Recently, the US Food and Drug Administration (“FDA”) published a new draft guidance entitled Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry, which outlines how the agency will weigh the benefits and risks of “proposed new opioid analgesics relative to other already approved opioid and non-opioid analgesics.” The draft guidance is based on a study the FDA commissioned from the National Academies of Science, Engineering and Medicine which was intended to identify additional actions the FDA could take to address the opioid crisis.
The draft guidance identifies five areas of information that a drug applicant should provide to the FDA, as follows:
- Benefits to the Patient Using the Drug as Labeled – This topic includes the analgesic efficacy and safety of the drug, and other issues, such as the evidence supporting the proposed duration of use, and whether the drug has characteristics that mitigate adverse events associated with opioids, such as respiratory depression, sedation and opioid use disorder.
- Risks to the Patient Using the Drug as Labeled – This topic includes whether the proposed drug has any “novel risks” not typically associated with other opioids, whether the particular formulation poses a risk to patients, including any abuse-deterrent excipients, whether the proposed drug alters the risk for respiratory depression, sedation, or development of opioid use disorder, and whether the adverse events typically associated with opioids occur at a higher rate or greater severity with the proposed drug.
- Effectiveness and Safety Relative to Approved Analgesic Drugs – This topic relates to comparative efficacy and safety data for the proposed drug relative to an approved opioid or nonopioid analgesic, and whether the proposed drug has any other advantages over other approved analgesics.
- Broader Public Health Effects: Risks and Mitigation of Risks Related to Misuse, Abuse, Opioid Use Disorder, Accidental Exposures, and Overdose – This topic relates to positive and negative public health effects of the proposed drug, and its potential risks to the patient and nonpatients, including patient’s family members.
- Risk Management – Here the FDA notes that a class-wide risk evaluation and mitigation strategy (“REMS”) will be required for all opioids intended for outpatient use, and that product-specific REMS may be required in cases where the safety profile of a proposed drug differs from those covered by the class-wide REMS.
In the draft guidance, the FDA noted that it is “committed to addressing the opioid crisis on all fronts,” and will also “continue to evaluate how drugs currently on the market are used, in both medical and illicit settings, and will take regulatory action where needed.” Interested parties may submit comments on the new draft guidance until August 20, 2019.