A major consumer advocacy group is strongly criticizing a proposed opioid surveillance plan put forth by federal regulators, alleging significant oversights and questionable connections to Purdue Pharma and other opioid manufacturers.
Public Citizen has submitted highly critical public comments regarding the U.S. Food and Drug Administration's (FDA) proposed opioid surveillance plan. This plan allocates public funds to the Research Abuse, Diversion, and Addiction-Related Surveillance Program (RADARS), a program with longstanding ties to the pharmaceutical industry.
The critique from Public Citizen accuses the FDA of providing insufficient details about the opioid surveillance plan and raises concerns about the allocation of public funds for the new program. The group specifically challenges the FDA's decision to direct public funds for opioid surveillance to the RADARS program, alleging that it is "excessively influenced by Purdue Pharmaceuticals and other opioid manufacturers." The response questions the FDA's exclusive focus on RADARS and its failure to direct funds to other drug intervention programs, such as the Substance Abuse and Mental Health Services Administration or the National Institute of Drug Abuse.
Public Citizen points out that RADARS was initially established by Purdue and highlights its involvement in "questionable lobbying efforts by the opioid industry." The letter underscores that two members of the RADARS advisory board reported receiving over $580,000 in financial payments from the pharmaceutical industry between 2016 and 2022, while three members received payments of $1,100 or more in at least one year during the same period.
Additionally, the letter cites a complaint filed by the Colorado Attorney General against Purdue and the Sackler family, emphasizing the intertwined interests of Purdue and RADARS with those of other opioid manufacturers.
Public Citizen's critique extends to the FDA's plan to gather data from patients in opioid treatment, arguing that the agency is overlooking the fact that many individuals in need of addiction treatment do not receive it. The letter contends that the FDA's research will lack crucial data from a significant portion of the targeted population, further accusing the FDA of placing blame on patients for their addiction.
Furthermore, the letter condemns the FDA for not acknowledging its role, along with that of the opioid industry and overprescribing doctors, in bearing "substantial responsibility" for the origins of the opioid epidemic.
The FDA's plan, unveiled on October 17, 2023, is part of the agency's broader initiatives to address the ongoing opioid epidemic. These initiatives include the recent announcement of mandatory warning labels for all opioid painkillers. Public comments on the surveillance plan were accepted until December 18, 2023, and the FDA will consider these comments, along with recommendations from industry experts, before finalizing the regulations for the surveillance plan.