Medications

The U.S. Food and Drug Administration (FDA) should undertake the same type of thorough review on the safety and efficacy of new potential medications like psychedelics as it does for all possible medications.

The Department of Veterans Affairs should update its National Formulary to make all clinically appropriate non-opioid therapies available to patients.

Congress should provide additional resources to the National Institutes of Health to increase research in concert with the pharmaceutical industry to develop and test innovative medications for substance use disorders (SUDs), including long-acting injectables, more potent opioid antagonists to reverse overdose, drugs used for detoxification, and vaccines, and treatments for stimulant use disorder.[1]

The Food and Drug Administration (FDA) should establish guidelines for post-market surveillance related to diversion, addiction, and other adverse consequences of controlled substances, especially extended release and long-acting opioids.[1]

When supported by strong clinical data, the U.S. Food and Drug Administration (FDA) should provide a formal indication for a specific psychiatric symptom when that symptom has been mapped onto specific neuronal circuits.

The U.S. Food and Drug Administration (FDA) should work to improve adolescents’ access to the best mental health and substance use disorder (MH/SUD) medications by bridging available adult data with bioequivalence studies and an open-label safety study.