Health News Review

While we recover from the news that flibanserin was unanimously rejected by a vote of an FDA advisory panel because the data didn’t match some of the hyped claims, let’s catch up on some stuff the FDA caught about the marketing of drugs it had already approved.

The Dow Jones Newswire reports:

“The U.S. Food and Drug Administration sent letters to several companies requesting that they stop distributing misleading promotional materials for their drugs.

The FDA said a 60-second television advertisement for Sepracor’s Lunesta sleep aid makes “unsubstantiated superiority claims” in violation of federal law. A voice-over in the ad says viewers who have trouble sleeping even after taking a sleep aid should ask their doctors about switching to Lunesta because Lunesta is “different.” The ad says Lunesta “keys into receptors that support sleep.”

The FDA said this language misleadingly implies that Lunesta is clinically superior to other insomnia medications, and that Lunesta might work where others fail. The agency says it isn’t aware of any evidence to support these claims. Also, the agency said the claim about how Lunesta works is misleading because there’s still some uncertainty about the drug’s mechanism of action.

In a separate letter to Eisai, the FDA said a promotional video for brain-tumor treatment Gliadel Wafer minimizes the risk of the drug and overstates its efficacy in violation of federal law. The drug’s risks, which include seizures, are relegated to the end of the video after several cues suggesting the video is over, when it’s unlikely to draw the viewer’s attention, the FDA said.

The FDA said a Cumberland Pharmaceuticals sales aid for Acetadote, which is approved to prevent liver injury after an overdose of the pain drug acetaminophen, contains unsubstantiated superiority claims and minimizes risk information.

The agency’s letter to Auxilium said a direct-to-consumer patient brochure for the drug Xiaflex, a treatment for a hand deformity, overstates the drug’s efficacy and minimizes its risks.”

These are stories most consumers probably don’t see. They don’t get much play in most news organizations. But they’re little pieces that, when put together, are part of the huge mosaic of marketing muck that inundates American health care consumers every day.

Comments

Krista posted on June 18, 2010 at 4:12 pm

Pharma Marketing Blog added that the Lunesta ad ran in 2009 has already been pulled, maybe due to the fact it was voted one of the worst TV ads of the year:
http://pharmamkting.blogspot.com/2010/06/fda-sucker-punches-sepracor-with.html
DDMAC may have been behind the ball on this one, but their warning letter may also dredge up the memory of a poorly executed ad that Sepracor and its advertising agency would rather forget.

Joseph Arpaia, MD posted on June 18, 2010 at 9:10 pm

Health care reform will be useless unless direct to consumer advertising is banned. There is really no other alternative. People are suggestible and if they are subjected to constant suggestions that they are in need of something they will succumb to those suggestions.