A group of House Democrats is calling on the Food and Drug Administration (FDA) to explain what the agency is doing to address the shortage of Adderall in the U.S. that was declared exactly one year ago.
Led by Rep. Abigail Spanberger (D-Va.), the Democratic lawmakers stated their “continued concern” over the ongoing shortage of amphetamine mixed salts, better known as Adderall.
“We are especially concerned by ongoing shortages coinciding with this fall’s return to school. Historically, there has been an uptick in the demand for ADHD medications at the start of the school year and we are hearing from parents caught in limbo trying to find medications for their children,” they wrote.
“Without the necessary medications, students struggle to learn and regulate their emotions, contributing to the mental health crisis facing children. This is unacceptable.”
Last year, Teva Pharmaceuticals, the largest supplier of Adderall in the U.S., cited ongoing supply disruptions and issues at one of its manufacturing facilities for the shortage. Though this issue has since been resolved, federal regulators recently said the U.S. is still feeling the impact of this disruption and that “record-high prescription rates” of stimulant products are worsening the problem.
The Congress members in their letter cited recent survey data from the National Community Pharmacists Association that indicated 94 percent of independent community pharmacies are reporting shortages of Adderall or generics.
While acknowledging the efforts the FDA has made to address the shortage, the lawmakers stated more needed to be done.
In their letter, they demanded to know what additional steps the FDA and the Drug Enforcement Administration (DEA) were taking to address the ongoing shortage as well as mitigate future shortages. They also asked what support Congress can provide to help them.
They requested that the agency answer questions on the shortage including whether the DEA was considering increasing the aggregate production quota for amphetamine mixed salts as it did for another drug earlier this month.
The aggregate production quota is the total amount of a certain class of drugs that is authorized to be produced in the U.S. In August, the DEA and the FDA called on manufacturers to fill their quotas, noting at the time that drugmakers have only sold 70 percent of their allotted quotas. This apparently has left 1 billion authorized doses unproduced and not shipped out.
The House Democrats asked what the two agencies are doing to work with manufacturers and get them to fill their quotas. They further asked how the DEA will use lessons from the COVID-19 pandemic to update telemedicine prescribing rules.
Along with Spanberger, the letter was signed by fellow Democratic Reps. Nydia Velázquez (N.Y.), Yadira Caraveo (Colo.), Elissa Slotkin (Mich.), Jim McGovern (Mass), Don Beyer (Va.), Chellie Pingree (Maine), Brad Schneider (Ill.), Paul D. Tonko (N.Y.), Kathy Manning (N.C.), Chris Pappas (N.H.), Chris Deluzio (Penn.), Sheila Cherfilus-McCormick (Fla.), Val Hoyle (Oreg.) and Haley Stevens (Mich).
