Kohl Hearing Examines Direct-To-Consumer Advertising For Medical Devices; Considers Mandatory Review And Moratoriums

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Sep 2008 - 0:00 PDT

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U.S. Senate Special Committee on Aging Chairman Herb Kohl (D-WI) held a hearing examining issues related to direct-to-consumer (DTC) advertising for restricted medical devices that are regulated by the Food and Drug Administration (FDA), such as heart stents, replacement hips, and other implanted devices. Medical, advertising, and consumer experts shared with the committee their concerns about DTC medical device advertisements, including whether health risks are appropriately conveyed to consumers. Panelists also discussed how the current regulatory process for these ads can be strengthened. Although Congress and the FDA have investigated DTC advertising for pharmaceuticals, little has been done to monitor medical device DTC advertising. Today's hearing, entitled "Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?," is part of an ongoing, fifteen-month series of oversight hearings Chairman Kohl has held on medical device and pharmaceutical marketing. Kohl concluded the hearing by promising to remain vigilant regarding the substance and balance of information that is directed to consumers about restricted medical devices.

"There are real risks and serious complications involved, and we are prepared to call for future moratoriums on these type of DTC ads for new medical devices," said Chairman Kohl in his closing statement. "Physicians and consumers must be appropriately educated about these critical devices and their benefits and risks alike. What we do in the near term will be dependent on the pro-active actions of FDA and industry."

The hearing began with testimony from Dr. Kevin Bozic, a professor of orthopedic surgery at the University of California, San Francisco. Bozic provided an overview of how DTC advertising has the potential to adversely impact the doctor-patient relationship, patient education, and health care costs and quality. Next, Dr. William Boden, a professor of medicine and public health at the University of Buffalo, and Dr. George Diamond, a senior research scientist, emeritus at the Cedars-Sinai Medical Center, shared the findings of their recent article in the New England Journal of Medicine, offering insight into how DTC advertising can distort patient understanding of medical device effectiveness and risks. Specifically, Boden and Diamond argued that Johnson & Johnson's Cypher heart stent and many other restricted devices are being directly promoted to millions of people who are ill-equipped to make judgments about complex therapeutic issues that even highly-trained medical specialists continue to debate.

Ruth Day, PhD, presented expert testimony on how DTC advertising influences consumer behavior and can hinder understanding of medical risk information. Day, a professor at Duke University and senior fellow at the Duke Aging Center, contends that the same techniques used in prescription drug advertisements to influence consumers and obscure risk information are also present in many of the DTC advertisements for restricted medical devices. Also on the first panel was Ami Gadhia, policy counsel for the Consumers Union. Gadhia testified about the concerns that led her organization to petition the FDA in December 2007 for pre-review and specific risk disclosures for medical device advertisements. The FDA has not yet responded to this petition.

Finally, an FDA official and representative from AdvaMed, the foremost medical device industry organization, offered testimony. Dr. Daniel Schultz, the director of the Center for the Center for Devices and Radiological Health (CDRH) at the FDA, discussed the current status of their enforcement activities related to DTCA for medical devices. The CDRH is the division of the FDA responsible for the regulation of restricted medical device advertisements. Stephen Ubl, president and CEO of AdvaMed, related the organization's current policy on DTC advertising, and answered questions about whether certain ads are misleading to consumers.

Special Committee on Aging
Senator Herb Kohl, Chair