The DEA struggles to balance the pressing need to provide pain relief for those suffering from the novel coronavirus with the ongoing effort to reduce the opioid epidemic in the United States.

I. Overview on the DEA and the CSA

The Drug Enforcement Administration (“DEA”) is a U.S. federal agency that is responsible for regulating individuals and companies that deal with controlled substances. The DEA Compliance Consultants & Specialists at Oberheiden, P.C. note that the DEA has the authority to initiate and conduct several types of actions, including audits and inspections; criminal enforcement proceedings; disciplinary actions; registration and renewal denials; and surrenders, suspensions and revocations. It also has the authority to initiate domestic and cross-border drug investigations. Critically, the DEA is responsible for regulating the production, sale, and distribution process of pharmaceutical companies. These pharmaceutical companies must register with the DEA, submit to periodic audits, and maintain compliance with the Controlled Substances Act of 1970 (“CSA”) [21 U.S.C. § 801, et seq.].

Section 306 of the CSA requires that the Attorney General establish aggregate production quotas for each class of controlled substance listed in schedules I and II, and for the list I chemicals—the authority of which has been delegated to the Administrator of the DEA. On September 1, 2020, the DEA published the 2021 aggregate production quotas for controlled substances in schedules I and II of the CSA as well as an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. These quotas and the assessment describe the quantities of the relevant controlled substances and chemicals that are to be manufactured in the United States for the 2021 year in order “to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks.”

Determining the proposed 2021 aggregate production quotas and the proposed 2021 assessment of annual needs for the list I chemicals requires an analysis of several factors. In its proposed aggregate production quotas, the DEA stated that it has considered the potential for diversion along with expected increase in demand for certain opioids for 2021.

II. What is the SUPPORT for Patients and Communities Act?

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (“SUPPORT Act”) mandates that the DEA, with the assistance of the Department of Health and Human Services (“HHS”), determine reliable rates of overdose deaths and public health when estimating diversion for the five types of covered controlled substances: (1) fentanyl, (2) hydrocodone, (3) hydromorphone, (4) oxycodone, and (5) oxymorphone. In other words, it requires annual production quotas for opioids to be adjusted to account for factors such as diversion rate, death and abuse of opioids, and public health.

When gathering information regarding the appropriate production quotas for the 2021 year, the DEA in February 2020 has met with members from the Food and Drug Administration ("FDA"), the Centers for Disease Control and Prevention ("CDC"), and the Centers for Medicare and Medicaid Services ("CMS"). These agencies discussed pertinent information on controlled substances needed to come to a solution that minimizes overdose deaths and protects the public health.

III. The DEA’s Response to the Coronavirus and the 2021 Proposed Quotas

In April 2020, as a response to the unprecedented coronavirus, the DEA increased the aggregate production quotas for opioid production. Specifically, the DEA increased the 2020 quotas for certain schedule II controlled substances and list I chemicals in order to provide for greater patient access to painkillers and to prevent disruptions to the supply chain. The coronavirus has resulted in an increase in ventilated patients and, therefore, has necessitated an increase in the demand for and the production of painkillers. While this quota increase earlier in 2020 has helped pharmaceutical companies, hospitals, and other healthcare entities deliver painkillers to ill patients, it has also resulted in an increase in opioid-related deaths and illicit uses.

The DEA’s April 2020 quota increase has elicited some negative responses from Capitol Hill. On July 30, 2020, two U.S. senators—Dick Durbin (D-IL) and John Kennedy (R-LA)—wrote a letter to the DEA urging it to reduce its opioid production quotas for 2021 and prevent pharmaceutical companies from producing high levels of opioids. Their letter was written in response to both a "recent surge in opioid overdose deaths linked to the COVID-19 pandemic" and after the CDC reported an increase to "the highest ever level" of fatal drug overdoses in 2019. The senators noted the potential for the "illicit diversion" of opioids from their increased availability. Even though the DEA has reduced production quotas over the past couple of years, the recent coronavirus has necessitated an increase mid-2020. However, the letter stresses the greater need for the DEA to protect the public health—which is severely threatened by the amounts of opioids that are allowed to be produced and sold each year within the United States.

The DEA apparently heeded the senators' urgent appeal in its 2021 proposed aggregate production quotas. As per the SUPPORT Act, DEA compliance includes reducing the production quotas for four out of the five controlled substances: (1) fentanyl, hydrocodone, (2) hydromorphone, (3) oxymorphone, and (4) oxycodone. In doing so, pharmaceutical companies may face manufacturing, production, and sale challenges during 2021.

“The proposed reductions to the DEA’s 2021 aggregate production quotas can potentially affect the business operations of manufacturing and pharmaceutical companies to the point where they are unable to fulfill the needs of their customers, especially in the midst of the challenges posed by the coronavirus. It is important for companies to ensure they have an effective DEA compliance policy in place that captures these proposed quota reductions.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden, P.C.

It remains to be seen whether the 2021 Proposed Aggregate Production Quotas will become a final rule subjecting pharmaceutical companies and other healthcare entities nation-wide to the DEA’s revised compliance and enforcement measures for the upcoming year.