How the FDA Will Combat Opioid Abuse


Gottlieb and the FDA are being praised for their efforts, but could they be doing more?

While the new FDA Commissioner’s plans to combat the opioid abuse epidemic are lauded, there are some other ways the agency could combat the problem, an expert told Drug Topics.

“Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction,” wrote Scott Gottlieb, MD, in a blog post to FDA staff and the public.

Gottlieb also established an Opioid Policy Steering Committee, “which will bring together some of the agency’s most senior career leaders to explore and develop additional tools or strategies FDA can use to confront this crisis,” Gottlieb said. “While there has been a lot of good work done by FDA to date, and many people are working hard on this problem, I have asked my FDA colleagues to see what additional, more forceful steps we might take.”

Related article: Is $485 million enough to end the opioid epidemic?

G. Richard Smith, MD, Professor of Psychiatry, Medicine and Public Health at the University of Arkansas for Medical Sciences (UAMS), told Drug Topics that the Opioid Policy Steering Committee will be useful because it focuses FDA’s attention on the problem of opioid addiction.The FDA has vast reach and depth; thus, its attention to this matter could make a big difference,” he said.

However, Smith argued that the agency could better combat the opioid addiction problem by helping speed development and market access to effective, non-opioid pain relievers. “We have been using opioids for pain for hundreds, if not thousands of years, why are there not other effective and non-addictive pain medications?” he asked.

However, Smith agreed with the issues that Gottlieb directed the Steering Committee to explore. Gottlieb wrote, “Should FDA take additional steps, under our risk management authorities, to make sure that the number of opioid doses that an individual patient can be prescribed is more closely tailored to the medical indication? For example, only a few situations require a 30-day supply. In those cases, we want to make sure patients have what they need. But there are plenty of situations where the best prescription is a two- or three-day course of treatment. This might require FDA to work more closely with provider groups to develop standards for prescribing opioids in different clinical settings.”

“Certainly, most acute pain situations such as surgery or trauma do not require a 30-day supply,” Smith said. “This recommendation, if followed, will reduce the likelihood that the patient may inadvertently become addicted, and it will reduce the potential for diversion of opioid to others.”

Related article: Will Gottlieb’s Faster Drug Approvals at FDA Help or Harm?

Other questions that Gottlieb said the Steering Committee should review include “Are there circumstances under which FDA should require some form of mandatory education for health care professionals, to make certain that prescribing doctors are properly informed about appropriate prescribing recommendations, understand how to identify the risk of abuse in individual patients, and know how to get addicted patients into treatment?” and “Is FDA using the proper policy framework to adequately consider the risk of abuse and misuse as part of the drug review process for the approval of these medicines? Are we doing enough when we evaluate new opioid drugs for market authorization, and do we need additional policies in this area?”

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