Spanberger Puts More Pressure on DEA to Address Adderall Shortage Following Silence from Federal Agencies

Feb 16, 2023
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 today is pressing the Drug Enforcement Administration (DEA) to do more to combat the nationwide Adderall shortage — and she is searching for answers about how the DEA will protect reliable access to prescription Adderall when the public health emergency ends on May 11.

At the beginning of the COVID-19 pandemic, Congress increased access to behavioral health professionals via expanded telehealth measures, including providers who can prescribe Schedule II controlled substances — such as Adderall — through telehealth. 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 December 2022, Spanberger urged the DEA and 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. However, she has yet to receive a response to her letter.

In a letter sent to DEA Administrator Anne Milgram, Spanberger today reiterated her concerns about the Adderall shortage. Additionally, she pressed the DEA to make clear its plans for handling the end of the public health emergency on May 11 of this year — when telehealth subscribing for controlled substances will snap back to pre-pandemic restrictions. The letter was first reported by Politico.

The shortages of Adderall and related medications have made it difficult for patients to manage their attention deficit hyperactivity disorder (ADHD), and created immense hardship for parents of children with ADHD,” said Spanberger. “I am disappointed that I have not received a response to my December 19th, 2022 letter to your agency about these shortages.”

Spanberger continued, “I appreciate the difficult task DEA faces in balancing the need to maintain patient access to controlled substances and the need to support safe prescribing practices after the public health emergency ends. As such, I urge you to make clear DEA’s plan for telehealth and controlled substance regulations and quotas as soon as possible so patients and providers have time to plan and operationalize compliance with the new requirements.”

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

Dear Administrator Milgram,

I write to express my concern about the ongoing shortages of Adderall and request additional information about how the Drug Enforcement Administration (DEA) plans to ensure patient access and safe prescribing of controlled substances when the public health emergency ends on May 11th.

The shortages of Adderall and related medications have made it difficult for patients to manage their attention deficit hyperactivity disorder (ADHD), and created immense hardship for parents of children with ADHD. I am disappointed that I have not received a response to my December 19th, 2022 letter to your agency about these shortages.

At the start of the COVID-19 public health emergency, DEA implemented significant flexibilities to ensure patients could continue to receive controlled substances – including Adderall – via telehealth. Specifically, the DEA waived the provision of the Ryan Haight Act that requires an in-person visit prior to prescribing controlled substances via telehealth provided that certain conditions were met.

The expanded telehealth flexibilities led to a surge in ADHD cases diagnosed over video calls and prescriptions for Adderall that put significant pressure on the drug’s supply chains. Indeed, according to an independent health data company, Adderall prescriptions for adults rose 15.1 percent during 2020, more than double the 7.4 percent rise seen the year before. Manufacturers struggled to respond to the increase in demand. In October 2022, the Food and Drug Administration (FDA) announced that Adderall had gone into shortage, with supply constraints for many medications expected to continue through April 2023.

The shortage has had serious effects on many ADHD patients’ ability to function in their daily lives. Providers have begun switching patients to alternative medications for ADHD, though alternatives do not work as well as the originally prescribed medication for some patients. Especially concerning are reports that desperate patients have died after turning to counterfeit pills laced with fentanyl.

I am concerned that many of these new prescriptions may be for inaccurate diagnoses. Reportedly, pharmacy and online providers advertised directly to consumers on the internet and through social media, and dispensed prescriptions not issued for a legitimate medical purpose. The apparent surge in prescribing (some potentially unlawful if they were not issued for a legitimate medical purpose) and dispensing of Adderall prescriptions and resulting pressure on the supply chain has affected patients’ ability to fill their lawful prescriptions.

I appreciate the difficult task DEA faces in balancing the need to maintain patient access to controlled substances and the need to support safe prescribing practices after the public health emergency ends. As such, I urge you to make clear DEA’s plan for telehealth and controlled substance regulations and quotas as soon as possible so patients and providers have time to plan and operationalize compliance with the new requirements. That plan should include:

  1. A clear timeline for finalizing a statutorily required regulation to create a special registry for telemedicine providers. The SUPPORT for Patients and Communities Act of 2018 requires DEA to finalize this regulation by October 2019, and I am disappointed that three years after the deadline the agency has not yet issued a notice of proposed rulemaking.
  1. Clear guidance to pharmacies, distributors, and patients about how to fill scripts for Adderall prescribed over telehealth under the current flexibilities after the public health emergency ends.
  1. Clear guidance about how DEA will continue exceptions for registered practitioners prescribing controlled substances across state lines that have medical licensing reciprocity agreements after the public health emergency ends.
  1. Discussion about how DEA will or will not adjust production quotas for controlled substances used to treat ADHD to ensure manufacturers have sufficient quota to meet surges in demand.

Thank you very much for your attention to this important issue.

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