DEA Issues Final Order Increasing APQs for Certain Controlled Substances
Health & Life Sciences Alert 04/09/20 Edward D. Rickert, Hunter G. DeKoninck
On April 7, 2020, the Drug Enforcement Administration (DEA) issued a Final Order that increased aggregate production quotas (APQ) for certain controlled substances and List I chemicals. DEA's order follows its receipt of an April 1, 2020 letter from a variety of associations in which practitioners warned DEA of critical supply shortages and increased demand for opioids in the COVID-19 environment. In response, DEA increased APQs by 15% for fentanyl, morphine, hydromorphone, methadone, codeine, ephedrine and pseudoephedrine. To further address supply challenges, DEA also eased import limitations on certain anesthetic and analgesic drugs used to treat COVID-19 patients on ventilators.
DEA did not reference any immediate concerns with patients' access to opioid prescriptions. Rather, it stated that the Final Order is a proactive measure intended to address potential supply challenges and to remove barriers to meeting patients' needs during the health crisis. As a reminder, this prompt easing of APQ levels for opioids comes on the heels of DEA's recent lifting of telehealth prescribing restrictions, which was another measure taken to enhance patient access to necessary prescriptions.
DEA's recent changes are especially noteworthy when considering DEA's long-term initiative to dramatically slash APQs for key opioid products as part of President Trump's Safe Prescribing Plan. For context, this week's 15% increase to fentanyl's APQ levels follows a 41% decline in 2017, a 1% decline in 2018, a 12% decline in 2019, and a 31% decline in 2020. Likewise, the 15% increase in hydromorphone APQ levels follows a 27% decline in 2017, a 12% decline in 2018, a 10% decline in 2019 and a 25% decline in 2020.
Yet, DEA cautioned that this week's order should not be interpreted as a reversal in the broader trend of increasingly-depressed opioid APQ levels. To that end, DEA reminded the industry of DEA’s right to re-adjust APQ levels once the health emergency recedes.
Find Answers to COVID-19 Issues, Impacts and Recommendations from Quarles & Brady.
Quarles & Brady's Health Law Team is continuously monitoring COVID-19's effect on the health care industry, and we are here to help. For more information, contact your Quarles & Brady attorney or: