Regulatory Focus™ > News Articles > Report Calls on FDA to Adopt New Standard for Reviewing Opioids

Report Calls on FDA to Adopt New Standard for Reviewing Opioids

Posted 14 July 2017 | By Michael Mezher 

Report Calls on FDA to Adopt New Standard for Reviewing Opioids

The National Academies of Sciences, Engineering and Medicine (NASEM) issued a report Thursday calling on the US Food and Drug Administration (FDA) to change its approach to reviewing opioids in light of the ongoing opioid epidemic.

The report, which FDA requested in March 2016 as part of its Opioids Action Plan, argues there is a "scientific and epidemiological basis for special treatment of opioids by the FDA that would involve greater integration of public health considerations at the time of preapproval testing, during regulatory review and approval, and during routine post-approval oversight."

FDA Commissioner Scott Gottlieb welcomed the report, but noted the agency already has started efforts in line with some of the recommendations.

"I've asked my FDA colleagues to take a fresh look at some key features of the agency's regulation of opioids, including provider education, benefit-risk assessment in the pre- and post-market setting, and steps we can take to reduce the overall exposure to these drugs," Gottlieb said.

Echoing the report's call to factor in other public health considerations, Gottlieb said FDA will "work to ensure drug approval and removal decisions are made within a benefit-risk framework that evaluates not only the outcomes of opioids when used as prescribed, but also the public health effects of the inappropriate use of these drugs."

Gottlieb also highlighted other recent agency efforts to stem the opioid epidemic, including its request that Endo Pharmaceuticals pull Opana ER (oxymorphone hydrochloride) from the market last month, and his announcement Monday that the agency soon will require immediate release opioids to follow the same Risk Evaluation and Mitigation Strategy (REMS) as extended release formulations.

NASEM Report

Specifically, the report calls for FDA to veer from its typical "product-specific" approach to approving opioids to an approach that looks at a much broader range of public health factors.

"While this approach works well in most cases, the committee believes it is necessary to view the regulatory oversight of opioid medications differently from that of other drugs because these medications can have a number of consequences not only at the individual level but also at the household and societal levels," the report says.

Instead, the report says FDA also should consider other factors such as the incidence of opioid use disorder, the risks to a patient's household and community, and other risks such as diversion, transition to illicit opioids and the transmission of diseases such as HIV or hepatitis C.

In addition, the report points out several shortcomings in the clinical trial data generated when it comes to opioids.

"Clinical trials sufficient to meet the FDA's efficacy standard can be conducted in a brief, highly protocolized setting and often exclude many patients who would be expected to get the drug following approval," the report says, pointing to the pivotal Zohydro ER (hydrocodone) study, which was conducted over 12 weeks and looked only at patients with lower back pain.

To address these shortcomings, the report calls on FDA to require wider ranging studies including subpopulations at higher risk for misuse or abuse, patients with mental health disorders and measuring outcomes reported by members of patients' household or other third parties.


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