A group of House Democrats is urging the Food and Drug Administration (FDA) to provide an explanation of their efforts to combat the shortage of Adderall in the United States, which was declared exactly one year ago.
Under the leadership of Representative Abigail Spanberger of Virginia, the Democratic lawmakers expressed their ongoing concern about the persistent shortage of Adderall, a medication containing amphetamine mixed salts.
“We are particularly concerned about the continuation of the shortage coinciding with the return to school this fall. Traditionally, the demand for ADHD medications increases at the beginning of the school year, and we have been hearing from parents who are struggling to find medications for their children,” they wrote.
“Without the necessary medications, students struggle with learning and emotional regulation, exacerbating the mental health crisis affecting children. This is unacceptable.”
Last year, Teva Pharmaceuticals, the largest supplier of Adderall in the U.S., attributed the shortage to supply disruptions and issues at one of their manufacturing facilities. Although the matter has since been resolved, federal regulators recently stated that the U.S. is still experiencing the repercussions of this disruption, and “record-high prescription rates” of stimulant products are exacerbating the problem.
The lawmakers referred to recent survey data from the National Community Pharmacists Association, which revealed that 94 percent of independent community pharmacies are reporting shortages of Adderall or its generic equivalents.
While acknowledging the FDA’s efforts to address the shortage, the lawmakers believe that more needs to be done.
In their letter, they demanded to know what additional steps the FDA and the Drug Enforcement Administration (DEA) are taking to address the ongoing shortage and prevent future shortages. They also inquired about the support Congress can provide to assist them.
Additionally, they requested that the agencies provide answers to specific questions regarding the shortage, such as whether the DEA is considering increasing the aggregate production quota for amphetamine mixed salts, as it did for another drug earlier this month.
The aggregate production quota represents the total amount of a particular class of drugs authorized for production in the U.S. In August, the DEA and FDA called on manufacturers to meet their quotas, noting that only 70 percent of the allotted quotas had been filled. As a result, it is estimated that 1 billion authorized doses have not been produced or shipped out.
The House Democrats also questioned the efforts being made by the agencies to collaborate with manufacturers and ensure they meet their quotas. Furthermore, they expressed a desire to learn how the DEA will utilize the lessons from the COVID-19 pandemic to update rules on telemedicine prescribing.
In addition to Representative Spanberger, the letter was signed by fellow Democratic Representatives Nydia Velázquez of New York, Yadira Caraveo of Colorado, Elissa Slotkin of Michigan, Jim McGovern of Massachusetts, Don Beyer of Virginia, Chellie Pingree of Maine, Brad Schneider of Illinois, Paul D. Tonko of New York, Kathy Manning of North Carolina, Chris Pappas of New Hampshire, Chris Deluzio of Pennsylvania, Sheila Cherfilus-McCormick of Florida, Val Hoyle of Oregon, and Haley Stevens of Michigan.
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