Turn on your TV, and you’re likely to be bombarded with slick ads promoting “the latest” in new drugs and drug devices to treat a variety of illnesses, diseases and disorders. Let’s take a brief look at how these treatments get approved.
Here’s a much-condensed version of how the FDA’s New Drug Approval process works, with a couple of actual examples.
- Early Research: Does It Look Promising?
Before any new product or drug reaches human testing, researchers need to determine how the treatment works in laboratory settings. Here’s a couple of popular psychedelic drugs being tested:
- Psilocybin-assisted therapy, or mushrooms: Preliminary studies indicate it may affect serotonin receptors and could reduce depressive symptoms.
- Ketamine: This was originally used as an anesthetic, but early research has indicated rapid antidepressant effects, fueling widespread mental-health studies.
- Permission to Test in People
Drug and device developers have to apply for FDA permission through an IND (Investigational New Drug).
- Digital Cognitive Behavioral apps don’t use an IND; they go through device pathways like 510(k) or de novo review.
- Clinical Trials (Phases 1–3)
Phase 1: Safety Testing
Small groups are first used to test safe dosing levels.
Example: Psilocybin trials monitored test subjects’ psychological well-being and physical safety with therapists on-site.
Phase 2: Efficacy: Does it work?
Does the drug improve symptoms?
Example: Ketamine demonstrated rapid reductions in depressed patients.
Phase 3: Large, controlled clinical trials
These clinical trials determine whether the treatment can be ultimately approved.
Example: Esketamine (Spravato) passed multiple Phase 3 trials before FDA approval in 2019.
- Full FDA Review – “The Big Kahuna”
The drug developers submit all data, usually consisting of hundreds of pages, within a massive application.
- Esketamine: This was reviewed by an FDA advisory committee that voted to allow its use due to its demonstrated rapid antidepressant effects.
- Digital apps: These must show real clinical benefit and software reliability.
- Post-FDA Approval: Ongoing Monitoring
The story doesn’t end here: Approved drugs must submit to in-clinic dosing and continuous safety tracking.
- Why Some Therapies Move Faster
The FDA is allowed to grant special programs (called “Breakthrough Therapy Status”,) when early clinical testing evidence is very strong. For example, Psilocybin therapy was granted this designation for treatment-resistant depression (but is not yet approved.)
The Bottom Line:
Every new mental-health treatment goes through the same core testing regimen:
Is it safe? Does it work? Are the benefits worth the risks?
Whether it’s a fast-acting drug, a promising psychedelic therapy, or a digital CBT app, government approval always requires solid evidence — marketing claims won’t cut it.
I’ll follow up soon with an examination of a new medical procedure designed to treat PTSD symptoms such as anxiety and depression.