Public Citizen Criticizes Proposed FDA Opioid Surveillance Plan

The FDA RADARS program was originally created by Purdue Pharma, which has often been blamed for its role in creating the opioid abuse and addiction crisis.

A prominent consumer advocacy group is criticizing an opioid surveillance plan proposed by federal regulators, indicating that it lacks major oversights and has questionable ties to Purdue Pharma and other opioid drug makers.

Public Citizen submitted scathing public comments (PDF) on December 18, aimed at the details of the U.S. Food and Drug Administration (FDA) proposed opioid surveillance plan that designates public funds for the Research Abuse, Diversion and Addiction-Related Surveillance program (RADARS), which has long-standing ties to the pharmaceutical industry.

The group accuses the FDA of providing vague details concerning the opioid surveillance plan and questionable practices when allocating public funds for the new program.

The response criticizes the FDA’s intent to direct opioid surveillance public funds to the RADARS program since it is “excessively influenced by Purdue Pharmaceuticals and other opioid manufacturers,” according to the letter. The response also questions the FDA’s intent to direct funds for research solely to RADARS.

The FDA’s plan does not indicate any other surveillance efforts will be involved in the program and does not direct funds to other drug intervention programs, such as the Substance Abuse and Mental Health Services Administration or National Institute of Drug Abuse.

Pharmaceutical Industry Participation in RADARS

RADARS was originally formed by Purdue and supports “questionable lobbying efforts by the opioid industry”, Public Citizen notes.

Among the eight-member RADARS advisory board, two reported taking more than $580,000 in pharmaceutical industry financial payments from 2016 to 2022, and three members received payments of $1,100 in at least one year from 2016 to 2022.

The Public Citizen letter cites a complaint filed by the Colorado Attorney General against Purdue and the Sackler family, noting their habit of blurring Purdue’s interests with RADARS efforts and other opioid manufacturer interests.

Opioid Surveillance Plan Inadequacies

The letter also condemns the FDA’s plan to compile data from patients in opioid treatment, claiming the agency is ignoring that most people who need addiction treatment do not receive it. In addition, some people affected by opioid poisoning have no history of abuse or dependence. Thus, data from a large portion of the intended population will be missing from the agency’s research.

Essentially, the lack of inclusion of populations who need treatment is another tactic by the FDA to blame patients for their addiction, according to Public Citizen.

The letter also blasts the FDA for failing to recognize the agency’s own part, as well as that of the opioid industry and doctor overprescribing, in bearing “substantial responsibility” for the origins of the opioid epidemic.

The FDA’s plan was published in the Federal Register on October 17, 2023, and public comment on the plan closed on December 18, 2023. The FDA will review public comments along with recommendations from industry experts before issuing a final regulation regarding the surveillance plan.

The surveillance plan is one of the FDA’s efforts to address the ongoing opioid epidemic, which also includes the agency’s announcement last month implementing mandatory warning labels for all opioid painkillers.