Device Center Increases Advertising/Promotion Enforcement Staff

Article preview from "The Gray Sheet" - September 22, 2010

FDA's device center will increase its focus on advertising and promotion enforcement efforts, as well as policy development, with recently expanded staff resources.

Device Center Increases Advertising/Promotion Enforcement Staff

By Monica Hogan and Jessica Bylander

FDA's device center will increase its focus on advertising and promotion enforcement efforts, as well as policy development, with recently expanded staff resources.

Last month, CDRH's Office of Compliance increased the size of its device advertising and promotion policy group from one person to three, FDA Regulatory Counsel Deborah Wolf reported Sept. 20 at the Food and Drug Law Institute's Advertising and Promotion Conference in Washington, D.C.

"We're hoping that with three people, we can focus not only on enforcement, but also on developing some policy," Wolf said.

For example, the FDAer said she would like to develop guidance specific to device advertising and promotion, and work on policy issues such as how to regulate mobile phone apps.

The agency also has growing concerns about medical practitioners promoting off-label use of devices that are cleared for other indications, and wants to learn the extent to which device makers could be encouraging such promotion, Wolf said.

Wolf currently heads the promotion and advertising policy staff. She is now joined by Terri Garvin, regulatory counsel, and Toni Stifano, a consumer safety officer.

Garvin, who most recently served as regulatory counsel on CDRH's regulations staff, previously worked in advertising and promotion at the center. Stifano, formerly a policy analyst at FDA's drug center, previously was a member of the advertising and promotion group at FDA's biologics center.

Despite the staffing boost, "We [still] need more people," Wolf acknowledged. Within the last ten years, CDRH's Office of Compliance had up to six people focused on device advertising and promotion, before staffing cuts were made, Wolf recounted.

CDRH's promotional compliance staff still pales in comparison to that of FDA's drug center, which employs nearly five dozen. However, while the Center for Drug Evaluation and Research must review television ads for pharmaceutical campaigns before they air, CDRH does not have similar requirements for device ads.

Although the volume of TV ads for medical devices also does not approach that of drugs, device ads have been on the increase in recent years, Wolf pointed out.

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