David Rosen on FDA GLP-1 Rethink – 'I would call it unprecedented'

Foley & Lardner LLP partner David Rosen discussed the U.S. Food and Drug Administration’s approach to GLP-1 compounders in the PharmaVoice article, “FDA’s GLP-1 decision kicks off ‘unprecedented’ tussle over shortage.”

Rosen said the FDA’s recent back-and-forth on its stance of removing some GLP-1s from the national shortage list following a lawsuit by the Outsourcing Facilities Association marks an unusual situation for compounding pharmacies.

“I would call it unprecedented, in terms of looking at the challenge to the policies and procedures for removing a drug from the shortage list,” Rosen explained.

He highlighted how the U.S. Supreme Court’s overturning of Chevron deference has created another unknown at play.

“Now FDA doesn’t have the deference under Chevron,” Rosen added. “It’ll be interesting to see what a court finds whether or not there was enough process protections in there.”

Rosen’s commentary also appeared in BioPharma Dive.