Abbott Youtube ad violates FDA requirements. Yesterday Abbott Labs, Medtronic, and Stryker all made headlines because they were found to be running illegal YouTube.com ads that one group alleged violated some U.S. Food and Drug Administration (FDA) requirements. Pharmalot.com reported that the watchdog group, The Prescription Project, petitioned the FDA to require the device makers withdraw their allegedly illegal ads, which marketed medical devices used in heart, hip, and neck surgeries without federally-mandated warnings. YouTube.com is a video-sharing Website in which videos are shared, downloaded and uploaded, and viewed.
Prescription Project is asking the agency to enforce its rules on device company marketing
Today, TwinCities.com reported that Medtronic Inc. pulled its ad following this week’s allegations by the Prescription Project and its petition filed with the FDA on Wednesday. Prescription Project is asking the agency to enforce its rules on device company marketing and mandate the device maker cease its ads, said TwinCities.com.
At issue, notes TwinCities.com, is that the Medtronic ad, which shows a woman who received relief following implantation with its Prestige cervical disc, does not contain federally-required information on the device’s “risks, warnings, precautions, or side effects,” such as the “government-approved product label” that notes risks such as “serious or fatal hemorrhage and neurological damage.”
Chuck Grothaus, a Medtronic spokesman, said, according to TwinCities.com, that he requested that the company that produced the video, VNR-1 Communications, pull the video from YouTube.
In response, said TwinCities.com, Allan Coukell, policy director for the Prescription Project said, “We’re very glad that they’ve taken the appropriate action. It shouldn’t have required someone to file a citizen petition for them to know what the rules are.”
Abbott Labs will include safety information on its Xience heart device
Meanwhile, the Chicago Tribune reported that Abbott Labs will include safety information on its Xience heart device into its YouTube.com ad. Abbott announced the planned change following the Prescription Project’s allegations, said the Chicago Tribune.
The Prescription Project, said the Chicago Tribune, has long argued that these types of video ads should be under the purview and responsibility of the FDA and should be treated in the same way as other health products.
Yesterday, Pharmalot noted that the Prescription Product alleged that Abbott was running four videos on YouTube.com advertising its XIENCE V drug-coated stent, which is used in coronary angioplasty surgery without required warnings.
Also running ads without federally mandated warnings were Medtronic, which was promoting its Prestige Cervical Disk used in degenerative disk disease surgery and Stryker, which was advertising its Cormet hip resurfacing technology, reported Pharmalot.
“The videos raise serious questions about whether drug and device companies are using the Internet to skirt laws that safeguard consumers,” said Coukell in a statement quoted by Pharmalot yesterday.
FDA must ensure that direct-to-consumer (DTC) ads are neither misleading nor deceptive
The Prescription Project noted in a press release that the FDA must ensure that direct-to-consumer (DTC) ads are neither misleading nor deceptive and that the FDA requires drug and device advertisers to include specific “disclosures” that not only contain mention of the product’s usage directions, but also “any relevant warning, precautions, potential side effects, and contraindications.
TwinCities.com noted that the number of physicians using YouTube.com is on the rise and that early this year, GlaxoSmithKline posted a video featuring its CEO talking about the benefits of working for the drug maker.
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