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- The US FDA held a public hearing to gather feedback on the therapeutic use of psychedelic drugs for serious mental illnesses. - The hearing follows an April order directing the FDA to qualify psychedelic programs for its priority-voucher pathway and coordinate with the DEA and VA. - The FDA has since issued priority vouchers for psilocybin in treatment-resistant depression, psilocybin in major depressive disorder and methylone in PTSD.
- The American Psychiatric Association plans to introduce biology into the next edition of the DSM, marking the first time the manual will integrate neurobiology into psychiatric diagnosis. - No scientifically valid biomarkers currently exist for any psychiatric condition except certain proteins used to diagnose Alzheimer's disease, reflecting psychiatry's lag behind other medical fields. - Three advances show particular promise: an FDA-approved blood test for Alzheimer's amyloid and tau proteins, C-reactive protein as a potential depression subtype marker, and polygenic risk scores for genetic risk. - Incorporating neuroscience is expected to give clinicians a more scientific perspective and eventually enable more precise diagnoses and personalized treatment for mental illness.
- HHS Secretary Robert F. Kennedy Jr. issued new federal guidelines in May 2026 targeting SSRI prescribing, including strengthened informed consent, deprescribing support, non-drug first approaches, and shorter prescribing windows. - A national survey of psychiatrists at the 2026 APA meeting found 97% believe RFK Jr. is unfit to serve as HHS Secretary and 94% say his policies have not benefited psychiatry. - Experts warn that Kennedy's rhetoric stigmatizes psychiatric medication and will disproportionately harm marginalized communities, with Black children specifically targeted in his comments. - Critics argue the real crisis is access: 35% of adults and 50% of children needing mental health care cannot obtain it, while insurance barriers and provider shortages persist.
- The FDA is revising labeling for all extended-release ADHD stimulants to include warnings about weight loss and adverse reactions in children under six years old. - Clinical trial data revealed that younger children have higher drug levels in their bodies and experience more side effects compared to older children. - Extended-release stimulants are not approved for children under six, but healthcare professionals can prescribe them off-label for ADHD treatment. - The agency determined that benefits may not outweigh risks in this younger patient population, prompting the new "limitation of use" labeling requirement.
- FDA advisory committees voted 14 to 1 to dismiss the clozapine REMS, deeming the monitoring requirements unnecessary and a barrier to patient access. - Experts testified that the REMS protocol causes delays in treatment, leading to missed doses, psychological distress, and potential hospitalizations for patients. - Concerns were raised that the REMS program disproportionately affects psychiatrists and limits access to clozapine, a crucial medication for treatment-resistant schizophrenia. - The decision follows evidence suggesting that the most serious risks of clozapine-induced neutropenia occur early in treatment, diminishing significantly after two years.
- Behavioral and Psychological Symptoms of Dementia (BPSD) affect nearly all dementia patients, increasing hospitalization, neglect, and mortality risks. - Atypical antipsychotics (AAPs) have historically been used off-label for BPSD, but carry risks of cerebrovascular events and increased mortality in older patients. - The DICE approach (Describe, Investigate, Create, Evaluate) prioritizes non-pharmacologic interventions, reserving AAPs for severe cases posing imminent harm. - Brexpiprazole is the first AAP with FDA approval for agitation in Alzheimer's dementia, showing improved safety and efficacy in clinical trials.
