Mental Health
Mental health conditions refer to a broad spectrum of health conditions affecting mood, thinking and behavior. This includes depression, bipolar disorder, schizophrenia, addiction, anxiety, eating disorders, obsessive compulsive disorder, attention-deficit/hyperactivity disorder and post-traumatic stress disorder.
Each of these vary in severity, ranging from mild to moderate to severe, and may occur together. Mental health conditions, if untreated, can place limits on daily life activities.
Biopharmaceutical innovation for mental health treatments has helped millions of Americans live healthier, more productive lives. Researchers are pursuing novel strategies to help bring new medicines to patients.
And while the science is promising, more can be done to improve mental health care in the country, including growing America’s behavioral health workforce, expanding insurance coverage of mental health treatments and breaking the stigma of mental health conditions.
It is vital to recognize that mental illness can be a serious disease and ensure Americans have access to life-saving care.
https://cdn.aglty.io/phrma/DrMike_OverallMentalHealth_16x9.mp4
Facts about Mental Health in the U.S.
1 in 4
Almost 1 in 4 Americans live with a mental health condition.
<50%
Less than half of adults living with mental illness receive any treatment.
https://www.nimh.nih.gov/health/statistics/mental-illness#part_2540
125 mil+
Over 125 million Americans live in areas with too few mental health professionals.
https://data.hrsa.gov/topics/health-workforce/shortage-areas/dashboard
Stigma is the biggest barrier to seeking treatment. 71% of adults who needed help, but didn’t seek it, reported it was because they felt they should “handle it alone.”
1 in 5
Nearly 1 in 5 children in America have been diagnosed with a mental, emotional or behavioral health condition.
https://www.cdc.gov/children-mental-health/data-research/index.html
Innovation in Mental Health Treatments
Researchers are leveraging a growing understanding of the brain to develop new treatments and bring therapeutic advances for patients who are not helped by current treatments. Studies are examining how medications work and identifying biomarkers that can be used to improve diagnoses, measure disease progression and assess a patient’s response to therapies.
But mental health treatment research and development has some of the lowest probabilities of success in drug development due to:
- Scientific complexities regarding mental health conditions and a need to better understand brain mechanisms underlying many of these illnesses
- Diverse nature of the diseases, which often manifest differently in different people
- Challenges in recruitment and retention of individuals with mental illness in clinical trials
There are currently over 160 promising mental health drugs in development.
Treatment works
When people get sick, they may need a medicine. Medications can do more than suppress symptoms. Medications, often paired with behavioral therapy, can improve quality of life, reduce relapses and prevent hospitalizations.
Camryn M., Texas
“I am a proud mom to three beautiful girls, and they have brought so much joy and happiness to my life. But like many new mothers, I dealt with postpartum anxiety and depression following their births. It is a scary feeling, but thanks to innovative treatments and medications available, my life, and the lives of many others, has changed for the better.”
Maya W., Florida
“I see a variety of patients from my work in mental health counseling and psychiatric care. While one medication may work for someone battling one mental health challenge, another patient with the same condition might not have the same results. It is imperative that new options continue to be found so that anyone who is suffering can find relief.”
Barriers to Treatment
Unfortunately, many patients suffering from mental health conditions do not seek treatment. There are four major steps that can be taken to improve mental health care in the U.S.:
Expand Access
Bolster America’s behavioral health workforce and expand access to care.
Over 125 million Americans live in areas with too few mental health professionals. This workforce shortage disproportionately affects rural areas. There is a need to increase qualified behavioral health workers through recruitment programs and other incentives such as ensuring competitive salaries in shortage areas. Equipping primary care and other providers to incorporate mental health into their routine practice can also help. Additionally, policy solutions should leverage and expand the appropriate use of telehealth, while ensuring safeguards to protect the quality of patient care.
Strengthen Insurance Coverage
Strengthen insurance coverage of mental health treatments.
More than 1 in 10 adults with mental health conditions report having no health insurance at all and nearly 40% of adults who did not receive mental health care were not covered for the treatments they required. Expanding coverage and access to comprehensive treatment is needed to adequately meet mental health challenges and improve the mental health benefit parity by extending parity requirements to Medicare and all of Medicaid.
Improve Care Coordination
Improve care coordination and delivery by enhancing integrated models of care to address both physical and mental health needs.
Mental and physical health are interconnected, and when they are treated together, outcomes improve. So, it is vital to advance policies to make it easier for mental and physical health care providers to work together in integrated models of care, such as expanding existing models that work and enhancing payment systems to ensure financial sustainability.
Break the Stigma
Break the stigma of mental illness.
People with mental health challenges often face social stigma or discrimination that can exacerbate an illness and delay recovery. Patients report stigma was the biggest barrier to seeking care - 71% of adults who needed help didn’t seek it — many felt they should “handle it alone.” Over one in ten (13.4%) adults believed that those around them would not approve of them if they sought help. We need to break the stigma so that our communities can have a better understanding of mental health conditions and patients feel comfortable seeking treatment.
The treatment of mental health has evolved
It’s important to look at the history of mental health treatment in our country and see how far we’ve come. The understanding of neuroscience, the pathology of mental health conditions, and effective treatment options have progressed tremendously.
Mental health treatment has evolved from inhumane institutionalization to comprehensive care that allows many patients to live quality lives.
1800s
- 1800s – Dorothea Dix documents the poor treatment of mentally ill patients in jails and hospitals and advocates for patients with mental illness. Dix plays an instrumental role in improving living conditions for the mentally ill and the expansion of mental hospitals across the US.
- 1844 – The association that would later become the American Psychological Association (APA) is established with a mission “to communicate their experiences to each other, cooperate in collecting statistical information relating to insanity, and assist each other in improving the treatment of the insane”
1900s
- 1908 – Clifford Beers writes his book “A Mind That Found Itself” to expose the maltreatment of people with mental illnesses and to reform care. A year later, the National Committee for Mental Hygiene was created.
1940s
- 1940s - Passage of the National Mental Health Act which made the mental health of the people in the U.S. a priority and established the National Institute of Mental Health (NIMH). It was during this time period that it was realized patients benefited more from evaluation and treatment rather than being institutionalized.
1950s
- 1952 – “Diagnostic and Statistics Manual of Mental Disorders” was published, including 106 mental disorders.
- 1952 – Thorazine (chlorpromazine) first given to a patient for psychosis. Chlorpromazine became widely prescribed and played a pivotal role in the deinstitutionalization of those with mental health disorders. At this time, psychopharmacology began to make a major impact on the practice of American psychiatry with a re-emphasis on symptom-based treatment.
- 1955 – Ritalin (methylphenidate) was approved by the FDA and soon started to be used for treatment of children with ADHD-like symptoms (ADHD was not recognized until later years).
1960s
- 1963 – President John F. Kennedy signed the Community Mental Health Act to reform the mental health care system. The Act shifted care from large institutions to community-based treatment centers.
1970s
- 1970 – The FDA approved the use of lithium for the treatment of mania and in 1974 for the maintenance treatment of bipolar disorder.
1980s
- 1987 – The FDA approved Prozac (fluoxentine), the first SSRI for the treatment of depression. This drug became pivotal in the treatment of depression, especially in an outpatient setting.
- 1989 – The FDA classified Clozaril (clozapine) as an antipsychotic. This approval gave rise to many antipsychotic drugs through the 1990s.
1990s
- 1996 – The Mental Health Parity Act (MPHA) was the first federal law to establish parity standards, but it only applied to annual and lifetime dollar amounts, meaning health plans and insurers could not impose lower maximum coverage amounts for mental health care than they did for physical health care over the course of a year or a person’s lifetime.
- 1999 – The Supreme Court found that keeping a person with a mental health condition in a psychiatric institution when treatment providers determined community-based care was appropriate violated the Americans with Disabilities Act. This landmark decision accelerated the shift toward community-based mental health care.
2000s
- 2008 – The Mental Health Parity and Addiction Equity Act was enacted to ensure health plans and insurers provide the same level of coverage for mental health and substance use disorders as they do for medical services.
- 2010 – The Affordable Care Act was signed into law by President Barack Obama, which included mental health as an Essential Health Benefit, meaning it must be covered by health plans, among other expansions.
Now
- Now – In recent years, the FDA has approved groundbreaking drugs for mental health conditions like post-partum depression and schizophrenia. Treatment options are science- and evidence-based and focus on helping patients manage symptoms and recover. The biopharmaceutical industry remains committed to delivering safe and effective mental health medicines to patients because all patients deserve access to treatments that can help them live a better life.
Related Resources
Advancing mental health in May and beyond
The reality: Nearly one in four adults in the U.S. experienced a mental health condition in the past year, and many did not get the care they needed. That gap between need and treatment is what makes Mental Health Awareness Month so important each May. It’s a reminder of something both simple and urgent: Mental health is health. And when patients are sick, they may need a medicine as part of their treatment plan.
This month, we encourage people to seek help for mental health conditions and work together to expand access to care and reduce stigma.
By the numbers:
- 23% of adults (61.5 million) experienced a mental health condition in the past year.
- 33% of young adults (ages 18–25) reported a mental health condition in the past year.
- 8% of adults (21.4 million) had a major depressive episode in the past year.
- 15% of adolescents (3.8 million) experienced a major depressive episode in the past year.
- Fewer than 40% of people with depression receive counseling or therapy.
Behind every statistic is a person navigating challenges that are real and too often untreated.
The burden: The impact of mental health conditions goes far beyond the patient and their reduced quality of life. Economic analyses show much of the burden of mental health conditions comes from lost productivity, medical costs and co-morbidities as well.
- $106.5 billion in annual mental health-related health care spending.
- About $2 million in lifetime societal costs per individual with serious mental illness.
- Higher costs and worse outcomes when mental illness co-occurs with other chronic diseases.
At a societal level, these effects influence workforce participation, economic growth and long-term health and wellbeing.
Why progress is challenging: Developing treatments for mental health conditions is uniquely complex.
- The brain remains one of the most complex and least fully understood organs.
- Biological causes of mental health conditions are not fully understood.
- Symptoms vary widely and treatments work for some patients and not others.
- Clinical trials face lower success rates and longer timelines than many other diseases.
At the same time, structural barriers to diagnosis and treatment persist, including shortages of mental health professionals, long wait times, geographic disparities and insurance and access challenges, like formulary restrictions and narrow networks.
Treatment works—and innovation is advancing: Despite these challenges, there is meaningful progress. Evidence consistently shows that treatment can reduce symptoms, prevent relapse and improve quality of life.
- Combined medication and psychotherapy improve outcomes more than either alone.
- Early intervention programs reduce hospitalizations and improve long-term functioning.
- Long-acting treatments can improve adherence in serious mental health conditions.
- For those with ADHD, sustained medication use is associated with improved mental health outcomes over time.
Innovation is advancing, with over 160 promising mental health drugs in development. New innovations, including novel therapies and digital tools, are expanding access to treatment and offering more personalized approaches to care.
Smart policy matters: Sustaining this progress requires policies that support continued innovation for mental health medications. Right now, that’s not guaranteed. The Inflation Reduction Act (IRA), and its drug price setting provisions, risk moving mental health policy in the wrong direction. These provisions discourage the development of small molecule medicines—a critical source of treatment for mental health conditions due to their unique ability to cross the blood brain barrier—and disregard the critical research and development that occurs in the years following FDA approval.
Working together for mental health: To support the mental health of the country, we can start by recognizing that many Americans are experiencing mental health conditions, and many go undiagnosed and untreated. It also requires policies that support the full continuum of care for patients and do not impose further barriers on a therapeutic area that already faces significant development challenges.
Mental health treatments work, so this May, and thereafter, encourage people to seek help, break down stigma and ensure timely access to effective care.
Learn more at PhRMA.org/MentalHealth.
Kristen Booze
The role of antidepressants in addressing America’s mental health crisis
Recent conversations about the role of selective serotonin reuptake inhibitors (SSRIs), often used to treat depression, have shined a light on the importance of addressing mental health. As an emergency physician, I see first-hand the value medication can play as one part of addressing mental illness.
As an industry, biopharmaceutical research companies have made tremendous strides towards understanding the root causes of mental illnesses and developing innovative medicines that help millions of Americans live healthier, more productive lives.
So what are SSRIs and why are they important?
Zoom in: SSRIs are a class of medications commonly prescribed to treat depression and other mental health conditions. Depression is one of the most common mental disorders in the United States. SSRIs are often used as first-line drug therapy, alongside psychotherapy. In fact, research demonstrates that combining psychotherapy with antidepressant medications improves treatment outcomes. SSRIs work by increasing levels of serotonin in the brain, which is thought to enhance communication between nerve cells. Like all medicines, SSRIs undergo the FDA’s rigorous review standards to ensure their safety and efficacy.
Why they matter: Nearly one in four Americans are battling some form of mental illness. Importantly, patients should feel free from stigma and have access to comprehensive care and treatments to manage their conditions effectively.
How thoroughly have SSRIs been studied, both in general and for pregnant women?
Since their introduction in the late 1980s, SSRIs have been extensively studied. A wealth of research has explored their safety and efficacy for different patient populations. Because of ethical considerations, there are not specific randomized clinical trials studying SSRI use in pregnant women, but there are many observational studies and analyses of health data.
Why might a pregnant woman take an SSRI and are there side effects?
About 10.3% of women aged 18-39 in the U.S. use an antidepressant to treat their depression, and many may rely on an SSRI. Like any medicine, SSRIs can cause side effects. Information about side effects can be found in a medication’s FDA-approved labeling.
The decision to take or not take SSRIs to treat depression during pregnancy should be made after a thorough discussion with the patient’s health care provider, who can consider the severity of the mother's mental health condition, her medical history and a risk-benefit analysis on the health of the mother and baby.
What systems are in place to report and address side effects with drugs if they arise?
The FDA and manufacturers monitor the safety of approved drugs, through several post-marketing surveillance programs. Biopharmaceutical companies have mandatory reporting requirements to share information about adverse events from their medications with the FDA and maintain their own surveillance systems as well. Any patient or health care provider can also voluntarily report adverse events directly to the agency.
Are SSRIs overprescribed?
Many patients with mental illness do not receive professional help for their symptoms and often remain undiagnosed and untreated. SSRIs are an important option for health care providers and patients to consider when discussing treatments for mental health conditions.
The bottom line: SSRIs are a safe and effective form of treatment for depression that patients may wish to consider with their doctor. Stigmatizing mental illness and treatments or imposing additional barriers to access comprehensive treatment options contributes to the significant burdens patients face. Looking ahead, America’s biopharmaceutical research companies remain committed to realizing a future where patients aren’t overshadowed by the daily challenges of a mental illness.
Mike Ybarra
The Facts about Mental Health Medications
Medications have transformed the treatment of mental health conditions. When prescribed and used appropriately, they can help children function better at school, build relationships and enjoy daily life. With diagnoses on the rise and growing attention on mental health medications, it’s important to know the facts about these tools that health care providers can use to treat mental illness.
The Facts about Mental Health Medications teaser
Mental Health
Fact Sheet
Three reasons Congress should fix the IRA’s pill penalty
The United States leads the world in the research, development and manufacturing of innovative medicines. But the Inflation Reduction Act’s (IRA) “pill penalty” puts this leadership at risk by discouraging the development of treatments that often come in pill form like a tablet or capsule, also known as small molecule medicines. Under the IRA, these treatments can be price set years before other medicines, signaling to researchers that developing them is not worth the risk.
While the IRA was intended to lower costs for Americans, it misses the mark and by no means resembles true negotiations that happen in the competitive market. Rather, the government is unilaterally determining the prices of medicines in a process that ignores how pills are often the most convenient, effective and affordable treatments for patients. At the same time, the law did nothing to rein in insurers and PBMs which, in response to making less money on price-set medicines, are adjusting their coverage policies to force seniors to pay more. Congress must do away with this harmful policy that takes treatment options off the table for patients.
We are already seeing the impact: Early-stage funding for small molecule development has fallen nearly 70% since the IRA was introduced.
What’s at stake for patients if Congress doesn’t fix the “pill penalty?”
- Fewer lower cost treatment options available
Unlike more complex therapies, pills do not require frequent hospital visits or specialized administration. Further, once generic versions of these medications are available, they can be purchased at a fraction of the original price, with an average copay of just $6.16 and generic competition driving down prices by nearly 85%. - Fewer convenient, accessible medications
Pills offer unmatched convenience, helping patients better manage their condition and improve adherence. Pills can be taken in the comfort of a patient’s home, reducing the need for frequent visits to the doctor’s office or hospital. This is particularly important for patients in rural areas who may have limited access to health care facilities. Transportation challenges can be a major barrier to adherence as patients are more likely to skip their medicine if they face difficulties getting to appointments. - Fewer treatments that are essential in the fight against cancer, mental illnesses and other diseases
Pills have unique therapeutic properties that make them the most effective in treating a variety of diseases. For instance, pills are uniquely suited to treat a variety of mental health conditions due to their ability to cross from the blood-brain barrier and into the central nervous system. Additionally, due to their smaller size, these medicines can reach therapeutic targets within cells, making them a critical tool in the fight against cancer.
Patients deserve policies that prioritize the fight against disease not treatments. Policymakers shouldn’t be putting their thumb on the scale to decide which types of medicines will be unfairly targeted and which future innovative treatments will be stifled. Congress must fix the pill penalty and ensure patients have access to affordable, effective and innovative treatment options for years to come. Learn more at phrma.org/pricesetting.
Brianna Allen
Pill Penalties Blog white bottle infographic