Spanberger Seeks Additional Answers from DEA, FDA on Efforts to Stop Ongoing ADHD Medication Shortages

The Congresswoman Has Consistently Pressed the Federal Government to Take Additional Steps to Protect Access to ADHD Medications & Work with Manufacturers to Prevent Future Shortages

WASHINGTON, D.C. — U.S. Representative Abigail Spanberger is urging the Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) to provide additional answers on their work to end shortages of attention deficit hyperactivity disorder (ADHD) medications — including Adderall.

On October 12, 2022, the FDA declared a shortage of amphetamine mixed salts, more commonly known by the brand name Adderall. In the more than two years since this announcement, other ADHD medications — like Vyvanse and Concerta — have also gone into shortage, worsening challenges already facing Americans with ADHD. While DEA has taken actions to adjust production quotas for certain ADHD medications and encourage additional transparency from manufactures, Spanberger has continued to hear from Virginians who face difficulties in getting their prescriptions filled in the more than two years that ADHD medications have been in shortage.

In a letter sent to DEA Administrator Anne Milgram and FDA Commissioner Robert M. Califf, Spanberger underscored her continued concern for the ongoing shortage of medications used to treat ADHD. The Congresswoman also urged the agencies to provide additional information about the implementation of DEA’s strategies to alleviate ongoing shortages, potential adjustments to Adderall’s production quota, and how the agencies are continuing to work with manufacturers to increase the supply of ADHD medications. Additionally, the Congresswoman asked what actions Congress can take to support these continued efforts.

“I continue to hear from constituents who still cannot access needed medications. Patients are living in limbo, embarking on scavenger hunts of pharmacies that might have the medication in stock, while frustrated providers are being required to prescribe possibly less-effective alternative medications,” wrote Spanberger. “Without the medications they rely on, children struggle to learn and regulate their emotions. Untreated ADHD is also associated with poor health outcomes for all individuals, including social and emotional impairment, increased risk of drug or alcohol use disorder, unintentional injuries, and suicide.”

Spanberger continued, “While I appreciate the efforts from your agencies, the shortage persists and more must be done to ensure patients can access the medications they need to function.”

Click here to read their letter, and the full text is below.

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Dear Administrator Milgram and Commissioner Califf,

I write to express my continued concern about the ongoing shortages of medications to treat attention deficit hyperactivity disorder (ADHD). Two years ago today, on October 12, 2022, the Food and Drug Administration (FDA) declared a shortage of amphetamine mixed salts, commonly referred to by the brand name Adderall. Yet, as we mark the two-year anniversary of the FDA’s October 12 announcement, shortages of ADHD medications persist. We must act to improve access to these critical medications for the patients who depend on them.

I continue to hear from constituents who still cannot access needed medications. Patients are living in limbo, embarking on scavenger hunts of pharmacies that might have the medication in stock, while frustrated providers are being required to prescribe possibly less-effective alternative medications. According to a February 2024 survey by the National Community Pharmacists Association (NCPA), 87 percent of pharmacists continue to have difficulty obtaining and stocking Adderall.

We know too well the dangerous impacts drug shortages have on patients. ADHD impacts all facets of daily life and without the necessary medications, it can be difficult to complete even the most basic of tasks. I am especially concerned about challenges families face as children return to school. According to experts, disruptions in medications can cause a child’s academic performance to decline. Without the medications they rely on, children struggle to learn and regulate their emotions. Untreated ADHD is also associated with poor health outcomes for all individuals, including social and emotional impairment, increased risk of drug or alcohol use disorder, unintentional injuries, and suicide. Ultimately, these shortages exacerbate the ongoing mental health crisis in America.

I understand that the FDA and Drug Enforcement Administration (DEA) have made efforts to provide relief to patients by approving several generic versions of Vyvanse in August 2023 and increasing the aggregate production quota (APQ) for methylphenidate (Concerta) in October 2023. The FDA predicts an average 3.5 percent increase in the domestic medical use of the schedule II stimulants amphetamine salts (Adderall), methylphenidate (Concerta), and lisdexamfetamine (Vyvanse). Although DEA announced plans to increase the APQ for lisdexamfetamine (brand name Vyvanse) on September 5, the proposed 2025 quotas do not reflect any adjustments for expected increased need of amphetamine mixed salts or methylphenidate. DEA has stated it believes the “established APQs are adequate to address FDA’s estimated increases in domestic medical use for amphetamine and methylphenidate.” However, I am concerned that with no further adjustments to quotas, shortages will only worsen amid projected increases.

In November 2023, when issuing proposed APQs for 2024, DEA outlined strategies to address shortages by increasing transparency and data from manufacturers. Specifically, the strategy requires manufacturers to submit their anticipated production timelines in advance of receiving their quota allotments, manufactures to apply for quota allotments on a quarterly instead of yearly basis, monthly digital reporting from manufactures and distributors on the amounts of drugs being purchased and shipped, and specification on whether a manufacture’s quota allotment will be used for domestic production or export production. I also appreciate the work of the FDA and DEA, in coordination with the Department of Justice (DOJ), to safeguard the controlled substances supply chain and crack down on bad actors.

While I appreciate the efforts from your agencies, the shortage persists and more must be done to ensure patients can access the medications they need to function. As such, I request answers to the following questions.

1. When releasing 2024 quotas, the DEA shared strategies to mitigate continuing drug shortages. Please share an update on the implementation and effectiveness of these changes.

2. The DEA has previously announced APQ increases for methylphenidate (brand name Concerta) and lisdexamfetamine (brand name Vyvanse). Will the DEA consider similar adjustments for amphetamine mixed salts?

3. How has the DEA and FDA continues to work with manufacturers of ADHD medications to address issues fulfilling quotas?

4. Please describe actions that Congress should take to support the DEA and FDA in addressing and preventing these challenges.

I kindly ask that you respond to these questions by November 12, 2024. Thank you for your commitment to addressing this critical issue impacting pharmacists, caregivers, and patients.

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BACKGROUND

Spanberger has consistently urged the federal government to work to alleviate shortages of ADHD medications. In 2023, Spanberger called on DEA to do more to combat the nationwide Adderall shortage — and in December 2022, she urged FDA and DEA to build a comprehensive federal response to protect access to the medication for all Virginians and Americans who rely on the drug.

On October 12, 2023 — one year after FDA declared a shortage of ingredients used to manufacture Adderall — Spanberger led a renewed effort urging DEA and FDA to provide more answers on their work to end shortages of ADHD medications.

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