Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “FDA Offers Psychiatric Device Flexibility, Expands ‘Wellness’ Definition,” by Kelly Lienhard. (Read the full version – subscription required.)
Following is an excerpt:
FDA recently released a temporary enforcement policy stating it does not intend to pursue regulatory action over distribution of unapproved computerized behavioral therapy and other digital health devices during the COVID-19 pandemic. While the agency doesn’t say how it will treat such devices at the end of the pandemic, the guidance appears to expand the agency’s definition of wellness products.
Emergency discretion is extended to devices that intend to give patients access to therapy tools used during treatment sessions and “general wellness products” that present a low risk to users, the April 16 guidance states. Digital devices that make clinical diagnosis or treatment decisions are exempt from the temporary policy.
Although FDA doesn’t address whether its regulatory flexibility for digital psychiatric devices will continue after the pandemic, Brad Thompson, a member of the law firm Epstein Becker & Green and general counsel of the Combination Products Coalition, told Inside Health Policy that FDA appears to be expanding what it views as a “wellness product.”
For example, the emergency guidance says wellness products include software functions that utilize a checklist or a questionnaire of common signs and symptoms for psychiatric disorders, or guide a user through a questionnaire of signs and symptoms for a psychiatric disorder and provide possible medical conditions and recommend possible health care options.
However, FDA does make clear that these tools should not replace the role of a physician.
“[This] appears to be a more permanent change to the wellness doctrine,” Thompson said. “These changes seem designed to expand -- FDA says clarify -- the number of products that fit within this wellness category.”
The guidance says the use of digital therapeutic devices could help patients with psychiatric conditions and poor mental health either brought on or intensified by shelter-in-place orders. Use of digital devices also could reduce patients’ contacts with health care providers, decreasing burden on the health care system and encouraging social distancing during the COVID-19 public emergency.
But Thompson said that while the guidance addresses an urgent need for flexibility during the pandemic, FDA should also lay out how it will treat the products when the pandemic ends.
“FDA has not addressed how this enforcement discretion policy will end,” he said. “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.”
Or, FDA may just be indicating that it will deal with those expectation when the time comes, according to Thompson.
"I think FDA owes companies some transparency about its intentions of what will happen. Someday this too shall pass. But companies need to know what will be expected of them when it does,” Thompson said.
The guidance has already had real-world implications. …
While disappointed in the agency’s lack of clarity for the post-coronavirus environment, Thompson also said he was impressed with FDA's actions.
“This guidance addresses a truly urgent need. I think just about everyone appreciates that social distancing as well as the economic stresses that are impacting people today are extraordinary,” Thompson said. “I personally am very grateful to FDA for taking this important step.”
While Thompson favors having additional flexibility after the public health emergency ends, he also says limits are needed. FDA has allowed for great flexibility in many areas during the COVID-19 outbreak, and Thompson stated that in some cases this has enabled disreputable companies to enter the market with unsupported claims.
“The evidence I've seen is not specific to the psychiatric device example, but in other areas where FDA has adopted greater flexibility. I'm hoping that FDA at least uses its enforcement powers to keep snake oil salesman from hurting consumers,” Thompson said.
When it come to the psychiatric area, however, Thompson said FDA has overregulated in the past, and this emergency flexibility is a “return to a more rational approach.”
While the agency waives a majority of regulatory requirements for these behavioral health devices in the emergency discretion, it still requires that companies releasing behavioral health devices under the temporary order demonstrate the products work as intended, include proper cybersecurity protections, meet labeling requirements and prompt patients to acknowledge instructions to consult a physician before using the device.
The guidance, “Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”, can be found for comment under docket number FDA-2020-D-1138-0068.