wrote a letter urging the DEA to formulate new telemedicine and prescription rules and take seriously increases in demand when setting production quotas, and to better map supply chains. And Maia Szalavitz, a leading commentator on substance abuse issues, suggested inThis week’s joint letter stated that the DEA is “committed to reviewing and improving” the quota process.
“The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug,” FDA commissioner Robert M. Califf, M.D., and Drug Enforcement Administration leader Anne Milgram wrote. “That said, we are working closely with numerous manufacturers, agencies, and others in the supply chain to understand, prevent, and reduce the impact of these shortages.
The agency leaders have requested that manufacturers either confirm they are working to increase stimulant production or relinquish their quota allotment so that it may be redistributed to other manufacturers. Califf and Milgram also call on professional groups and healthcare providers to “accelerate efforts to support appropriate diagnosis and treatment,” including additional clinical guidelines for ADHD in adults and the development of alternative treatment options, such as non-stimulants and digital therapeutics. The letter cited the 2020 FDA approval ofThe letter also addressed concerns about medication misuse, addiction, and overdose.
Ongoing manufacturing delays, supply-chain issues, and record-high prescription rates for stimulant medications were among the “many factors” contributing to the