On September 6, The Food and Drug Administration (FDA) issued a memo rejecting the request for a suspension of new opioid drug approvals. The moratorium request was made in March by a nonprofit advocacy group, Public Citizen’s Health Research Group, in response to a 2017 report by the National Academies of Sciences, Engineering, and Medicine. This report provided recommendations for addressing the growing opioid crisis by modifying the FDA’s opioid policy. The moratorium request had also received support from the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee Raeford Brown.
Reason For Petition For Moratorium
The Public Citizen’s petition requested the moratorium (or temporary prohibition) of new opioid drug approvals in response to the growing number of opioid-related overdoses and deaths, with the hopes of encouraging changes in the FDA’s drug approval process.
Their demand came on the heels of the FDA’s approval of a new opioid drug, Dsuvia. Public Citizen argued that the FDA failed to consider Dsuvia’s high potential for abuse and public harm. The group argued that when considering new drugs, the FDA must consider public health considerations, such as the potential for abuse and whether the drug is safe under its labeling guidelines.
Risks Of Dsuvia
Dsuvia, the newly approved opioid drug, is reportedly ten times stronger than fentanyl and is approved for use only in a hospital setting. Public Citizen argued that Dsuvia’s FDA approval will endanger public health due to the drug’s risk of overdose and death. Dsuvia’s high potency led to a boxed warning about the high risk of misuse and abuse, which can lead to addiction.
Dsuvia’s side effects also include extreme sleepiness, respiratory depression, coma, and death. The moratorium’s authors believe that the FDA’s approval process for drugs like Dsuvia does not sufficiently analyze abuse potential or include sufficient safeguards to protect the public. The group contends that regulations should be modified to ensure the potential benefits of a drug outweigh the risk to the general public.
Reasons FDA Rejected Application
In its response to Public Citizen’s FDA petition, the agency explained its decision to continue accepting new opioid applications while acknowledging the need for change. The FDA’s response memo stressed it is required to follow existing legal and regulatory requirements when analyzing new drug submissions. The FDA also noted that “a moratorium on the approval of new opioid drug products could stifle the development and availability to patients of new opioids that could offer greater safety or other therapeutic advantages over products already on the market.”
Despite its rejection of the petition, the FDA’s opioid policy is receiving a continued examination, and the agency promised additional modifications to help combat the opioid epidemic. Accordingly, the FDA recently issued draft guidance regarding their opioid benefit-risk assessment framework that incorporates public health considerations.
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Woodcock, Janet. “FDA Final Response to Opioid Moratorium Petition.” U.S. Food and Drug Administration, September 6, 2019. Accessed October 4, 2019.
Wolfe, Sidney; Brown, Raeford. “Citizen Petition Requesting an Immediate Moratorium o the Approval of New Drug Applications for New Opioids or New Opioid Formulations.” Public Citizen, April 10, 2019. Accessed October 4, 2019.
National Academies of Sciences, Engineering and Medicine. “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use.” July 13, 2017. Accessed October 4, 2019.
Gottlieb, Scott. “Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids.” U.S. Food and Drug Administration, November 02, 2018. Accessed October 4, 2019.