Bradley Merrill Thompson Quoted in “Akili’s Digital Therapeutic Launches Early for Housebound Children with ADHD”


Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “Akili’s Digital Therapeutic Launches Early for Housebound Children with ADHD,” by Dave Muoio.

Following is an excerpt:

Less than a week after FDA opened the faucet for digital health products treating psychiatric conditions during the COVID-19 health crisis, Akili has fast-tracked and released its approval-pending digital therapeutic for children with ADHD.

Now known as Endeavor and flanked by a symptom tracker and caretaker support line, the video game-like app will be provided at no cost for a limited time to qualifying families with children aged 8 to 12 who have been diagnosed with ADHD. And although Akili has been developing and testing its product as a prescription therapeutic, this early release will not require a prescription from a doctor to download and use. ….

Could families hold onto Endeavor after COVID-19 winds down?

The FDA wrote in last week’s guidance that the relaxed restrictions enabling Akili’s release are only intended to last for the duration of the COVID-19 emergency. And while the document outlined which types of digital products would be allowed to launch, the FDA was mum on how it would be handling the end of this grace period.

“What will FDA expect when they lift the emergency? Will they expect companies to go and rip these products out of patients’ hands? The silence in the document would suggest so,” Epstein, Becker and Green’s Bradley Merrill Thompson, who counsels on the regulation of medical devices and related products, told MobiHealthNewslast week. “Maybe FDA is just saying they will deal with that eventuality when it comes. But I think FDA owes companies some transparency about its intentions of what will happen.”