Device Firms Want Their Own Guidelines On Risk Information In Ads

Full article reprinted from "The Gray Sheet" - August 31, 2009

FDA's draft guidance on presentation of risk information in advertisements fails to adequately distinguish between devices and drugs, according to device trade group AdvaMed. Read more...

Full article reprinted from "The Gray Sheet" - August 31, 2009

Device Firms Want Their Own Guidelines On Risk Information In Ads

FDA's draft guidance on presentation of risk information in advertisements fails to adequately distinguish between devices and drugs, according to device trade group AdvaMed.

The May 27 1 draft guidance was meant to provide more insight into how FDA gauges the "net impression" of promotional materials, rather than just specific claims, when determining if an ad is misleading ('The Gray Sheet' June 1, 2009).

In Aug. 25 3 comments to the agency, AdvaMed maintains the document focuses too heavily on drugs and does not take into account the considerations and requirements specific to devices.

"A separate guidance on device promotion may be more appropriate than a single prescription drug/device guidance," the trade group suggests.

FDA has authority to regulate advertisements for drugs and "restricted" medical devices, which cannot be used without authorization from a health care practitioner. The agency also regulates certain promotional labeling for all devices and drugs.

Contrary to FDA's suggestion, regulations on false and misleading promotional materials for drugs "should not be applied generically to devices," AdvaMed states.

Instead, final guidance should consider the "inherent and significant differences" between drugs and devices.

While a drug is usually a stand-alone therapy, devices are often used in procedures that involve surgery, highly-trained professionals and other devices or drugs. The risks of the overall procedure may not necessarily be attributable to the one specific device, AdvaMed argues.

The trade group also urges FDA to include more device-specific examples and device regulation citations in the final guidance, adding that sample print and audio promotional pieces for devices and drugs should be provided.

Separate Guidances Based On Audience, Media?

Additional issues raised in the draft guidance document may warrant separate guidance of their own, according to AdvaMed and other commenters.

Drug maker Pfizer suggests that the distinction between health care professional and consumer audiences is not adequately recognized in the draft guidance, and asks FDA to consider separate documents to address the different expertise levels of the advertising target groups.

Some commenters also recommend that FDA explain how to convey risk information in internet ads separately and more extensively than it has in the draft document.

The guidance does not specifically address internet promotion, other than a footnote stating that the promotional materials under discussion include print and TV ads, brochures, radio ads and "internet Web sites."

However, the internet "cannot so easily be combined with traditional television and print promotion," Pfizer contends in Aug. 24 ⁴ comments.

Final guidelines should clarify the circumstances under which internet communications count as advertising, promotional labeling or neither, the drug maker says, and should outline FDA's specific requirements for web communications.

"Some models of risk communication discussed in the draft guidance may be less optimal for the internet," AdvaMed notes, agreeing that separate requirements should be outlined for "this unique communications vehicle."

Comments on the draft guidance were due Aug. 25.

- Jessica Bylander

Download this full article and the rest of the “The Gray Sheet” issue when you sign up for a 30-day, risk-free trial. Click here

Problems With Manufacturer Employee Training Programs Worry FDA. Click here to find out more...

To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Sean Smith at 240-221-4535 or se.smith@elsevier.com.