David Rosen Details FDA Approach to Resolving Drug Shortages

Foley & Lardner LLP partner David Rosen detailed the U.S. Food and Drug Administration’s approach to resolving pharmaceutical drug shortages in the Hunterbrook article, “Hims: Why The Semaglutide Shortage May End Imminently“

Rosen said the process of resolving a shortage once product is available “should be relatively quick,” and that for the FDA, it is a “pretty straightforward” determination whether a shortage has been resolved.”

“Do they have sufficient materials in the supply chain, and can they meet the market demand for the product?” he asked. “In my experience, FDA wants at least one year of finished goods in stock, and six months or more of raw materials to be able to continue to make sure that the pipeline is secure. In this situation, there might even be more because the demand has been so great.” 

Expecting the FDA to resolve the shortages “in the near future,” Rosen said that taking time before declaring a shortage’s conclusion can buttress the agency’s public health mission. “What they don’t want to do is stop everybody from compounding, have the product not being available, create more of a problem for people that have been already on it,” he added.