David Rosen on FDA GLP-1 Legal Battle – 'It's a precedent in this area'

Foley & Lardner LLP partner David Rosen described the legal battle between compounding pharmacies and the U.S. Food and Drug Administration over GLP-1 drugs in the BioSpace article, “Legal Challenge Over Lilly’s GLP-1 Shortages Highlights FDA’s Post-Chevron Vulnerability.”

“It’s a precedent in this area. No one has ever challenged the FDA’s decision to remove a therapy from the drug shortage list,” Rosen said of the Outsourcing Facilities Association lawsuit filed in response to the FDA’s announcement that certain GLP-1s were no longer in shortage. “In the past, if the FDA had a reasonable administrative record and a reasoned decision-making process, they got the benefit of the doubt and that was very hard to overcome. With the change in standard due to the Chevron decision, the FDA doesn’t get the deference it used to.”

As the FDA has pushed back its final determination on whether certain GLP-1s should remain on the shortage list, Rosen said that this means that pharmacies will be able to sell compounded products despite the FDA’s initial conclusion that there is sufficient supply, which he noted is an extremely rare event for the agency.

“I’m very surprised that the FDA changed its position,” he said. “I think that the process around removing drug shortages was not well elucidated in any guidance or information. I think that has caused the FDA to take a step back.”