Martha M. Leon Fernandez
Associate Editor
Loyola University Chicago School of Law, JD 2024
The U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA) have guarded controlled substances zealously since the inception of the Controlled Substances Act (CSA), passed in the 1970s. However, the coronavirus (COVID-19) pandemic challenged nearly all of society’s conventional protocols, and the federal government responded to concerns that patients wouldn’t receive care by loosening its regulations for healthcare services. In 2020, the DEA permitted health providers to prescribe schedule II-controlled substances to patients via telehealth appointments instead of in-person visits. Now, two years later, the FDA has confirmed an Adderall shortage, which is a schedule II controlled substance that is in high demand and used to treat attention-deficit/hyperactivity disorder (ADHD). The Justice Department’s DEA division has initiated probes against various online mental health companies and worries that the drug is overprescribed and abused by young adults.
Coronavirus and controlled substance regulations
Before the pandemic, the Ryan Haight Online Pharmacy Consumer Protection Act, enacted in 2008, amended the Controlled Substances Act to address online pharmacies by outlining strict regulations for internet prescriptions. The restrictions made it increasingly difficult to obtain controlled substances and implemented new procedures that required prescribers to evaluate patients in person. More specifically, the law necessitates at least one in-person appointment before prescribing a controlled substance.
At the onset of the coronavirus pandemic, Congress waived the Ryan Haight Online Pharmacy Consumer Protection Act to allow individuals to see their care providers during the lockdowns virtually. Additionally, the U.S. Department of Health and Human Services waived some potential penalties surrounding federal health privacy law to allow teleconferencing tools to be used. This was intended to divert COVID-19 cases from overcrowded health offices, provide primary care, and address backlogs. However, these changes also allowed physicians and practitioners to prescribe controlled substances without the previous in-person restrictions, allowing telehealth providers to offer coveted ADHD treatment at just one tap away.
The effects of scaling back regulation
These changes troubled the DEA, which expressed concern that the relaxed regulation requirements led to over-prescribing controlled substances, such as Adderall, for illicit use and abuse by those who do not need it.
From 2019 to 2022, total prescriptions of Adderall rose from 35.5 million to 41.2 million, about a 16% increase. Despite the uptick in demand for ADHD medications since the pandemic and the shortage, the DEA has maintained its limited quotas and is not planning to increase them in the next year. Since Adderall is a Schedule II controlled substance, the DEA regulates them, and pharmacies usually forgo doubling their supply to avoid DEA scrutiny. Since the announcement of the Adderall shortage, the FDA has encouraged patients to work with their healthcare providers to seek alternative therapies, including less coveted extended-release versions of ADHD medication.
DEA investigation against Done Global, Inc. and Cerebral Inc.
In 2019, there was a rise in Silicon Valley digital health startups that strove to ease the healthcare demand and eliminate common barriers to healthcare accessibility. Advocates claim that remote services have not only managed to improve on those fronts but also that they have lowered costs for both parties. Government authorities, however, are cautious about telehealth services, mainly because of the ease of obtaining a prescription stimulant with a simple video call. For example, the relaxation of rules has corresponded with a rise in Adderall prescriptions. Concerns over whether telehealth businesses use adequate evaluation practices have heightened the DEA’s scrutiny.
Done Global, Inc. and Cerebral Inc., two leading telehealth providers, took advantage of the pandemic’s opportunity to provide online evaluations and treatment for ADHD patients. Diagnosing ADHD can be challenging, and it often takes at least 90 minutes to distinguish the ADHD symptoms from other conditions that can present similar symptoms, like anxiety and depression, but require another treatment. Both companies heavily marketed their ADHD subscription services on social media and hired nurse practitioner contractors to evaluate and prescribe medication after only a thirty-minute video appointment. They are presently under investigation by the DEA for potential CSA violations, and federal prosecutors have already issued Cerebral a subpoena to investigate their practices. Cerebral stopped prescribing stimulants to treat ADHD in May 2022, while Done continues to prescribe stimulants.
Former vice president of Cerebral, Matthew Truebe, claimed in his wrongful termination lawsuit against the company that Cerebral’s goal was to prescribe stimulants to 100 percent of the company’s ADHD patients. Similarly, former clinicians of the two telehealth companies were interviewed about their experience and expressed frustration and concern. They indicated that the advertising created the expectation for patients that getting stimulant prescriptions was easy, and they felt they had to prescribe Adderall despite the short evaluation times that did not give them the opportunity to diagnose properly. Cerebral clinicians said that management rejected their suggestions to increase evaluation times from 30 minutes to 45 minutes because it would cost the company more and disrupt the scheduling system. Cerebral and Done have denied that they pressured clinicians to prescribe stimulants.
The aftermath
Nationwide pharmacies, including Walgreens, Walmart, and CVS, have delayed and stopped filling Cerebral prescriptions for controlled substances. While insurance companies like Aetna, UnitedHealth Group Inc., and Optum health services have removed Cerebral from their network coverage.
Telehealth investors are deeply concerned about the effects of the DEA’s investigation. They worry that Congress will choose not to extend the waiver of the Ryan Haight Online Pharmacy Consumer Protection Act. If the waiver is not extended, telehealth services must meet with patients at least once in person before any controlled substances can be prescribed. This will defeat their motto, which promulgates that the process for getting treatment “is as easy as 1-2-3.”
The growing demand for ADHD treatment has also motivated the American Professional Society of ADHD and Related Disorders to create guidelines for diagnosing and treating ADHD. The guidelines recommend steps that any apt provider will have difficulty completing in less than 30 minutes. Their hope is to avoid repeating the opioid crisis and curtail the irresponsible prescription of stimulants so that ADHD medications are prescribed appropriately.
The effects of scaling back regulation for telehealth services have led to a definite increase in Adderall prescriptions. This has disadvantaged those who need this prescription to function daily, adding an additional burden to their lives when they can’t get their prescription filled because of the Adderall shortages. The DEA must regulate telehealth providers issuing addictive Schedule II controlled substances more closely to ensure that patient diagnoses are made accurately, and the prescriptions are not just being handed out to anyone who asks for the substance.