Device Makers Illegally Advertise On YouTube?
Make a commentBy Ed Silverman // December 3rd, 2008 // 11:21 am
That’s the charge by a watchdog group known as The Prescription Project, which today petitioned the FDA and asked the agency to enforce its rules by requiring Abbott Labs, Medtronic and Stryker to withdraw YouTube.com video ads for medical devices used in heart, hip and neck surgeries (see full petition and videos here).
The group claims that four Abbott videos on YouTube promote its XIENCE V drug-coated stent for use in coronary angioplasty surgery, but fail to mention federally-mandated warnings. Similarly, the Medtronic videos tout the use of its Prestige Cervical Disk for surgery for degenerative disk disease and the Stryker video promotes its Cormet hip resurfacing technology without required warnings.
“The videos raise serious questions about whether drug and device companies are using the Internet to skirt laws that safeguard consumers,” Allan Coukell, director of policy for the Prescription Project, says in a statement. Here is the Abbott petition, the Medtronic petition and the Stryker petition.
The group is calling for the FDA to advise drug and device makers that online and Internet ads and promotions are subject to the same requirements pertaining to other media, and recommend they conduct compliance reviews. They also want the agency to issue a “Guidance on Consumer-Directed Broadcast Advertising of Prescription Drugs and Restricted Devices on the Internet” to clarify how federal law and FDA regs applying to online drug and device promotions.
We await comment from the device makers. UPDATE: A Stryker spokesman declines to comment. We have still not heard from Abbott. But a Medtronic spokesman writes us this: “We are committed to U.S. Food and Drug Administration guidelines on direct-to-consumer advertising. Unfortunately, Medtronic content also can be posted to other web sites by third parties. The video in question has been removed from the Internet. Any additional video produced by, or on behalf of, Medtronic that does not comply will be addressed immediately.”
UPDATE TWO: An Abbott spokesman called to say: “Abbott’s practice is to comply with all regulatory requirements and to provide patients and consumers with accurate and complete product information. All Abbott’s Xience V videos on YouTube were posted in July 2008 with links to the ‘Brief Summary of Instructions for Use,’ which details the product’s risk and safety information. To avoid problems in the future, we will imbed safety and risk information in the videos moving forward.”
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Tags
Abbott Laboratories, Citizen Petition, Cormet, Medtronic, Prestige Cervical Disk, Stents, Stryker, Xience