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.
“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.”
Read the full MedPage article here: Groups Blast FDA’s Opioid Abuse Surveillance Proposal | MedPage Today
Read PROP’s submitted letter here: FDA-2023-N-3595-0014_attachment_1 (1)
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