DEA, Drug Manufacturers Trade Blame for Generic Adderall, Vyvanse Shortages

additudemag.com:

December 8, 2023The nationwide shortage of Adderall (amphetamine mixed salts) has triggered a domino effect. Patients are now struggling to fill prescriptions for other stimulant medications used to treat ADHD, including the generic equivalents of Vyvanse and Ritalin.Some drug manufacturers blame the shortage on production quotas for stimulant medications, which are classified as Schedule II controlled substances, set by the Drug Enforcement Administration (DEA).

The DEA disagrees and says that drug manufacturers aren’t producing their full quota of medication.“For amphetamine medications, like Adderall, our data showed that in 2022, manufacturers did not produce the full amount that these limits permitted them to make — resulting in a shortfall of 1 billion doses that could have been produced but were not made or shipped — and the data for 2023 has shown a similar trend,” DEA Administrator Anne Milgram wrote in a letter on November 1.The agency adjusted quota regulations in August 2023 to reduce the amount of a drug that manufacturers must keep in inventory, making it easier for them to voluntarily relinquish unused quota allotments.

According to Milgram’s letter, 17 out of 18 manufacturers informed the DEA that they would use their allotted quota amounts by increasing stimulant medication production.“Those manufacturers are currently in the process of providing us with information on how long it will take those stimulant medications to hit pharmacy shelves,” she wrote.However, Bloomberg reported on November 17 that a letter addressed to the DEA from the Association for Accessible Medicines (AAM) said that generic drugmakers haven’t been able to obtain enough raw material to “launch their products at full commercial.