David Rosen on FDA's CRL Release – 'It hasn't happened in the past'

Foley & Lardner LLP partner David Rosen commented on the U.S. Food and Drug Administration’s decision to publish a package of complete response letters to pharmaceutical companies in the PharmaVoice article, “Why FDA’s CRL release could open the door to lawsuits against pharma.”

“It hasn’t happened in the past,” Rosen said of the document release, noting the potential for litigation over discrepancies over what companies were told by the FDA and what was revealed to the public.

“It wouldn’t surprise me if someone tried to represent a class of investors for stock that went upside down from what companies disclosed,” he noted, adding though that it may be too late to act on information reveal in the CRLs given their age.

Rosen explained that while the FDA has indicated it may publish more letters in the future, the calculus for what companies tell the public has not changed.

“I have always advocated that companies disclose information, whether good or bad,” he continued. “Not necessarily all the substance [of CRLs] — but certainly enough so the public can have an understanding of what could have a material impact.”

Rosen added that while the release is currently a “mixed bag” for pharma, the insight into the administration’s thinking can be helpful. “This information can provide thought-provoking insights into how to develop a particular product and avoid issues from the past,” he said.