FDA Policy/General

2022 FDA Advertising, Promotion Enforcement Reviewed

Five King & Spalding attorneys say that in 2022 FDA issued nine enforcement letters targeting advertising and promotion violations for prescription drugs and medical devices. Their online post summarizes noteworthy trends and issues seen in the letters.

Of the nine letters issued in 2022, four were from CDER’s Office of Prescription Drug Promotion (OPDP), including one Warning Letter and three untitled letters. The attorneys say that was the lowest number seen since 2010, continuing a more than decade-long decline in the volume of OPDP enforcement letters.

Of the four letters, three cited violations of false or misleading risk presentation and false or misleading benefit presentations, while one letter addressed misbranding of an investigational new drug.

The remaining five letters issued in 2022 related to medical device advertising and promotion violations, coming from the CDRH Office of Product Evaluation and Quality, usually in conjunction with the Office of Medical Device and Radiological Health Operations.

In addition to the traditional letters, CDRH issued an additional four Warning Letters related to the marketing and sale of Covid-19 products without FDA emergency use authorization, clearance, or approval.

“This is a substantial decrease compared to the Covid-19-related letters issued in 2021, which tallied at a whopping 46 and which came on the heels of 21 letters issued in 2020 for Covid-19-related marketing,” the attorneys write. “Worth noting, the number of advertising and promotion letters in 2022 appears to remain relatively consistent with recent years, as there were six in 2020 and five in 2021.”

All five of the device non-Covid-19 Warning Letters issued in 2022 addressed the promotion of unapproved devices or unapproved new indications of already marketed devices. The attorneys say it is notable that three of the five letters were for aesthetic devices, continuing a trend from last year when aesthetic devices were over-represented in the device Warning Letters issued by FDA. “Thus,” the attorneys say, “these devices appear to remain high among FDA’s enforcement priorities.”

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