Online advertising and promotion appear set to take up a larger proportion of brand ad budgets in 2009. But for some industries that must comply with heavy regulation and disclosure requirements, that transition to digital marketing can raise issues.
Abbott Laboratories is facing some of those issues now that a consumer watchdog group has asked the Food and Drug Administration to force the company to take down some YouTube videos promoting a new medical device.
The group, the Boston-based Prescription Project, said yesterday that the videos for a new heart stent from Abbott’s Xience division do not properly disclose the known safety considerations that the company is required to disclose in other types of advertising.
Prescription Project said that the four videos promoting the Xience V, a drug-coated heart stent that won FDA approval in July, “contain none of the federally mandated warnings or provisions required of medical-device advertisements,” the group said in a statement.
In response to the request to the FDA, Abbott originally said that a link on the brand’s AbbottChannel on YouTube that housed the videos was sufficient to provide “important safety information” on the product. But a few hours after the Prescription project made its request public, Abbott announced that it would embed such safety information directly into YouTube video spots for future promotions.
“Abbott’s practice is to comply with all regulatory requirements and to provide patients and consumers with accurate and complete product information,” the company said in a statement quoted in the Chicago Tribune. “To avoid any problems in the future, we will embed safety and risk information in the videos moving forward.”
The Xience videos on YouTube include an animation of the workings of a stent, a device that holds open arteries after angioplasty and prevents them from clogging again. Another video offers an extended three-minute-plus interview with a patient who received the Xience V stent that contains strong endorsements for the product.
The Xience Web site linked to on the AbbottChannel YouTube page lists dozens of possible side effects and contraindications for stents such as the Xience V—including a caution that it shouldn’t be used in patients who can’t take anti-clotting drugs.
Besides raising objections to the Xience videos, prescription project also asked the FDA to crack down on a lack of disclosure in YouTube videos promoting products from Medtronic and Stryker Corp.
In passing its request to the FDA, the Prescription Project also called for the agency to draft guidelines on “consumer-directed broadcast advertising of prescription drugs and restricted devices on the Internet… clarifying that Internet promotions are encompassed in the definition of broadcast advertisements.”
In the Medtronic case, the Prescription Project claimed that the video was placed on YouTube by an agency, VNR-1 Communications, that produced the video newsreel for the company to promote a new spinal disk. Medtronic confirmed that placement and said the video has been removed from the Web.
“We are committed to U.S. Food and Drug Administration guidelines on direct-to-consumer advertising,” Medtronic said in a statement yesterday. “Unfortunately, Medtronic content can also be posted to other Web sites by third parties.”
Stryker also pulled one YouTube video promoting its Cormet hip resurfacing procedure and re-posted it with a pre-roll disclaimer. “Hip surgery is not for everyone,” a preamble to the new video reads. ”As with any surgery, joint replacement carries certain risks.” The warning, which lasts for the first 10 seconds of a 1:56-minute video, directs viewers looking for risk information online or to call a toll-free number.
A silent 42-second video animation of the Cormet resurfacing process, made in 2007 and posted to YouTube in October 2008, still carries no pre-roll warning.
With growing numbers of consumers going online for medical advice and getting exposed to direct-to-consumer medical advertising, the pharmaceutical and medical device industries are increasingly being called to account to make sure required safety data in part of their online branding.
In September, drug maker Pfizer received a warning letter from the FDA asking it to stop showing an online version of its “Viva Viagra” TV spot on the CNN Web site because the video omitted warnings about the drug’s side effects. Pfizer said the omission was due to a technical error on the part of the CNN.com Webmaster.
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