Calling direct-to-consumer advertising an important tool for educating patients, the Advanced Medical Technology Association, a group representing the interests of medical-device makers, has issued a set of guiding principles for devicemakers ads.
The guidelines contain 13 principles that support compliance with the Food and Drug Administrations and Federal Trade Commissions existing direct-to-consumer regulations and also include additional principles, which devicemakers are encouraged to adopt for developing and airing advertising. They include revising or withdrawing ads when new safety-risk information comes to light; excluding content designed to minimize risk information; educating healthcare professionals about new products or new-use indications before the launch of an ad campaign; and submitting TV ads for restricted devices to the FDA at the time of an ads release.
The new guidelines stop short of suggesting that medical-device makers submit print and internet ads to the FDA, but AdvaMed President and Chief Executive Officer Steve Ubl said the guidelines take a great step towards standards for all media.
Responding to questions about the timing of the guidelines and whether they were created in response to an ongoing congressional investigation into devicemakers marketing practices, Ubl insisted the principles were not an effort to ward off stricter regulation. I think the goal is not to avoid legislation, but to make sure that consumers have accurate information, he said. I believe weve responded to their concerns.