Regulatory Focus™ > News Articles > 2019 > 3 > Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

Posted 21 March 2019 | By Michael Mezher 

Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.
The petition is undersigned by Raeford Brown, the chair of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee who has spoken out against the agency’s controversial approval of AcelRx’s sublingual opioid Dsuvia (sufentanil).
“We demand a moratorium on the approval of opioids out of a sense of urgency, after repeatedly attempting to provide insights concerning the opioid crisis to the principals of the FDA. Tragically, they have not listened,” Brown said.
The call for a moratorium comes as FDA considers taking new steps to address the opioid epidemic and amid media reports questioning whether the agency helped fuel the crisis.
In 2016, FDA leadership acknowledged the need to change its approach to regulating opioids and asked the National Academies to provide a set of recommendations for a new regulatory framework for the drugs.
The report, Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use, was released the following year and called for FDA to incorporate public health considerations into its regulatory decision-making for opioids.
“Public health considerations need to be embedded in a regulatory framework that is flexible enough to capture and weigh an array of diverse outcomes occurring at multiple levels, from individual to societal. This integrated framework needs to facilitate informed regulatory decisions throughout a drug’s life cycle, and include built-in periodic monitoring of each decision’s consequences instead of decisions being treated as self-contained events,” the report states.
In the petition, Public Citizen argues that FDA has the statutory authority to refuse applications of opioids under the Food, Drug and Cosmetic Act if the applications “do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.”
In the case of Dsuvia, Public Citizen argues that FDA should have considered the potential for diversion for the drug, as its active ingredient sufentanil has been identified as early as 1990 “as one of the leading opioid drugs of diversion and abuse by anesthesiologists.”
Public Citizen also points out in the petition that FDA Commissioner Scott Gottlieb, in announcing the approval of Dsuvia, questioned whether the agency should change its approach to reviewing opioids in response to the ongoing epidemic.
“To what extent should we evaluate each opioid solely on its own merits, and how should we also consider, within the broader context of our public health mission including the overall therapeutic armamentarium that we have available for addressing pain, the other opioid analgesics that are already on the market, the epidemic of opioid misuse and abuse that’s gripping our nation and the risk for illicit diversion and abuse?” Gottlieb asked.
Public Citizen, Citizen Petition


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