Wyden’s call follows joint statement released by DEA and FDA at his request providing an update on the shortage crisis hitting Oregon and entire country
DEA tells Wyden manufacturers are on track to fall one billion doses below quota
Washington, D.C. – U.S. Senator Ron Wyden, D-Ore., today urged manufacturers of much-needed amphetamine medications for attention deficit hyperactivity disorder (ADHD), including Adderall and generic equivalents, to either increase their manufacturing of these medications or relinquish their remaining quota allotment for the Drug Enforcement Agency (DEA) to redistribute to manufacturers wanting to produce more than their allotted quota.
In the wake of ongoing concerns from people with ADHD and their loved ones about the serious shortage of these medications, Wyden also asked that manufacturers sufficiently report voluntary and required information on their production so the DEA and U.S. Food and Drug Administration (FDA) have a complete understanding of how the shortage is being resolved and potential future shortages.
Wyden’s letters to ADHD drug manufacturers come after the DEA and FDA released a joint statement at his request updating the American people on the drug shortage and sharing that manufacturers had allotted quota they had not fully used – and are on track to fall one billion doses below quota. Wyden also received separate responses from the DEA and FDA to his June letters to the agencies.
“After pressing the FDA and DEA for months about issuing a joint statement to address Oregonians’ and Americans’ serious concerns about troubling shortages of medications essential to treating ADHD, I’m glad to see it out and the clarity it provides around the quota allotment issue. It’s clear that manufacturers have work to do in easing this crisis – they need to either produce more or let other manufacturers do it, and make sure the DEA and FDA have the information they need,” Wyden said. “Based on what I’ve heard during town halls this summer in Eastern Oregon and on the South Coast and in conversations around the state, constituent concerns on this healthcare topic have only increased these past three months since my initial inquiry. Manufacturers must step up, and the FDA and DEA need to continue pressing the manufacturers for the information the agencies require to come up with the solutions that Oregonians deserve. And it’s not just patients with ADHD who are suffering from drug shortages, cancer patients and others are struggling to find the medication they need to get better. I’m going to continue pressing the FDA, DEA, and manufacturers to do all they can to make sure Americans have the medicine they need.”
On Monday, the DEA responded separately to a June letter sent by Wyden, informing him that the agency told all manufacturers in a May 18 letter about its concerns regarding the supply of amphetamine and amphetamine products. In that letter, the DEA notes that in 2022, manufacturers sold about 70 percent of their allotted quota for ADHD products for the year, with 1 billion dosage units that were authorized but not shipped or sold. A few months into the 2023 calendar year, manufacturers also had allotted quota they had not fully used. The agency added in the letter that it stood ready to “expeditiously review and adjudicate individual applications under the current authorized quota levels for amphetamine, in accordance with DEA regulations.” However, shortages persist.
The DEA-FDA joint statement also mentioned the 2022 shortfall and added that this year showed a similar trend – that manufacturers are not using their entire quotas. Both agencies called on manufacturers to either increase their manufacturing of these medications or relinquish their remaining allotment for the DEA to redistribute to manufacturers that wished to produce more than their allotted quota.
Wyden asked the manufacturers to respond to the following questions by August 10:
- Have you met or do you expect to meet your allotted quota amount to produce amphetamine products for 2023?
- If you will not meet the quota amount, how much of the remainder do you expect to use?
- Have you or will you commit to relinquishing quota you will not use to the DEA?
- If not, please explain the reasoning.
- If you have or will meet the quota, do you have excess production capacity and have you requested permission from the DEA to increase your quota allotment?
- If you have excess production capacity, are there other obstacles to requesting a quota allotment increase or using that capacity?
Wyden’s letter to manufacturers is here.
DEA’s response to Wyden, including its attachment of a May 18 letter to manufacturers, is here.
FDA’s response to Wyden is here.
Wyden has been sounding the alarm on the ADHD medication shortage. On April 18, he had a meeting with DEA Administrator Anne Milgram and FDA Commissioner Robert Califf on the issue’s huge impact on patients in Oregon and nationwide.
After Administrator Milgrim and Commissioner Califf failed to keep their commitment to promptly issue a joint statement on the ADHD medication shortage after that meeting, Wyden sent letters to the agencies in June again asking for a joint statement to clarify the role and management of drug manufacturing quotas at both the national and regional levels, as well as the conflicting reports from agencies, manufacturers and pharmacies that fail to explain these generic drug shortages. Wyden’s letters to the agencies also contained detailed questions for each agency to inform further legislative and regulatory action.
That same week Wyden went to the Senate floor and shared stories of real Oregonians suffering because of the shortage.
A web version of this release is here.
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