The AHA appreciates the opportunity to comment on the Drug Enforcement Administration’s proposed notice on aggregate production quotas for schedule I and II controlled substances.
We believe that in its intense focus on diversion, the DEA must also address another critical challenge – ensuring enough medication to fulfill legitimate and critical medical needs.
To ensure that legitimate medical needs are met, it is essential that drug shortages be explicitly considered in setting and adjusting aggregate production quotas and that resolving shortages be deemed as a relevant factor considered in the procedures for applying for and fixing individual manufacturing quotas. Proactively considering shortages will safeguard patient health and safety and ensure critical needs are met.
Furthermore, we continue to recommend that the DEA routinely consult with the FDA’s drug shortage staff, which collects and publishes relevant data on all national drug shortages, when establishing and adjusting quotas.