Responses of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen's Health Research Group, to Gottlieb Testimony on Opioids
Scott Gottlieb, U.S. Food and Drug Administration (FDA) commissioner, today testified about opioids at a U.S. Senate Appropriations Committee Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.
Three years ago, Gottlieb’s predecessor, Dr. Robert Califf, asked the National Academy of Medicine, now part of the National Academies of Sciences, Engineering and Medicine (National Academies), for assistance in dealing with the prescription opioid crisis in the form of helping the FDA develop a regulatory framework for approval of opioids.
Almost two years ago, the Academies’ lengthy report was released, predicated on their overall concern that the FDA had failed to adequately “incorporate public health considerations into opioid-related regulatory decisions.” The National Academies therefore recommended many specific changes, compatible with the agency’s existing statutory authority, to be incorporated as a blueprint for an FDA framework for opioid regulation that would address the agency’s long-standing deficiencies in this process. As of now, such a framework does not exist.
Misleading or omitted statements by Commissioner Gottlieb in today’s Senate testimony:
- The absence of any mention of the National Academies’ crucial role in this process let Gottlieb take personal or FDA credit for these yet-unimplemented “new” ideas while detracting attention from the fact that two years later, no FDA framework exists. Gottlieb comment today: “Today, I come before you to say that, after careful deliberation, I believe that the FDA needs a new, comparative standard for future approvals of new opioid drugs.”
- Gottlieb’s comment today: “During the last two years, the FDA worked to change our approach to this crisis. We’ve committed to act more quickly as we confront new risks and to take a much more aggressive approach to regulatory action.” But this isn’t true. Gottlieb on Nov. 2 approved the superpotent fentanyl-like Dsuvia (sufentanil) in violation of FDA laws and regulations and multiple National Academies’ recommendations against approving such abusable opioids. This constituted an “aggressive” but reckless and wrong approach to this crisis.
- Gottlieb comment today: “We want to incentivize drug developers to focus on developing new opioid drug products that offer safety advantages, effectiveness advantages, or other material therapeutic advantages over already-approved opioids. …We hope this new approach would also incentivize developers to increasingly focus their efforts on nonopioid alternatives that could, eventually, begin to replace opioids as the drugs of choice in the armamentarium of drug products used to treat pain.”
One of the reasons Public Citizen petitioned the U.S. Department of Health and Human Services for an immediate moratorium on approving new or reformulated opioids is that at as long as the existing, dangerously inadequate regulatory process for opioids exists and until the new framework is in place, the incentives to the opioid industry will be to keep developing dangerous but approvable Dsuvia-like opioids with little incentive for developing non-opioid alternatives without such a moratorium.