STAT+: FDA is blasted by advocates for pursuing a deal with data provider that has ties to opioid makers
Advocacy groups are blasting the FDA's plan to work with a Denver Health surveillance system for monitoring misuse of prescription opioids over its ties to the pharmaceutical industry.
Several advocacy groups are blasting a Food and Drug Administration proposal to work with a Denver Health surveillance system for monitoring misuse of prescription opioids over long-standing ties the operation has to the pharmaceutical industry.
At issue is the Research, Abuse, Diversion, and Addiction-Related Surveillance system, or RADARS, which was originally created as in-house monitoring program by Purdue Pharma and later sold to the Denver Health and Hospital Authority. The RADARS system primarily collects real-world evidence from patients about opioid treatment programs, which is why the FDA is interested in its data.
But RADARS also works with the pharmaceutical industry in certain ways that advocacy groups argue is problematic. For instance, RADARS provides consulting services to drug companies as they prepare for meetings with FDA advisory panels, according to its web site. These meetings are convened by the agency to determine whether a medicine should be recommended for a particular use.
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