In a statement released on November 2, 2018, accompanying the approval of Dsuvia, a new opioid analgesic, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. outlined principles for the approvals of future opioids that may slow the introduction of new opioids to the market.
He announced that the FDA is in the process of developing a formal risk and benefit framework for evaluating the safety and efficacy of opioids, and Commissioner Gottlieb said that drugs would be considered in the context of existing similar drugs, as well as in consideration with the opioid crisis. Gottlieb seemed to suggest that the FDA would condition new opioid approvals on whether they are sufficiently better than existing drugs, rather than solely making independent approval decisions. “As we look at the public health implications of each new approval,” said Gottlieb, “we should evaluate whether we need to take additional steps to systematically consider new opioids relative to the comparative benefit and risks of other opioids already on the market.”
Gottlieb provided the reasoning for this change as “opioids are a unique class of medicines,” and that he is responding to a recent direction from Congress to think differently about opioids as a drug class in “enacting novel and specific authorities that enable the FDA to, among other things, require post-market studies to evaluate efficacy of opioids if we have concerns that these products may not be as effective as previously thought; to consider the risks associated with the misuse and abuse of opioids as a factor in how we make pre- and post-market regulatory decisions; to require opioids to be sold in unit dose packaging; and to require that certain opioids be dispensed with packaging or systems that enable the drugs to be safely disposed.”
Commissioner Gottlieb noted that the FDA has started to implement the new authorities authorized by the recent opioid legislation, including mandating unit-dose packaging for opioid painkillers, and he also emphasized that even before the passage of the law, the FDA was taking “a different approach to the benefit-risk evaluation of opioids.”
Gottlieb has asked that the FDA create and evaluate a new framework for opioid approvals, one that provides a transparent process, which will eventually be turned into a new guidance. The framework is expected to highlight how the FDA intends to consider the benefits and risks of opioids in the context of the current crisis. Specifically, Commissioner Gottlieb would like the following questions answered:
- How does the availability of an additional opioid drug benefit the public health through its ability to, for example, provide therapeutic differentiation, promote more appropriate access, or advance safer use of these medicines?
- Does the approval of an additional opioid drug create added risks for diversion, accidental overdose, abuse and misuse, or other concerns?
- If the approval of an additional opioid will create such added risks, will the new drug provide sufficient clinical differentiation that can benefit certain groups of patients, or offer other important clinical benefit, such that the benefits to patients of introducing the additional opioid outweigh the risks? And can the implementation of REMS help mitigate some of these risks?
As FDA staff and the FDA’s Opioid Policy Steering Committee (OPSC) move forward with policy development and recommendation, Commissioner Gottlieb also suggested that he may seek help from Congress to build additional ideas and effectuate change.