Groups Blast FDA’s Opioid Abuse Surveillance Proposal

Several advocacy groups urged the FDA to not rely on a drug surveillance system that reportedly has ties to embattled opioid maker Purdue Pharma and other drug companies.

Public Citizen, Physicians for Responsible Opioid Prescribing (PROP), PharmedOut, the National Center for Health Research, and others submitted comments to a docket on Regulations.gov proposing that FDA will use data from the Research, Abuse, Diversion, and Addiction-Related Surveillance (RADARS) system to help monitor opioid abuse in the U.S.

The groups charged that the RADARS system was created by Purdue Pharma and still has close ties to that company and to other pharmaceutical manufacturers, raising concerns about FDA’s use of its data.

“Congressional investigations, books, documentary films, and television mini-series have detailed the role played by Purdue, the Sacklers, and the opioid industry in causing the opioid crisis,” the PROP letter stated. “Many of these accounts have featured the opioid industry’s influence on the FDA.”

“The time for FDA to learn from its past mistakes is long overdue,” the letter continued. “FDA should enforce strict firewalls to prevent the opioid industry from having undue influence on its decision-making.”

PROP’s letter noted that RADARS was created in 2001 by Purdue Pharma and the Sackler family in response to DEA and FDA concerns about OxyContin. Though Purdue transferred ownership of RADARS to the Denver Health & Hospital Authority in 2005, turning it into a non-profit, PROP argued that this just “gave the appearance that RADARS was now independent.”

Purdue continued to have influence on the surveillance system, PROP argued. For instance, the Sackler family appointed the original board for RADARS, and five of those people remain on the current eight-person scientific advisory board, PROP stated.

RADARS also received payments from Purdue for “consulting, lobbying, and advocacy services” until at least 2018, the letter stated, noting that the organization has also “provided opioid manufacturers, including Purdue, with a unique suite of services to help them avoid regulations and sell more opioids.”

The PROP letter cited a lawsuit filed by the Colorado Attorney General against Purdue Pharma and the Sackler family in 2019 as the source of much of the information about RADARS. PROP President Andrew Kolodny, MD, of Brandeis University in Waltham, Massachusetts, said the lawsuit is tied up in the Purdue bankruptcy court proceedings.

A spokesperson for the RADARS system told MedPage Today in an email that it is “simply a service provided by: the Denver Health & Hospital Authority [DHHA] that has “many subscribers who purchase data only. It is our understanding that these companies share the data with the FDA.”

“We offer no additional services such as trying to promote or market a drug in any way,” the spokesperson said. “All subscribers have the same contractual relationship with DHHA. None have any special services or rights.”

The FDA docket, titled in part “Improving the Quality and Representativeness of the Treatment Center Program Data,” explains that the agency is planning on “funding the evaluation and improvement of the data validity and reliability of the [RADARS] Substance Abuse Treatment Center Programs Combined (TCPC) survey.”

This program collects data from patients entering private and public opioid addiction treatment programs, and the objective is to “provide timely prevalence estimates of abuse of legal and illegal opioids and other substances.” Ultimately, the data are used by FDA and others to “inform policy and regulatory decision,” the docket stated.

In its comments, the National Center for Health Research said the fact that RADARS is supported by subscriptions from drug companies and other agencies is an “obvious conflict of interest” and this will “undermine the credibility of whatever information is collected.”

Public Citizen in its letter called RADARS “a drug abuse and dependence monitoring organization that has long been excessively influenced by Purdue Pharmaceuticals and other opioid manufacturers, at the expense of the public’s health.”

PharmedOut said RADARS “has a terrible history of involvement in creating and maintaining dangerous overprescribing of opioids.”

“Rather than relying on an opioid industry-funded organization with a track record of disseminating deceptive information for surveillance, we believe that FDA should rely on SAMHSA’s Drug Abuse Warning Network, which could be enhanced by additional funding,” the PROP letter concluded. “Alternatively, FDA could issue a Request for Proposals from research groups and academic institutions with safeguards to ensure that these entities do not have relevant conflicts of interest.”

As of press time, the FDA had not returned a request for comment from MedPage Today.

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