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FDA should regulate medical devicemakers' DTC advertising, advocates say

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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 (reg. req.)

Related Articles:
Drugmakers agree to six-month DTC delay
Who will pay for DTC pharma ad oversight?
Drugmakers face direct-to-consumer ad ban
AMA to study the impact of drug advertising

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It's deja vu all over again. When DTC ads were proposed, practicing doctors opposed the idea as oversimplifying a complex decision making process. We erer told we were naive, or in the way of patient education. Pharma profited, & MD's had to spend hours/week telling patients why they were wrong about the meds/devices they wanted. Many of us lost patients if we didn't cave to their DTC ad-driven demands.
Now the ads are a problem? It's been inherent in the process from Day 1.
The 'brilliant meddling' with medicine by marketing forces has cost us a lot in quality & commitment to care. Pull the ads & overall costs could go down, tho I think that dangerous genie won't go readily back in the bottle.

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