Improve adolescents’ access to MH/SUD medications

Prevention, Early Intervention, & Youth
Research & Technology
social determinants of health
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Federal department
Health and Human Services
house committees
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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.


Untreated psychiatric disorders in adolescents can lead to major lifelong problems for adults. It is particularly urgent for adolescents to receive treatment since about 14 percent of adolescents experience some type of mental health condition[1], and half of all mental illnesses begin by the age of fourteen.[2] However, medications to treat mental health and substance use disorders (MH/SUDs) have often not been approved for children and adolescents. For many health conditions, there can be a long lag between when the FDA approves a medication for adults to when (if ever) a medication is approved for children and adolescents.[3]

While it is critical to recognize differences between adults, children, and adolescents – and not to assume similarities – the fact that clinical trials are more expensive and burdensome for children and adolescents means that prescribers frequently prescribe FDA-approved medications “off-label” for youth.[3] A more rigorous approach is needed to help guide safe and effective treatments for adolescents, particularly those experiencing MH/SUD.

In early 2023, FDA staff presented to ISCTM (International Society of CNS Clinical Trials and Methodology) on potential opportunities to improve the availability of mental health medications for adolescents, particularly for schizophrenia, bipolar disorder, and major depressive disorder.[4] Large databases exist for all three diagnoses that contain thousands of adults and pediatrics. These databases could potentially be used to extrapolate the efficacy of medications for children and adolescents. There was “substantial evidence to support the full extrapolation of efficacy from adults to adolescents” where the disease is similar, the pharmacokinetics (medication levels in the blood/body) are similar, and the method of action and patient response are similar.[4]

The FDA should continue to explore avenues to increase the availability of key MH/SUD medications for adolescents when significant mental health conditions often first present. One option could be to allow a bioequivalence study and an open-label safety study to be done post-approval. Doing this could accelerate approvals to increase adolescents’ access to the best MH/SUD medications (which often have fewer side effects), encourage additional research, and leave in place incentives to study diseases in children and adolescents.


1. World Health Organization. Mental health of adolescents. Last Updated November 17, 2021.

2. National Alliance on Mental Illness. Mental Health By the Numbers. Last Accessed August 14, 2023.

3. Patrick Boyle. The wish of pediatricians: More medications deemed safe for kids. AAMC News. Last Updated June 21, 2022.

4. U.S. Department of Health and Human Services, Food & Drug Administration. “Use of existing datasets to inform regulatory decision making.” ISCTM 19th Annual Meeting, Washington DC. Last Updated February 15, 2023.