Advocacy Group Prescription Project Asks FDA To Review Direct-To-Consumer Ad Regulations For Medical Devices

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals;  Public Health
Article Date: 05 Dec 2008 - 3:00 PDT

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Direct-to-consumer advertisements for several medical devices on the video Web site YouTube violate federal regulations because they do not include required warnings and disclosures about potential risks, according to the consumer watchdog group Prescription Project, the AP/Los Angeles Times reports. On Wednesday, the group petitioned FDA to update its advertising rules to specifically address Internet marketing (Perrone, AP/Los Angeles Times, 12/3).

In its complaint to FDA, the group cited ads for the drug-coated stent Xience V, manufactured by Abbott Laboratories; the Prestige Cervical Disc, a spinal implant manufactured by Medtronic; and the Cormet hip-surfacing system, manufactured by Stryker (Rockoff, Wall Street Journal, 12/4). The group said that the ads tout the benefits of the products but they do not inform consumers about the potential risks with using them (AP/Los Angeles Times, 12/3). The Prescription Project also asked FDA to urge the device makers to remove the ads from YouTube.

Allan Coukell, director of policy for the group, in a statement said, "The videos raise serious questions about whether drug and device companies are using the Internet to skirt laws that safeguard consumers" (Moore, Minneapolis Star Tribune, 12/3). "We'd argue that on the Internet, real estate is not limited, so there's much more room to give a full statement of risks," he added (Snowbeck, St. Paul Pioneer Press, 12/3).

Federal regulations that require pharmaceutical and medical device manufacturers to ensure product advertisements include information about possible side effects apply across all media platforms, including the Internet, according to an FDA spokesperson. The spokesperson declined to comment on the Prescription Project's complaint.

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A spokesperson for YouTube in a statement said that videos that are placed on the Web site "must comply with local laws and regulations, as well as our own policies," adding that the video-sharing service regularly reviews its guidelines and collaborates with the videos' producers and government agencies "to keep them current and effective" (Wall Street Journal, 12/4).

In a statement issued on Wednesday, Abbott said that the company's "practice is to comply with all regulatory requirements and to provide patients and consumers with accurate and complete product information," adding, "All Abbott's Xience V videos on YouTube were posted in July 2008 with prominent links to the 'Brief Summary of Instructions for Use,' which details the product's risk and safety information." The Illinois-based company noted, "To avoid any problems in the future, we will embed safety and risk information in the videos moving forward" (Japsen, Chicago Tribune, 12/3).

Chuck Grothaus, a spokesperson for Medtronic, said he has asked VNR-1 Communications, the Texas-based advertising firm that produced its YouTube ad, to remove the video on Wednesday (St. Paul Pioneer Press, 12/3). In a statement, the company also said, "Any additional video produced by, or on behalf of, Medtronic that does not comply will be addressed immediately" (AP/Los Angeles Times, 12/3). A spokesperson for Michigan-based Stryker declined to comment (Minneapolis Star Tribune, 12/3).

The ads and petitions are available online.

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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