the opioids are doing so for properly indicated patients and under appropriate clinical circumstances,” Dr. Gottlieb said.

The FDA recently called for Endo Pharmaceuticals to remove its reformulation of oxymorphone hydrochloride extended-release citing that the benefits no longer outweighed the risks of abuse and misuse.

Numerous state medical boards have already implemented mandatory education programs for health care providers and new restrictions on opioid prescribing.

Sources: The Washington Post, July 10, 2017; The Wall Street Journal, July 10, 2017.