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 "FTC Settles Cases Alleging Unsubstantiated Claims by Developers of Apps to Cure Acne."
Following is an excerpt:
The Federal Trade Commission Sept. 8 said the marketers of two mobile health care applications claiming to treat acne have agreed to stop "making baseless claims" about the apps in order to settle FTC charges in two separate cases. Specifically, FTC said the settlements would bar the marketers of AcneApp and Acne Pwner from making certain health-related claims associated with the apps without scientific evidence.
Attorney Bradley Merrill Thompson called the FTC's action in the cases "surprising," saying oversight action might have been more anticipated by the Food and Drug Administration. In particular, Thompson noted, draft guidance on the oversight of mobile medical applications issued by the FDA in July (5 MELR 476, 7/27/11) would cover these kinds of apps because they would seem to "transform a cell phone into a medical device, and thus fall within FDA's jurisdiction."
Nevertheless, Thompson said the two federal agencies typically communicate "quite a bit" about medical-related products since FTC regulates their advertising and FDA regulates their labeling.
After the FDA guidance on mobile medical apps — which provides some insight into how FDA might oversee the mobile medical app industry — is finalized, these types of cases might be handled instead by FDA, he said.
The enforcement action by FTC is not necessarily unwelcome by many medical apps developers, Thompson noted. "There's been a gold rush mentality in the medical app field of late, and I worry that it [has] caused some people to jump in looking for gold without really having the patient's interests in mind," he said. "Those companies then compete unfairly in the marketplace making claims that are completely unsupportable, and hurt ethical companies trying to do the right thing."
The agreement, which was approved 5-0 by FTC commissioners — is subject to a 30-day comment period that began Sept. 8. FTC will accept public comments on the AcneApp case and the Acne Pwnr case through Oct. 10.
