To Address Mental Health Amid COVID-19, FDA Looks Digital

Social distancing measures during the COVID-19 pandemic have profoundly impacted the way health care services are delivered. In order to reduce risk to both health care providers and to patients, as many services as possible are now being delivered remotely. While there is a critical and immediate need for COVID-19 testing and treatment during this time, there is also a heightened demand for mental health services.

Those that were receiving treatment for behavioral health and substance use disorder before the pandemic will continue to need those services, especially in a time of increased isolation. Additionally, the uncertainty of this crisis will generate new stress and anxiety in the population that we would be wise to address head on. Due to the need for continued, if not expanded, access to mental health services, digital mental health has seen a precipitous increase in interest and utilization since early March.

Importance of Mental Health Services During the Pandemic

In particular, the confluence of the COVID-19 pandemic with the domestic opioid epidemic presents daunting challenges. While social distancing is a necessary measure to mitigate the threat of COVID-19, increased social isolation poses a serious threat to individuals with substance use disorders and other mental health struggles.

In a recent Health Affairs blog, Dr. Navdeep Kang astutely noted that infectious disease precautions “are more than inconveniences to a person struggling with addiction. They are risk factors for relapse that can impede access to highly regulated but critical medications.” While Dr. Kang is referring directly to treatment for opioid use disorders, lack of face-to-face interventions or access to medications or therapies could prove devastating, if not deadly, for other behavioral health conditions as well. What had already required immense investment is now upended by a public health emergency that increases reliance on unhealthy behaviors or exacerbates stresses and, in turn, emotional responses.

Making Digital Health Tools for Mental Health Services More Available

Augmented by the Department of Health and Human Services’ (HHS) efforts to expand the availability of telemedicine services, the U.S. Food and Drug Administration (FDA) has made concurrent strides to ensure access to evidence-based treatment for mental health and substance use disorders. On April 14, the FDA issued guidance that aims to improve availability and accessibility of two types of digital health products for mental health care:

1. Prescription digital therapeutics providing computerized cognitive behavioral therapy (CBT) for psychiatric disorders; and
2. Low-risk wellness apps designed to address mental health needs.

FDA recognizes that digital care helps remove unnecessary exposure to care environments, such as clinician offices and hospitals, where risks of viral transmission remains high, but that continuity of care for patients with mental health conditions is critical.

FDA Temporary Policy on Prescription Digital Therapeutics

To date, FDA has authorized two prescription digital therapeutic CBT products for marketing through its 510(k) approval process — one for opioid use disorder and the other for chronic insomnia. Building on that experience, this policy looks to address the complex needs of patients presenting with various psychiatric conditions, whether a preexisting condition or one diagnosed since the declaration of a public health emergency (PHE). FDA recognizes that telehealth or virtual physician visits are appropriate for making diagnoses, which then qualify a patient for a prescription digital therapeutic.

Ultimately, the agency has recognized the clinical and psychosocial utility of making products accessible to patients so long as they do not pose undue risk amid the pandemic. One such undue risk would be when the patient’s situation demands immediate clinical intervention, such as suicidality.

The first temporary policy announced April 14 relates to “Computerized Behavioral Therapy (CBT) and other digital health therapeutic devices for psychiatric disorders.” This includes only Class II devices that provide computerized cognitive behavioral therapy (CBT) with a prescription and concurrent with supervised outpatient treatment for psychiatric conditions, including:

• Obsessive Compulsive Disorder (OCD)
• Generalized Anxiety Disorder
• Insomnia Disorder
• Major Depressive Disorder (MDD)
• Substance Use Disorder (SUD)
• Post-traumatic Stress Disorder (PTSD)
• Autism Spectrum Disorder
• Attention Deficit Hyperactivity Disorder (ADHD)

For these CBT-based digital therapeutics, FDA will not require products to go through typical approval processes as long as they do not create an undue public health risk. In order to help ensure no undue risk, manufacturers should perform software verification to make sure software performs as intended, have appropriate cybersecurity protections in place, and include labeling and instructions to the patient to contact their physician before using the product.

Rather than requiring adherence to strict FDA approval on labeling, FDA provides in this guidance 15 recommended elements that should be included in the product labels to convey device utility to the consumer.

FDA’s Temporary Policy on “Low Risk” Behavioral Health Apps

The second temporary policy announced April 14 intends to increase availability of low-risk devices (apps) for general wellness use. This policy also builds on previous FDA work, reiterating its September 2019 policy guidance documents for low risk devices for general wellness and device software functions and mobile medication applications. In those guidances, FDA laid out that formal approval is not required for low-risk digital health products and devices.

Low-risk digital health products and devices include general wellness apps (such as those that promote relaxation or mindfulness, good sleep, and physical activity), apps that perform functions related to mental health (such as providing motivational tips), and apps that provide public health messages related to COVID-19 (such as reminders to social distance). This excludes devices used for diagnoses or clinical decision-making. The policy also does not apply to software used for video visits with health care professionals as FDA does not consider those medical devices.

Looking Into the Digital Crystal Ball

Overall, for both parts of this new guidance, FDA specifies that it has not undergone formal comment due to need and authority for quick action during the pandemic, but that the public remains able to comment on the guidance document through normal channels — the Regulations.gov portal referencing FDA-2020-D-1138 — on an ongoing basis. FDA also specifies that these policies are in effect temporarily, for the duration of the PHE.

The PHE remains a critically important time for the growth and expansion of the digital mental health industry. While access to products outside of the 510(k) and de novo approval pathways has been limited to date, the digital and biotech industries have an opportunity here to demonstrate efficacy and value with long-term implications for continued utilization and viability of product classes and new interventions. The agency’s recognition of these interventions as a value-add to the comprehensive pandemic response is telling, but it’s contingent on those affected by the enforcement policy to leverage its flexibility and solidify the technology’s place in a physician’s toolkit.

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.