Washington, D.C. – U.S. Senator Ron Wyden, D-Ore., today announced he is urging regulators at two federal agencies to provide a comprehensive explanation for the continued shortage of affordable, generic ADHD medications and how the agencies are working together to tackle this national crisis.
Wyden’s letters to Drug Enforcement Agency (DEA) Administrator Anne Milgram and Food and Drug Administration (FDA) Commissioner Robert Califf follow an April 18 meeting between Wyden, the Administrator and Commissioner on the issue’s huge impact on patients in Oregon and nationwide.
Because the agencies have failed to issue a public joint statement on the ADHD medication shortage after that meeting, Wyden is again asking them 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.
In the letters, Wyden raises the impacts of these shortages on rural communities, in particular: “ADHD can severely interfere with daily activities, including work and school, but stimulant medications like amphetamine mixed salts are commonly used treatments that are very effective and safe. As I pointed out in the April 18 meeting, in rural areas of Oregon largely served by independent pharmacies, these generic medication shortages may require unsustainable expenses for both the pharmacies and the consumers. In addition, these shortages can create challenging travel times of 60-90 minutes each way – especially in the winter months – to have access to this much-needed medicine. Shortages of these generics have also had a domino effect causing shortages of alternative medications to treat ADHD that may themselves be less effective. Pharmacies across Oregon are closing, in part due to unsustainable costs. Rural healthcare and access to medication should be a significant consideration for the agency.”
In addition to a comprehensive joint statement, Wyden asked the agencies to respond in writing to several questions, including for the DEA to provide more information on the quota process and what the agency is doing to improve transparency, as well as the role the FDA plays in preventing and mitigating drug shortages.
The letter to FDA Commissioner Califf is here.
The letter to DEA Administrator Milgram is here.
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