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# Adderall Shortage Process “Muddy, Obscure”: Wyden
- URL: https://www.fdaweb.com/adderall-shortage-process-muddy-obscure-wyden/
- Published: 2023-06-06T12:00:00.000Z
- Updated: 2026-09-14T18:36:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154616

Sen. **Ron Wyden** (D-OR) says FDA and the Drug Enforcement Agency (DEA) need to issue a joint statement on the attention deficit/hyperactivity disorder medication Adderall and its generics “to clarify the role and management of quotas, as well as the conflicting reports from agencies, manufacturers, and pharmacies that fail to explain these generic drug shortages.” In a 6/2 [letter](https://www.wyden.senate.gov/imo/media/doc/wyden%5Fletter%5Fto%5Ffda%5Fon%5Fadhd%5Fdrug%5Fshortages.pdf?ref=fdaweb.com) to the heads of the two agencies, Wyden says he expected such a joint statement would be issued following a 4/18 meeting he and his staff had with FDA and DEA officials.

“While I appreciate that your staff followed up with more information on the role CDER plays in preventing and mitigating drug shortages,” Wyden wrote to FDA commissioner **Robert Califf**, “it falls short of the statement and actions needed. Specifically, the process is muddy and obscure as to how generic manufacturers are navigating the process to request a quota increase, and the fact that your agency does not seek out or report regional data is a grave concern.”

Wyden wrote that FDA has a responsibility to provide clear guidance and outreach to manufacturers of the drugs that are now difficult to access. “The agency should request updates from manufacturers on their ability to meet consumer demand, and inform the public accordingly,” he said.

The letter contains six questions and requests for which Wyden wants answers:

- whether FDA has the authority to disclose when a manufacturer refuses a request from the agency to provide information on the cause or extent of a drug shortage;
- how FDA works to reconcile a situation in which both the agency and the American Society of Health-system Pharmacists (ASHP) maintain drug shortage Web sites and shortages appear on both lists but some drugs are only on the ASHP site;
- how FDA uses market data to factor in the availability of more affordable generics and access to rural areas in its work to anticipate and mitigate shortages;
- whether FDA has plans or a position on identifying medical products that do not fall into the category of essential medicines, but whose shortage would present serious public health concerns;
- an update on FDA finalization of a 5/2022 draft guidance on certain risk management plans and plans for further rulemaking in this area; and
- whether Congress should require manufacturers to provide any of the recommended additional information included in a recent draft guidance or give the agency the authority to require certain of the information be provided as relevant to the situation.