Lawyers Predict Increased Marketing Scrutiny for Devicemakers

Devicemakers should be on the lookout for increased FDA enforcement of promotion regulations, according to attorneys from Arent Fox.

Some of the biggest healthcare fraud prosecutors in the field have been speaking publicly about impending device investigations, Linda Baumann said at an FDAnews audioconference. Since November 2006, there have been numerous warnings from prosecutors about device investigations, including off-label issues, she said, adding that approximately half of all uses of drug-eluting stents in 2004 and 2005 were off-label.

“It’s only a matter of time before the medical device industry sees almost the same amount of scrutiny in the context of enforcement as we’re seeing now in pharmaceuticals,” James Ravitz added.

One area where devicemakers should exercise more caution is approval claims, he advised. It is common for device companies to claim that products are “FDA-approved” when they are in fact cleared under the premarket notification (510(k)) process, Ravitz said. Approval can only be granted for a premarket approval application, he said.

Baumann pointed to a case where NuMED and its president pleaded guilty to distributing cardiac stents without premarket approval by the FDA. The company had to pay a criminal fine of $2.3 million and an additional $2.3 million to Johns Hopkins to fund a clinical trial. If the FDA approves the stent, the defendants must furnish it to providers for five years at no charge.

Labeling can also be a tricky area for devicemakers because it applies to materials that are not necessarily provided with a product, Ravitz said. Labeling refers to anything that “accompanies” the product, which is interpreted broadly and can include television or radio broadcasts, websites and other promotional materials.