May 4, 2018
Re: Docket No. DEA-480, Controlled Substances Quotas; Notice of Proposed Rulemaking (Vol. 83, No. 76), April 19, 2018.
We concur with the DEA that setting quotas for the production of opioid medications can be an effective step in “preventing the accumulation of controlled substances in amounts exceeding legitimate need,” and therefore reduce the chance that these powerful medications will be diverted for non-medical illicit purposes. However, opioids are commonly administered in hospitals to relieve the pain of significant trauma, surgery, cancer that has metastasized to the bone or invaded the brain, severe burns and other significant diseases or disorders.
Given its commitment to addressing injectable opioid shortages, the AHA strongly recommends that the DEA amend its proposed rule to ensure that, in addition to diversion, that drug shortages be considered when aggregate production quotas are set and adjusted.
We also recommend that the DEA routinely consult with the Food and Drug Administration’s drug shortage staff, which collects and publishes relevant data on all national drug shortages, when establishing and adjusting quotas.
Read the full comment letter below.