FDA Announces New Plans To Address Opioid Abuse Crisis

Federal regulators have released new plans for combating the worsening opioid abuse crisis plaguing the nation, including new prescriber programs and workshops. 

In a press release issued on January 30, FDA Commissioner Scott Gottlieb indicates that the agency will focus on the “urgency and complexity” of the opioid crisis, and take steps to address the issue and reduce narcotic painkiller abuse across the United States.

The FDA recently convened the Part 15 hearing on opioids, which involved a gathered of patients, industry professionals, members of academia, healthcare professionals, and advocacy organizations to get feedback on how the agency can strengthen oversight of opioids. The meeting came as the number of opioid overdose deaths reached an all-time high in recent years, increasing nearly 140%.

Gottlieb indicated the agency’s role is to address the epidemic and to reduce new addictions. The FDA plans to do this through their influence on prescribers using the Risk Evaluation and Mitigation Strategy (REMS) authorities, and an update to the REMS Education Blueprint. This is an educational program geared toward health care providers who prescribe opioid painkillers.

The new blueprint also includes information focusing on pain management, principles of acute and chronic pain management, non-pharmacologic treatments for pain, and pharmacologic treatments for pain (both non-opioid and opioid).

Additionally, the FDA is working on changing immediate formulations and packaging of opioid drugs, like Vicodin and Percocet. These drugs are typically prescribed for short-term use. Thus, new packaging could focus on blister packs of 3 or 6 pills, instead of monthly supplies.

A study published earlier this month indicated nearly half of all patients prescribed opioids don’t need them for pain relief. So shorter duration prescriptions would be helpful in cutting down unnecessary prescriptions.

“I believe anyone who is distributing health care products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse,” Gottlieb said.

Nearly 12 million Americans misused prescription opioids in the past year. More than 40 people die every day from overdoses involving prescription opioids. In fact, opioid deaths now outnumber breast cancer fatalities each year.

The FDA is accepting comment on the opioid Part 15 hearing until March 16, 2018. The agency plans to host a public workshop on February 15 focused on strategies for safe narcotic painkiller use and prescribing.

The workshop will be held in collaboration with the Duke Margolis Center for Health Policy. It is one of many efforts to move forward to mitigate the opioid crisis, while helping patients find safe and effective treatment.

“The issue of opioid misuse and abuse remains one of my highest priorities and we believe it’s going to take carefully developed, sustained, and coordinated action by everyone involved to reduce the tide of opioid addiction and death afflicting our communities; while maintaining appropriate prescribing for patients in medical need,” Gottlieb said.