If the FDA is looking for a streamlined approach to respond to the opioid crisis, it didn’t come from a public meeting of the agency’s Opioid Policy Steering Committee.
At the meeting Tuesday, academics, physicians, patients, advocates, and industry officials shared sometimes conflicting recommendations on how the FDA can best handle the problem.
Advocates generally fell into two camps: pain patients and their supporters, concerned that opioids are being over-regulated and becoming harder to access, and people who have lost loved ones to addiction and overdoses, and would like to see stronger restrictions on such products.
Meanwhile, healthcare experts stressed addiction and overdose prevention, better provider education and awareness efforts, and the elimination of “doctor-shopping.”
In September 2017, the FDA issued a request for comment, which said the national crisis is one that requires “action by federal agencies that may in some instances be unprecedented.” The notice solicited public input to help the agency determine what it should leverage to respond to the crisis.
President Trump declared the opioid epidemic a public health emergency a month later. Approximately 64,000 people died from opioid overdoses in 2016.
The FDA notice included a handful of direct questions for stakeholders, such as:
- How can the agency use the available public health data to influence opioid related regulatory decisions?
- What changes can the agency make with regard to “dispensing and packaging” to encourage proper prescribing practices?
- Should mandatory education be required for clinicians who prescribe opioids? […]
Another concern is the language used to describe opioids, stated Diana Zuckerman, PhD, of the National Center for Health Research. She said “abuse deterrent” may mean different things to doctors, patients, and family members.
She urged the FDA to include education on the meaning of “abuse deterrent” within its Risk Evaluation and Mitigation Strategies (REMS) because “too often it’s misinterpreted to mean it’s not as addictive.”
But Zuckerman also questioned the value of REMS itself, claiming that the “vast majority” of physicians don’t even know REMS exists. Following the implementation of REMS, one prescriber-based survey found 48% of respondents said they did not change their prescribing habits, she noted. Also, while 49% said they made use of the patient counseling documents, that means roughly half did not, she added. […]
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