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FDA’s Double Denial Concerning Its Delinquency in Urgently Implementing Better Opioid Regulation

Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group

Note: On Friday, the U.S. Food and Drug Administration (FDA) denied Public Citizen’s April 10, 2019, petition to the agency to immediately impose a moratorium on approval of all new applications for new opioids or new opioid formulations until the FDA has implemented the National Academies of Sciences, Engineering, and Medicine (the National Academies) mid-2017 recommendations regarding the review and approval of opioids. The recommendations were intended to prevent a continuation of dangerous regulatory errors that clearly have contributed to the current deadly opioid crisis in the U.S. Dr. Raeford E. Brown, Jr., professor of anesthesiology and pediatrics at the University of Kentucky/Kentucky Children’s Hospital and the former chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, was a co-petitioner.

The FDA’s denial of our April petition for a temporary moratorium on new opioid approvals until the agency adopts a more rigorous regulatory framework for reviewing opioids that was recommended two years ago by the National Academies ironically also contains elaborate denials of the agency’s own dangerous lack of progress in adopting such an improved regulatory framework.

Had the FDA acted with the urgency demanded by the ongoing opioid crisis and begun the important public process of developing a desperately needed improved opioid regulatory framework soon after it received the detailed, carefully considered National Academies recommendations two years ago, it is likely that the process of creating this framework would have been completed by now, rather than, unacceptably, just beginning.

In early 2016, the FDA commissioned the National Academies to review the agency’s regulatory oversight of opioids and make recommendations for improving it. Acting with appropriate urgency and informed through a series of public hearings, the National Academies in mid-2017 presented the FDA with a completed report, “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use,” that contained many detailed recommended improvements for the opioid regulatory review and approval process.

The FDA, in its exaggerated “progress report” contained in Friday’s denial of our petition, focuses heavily on the good news of a public proposal announced this past June: a draft guidance titled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.”

Our comments submitted to the FDA seriously criticized this inadequate draft guidance because it was “more focused on the nonspecific, generalized factors that the FDA itself will consider when reviewing [a new drug application (NDA)] for an opioid, rather than providing industry with guidance as to what specific benefit and risk information should be sought out and included in future NDAs for opioids.” In addition, lacking from the guidance is the recommendation that companies seeking approval for new opioids review the previous evidence for diversion – using legal drugs for illegal or unprescribed uses – of similar, earlier marketed opioids and that the companies discuss in the NDAs what intervention they plan to implement to ensure that their new opioids would be diverted less frequently than similar predecessor drugs, as recommended in the National Academies report.

The most noteworthy critique of this draft guidance, however, was submitted by the chair, one member and two consultants of the National Academies committee that wrote the 2017 report. Expressing their own views, they noted that although pleased that the FDA was at least “developing the Draft Guidance with the recommendations of the [National Academies] Committee’s 2017 report ‘in mind,’” the draft guidance falls far short of what is needed.

Their criticisms included:

“[T]he Draft Guidance … is an important first step in implementing the 2017 report’s recommendations that will lead to benefits for the public health … [but] there remain critical actions for the agency to take using existing authorities to help address the opioid crisis in a balanced way and to fully implement the ‘comprehensive systems approach’ recommended in the 2017 report …

“[M]uch remains unstated in the Draft Guidance. We encourage the agency to integrate more recommendations from the 2017 report in its Final Guidance (or additional guidance documents), with the goal of using the full reach of the agency’s existing authority to help reduce the harms associated with prescription opioids while also helping to ensure that evidence-based pain management therapies are available for patients.”