David Rosen Weighs in on FDA's Pharma Advertising Crackdown
Foley & Lardner LLP partner David Rosen commented in the Endpoints News article, “Legal pressure builds around FDA’s direct-to-consumer pharma ad crackdown,” sharing developments on the U.S. Food and Drug Administration’s enforcement actions targeting prescription drug advertising.
Rosen said recent warning letters from the FDA “certainly surprised” the pharmaceutical industry, particularly as the letters were not signed by someone from the FDA’s Office of Prescription Drug Promotion as is typical.
“I don’t think at this point that an all-out ban on advertising promotion is going to happen,” Rosen commented. “But I think that people are going to be more careful with their promotional activities.”
He continued that if the FDA relies solely on issued guidance for the advertising restrictions instead of the formal rulemaking process and its accompanying public notice-and-comment period, litigation may arise.
“It really depends on how restrictive any rules are,” he added. “But they will likely be subject to some sort of legal challenge too.”
