The FDA feels the pain in a court decision about promoting prescription drugs

You’d think that once a drug maker had enjoyed successful clinical trials and received FDA authorization to market its drug, the FDA would move on to other matters. You’d be wrong.

Having a proven-effective drug on the market is one thing; how you promote it is something very different, according to Meredith Manning, an FDA pharmaceutical lawyer at Hogan Lovells.

“I help companies deal with the regulatory structure around the advertising and promotion of their products,” she says. “Compliance and enforcement in this area falls under the purview of the FDA’s Office of Prescription Drug Promotion (OPDP), and while historically the OPDP has strongly regulated the marketing messages of prescription drugs, a potentially major shift is occurring that indicates its influence is weakening.”

The shift that Manning refers to is a court case brought by the FDA against pharmaceutical company Amarin. The company’s product, Vascepa, is an approved triglyceride-lowering drug; but when the company tried to market it to physicians for treatment of persistently high triglycerides—an indication for which the FDA did not grant its approval—the agency sued. Last August, however, the U.S. District Court for the Southern District of New York ruled that Amarin could promote this “off label” usage because its promotional statements were “truthful and non-misleading.”

“The FDA has legal authority to regulate labeling, which is defined as written material,” says Manning. “But in this case, the court seems to be saying that the FDA doesn’t necessarily have the last word, so long as the company’s messaging is honest. Rather than being solely a scientific issue, drug promotion has become a First Amendment issue.”

The upshot is that manufacturers could potentially skirt the FDA by presenting its data in a way that the FDA hasn’t formally blessed but is nevertheless truthful. However, this is not a strategy one should take lightly.

Says Manning, “We provide our clients with comprehensive advice about how they can market their products, including helping with all stages of their promotion. It can be a two-part assessment: is the data rigorous, and is the execution of the messages appropriate? We’re watching the fallout from this court decision closely and will advise our clients accordingly.”

To learn more about how prescription drug promotions are regulated and keep up-to-date on changing regulations, subscribe to Hogan Lovells’ Focus on Regulation blog.

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