The Prescription Project Petitions FDA to Order Pharmaceutical and Medical Device Companies to Remove Illegal Internet Ads

Abbott, Medtronic and Stryker YouTube videos fail to include required product warning statements

BOSTON (December 3, 2008) – Pharmaceutical and medical device companies are illegally advertising their products on YouTube, the Prescription Project said in citizen petitions filed today with the Food and Drug Administration (FDA). The non-profit industry watchdog group is asking the FDA to enforce its rules and require Abbott Laboratories (NYSE: ABT), Medtronic (NYSE: MDT) and Stryker (NYSE: SYK) to withdraw YouTube.com video advertisements for medical devices used in heart, hip and neck surgeries.

The FDA regulates prescription drugs, medical devices and advertisements for both. In addition to ensuring that direct to consumer (DTC) advertisements are not misleading or deceptive, the FDA requires them to include “disclosures,” including brief statements of the drug or device’s usage directions as well as any relevant warning, precautions, potential side effects and contraindications.

The four Abbott Laboratories videos currently available on YouTube promote use of the company’s XIENCE V drug-coated stent for use in coronary angioplasty surgery but contain none of the federally-mandated warnings or provisions required of medical device advertisements. Likewise, the Medtronic videos touting the use of its Prestige® Cervical Disk for surgery to address degenerative disk disease and the Stryker video promoting its Cormet™ hip resurfacing technology lack required warning statements.  To view the videos, please visit http://prescriptionproject.org/citizen_petition.

“Whether through a TV ad or an Internet video, the promotion of a medical device for use in complex surgery without adequate warnings is a blatant violation of the law and could put lives at risk,” said Allan Coukell, director of policy for the Prescription Project. “The videos raise serious questions about whether drug and device companies are using the Internet to skirt laws that safeguard consumers.”

In addition to calling for the immediate removal of the videos and posting of “curative” videos that correct the misleading messages, the Prescription Project petitions the FDA to:

Advise all major prescription drug manufacturers and medical device manufacturers that online/Internet drug and device advertisements and promotions are subject to the same requirements as drug and device promotions in other media, and recommend that they review their online advertisements for compliance.

Issue a Guidance on Consumer-Directed Broadcast Advertising of Prescription Drugs and Restricted Devices on the Internet to clarify how federal law and FDA regulations apply to online drug and device promotions.

The FDA’s role in policing DTC advertising is more important than ever because consumers injured by medical devices can no longer sue device manufacturers for failing to warn them about known but undisclosed risks, a result of the February 2008 Supreme Court decision in Riegel v. Medtronic. Consumers injured by prescription drugs may also lose their right to sue if, as expected by many, the Supreme Court issues a similar ruling in Wyeth v. Levine, a case just argued before the Court last month.

Abbott’s XIENCE V, just approved by the FDA in July 2008, is already the top selling drug-eluting stent on the market, posting $383 million in worldwide sales in the third quarter of this year. This is despite the fact that sales of such stents dropped significantly after a series of studies published in the March 2007 issue of the New England Journal of Medicine indicated that drug-releasing stents may increase the risk of blood clotting.

Industry has nearly doubled its spending on device ads aimed at consumers – from $119 million in 2005 up to $193 million in 2007. DTC advertising of devices has come under recent Congressional scrutiny. In September, U.S. Senate Special Committee on Aging Chairman Herb Kohl (D-WI) held hearings to examine whether such advertisements adequately communicate to consumers the health risks posed by devices. At the hearing, Kevin J. Bozic, M.D., author of “The Impact of Director-to-Consumer Advertising in Orthopaedics,” testified that 78 percent of surgeon respondents surveyed believed their patients were “confused or misinformed about the appropriate treatment for their condition based on an advertisement,” and 84 percent believed their patients had “unrealistic expectations regarding benefits” of the devices.

The Prescription Project’s full petition to the FDA is available at http://www.prescriptionproject.org/citizen_petition

About The Prescription Project

The Prescription Project is led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Created with The Pew Charitable Trusts, the Project promotes policies to encourage the safe and effective use of drugs and to eliminate conflicts of interest in medicine caused by pharmaceutical marketing. The Prescription Project also leads the National Coalition for Appropriate Prescribing. For more information, please visit www.prescriptionproject.org.

Kate Petersen-Communications Coordinator-The Prescription Project

Community Catalyst ? 30 Winter Street, 10th Floor - Boston, MA  02108
617-275-2853 (w) kpetersen@communitycatalyst.org

www.prescriptionproject.org 

Posted: December 2008


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