FDA Warns Drug Makers On Misleading Promotional Efforts
June 17 2010 - 2:00PM
Dow Jones News
The U.S. Food and Drug Administration sent warning letters to
several companies requesting that they stop distributing misleading
promotional materials for their drugs.
The letters were sent in recent weeks to Eisai Co. (4523.TO),
Auxilium Pharmaceuticals Inc. (AUXL), Cumberland Pharmaceuticals
Inc. (CPIX) and Dainippon Sumitomo Pharma Co.'s (4506.TO) Sepracor
unit, and posted on the FDA's website this week.
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's not 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.
The FDA requested that Sepracor stop distributing promotional
materials such as the ad cited.
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.
Representatives of the companies weren't immediately available
for comment.
-Peter Loftus, Dow Jones Newswires; +1-215-656-8289;
peter.loftus@dowjones.com