On June 21, 2019, the US Food and Drug Administration (FDA) released a draft guidance for industry titled Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework. These FDA guidances are not legally binding, and instead are intended to provide relevant stakeholders with the FDA’s current thinking on a particular issue.
This draft guidance pertains to the means by which the FDA approves or rejects a new opioid drug. Specifically, the guidance expands on the FDA’s rationale behind its benefit-risk assessment framework, which accounts for factors pertaining to both the specific drug and the therapeutic area in question. For opioid analgesics, the FDA also considers public health factors including the risks of misusing, abusing, and overdosing on these drugs. Broadly, the FDA considers both the benefits and the risks to the patient if using the drug as labeled. Some benefits considered include the analgesic efficacy and safety of the drug. The risks considered include adverse effects, the development of opioid use disorder, and any unique risks of the drug in question compared to opioid analgesics broadly. Finally, the FDA also considers how the safety and effectiveness of this new drug compare to other, previously approved opioid analgesics, and the wider public health effects associated with this drug.
The comment period is open on this draft guidance until August 20, 2019. Additionally, the FDA will hold a public hearing titled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction” on September 17, 2019.