FDA Policy/General

40 DTC Untitled Letters Posted by FDA

David McFarland

— 3 min read
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FDA has released 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it unveiled a major push (see earlier story) to crack down on misleading direct-to-consumer drug advertising.

For example, a letter to AstraZeneca addresses a specific DTC TV commercial that was false and misleading and contained incomplete risk representation. The ad depicts people doing everyday, active things: exploring, sightseeing, splashing, playing with a dog, etc., while being treated with Calquence. The visuals give the impression that patients can maintain a normal, active lifestyle during treatment with minimal disruption. However, FDA says, “adverse reactions are most likely to happen when patients first begin using the drug, when they discontinue it, or when the dosage changes,” and that frequent monitoring with a healthcare provider is required. These aspects were downplayed, it says.

In a letter to Boehringer Ingelheim Pharmaceuticals about a DTC broadcast ad for Jardiance (empagliflozin tablets), FDA determined that it was false or misleading, thereby misbranding the drug. The ad features fast-paced visuals, including choreographed dancing at a “movie night” event, flashing cameras, and movie-related props. The agency says that such attention-grabbing elements compete for a viewer’s attention, undermining the presentation of important information about Jardiance. The agency says the ad also inadequately presented risk information because the major statement, which communicates the drug’s most serious risks, is presented with frequent scene changes and competing visuals.

And, a letter to AbbVie cites a DTC television ad for Linzess (linaclotide) that FDA determined was false or misleading. Specifically, it says the major statement is presented from frames 10 through 16, but during this segment, the ad depicts a series of quick scene changes and visuals that interfere with a viewer’s ability to comprehend the information.

Links to the letters are below (some companies have multiple letters):

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