July 12, 2011
ASA Details How the DEA Can Help Alleviate Drug Shortages in Comment Letter to DOJ
In addition to the current multifaceted ASA lobbying campaign to help alleviate drug shortages, ASA signed a regulatory comment letter to the Department of Justice (DOJ) recommending they review Drug Enforcement Administration (DEA) regulations involving quotas of controlled substances. The current quota system has been identified by the ASA co-convened Drug Shortage Summit Legislative and Regulatory Activity Work Group as one cause of drug shortages. The letter was signed by eight organizations and businesses including health care providers, drug manufacturers and distributors.
The letter states, “We firmly support the department’s plan to evaluate regulations that apply to quotas to registered manufacturers of Schedule I and II controlled substances and certain List I chemicals found in 21 C.F.R. §§ 1303, 1315. We believe the current regulations of controlled substances, and in particular the quota system, have negatively impacted patients across America by contributing to the number and duration of drug shortages.”
The letter was signed by the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), the American Society of Health-System Pharmacists (ASHP), the Generic Pharmaceutical Association (GPhA), Hospira, Premier Inc. and Teva Pharmaceutical Industries Ltd.