Bradley Merrill Thompson Quoted in Article, “FDA’s Deferral to FTC on mHealth Enforcement Raises Questions”FDA Week September 15, 2011
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in an article titled "FDA's Deferral To FTC On mHealth Enforcement Raises Questions."
Following is an excerpt:
FDA's lack of enforcement against two mobile health application developers targeted by the Federal Trade Commission for faulty promotion might signal that FDA is trying to finalize how to regulate these products before taking any enforcement actions, sources said while questioning why FDA did not get involved in the cases although they clearly fall under the agency's jurisdiction. FTC, though, did not consult with FDA and is closely monitoring this technology, an FTC attorney said.
FTC for the first time brought a case against marketers of two smart phone applications for making baseless health claims, saying the claims marketers made about the applications' ability to treat acne with colored lights emitted from smart phones were unsubstantiated.
The applications would fall under FDA's jurisdiction, and it's interesting that FTC took the action rather than FDA, industry attorneys said.
Although FDA did not take action against these apps, it sends a signal to developers that making false health claims about smart phone apps won't be tolerated, said Bradley Merrill Thompson. "This is important because it gives, frankly, the FDA another federal agency to sort of align with when it comes to enforcing what I would call some of the fringe claims," he said.
He said the cases also send a signal to app developers that they must follow the law and perform studies to back up their claims.
But Thompson said he sees the cases having little impact on those in the medical device industry that are developing apps because these companies are familiar with the regulations. For these more traditional device companies, federal enforcement, like the type done in this case, can be helpful.
"People doing this have to understand there are risks," he said. "It sends a message to these fly by night organizations that we are not going to tolerate it and we're going to come after you."