David Rosen Weighs in on FDA's Pharma PR Crackdown – 'Stick to the Data'

Foley & Lardner LLP partner David Rosen shared insights on the regulatory challenges pharmaceutical companies face when publicly communicating around new cancer therapies in the MM+M article, “When a podcast becomes promotion: Inside the FDA’s warning shot at ImmunityBio.”

“There’s a sensitivity in the cancer space that you don’t broaden claims beyond what you’ve demonstrated,” he explained.

He cautioned that overstating results, even on a podcast appearance, can generate false hope, particularly among vulnerable patient populations. Rosen added, “Anything that you say is associated with the company and can be construed as advertising or promotional material.” He stressed that these restrictions apply equally to podcasts, conference presentations, and social media.

“If you’re associated with the company, you have to stay within the scope of what FDA approved for that drug,” Rosen said. On heightened FDA scrutiny potentially influencing industry approaches to public communication, he added, “I think it puts people on notice that they have to be careful what they say.”

“You can present the data. You just can’t go outside the scope,” Rosen concluded.