Senate hearing discusses recommendations for increased regulations on direct-to-consumer ads for medical devices

Sep 22 2008

Lawmakers and witnesses on Wednesday at a Senate Special Committee on Aging hearing discussed recommendations for increased regulations on direct-to-consumer advertisements for medical devices, Dow Jones reports (Corbett Dooren, Dow Jones, 9/17).

According to supporters, DTC ads provide consumers with information that might encourage consumers to ask their physicians about medical devices, but opponents maintain that such ads often overstate the benefits of the products and can mislead consumers (Carey, CQ HealthBeat, 9/17).

During the hearing, Daniel Schultz, director of the Center for Devices and Radiological Health at FDA, said that current regulations require pharmaceutical companies, but not medical device companies, to obtain from the agency prior authorization for DTC ads, which must meet criteria for accuracy and include balanced representation of the risks and benefits of the products. Schultz said that FDA can take action against the medical device companies for misleading DTC ads after they appear (Dow Jones, 9/17).

In addition, FDA continues to monitor the marketing practices of medical device companies and has asked companies to review the labels of their products to ensure that they feature the same usage instructions included in their applications to the agency, Schultz said. He added, "FDA is committed to ensuring that medical device promotion and advertising, including DTC advertising, is truthful and not misleading, that it helps consumers make better informed choices about their health and health care, and that it helps prevent potential misconceptions about benefits and risks of the advertised treatment" (CQ HealthBeat, 9/17).

Additional Testimony

Kevin Bozic, a board director of the American Academy of Orthopaedic Surgeons, said that the discrepancy in regulations for DTC ads for prescription drugs and medical devices can "create unrealistic expectations among patients and lead to overutilization of inappropriate and costly, unproven technologies" (Perrone, AP/San Francisco Chronicle, 9/17). He said that DTC ads for medical devices also might not "inform patients about the differences in product design, composition of materials, strength of the devices or proper clinical indications."

Stephen Ubl, president and CEO of the Advanced Medical Technology Association, said that medical device companies "believe strongly that direct to consumer advertising of devices must provide truthful and non-misleading information." He added that FDA and the Federal Trade Commission have "ample legal authority" to take action against misleading DTC ads for medical devices. In addition, DTC ads provide consumers with information about new medical devices that could improve or save their lives, Ubl said.

Lawmaker Comments

During the hearing, committee Chair Herb Kohl (D-Wis.) called for increased collaboration between the medical device industry and FDA to ensure that consumers receive accurate and balanced information about the benefits and the risks of the medical devices in ads (CQ HealthBeat, 9/17). Committee member Ken Salazar (D-Colo.) recommended a ban on DTC ads for medical devices (Dow Jones, 9/17).