Spanberger Urges FDA, DEA to Address Prescription Adderall Shortage

Dec 20, 2022
Healthcare
Press

Adderall Production Has Not Been Able to Meet Surge in Demand as Total Prescriptions in the United States Increased from 35.5 Million in 2019 to 41.2 Million in 2021

WASHINGTON, D.C. — U.S. Representative Abigail Spanberger yesterday urged the U.S. Drug Enforcement Agency (DEA) and U.S. Food and Drug Administration (FDA) to initiate a comprehensive federal response to alleviate the nationwide shortage of prescription Adderall and ensure access to the medication for all Virginians and Americans who rely on the drug.

Congress relaxed restrictions on providers prescribing Schedule II controlled substances — such as Adderall — through telehealth at the start of the pandemic. This change led to an increase in both attention deficit hyperactivity disorder (ADHD) diagnoses and prescriptions for Adderall. The total number of Adderall and generic-equivalent prescriptions increased 16 percent from 35.5 million in 2019 to 41.2 million in 2021, according to IQVIA, a health research firm. In October, FDA reported that Adderall, the brand name for the immediate-release formulation of amphetamine mixed salts, went into shortage due to ongoing manufacturing delays.

In a letter to DEA Administrator Anne Milgram and FDA Commissioner Robert Califf, Spanberger urged the two leaders to coordinate their agencies’ efforts to institute a comprehensive federal response to ensure access to Adderall for all Americans who depend on it. Additionally, the Congresswoman requested information as to how the agencies intend to work both independently and jointly to alleviate the shortage.

“The ongoing shortage has made it incredibly difficult for ADHD patients to manage their daily lives, and I encourage your agencies to collaborate and do everything possible to alleviate this shortage as quickly as possible,” wrote Spanberger. “Shortages of essential drugs, especially ones that have been on the market for years, have been a persistent problem in our healthcare system for years. Drug shortages pose significant challenges to the public health because they delay care for patients, frustrate providers who must prescribe alternatives that may be less effective or pose additional risks to the patients, and expose consumers to price gouging by unscrupulous manufacturers.”

Spanberger continued, “Patients who rely on Adderall to function daily deserve a comprehensive federal response to ensure access to their medications. Given the complicated regulatory framework around controlled substances and the incentives in the drug industry, addressing the shortage of Adderall will require coordination between FDA, DEA, and industry.”

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

Dear DEA Administrator Milgram and FDA Commissioner Califf,

I write to express my concern about shortages of Adderall and other medications needed to treat attention deficit hyperactivity disorder (ADHD). The ongoing shortage has made it difficult for ADHD patients to manage their ADHD and created especially acute challenges for parents of children with ADHD. As I continue hearing about the impact of these shortages on adults and children with ADHD who rely on their medication, I encourage your agencies to collaborate and do everything possible to alleviate this shortage as quickly as possible.

Shortages of essential drugs, especially ones that have been on the market for years, have been a persistent problem in our healthcare system for years. Drug shortages pose significant challenges to the public health because they delay care for patients, frustrate providers who must prescribe alternatives that may be less effective or pose additional risks to the patients, and expose consumers to price gouging by unscrupulous manufacturers. While the number of new drug shortages has declined dramatically in the past decade, the number of ongoing shortages has increased in recent years, according to the Food and Drug Administration’s annual report.

Medications that include controlled substances may be especially vulnerable to prolonged shortages, given the complex regulatory structure governing their production and distribution. The Drug Enforcement Agency (DEA) regulates controlled substances due to their potential for abuse and addiction, as well as sets quotas that limit the amount of controlled substances available in the U.S. Every year, manufacturers apply to DEA for the quota needed to make a basic class of a controlled substance.

At the start of the COVID-19 pandemic, Congress waived in-person restrictions on providers prescribing Schedule II controlled substances – such as Adderall – through telehealth. This change led to a surge in ADHD cases diagnosed over video calls and prescriptions for Adderall. Since 2019, the number of total Adderall prescriptions has increased from 35.5 million to 41.2 million – a 16 percent increase. The surge in demand through online providers has caused concerns that many of these new prescriptions may be for inaccurate diagnoses.

Production has not been able to keep up with the surge in demand and in early October FDA reported that Adderall, the brand name for the immediate-release formulation of amphetamine mixed salts, went into shortage due to ongoing manufacturing delays at Teva. While other producers continue to manufacture amphetamine mixed salts, there is insufficient supply to meet U.S. demand. The current shortage has been a crisis for patients who rely on Adderall to function, making daily life significantly more difficult.

Patients who rely on Adderall to function daily deserve a comprehensive federal response to ensure access to their medications. Given the complicated regulatory framework around controlled substances and the incentives in the drug industry, addressing the shortage of Adderall will require coordination between FDA, DEA, and industry. As such, please provide answers to the below questions:

  1. How do the DEA’s final 2023 aggregate production quotas for schedule II-controlled substances respond to patients’ concern about the shortage of Adderall and other ADHD medications?
  1. How have new flexibilities around telehealth during the COVID-19 public health emergency and resulting increases in prescriptions influenced DEA’s production quotas over the past two years?
  1. How has the FDA engaged with Adderall manufacturers to address raw material and workforce shortages?
  1. How are the DEA and FDA collaborating to identify other manufacturers of ADHD medications and determine their capability to meet legitimate patient needs?
  1. What guidance, if any, has the DEA provided to pharmacies seeking to change their supplier or otherwise modify their regular order to have a sufficient supply of Adderall for their patients’ needs?
  1. How does the DEA monitor and evaluate online providers’ prescribing practices to ensure ADHD diagnoses are made accurately and minimize diversion?

Thank you very much for your commitment to protecting patients’ access to their medications.

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