Vyvanse Shortage Update: DEA OKs Expanded Production of the ADHD Medication
In response to the ongoing stimulant shortage, the DEA has approved a 24% production increase for name brand Vyvanse and its generic equivalent (lisdexamfetamine dimesylate), a change that impacts millions of patients with ADHD.
September 12, 2024
Vyvanse and its generic equivalents (lisdexamfetamine dimesylate) may be more readily available at pharmacies following a decision by the Drug Enforcement Administration (DEA) to allow expanded production of the stimulant medication used to treat ADHD and moderate-to-severe binge-eating disorder (BED) in adults. About one-quarter of the 24% (6,236 kg) production increase in lisdexamfetamine will address domestic demand, and the remaining 75% will address foreign demand.1
“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA said in a letter on September 5.
The DEA’s decision arrives amid a stimulant shortage that has disrupted treatment for millions of patients with ADHD for nearly two years. The U.S. Food and Drug Administration (FDA) first reported a shortfall of Adderall (the brand name for the immediate-release formulation of amphetamine mixed salts used to treat ADHD) due to manufacturing delays at Teva Pharmaceutical Industries in October 2022. The nationwide Adderall shortage triggered a domino effect, with ADHD patients struggling to fill prescriptions for other stimulant medications, such as Vyvanse and Ritalin.
In August 2023, the FDA granted approval for 15 manufacturers to produce generic Vyvanse capsules and chewable tablets after Takeda Pharmaceuticals’ U.S. patent for the medication expired.2 (The FDA stipulates that generic ADHD medications contain exactly the same active ingredients as their name-brand counterparts; however, compounds in generic drugs are allowed to include different binding chemicals, fillers, and colors.) However, one year later, the promise of generic Vyvanse has done little to ease the stimulant shortfall.
As of September 9, the American Society of Health-System Pharmacists (ASHP) reported lisdexamfetamine dimesylate capsule shortages among nine drug manufacturers. Eight attributed the shortage to an “issue with the active ingredient.”
Controversy Surrounding APQs
The DEA sets yearly aggregate production quotas (APQs) for stimulant medications, which are classified as Schedule II controlled substances due to their high potential for abuse. The process has drawn the ire of many drug manufacturers, clinicians, and patients with ADHD, who cite production limits as the main reason for the stimulant shortage.
“The DEA is the only governmental agency that sets production and distribution quotas for every drug company manufacturing controlled medication,” William Dodson, M.D., LF-APA, wrote in an ADDitude Op-Ed earlier this year. “The DEA decides how much of each medication can be released to pharmacies in any given month. Therefore, this problem traces its roots and long tendrils back to the DEA alone. No other agency has the authority to create and prolong it.
“This process tries to predict in March of 2024 how much medication will be needed 21 months later in December of 2025,” Dodson continued. “It is a crude and inadequate system that the DEA is too inflexible to relinquish.”
Stimulant Drug Manufacturers Speak Out
Mounting frustration over the stimulant shortage has begun influencing some positive change.
The public comment period for the DEA’s “Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances” drew 4,699 comments, according to The Federal Register. (Last year, the DEA received 357 comments.)
Commentators included patients with ADHD, drug manufacturers, members of U.S. and Australian professional associations, representatives from the Royal Australian and New Zealand College of Psychiatrists, and others. They expressed concerns about the ongoing ADHD medication shortage and the DEA’s lack of transparency in setting quotas, among other issues. 3
In response, the DEA said it is “considering methods that might increase transparency in its quota-setting process,” including public notification and an opportunity for public input when prescribing rates for controlled substances substantially deviate from FDA’s estimate of medical needs. The agency is also considering regulatory changes to gain access to more real-time data, such as monthly updates in the Automated Reports and Consolidated Ordering System (ARCOS), a database where manufacturers and distributors report their controlled substances transactions to the DEA.
However, an association representing drug manufacturers asserted that the DEA’s practice of allocating procurement quotas based on a company’s historical drug sales disadvantages generic lisdexamfetamine drug manufacturers because they lack an established sales history.
The DEA disputed the claim. “DEA has always been cognizant that new manufacturers entering the market for the first time would not have any established sales history, and thus the manufacturer’s past sales history is not a factor when determining the quota needed to launch a new product,” it said in the January 3 issue of The Federal Register.3
The federal agency also denied that APQs are causing the stimulant shortage. “The DEA utilizes the available, reliable data and information received by the agency at the time APQs are proposed and proactively monitors drug production, distribution, and supply during the year,” it said. “Drug shortages may occur subsequently due to factors outside of DEA control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations.”
Drug manufacturers’ hands are not necessarily tied after the DEA releases its yearly APQs. Any DEA-registered manufacturer may apply for an increase in the manufacturing quota for a basic class of controlled substance in Schedule I or II throughout the year. The DEA must review such requests within 30 days of receipt.
The decision to raise the APQs of name brand and generic Vyvanse came at the behest of the FDA and a DEA-registered manufacturer earlier this summer. In October 2023, the DEA raised the production limits of methylphenidate (brand names: Ritalin, Concerta) by 27% after receiving requests from the FDA and a DEA-registered drug manufacturer.
It is too early to tell if the expanded Vyvanse APQs will inspire more DEA-registered drug manufacturers to request quota reviews. In the meantime, the increased production of Vyvanse and its generic equivalents will promise welcome relief to the estimated one million Americans regularly taking the stimulant.
Vyvanse was the most popular prescription stimulant, according to ADDitude’s 2023 treatment survey. Nearly one-quarter of respondents said they (or their child) were taking Vyvanse to treat ADHD symptoms, outnumbering other prescription stimulants used by ADDitude readers, including Concerta (15%), Adderall (15%), Adderall XR (13%), and Ritalin (10%).
Among ADDitude survey respondents taking Vyvanse, 44% said the medication is extremely or very effective at treating their ADHD symptoms.
“Vyvanse has, without exaggeration, changed my life and made me into the kind of person I’ve always wanted to be,” one survey respondent said.
View Article Sources
1Adjustment to the Aggregate Production Quota for Lisdexamfetamine and dAmphetamine (for Conversion) for 2024. Drug Enforcement Administration. The Federal Register. September 5, 2024. https://public-inspection.federalregister.gov/2024-20114.pdf
1FDA Approves Multiple Generics of ADHD and BED Treatment. FDA. Published August 28, 2023. Accessed August 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-multiple-generics-adhd-and-bed-treatment?utm_medium=email&utm_source=govdelivery
1Established Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024. Drug Enforcement Administration. The Federal Register. January 3, 2024. https://www.federalregister.gov/documents/2024/01/03/2023-28962/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment
