DEA, FDA Address Adderall Shortage by Urging Drugmakers to Boost Production
Nearly a year after the Adderall shortage began, two federal agencies call on drugmakers to increase production of prescription stimulants and health care providers to explore alternative ADHD treatments like digital therapeutics and non-stimulants.
August 3, 2023
Amid the ongoing shortage of prescription stimulants used to treat ADHD, the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) issued a joint letter this week urging key stakeholders, including manufacturers, distributors, pharmacies, and payors, to work together to resolve drug shortages as quickly as possible. The letter calls for the development of ADHD diagnostic criteria for adults, re-evaluation of drug quota allotments, adoption of non-stimulant and digital therapeutics where appropriate, and the thoughtful and responsible prescription of stimulant medications.
Since the FDA first reported a shortage of Adderall (the brand name for the immediate-release formulation of amphetamine mixed salts used to treat ADHD) in October 2022, 38% of ADDitude readers say they have experienced problems accessing ADHD medication, according to a recent survey of 10,044 caregivers and adults. Patient advocates and legislators have called on federal agencies to do more to combat the nationwide Adderall shortage since late last year.
In December 2022, Rep. Abigail Spanberger (D-Va.) called on the FDA to coordinate a response with the DEA that addresses artificially low production quotas for stimulant medication, among other roadblocks to accessing care. In March 2023, 20 other members of Congress wrote a letter urging the DEA to formulate new telemedicine and prescription rules and take seriously increases in demand when setting production quotas, and to better map supply chains. And Maia Szalavitz, a leading commentator on substance abuse issues, suggested in a column published in The New York Times that the FDA should assume oversight of ADHD medication from the DEA.
This week’s joint letter stated that the DEA is “committed to reviewing and improving” the quota process. According to the agency, “manufacturers only sold approximately 70% of their allotted quota for the year, and there were approximately 1 billion more doses that they could have produced but did not make or ship” in 2022. Data for 2023 show a “similar trend.”
“The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug,” FDA commissioner Robert M. Califf, M.D., and Drug Enforcement Administration leader Anne Milgram wrote. “That said, we are working closely with numerous manufacturers, agencies, and others in the supply chain to understand, prevent, and reduce the impact of these shortages.”
The agency leaders have requested that manufacturers either confirm they are working to increase stimulant production or relinquish their quota allotment so that it may be redistributed to other manufacturers.
Califf and Milgram also call on professional groups and healthcare providers to “accelerate efforts to support appropriate diagnosis and treatment,” including additional clinical guidelines for ADHD in adults and the development of alternative treatment options, such as non-stimulants and digital therapeutics. The letter cited the 2020 FDA approval of EndeavorRx, the first prescription-only game-based device to improve ADHD symptoms in children, as an example.
The letter also addressed concerns about medication misuse, addiction, and overdose. Earlier this year, the FDA began requiring updates to Boxed Warning labels and prescribing information on stimulants, such as Adderall and Ritalin, to include information about the risks associated with the drugs and to instruct providers to watch for signs of abuse and addiction.
Ongoing manufacturing delays, supply-chain issues, and record-high prescription rates for stimulant medications were among the “many factors” contributing to the Adderall shortage, according to the letter.
In a recent interview with WebMD’s John Whyte, M.D., Califf claimed that telehealth providers were largely responsible for driving a “tremendous” increase in ADHD diagnoses and stimulant prescriptions over the last few years and, in his words, not all of them are warranted.
“If only the people that needed these drugs got them, there probably wouldn’t be a [stimulant medication] shortage,” Califf said. “There’s a large amount of use which is on the margins.”
The letter by Califf and Milgram displayed more empathy for the millions of Americans with ADHD who have been unable to access reliable treatment, and it assured them that federal agencies take ADHD and its treatment seriously.
“We recognize the important role of prescription stimulants in treating conditions such as ADHD, binge-eating disorder, and uncontrollable episodes of deep sleep (narcolepsy). The lack of availability of certain medications in recent months has been understandably frustrating for patients and their families,” Califf and Milgram wrote. “We want to make sure those who need stimulant medications have access. However, it is also an appropriate time to look closely at how we can best ensure these drugs are prescribed thoughtfully and responsibly.”