In-Depth: Anticipating FDA Regulation of Pharmaceutical Apps. By Bradley Merrill Thompson Over the last couple years, FDA has clarified the scope of its regulation over mobile health.
In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile medical apps. Then, last month, in two separate draft guidances FDA explained the limits on its oversight of apps used for general wellness like fitness trackers, as well as apps that may be accessories to a medical device. And already in February, FDA published a final guidance deregulating medical device data systems, a category that includes numerous mobile apps. The agency has been busy. But one area FDA has yet to clarify is apps that guide the appropriate use of drugs. To be fair, this is undoubtedly one of the most difficult guidances to write. Pharmaceutical App Categories Before talking about FDA’s regulatory guidance, I’d like to explain what I mean by the term “pharmaceutical app.” 1. Serve as electronic health records for drug therapy 2. 3. 4. 5. 6. 7. FTC fines two melanoma risk detection apps, MelApp and Mole Detective. The Federal Trade Commission has taken action against two melanoma detection apps: MelApp and Mole Detective.
Some of the marketers behind the apps have agreed to settle with the FTC, while two additional marketers of Mole Detective have refused. Total settlements for the two apps came to just north of $20,000. Both apps claim to provide an “automated analysis of moles and skin lesions for symptoms of melanoma and increase consumers’ chances of detecting melanoma in its early stages”, according to the FTC. This move was not unprecedented. In 2011 the FTC took similar action against two acne apps. Here’s how the FTC summed up each of the melanoma app’s claims: Mole Detective was first developed by Kristi Kimball and her company, New Consumer Solutions in January 2012, according to the FTC.
Health Discovery Corporation launched MelApp in 2011 for $1.99, according to the FTC. FDA finalizes plans to deregulate MDDS health software. FDA’s Bakul Patel Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from FDA-registered Class 1 devices to an unregulated status.
Last week the FDA moved to finalize that guidance, building on a spate of recent guidances that both make clear where regulatory lines for health software already exist and move some healthtech categories into unregulated territory. The most recent final guidance specifically relates to MDDS software, which the FDA deregulated from Class 2 to Class 1 in 2011. MDDS are systems designed and marketed to transfer, store, convert according to preset specifications, or display medical device data without controlling or altering the function or parameters of any connected medical device. “Why would we do that?” FTC goes after kids’ brain training game for unsubstantiated health claims. Days after the FDA issued new draft guidance that may be softer on devices making certain kinds of medical claims, the FTC has reminded companies that it also has regulatory power over health claims and might be stepping up to the plate.
The FTC announced an administrative complaint against Focus Education, a company that makes a brain training game for children called Jungle Rangers. The complaint charges that the company advertised permanent brain improvements in “focus, memory, attention, behavior, and/or school performance”, including for children with ADHD, and backed up the claims with what the FTC said were nonexistent scientific studies. “This case is the most recent example of the FTC’s efforts to ensure that advertisements for cognitive products, especially those marketed for children, are true and supported by evidence,” Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, said in a statement. FDA wellness clarifications helpful, accessory proposal is just a start. Bradley Merrill Thompson At the end of last week the FDA posted two draft guidance documents related to digital health.
One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical device. The other intended to help clarify when an “accessory” device (PDF) to a regulated medical device, like a companion smartphone app, for example, would also fall under the agency’s purview and be regulated as a medical device. The first draft guidance document was fairly straight forward — we summarized it here. Bradley Merrill Thompson, who has written extensively about mobile health regulation for MobiHealthNews over the years, sent us his initial analysis of the documents. We need rules not just examples: “FDA responded by including clear rules on page 3 and 4 of the draft guidance. Don’t claim jurisdiction over every product that identifies a disease and consider “general recognition”: “That’s exactly what FDA proposes to do.
FDA clarifies the line between wellness and regulated medical devices. As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory.
As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days. “A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition,” the guidance explains.
“Where it is well understood” is an important turn of phrase here. And: