FDA Decisions Could Impact Our Field Broadly

The FDA recently approved a drug for Alzheimer’s disease with marginal clinical results. Aducanumab was not recommended for approval by an independent advisory panel, but the FDA approved the drug anyway. This story will probably gain momentum with the agency being portrayed as too politicized. However, few policy decisions are immune to social influence, even when the matter is scientific.

While approving this medication may be a watershed event that changes the public discourse, a focus on this agency is overdue for other reasons. Influence on the FDA, and criticism of it, comes from every direction. The FDA has been assailed as much for what it has failed to do—for example, alerting the public earlier to an opioid addiction crisis or regulating youth vaping—as for overstepping its bounds.

Everyone in our field should pay attention to these issues, especially those with no prescriptive authority. These individuals may incorrectly see FDA stories as mainly applicable to those with such authority. This is myopic. The FDA is a regulator of medical products, including drugs and devices. These products are growing and impacting consumers and a wide range of professional services.

We should think of the FDA as the vanguard of the medical model. Developing drugs to treat specific diseases is the essence of the medical model. The key institutions representing this model have long been buffeted by social forces. National Institute of Allergy and Infectious Diseases Anthony Fauci, MD, first gained national prominence during the AIDS crisis when social activists influenced his thinking on the timing of public access to new medications.

The tension between releasing innovative products for desperate consumers and protecting the public from danger is routinely negotiated by the FDA. The media rightly highlight the passion on both sides of this tension. This is not the big news for our field. Stakeholders in our field should understand a more obscure reality, namely, that the medical model is acquiring new territory called “digital therapeutics.”

Psychotherapy is a psychosocial solution marked by a mix of subjective features like interpersonal communication and objective clinical techniques. We have long had proponents of a so-called “medical model of psychotherapy” that views psychotherapy as analogous to medical solutions. How? Therapy techniques are designed for a specific diagnosis with mechanisms of action analogous to a medication.

Several of these therapies are now regarded as evidence-based practices and are the basis for digital solutions. Many digital tools are derived from cognitive behavioral therapy (CBT), and early research in peer-reviewed journals has shown them to be effective. While the extraction of some clinical techniques from the complexity of therapy has clear value, its limitations are noteworthy.

The FDA’s product class called digital therapeutics might be considered therapy analogues. Do we lose anything by removing the therapist from therapy? One would expect so since variability in outcomes is associated with the therapist. Differences in result are not driven by how faithfully clinicians adhere to technique. Yet the FDA has designated digital therapeutics as products to be regulated.

Are these FDA-approved products different from other available digital tools? FDA tools can boast of empirical support from randomized clinical trials, while other digital products rely on retrospective, non-randomized studies. Yet all products, approved by the FDA or not, are based on the same well-validated CBT procedures. Given that, one might question the value of additional FDA scrutiny.

This is best understood as the medicalization of psychotherapy. These standardized digital products, now stripped of subjectivity and approved by the FDA, are available only through a physician’s prescription. Is this progress? It seems regressive in that there is a new restriction for access to the approved modules. Yet it is progress for those who see psychotherapy as part of the medical model.

Is this another example of the FDA making decisions that are not strictly science-based? The lesson to be learned with all controversies surrounding the FDA is that science does not speak for itself. It is always pressured by social interests. This should be understood and accepted, not decried. It is not clear how behavioral health services might change under the influence of continued medicalization.

It may be time to take the FDA’s decisions as a call to action. Those who value psychosocial services and want them readily accessible should assume nothing. Social forces drive scientific policy. Outrage at the FDA will accomplish little. The medicalizing of healthcare is not abstract. It is institutional and financial. Psychosocial services need strong, well-funded institutions. They do not thrive on research data alone.

Ed Jones, PhD, is senior vice president for the Institute for Health and Productivity Management.