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Pharmaceuticals / Regulatory Affairs

Gottlieb Says Agency to Issue Guidelines on Opioid Use for Cancer Pain

Nov. 21, 2018

The FDA plans to develop evidence-based guidelines for the use of opioids to treat cancer pain,  Commissioner Scott Gottlieb said at a Nov. 13 Washington Post forum.

“I think FDA has a mandate to try to rationalize prescribing,” Gottlieb said, adding that the  agency must strike a balance between responsible prescribing and not removing access from cancer patients in severe pain who genuinely need the drugs.

To that end, Gottlieb said, the agency must develop evidence-based guidelines rather than consensus guidelines, which rely too much on “what we currently know.”

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