By Emma Bilton, JHBL Staff Member
For many patients, inaccessibility to prescription medication can lead to catastrophic consequences. Unfortunately, this is a reality for many Americans today. Since October of 2022, over 41.4 million Americans are facing a medical crisis. This medical crisis is the Adderall shortage sweeping the nation, leaving Americans to face the health consequences of withdrawal and physical and behavioral regression with no end in sight.[1]
Adderall is a stimulant medication most commonly used to treat hyperactivity and sleep disorders, such as attention deficit hyperactivity disorder (ADHD) and narcolepsy.[2] Stimulants are a class of drugs that speed up the body’s metabolic processes.[3] In exciting the metabolic processes of the body, stimulants can cause an increased sense of wakefulness, increased attention, and lessen the fatigue felt from completing physical and mental tasks.[4] Under the guidance of a licensed prescriber, stimulants, like Adderall are effective for treating a variety of disorders on a daily basis.[5] There has been a drastic rise in the number of Americans who are prescribed Adderall, jumping from 32.2 million people in 2017 to 41.4 million people in 2021.[6] This number has only continued to rise over the course of the last two years.[7] The spike has been attributed to multiple sources and it is debated as to whether it is over-prescribing, whether the pandemic played a part in the increase, or because ADHD has become more prevalent.
The Food and Drug Administration (FDA) protects the welfare of the nation’s health and food supply by monitoring and regulating the drugs and biological products that enter into the markets.[8] The FDA works with the Drug Enforcement Administration (DEA) to regulate and classify drugs entering and circulating the market.[9] Stimulants, including Adderall, are classified as a Schedule II substance, meaning that it is a prescription drug, having a high potential for misuse, which can lead to dependency.[10] Under this classification, Adderall and the active ingredients in Adderall are highly regulated within the pharmaceutical market. On October 12, 2022, the FDA released a statement regarding the growing shortage of Adderall.[11] The letter cited manufacturing delays, supply chain issues in acquiring the active ingredient of Adderall, and an increased demand for the drug as the main sources of the shortage, leaving millions of Americans helpless without their medication.[12]
Since the 2022 letter, the shortage has continued, making Adderall a scarcity for prescribed patients. The shortage has since extended to other stimulant medications, which have been prescribed as replacements for Adderall due to the inability to get Adderall in the proper quantity and dosages.[13] On August 1, 2023, the FDA and DEA wrote a letter in which they urged drug manufacturers to produce more medication and to monitor their prescribing practices, citing those outside groups as the forces that controlled the shortage.[14]
While the manufacturers and prescribing physicians are a part of the driving forces behind the shortage, the FDA and DEA’s classification of stimulants as a Schedule II substance also places restrictions on access to Adderall and similar prescription drugs. Pharmacies are monitored on how many stimulant prescriptions they fill, which can raise red flags when patients now must call multiple pharmacies to find one with Adderall in stock.[15] In addition, the DEA and FDA have limits on how much can be produced for stimulants, like Adderall. While they are encouraging manufacturers to increase the amount of medication they are producing, the FDA and DEA are not raising the limit on production for stimulants, they are only encouraging manufacturers to meet the limit, as manufacturers fell short of the limit by 30% at the start of the shortage.[16]
The FDA and DEA should aim to remedy the crisis through actions and real change, such as policy, rather than mere pleas. The DEA and FDA should look to change the limitations and restrictions placed on Adderall and similar stimulates as a Schedule II substance to reflect the increase in Americans taking the medication. With a higher demand for Adderall, but with restrictions that do not allow for an increase or surplus to account for the sudden increase in demand, there is no way for manufacturers and pharmacies to escape the shortage.[17] Asking physicians to prescribe less Adderall to less people does not account for the 41.4 million people who are still in need of and cannot get their prescribed medication.
Overall, while the DEA and FDA are taking steps to encourage or work with other perpetuators of the Adderall shortage, they themselves have not taken the steps they can to remedy the situation. The FDA and DEA cannot make laws, but they make and enforce the regulations and classifications of the drugs circulating the markets in the United States. In working to make regulations that fit the current climate of shortage and increased demand in a post pandemic world, the FDA and DEA could look to minimize the negative consequences of regression and withdrawal that millions of Americans are facing currently.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.
Emma Bilton is a second-year law student and interested in biotech, pharmaceutical, health, and family law. She worked at a civil litigation, family law, and real estate law firm as a legal intern this past summer. She graduated from Hobart and William Smith Colleges with a Bachelor of Arts in Psychology and Sociology, and a minor in Child Advocacy.
[1] See Julia Ries, What to Know About Adderall Withdrawal, as ADHD Medication Shortage Continues, Health (Feb. 15, 2023), https://www.health.com/adderall-withdrawal-adhd-medication-shortage-7109240.
[2] See Stimulants Information, Fed. Drug Admin. (March 2007), https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf
[3] See Stimulants, U.S. Drug Enf’t Admin., https://www.dea.gov/factsheets/stimulants.
[4] Id.
[5] See Julia Ries, What to Know About Adderall Withdrawal, as ADHD Medication Shortage Continues, Health (Feb. 15, 2023), https://www.health.com/adderall-withdrawal-adhd-medication-shortage-7109240.
[6] See Erica Pandey, America’s Adderall shortage, Axios (Nov. 15, 2022), https://www.axios.com/2022/11/15/adderall-shortage-adhd-diagnosis-prescriptions
[7] Id.
[8] See What We Do, U.S. Food & Drug Administration (Mar. 28, 2018), https://www.fda.gov/about-fda/what-we-do#:~:text=The%20Food%20and%20Drug%20Administration,and%20products%20that%20emit%20radiation.
[9] See Who We Are, United States Drug Enforcement Administration, https://www.dea.gov/who-we-are (last visited Sep. 15, 2023).
[10] See Controlled Substance Schedule, U.S. Drug Enf’t Admin., https://www.deadiversion.usdoj.gov/schedules/#:~:text=Substances%20in%20this%20schedule.%20have%20a%20high%20potential%20for%20abuse,Sublimaze%C2%AE%2C%20Duragesic%C2%AE (last visited Sep. 15, 2023).
[11] See FDA Announces Shortage of Adderall, U.S. Food & Drug Administration (Oct. 12, 2022), https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shortage-adderall.
[12] See Id.
[13] See Leah Kuntz, The Rx Crisis: The Impact of Ongoing ADHD Medication Shortages, Psychiatric Times (Aug. 7, 2023),
https://www.psychiatrictimes.com/view/the-rx-crisis-the-impact-of-ongoing-adhd.
[14] See Joint DEA FDA Letter, U.S. Food & Drug Admin. (Aug. 1 2023),
https://www.fda.gov/media/170736/download?attachment.
[15] See Christina Jewett, F.D.A. Confirms Widespread Shortages of Adderall, The New York Times (Oct. 13, 2022),
https://www.nytimes.com/2022/10/13/health/adderall-shortage-adhd.html.
[16] See Deirdre McPhillips, FDA, DEA call on drugmakers to boost manufacturing amid ongoing shortage of prescription stimulants, CNN Health (Aug. 1, 2023), https://www.cnn.com/2023/08/01/health/adderall-shortage-fda-dea-letter/index.html.
[17] See Id.