Posted October 8, 2020

Presentation to the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration

Public Meeting on Patient-Focused Drug Development for Stimulant Use Disorder

Presented by Robert Cattoi, CHADD Chief Executive Officer

Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) appreciates the opportunity to comment on the development and evaluation of abuse-deterrent formulations (ADFs) of central nervous system stimulants.

Founded in 1987, CHADD is a national nonprofit organization dedicated to the mission of improving the lives of people affected by ADHD. CHADD provides support, education, and encouragement to children and adults with ADHD, their parents, educators, and professionals. With the help of more than 5,000 members and 120 support groups and affiliates across the country, as well as more than 1,000 volunteers, CHADD reaches out to individuals affected by ADHD, providing support right in their own community. As the home of the CDC-funded National Resource Center on ADHD, CHADD is the trusted source for evidence-based information on ADHD.

ADHD is one of the most prevalent mental disorders in children in the United States (about 10%) and often persists into adulthood with associated symptoms and impairments. An estimated 4.4% of U.S. adults meet the criteria for ADHD in the U.S. based on clinical interview. ADHD is estimated to affect nearly 10.5 million adults in the U.S.

ADHD is well recognized as a neurobiological condition that causes significant impairment. As important, ADHD must be viewed as not just a mental health disorder that is the specific domain of mental health and special educational professionals, but as a public health problem producing a substantial impact on the health, quality of life, and economic viability of the US population.
Individuals with ADHD are at greater risk than unaffected individuals for eating disorders, obesity, diabetes, sleep disorders, dental issues, substance use disorder—including smoking—, unemployment, academic underachievement, accidental injury, teenage pregnancy, sexually transmitted diseases, depression, suicide, and premature death.

There are over 25 relevant studies on the economic costs associated directly or indirectly with ADHD. In sum, research shows that ADHD poses a considerable cost to families, insurers, government health care providers, and to society generally. Economic costs of ADHD in the United States range from $143 to $266 billion annually. This makes ADHD a far too costly disorder to continue to be undertreated or even ignored in not just mental health settings but especially by primary care, government public health programs, third-party payers, and particularly among adults.

Fortunately, ADHD is a condition for which we have viable treatments. A multimodal treatment approach using medication and behavioral therapy has been shown to reduce symptoms of impulsivity, inattention, and hyperactivity. Treatment allows individuals to focus, work, and learn.

Stimulant medications are generally the first-line medical treatment for ADHD as they are highly effective at reducing symptoms. They act quickly (within 20 to 45 minutes, depending on the specific medication). And most people experience few side effects. A significant amount of research has demonstrated that when taken as directed by a prescriber, stimulants are safe and effective in treating ADHD. Recent studies confirm that stimulant medications often lead to improvements in self-regulation, planning, and organizational skills.

Although prescription stimulants are often highly effective in reducing ADHD symptoms in children, adolescents, and adults, problems of non-medical misuse and abuse of prescription stimulants among adolescents, college students, and adults has become evident in recent years. Estimates of non-medical use of stimulant medications vary widely depending on the definitions used in different studies. A population-based estimate from the National Survey on Drug Use and Health reported that approximately 5 million adults had engaged in non-medical use of stimulant medication at least once in the last year. This non-medical use places a substantial burden on health care facility use. Data from 2005 - 2010 show an increase of between 67 - 156% in the number of emergency room visits for non-medical use of stimulant medications.

As part of the Coalition to Prevent ADHD Medication Misuse (CPAMM), CHADD works with a diverse group of organizations to help prevent the misuse, abuse and diversion of prescription stimulant medication. CHADD is committed to being part of solutions aimed at reducing the misuse of ADHD medications through education of both health care providers and individuals with ADHD.

We applaud any steps that reduce misuse and abuse of these medications without impeding access and affordability for those who require them for treatment. We recognize that the development of abuse-deterrent formulations of stimulant medications may provide a means—albeit limited—of reducing abuse. Research suggests that between 550,000 and 2 million US adults snort stimulant medications each year and that between 50,000 and 550,000 adults smoke or inject stimulant medications each year. Data from Poison Control Centers reveal that the odds of dying from non-medical use of stimulants is 13 times greater for nasal abusers and 22 times greater for intravenous abusers than for oral abusers.

While ADFs may help to reduce abuse through snorting, smoking or injection, it is important to recognize that the majority of individuals who abuse stimulant medications do so through an oral route, which will not be deterred by ADFs. But given that 38-40% of stimulant misusers are doing so via intranasal and intravenous use, we support the development of a stimulant that has abuse deterrent physical features (e.g. can’t crush and snort). This would be a very helpful addition to the repertoire of ADHD medications prescribed to high school and college students, who are the highest group at risk for abuse.

It is CHADD’s position that all individuals with diagnosed ADHD should have access to the full range of safe and effective prescription medications indicated to treat ADHD. In light of rampant misconceptions about ADHD treatment, the stigma surrounding the disorder, and other external pressures, individuals with ADHD often face significant barriers to accessing prescribed medications. We respectfully urge the FDA to consider these systemic burdens on the ADHD population. Any steps to reduce stimulant abuse must not be taken at the expense of ADHD patients’ access to required medical treatment. Individuals with ADHD often experience great hardship with timely and affordable access to their prescribed medications. It is imperative that any FDA actions to reduce stimulant abuse, including approval of abuse-deterrent formulations of prescription stimulants, not exacerbate current coverage and access hardships.

Thank you for allowing us to comment on this issue.