FDA should regulate medical device-makers' DTC advertising, advocates say

by Anne Zieger
September 22, 2008

Recently, critics have made quite an uproar over the prevalence of direct-to-consumer advertising created by pharmaceutical companies, suggesting that such ads could be deceptive in their claims, could mask the dangers of the medications they were promoting and encouraged the use of costly new drugs over equally-effective generics. Now, advocates are expressing similar concerns over DTC ads created by medical devicemakers.

At a hearing this week in front of the Senate Special Committee on Aging, Consumer Union Policy Counsel Ami Gadhia argued that such ads could endanger patient health by not adequately disclosing risks associated with implantable products like cardiac stents and artificial hips. Along with other witnesses, Gadhia recommended that the FDA be made to require that medical-device ads disclose related risks like post-surgical infections. She also wants the agency to create a process to review ads before they're published. In addition, she'd like the agency to have the authority to punish companies that violate disclosure requirements.

Medical device industry lobbyists, for their part, said that federal agencies already have enough authority to do this job. Its powers include warning letters, injunctions, seizure of products and complete removal of the product from the market, said Steve Ubl, CEO of medical-device maker lobbying group Advanced Medical Technology Association.

To learn more about this debate:
- read this Modern Healthcare article