The Food and Drug Administration proposed on Monday new guidelines to fight the growing opioid epidemic that’s hitting the U.S., and pledged to make it its priority.
FDA Commissioner Scott Gottlieb announced plans to require manufacturers of immediate-release painkillers to provide thorough education for physicians and health care professionals who prescribe these drugs.
The announcements were part of the opening statement of a two-day FDA meeting on painkiller abuse. Painkiller prescriptions account for 90 percent of the opioids prescribed in the United States, and some of the compounds include dangerous opioids like hydrocodone or combinations such as oxycodone with acetaminophen.
FDA will require training to prescribe extended-release opioid painkillers
Gottlieb noted that, for the time being, only makers of extended-release painkillers, which account for the remaining 10 percent of prescriptions, are required to provide training.
“America is simply awash in immediate-release opioid products,” said Gottlieb.
He noted that the new training requirements would aim at making sure that prescriptions are for patients who actually need them and under appropriate clinical circumstances.
The FDA will also survey doctors to ensure the term “abuse deterrent” isn’t giving a false sense of security that these drugs are less likely to lead to addiction than pills without that designation. Gottlieb noted that while abuse-deterrent versions of painkillers are manufactured to be harder to crush, snort or inject, the FDA doesn’t want to convey a perception that these versions are less prone to fueling addiction because they’re not.
Although the FDA does not require doctors to undergo the training currently, Gottlieb said he wants to pursue that possibility.
“Based on the feedback we’ve received from two public meetings over the past year, we’re actively exploring the question of whether, in the future, there should be mandatory provider education, and how we’d operationalize such a condition,” he said.
The commissioner that most people who become addicted to opioid painkillers will eventually move on to look higher dose formulations of these compounds or they’ll seek illicit street drugs that are “increasingly the low-cost alternatives.”
Endo International Plc halted sales of its addictive painkiller Opana ER
The agency has been taking measures against pharmaceutical companies, too, as the opioid epidemic continues to claim lives around the country. Last week, Endo International Plc complied with FDA’s request to halt U.S. sales of its powerful opioid painkiller Opana ER.
The FDA had said the abuse-deterrent version of the painkiller was linked to an outbreak of HIV and hepatitis C after users would inject it for a more potent high and share used needles. That marked the first time the FDA asked for the removal of an opioid from the market because of a public health consequence of abuse.
A court filing against Endo and Purdue Pharma, another pharmaceutical manufacturer, were also added last week to a lawsuit from 2014 by two counties in California. The lawsuits were filed as an effort to make the drug companies pay for the cost of addressing the opioid crisis.
Gottlieb also noted the agency would examine whether it should take action to reduce the number of 30-day prescriptions that are issued for pain related conditions that don’t need a whole month’s supply, such as dental procedures.