What’s On Our Minds: A New Vision for Pharma in Youth Mental Health

Across the United States, rates of mental health conditions among children and adolescents have risen sharply over the past two decades. From 2013 to 2023, nearly all indicators of poor mental health and suicidal thoughts worsened among high school students. This issue reached a pivotal moment in 2021 when the American Academy of Pediatrics declared a national emergency in child and adolescent mental health based on alarming increases in the rates of depression, anxiety, trauma, and suicidality. Despite the increasing demand for mental health interventions, there are still many barriers children and adolescents face when accessing care. A study by Kaiser Family Foundation found that 20% of adolescents reported not receiving the mental health care they needed because of cost, stigma, or limited understanding of how to get help. Pharmaceutical companies play a large role in responding to the needs of these populations by developing treatments that have targeted mental health challenges. However, these pharmaceutical advancements have come alongside growing public and governmental concern about overprescription and the overmedicalization of the nation’s youngest population. As the demand for care outpaces access, pharmaceutical companies have a unique opportunity to enhance their involvement in child and adolescent mental health care beyond therapeutic development.

The mental health crisis in the US brings profound long-term consequences for both individuals and public systems. Mental health conditions now cost the U.S. economy more than $280 billion annually. This issue was highlighted in the Make Our Children Healthy Again Assessment recently published by the Make America Healthy Again team, led by Secretary of Health and Human Services, Robert F. Kennedy Jr. This document serves as an initial assessment of the state of pediatric health across the country and the commission now has 55 days to develop a strategy in response to the highlighted issues. Addressing overmedicalization is identified in the report as one of the recommended ways to reduce childhood chronic disease. For government agencies and other key stakeholders, addressing mental health is not only a public health priority, but also an economic concern. While the report does not reject mental health medication altogether, it shines a spotlight on the role pharma can play in promoting holistic and whole-person treatment models. Pharmaceutical companies can respond constructively to this moment by focusing on three key strategies: leading with transparency, investing in Real World Evidence, and building cross-sector partnerships.

MAHA’s assessment presents a meaningful opportunity for pharmaceutical companies to lead with transparency and openness. While the industry has taken visible steps to support mental health more broadly, particularly across the adult population, there has been less public discussion around its role in addressing the needs of the younger population. Companies can respond firstly by acknowledging the current dialogue and expressing their commitment to improving the mental health of children and adolescents across the country. Recognizing both the benefits and limitations of available treatments can foster a sense of trust among clinicians, community, and policymakers. In an environment of growing distrust in mental health therapeutics, pharma companies should also place a greater emphasis on data-driven innovations.

Leveraging Real World Data (RWD) and Real World Evidence (RWE) is one way to work towards closing the existing evidence gaps. The U.S. Food and Drug Administration (FDA) has expressed strong support for weaving RWD and RWE into the development of new therapies. Relying only on clinical trials to drive the development of new and innovative therapeutics can often result in data that is not entirely representative, particularly when studying vulnerable populations like children and adolescents. By combining insights from clinical trials with RWE, companies can ensure that therapeutic development reflects real-life experiences, not just controlled environments. RWE offers a path to greater transparency and trust. Pharmaceutical companies can use RWE to: (1) track long-term safety outcomes of medications prescribed to youth, (2) understand differences in response between demographic subgroups, (3) identify real-world adherence patterns and their implications for treatment success or failure, and (4) monitor off-label use in pediatric populations and assess associated risks and benefits. RWE can deepen understanding of how medications perform outside of clinical trials, while also accelerating approval timelines and reducing development costs. Beyond regulatory benefits, RWE can help caregivers, clinicians, and policymakers make more informed decisions by providing insights into treatment outcomes, side effects, and long-term impacts in real-world settings. When shared proactively and in accessible formats (e.g., white papers, public dashboards, or partnerships with academic institutions), RWE can shift public perception by demonstrating that pharmaceutical companies are invested not only in promoting their products, but also in improving real-world outcomes for children and adolescents.

Finally, pharma companies should consider partnering with schools and community-based organizations (CBOs) to promote a holistic, whole-person approach to youth mental health. Whole-person health means helping and empowering individuals, families, communities, and populations to improve their health in multiple interconnected biological, behavioral, social, and environmental areas. Cross-sector collaborations can help integrate therapeutics with other forms of social support, all working towards improving outcomes for children and adolescents. Research indicates that integrating mental health services with social support in schools can improve the emotional well-being and overall health outcomes for children and adolescents. A study published in Healthcare underscored the efficacy of holistic approaches in pediatric care, noting that integrating psychological and physical health needs can improve overall outcomes and is cost-effective. Pharma companies can support these initiatives by funding school-based health centers focused on increasing access to mental health services and organizing trainings for teachers to identify and respond to the mental health needs of students. By investing in these programs, companies can play a prominent role in improving the long-term outcomes of children and adolescents.

By embracing transparency, utilizing RWE, and prioritizing collaborations with cross-sector organizations, pharma companies can position themselves to lead a new movement aiming to improve the state of mental health among the young population of the US.

Policy Cheat Sheet

• The Patient Protection and Affordable Care Act (ACA): Passed by Congress in 2010 and includes several provisions aimed at helping people living with mental health conditions or substance use disorders.
• The Americans with Disabilities Act (ADA): Passed in 1990, ADA establishes requirements for equal opportunities in employment, state and local government services, commercial facilities, transportation, and telecommunications for citizens with disabilities – including people with mental health conditions and substance use disorders.
• The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA): This is a federal law that generally prevents group health plans and health insurance issuers that provide mental health or substance use disorder benefits from imposing worse benefits limitations on those benefits than on medical/surgical benefits.
• Bipartisan Safer Communities Act (BSCA): BSCA provided SAMHSA with $800 million over four years, from Fiscal Years 2022 to 2025 to address the nation’s mental health and substance use crises.

Industry Updates

Boehringer Ingelheim (BI) and Click Therapeutics are expanding their collaboration to develop and commercialize a second prescription-based therapeutic (PDT) that will provide additional treatment options to those living with schizophrenia. The mobile application combines multiple clinically validates therapeutic interventions for use alone and in combination with pharmaceutical therapy to help people with schizophrenia achieve positive health outcomes.

Syndeio Biosciences announced its launch to pioneer the emerging field of synapse-targeted neurotherapeutics. The company’s clinical-stage pipeline and proprietary R&D platform are built on cutting-edge discoveries in synapse biology and translational biomarkers, with a mission to transform treatment for patients living with major depression disorder (MDD), Alzheimer’s disease, schizophrenia, and other conditions. Abbvie and Lilly are both strategic shareholders of the company.

Teva’s schizophrenia newcomer Uzedy plays a key role in the company’s plans to accelerate momentum over the next two years. The long-acting injectable formulation of the antipsychotic risperidone won FDA approval in April 2023. The company is taking the same approach that won Uzedy its approval by developing a long-acting formulation of another well-established schizophrenia drug, olanzapine, which Teva plans to submit to the FDA for review later this year.

What We’re Reading: Mental Health in the Headlines

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