Court challenge raises questions about due process and whether agency perceived immediate and serious threat.
Issue of the Case
When a pharmacy in a mid-Atlantic state received an Order of Immediate Suspension of Registration from the US Drug Enforcement Administration (DEA), did a challenge to that action in federal court succeed?
Facts of the Case
The pharmacy was notified of the immediate suspension of its DEA registration and pursued court review by filing an action in the local federal district court 2 months later. An Immediate Suspension Order is unusual. It is an ex parte, or 1-sided, action without an opportunity for the entity receiving the order to present information to rebut the necessity of the action.
On the surface, this would appear to violate a basic right of US citizens known as due process. Protected by the US Constitution, due process dictates that before governmental action affecting life, liberty, or property, such as the dire consequences seen in this case, can be taken, certain steps must occur. The entity or individual that is the target of such governmental action must be given notice of the allegations regarding alleged illicit activity and an opportunity to be heard to address the allegations. Many people think of this as the right to be treated fairly. That would occur in the traditional approach to enforcement in this area of the law, known as an Order to Show Cause. That does not occur with an Order of Immediate Suspension of Registration from the DEA as was used here. Congress had authorized that end run around due process as an available approach when the DEA perceived an immediate and serious threat. The statutory framework authorizes the DEA to use an Order of Immediate Suspension in conjunction with the launch of the standard approach of administrative hearing proceedings, with the order remaining in effect until conclusion of the administrative proceedings.
The DEA took this unusual action based on review of data about the number of prescriptions dispensed at the pharmacy for Subutex (buprenorphine) and Suboxone (buprenorphine and naloxone).
In the view of DEA officials, this was a “suspicious pattern of filling lawful prescriptions for medications designed to treat opiate addiction.”1
There was no identification of a single instance of violation of the federal controlled substances laws. There was no conclusion that a specified single patient had abused or diverted Subutex or Suboxone.
The court surmised that the DEA had reached a conclusion that prescriptions issued for Subutex to patients who could tolerate naloxone and thus could use Suboxone was “always indicative of potential illicit drug use.” The government did not identify a single regulation or statute that would prohibit prescribing Subutex to patients for whom Suboxone, with its naloxone component, would be safe.
To issue such an emergency order, the DEA must show that continued registration of the pharmacy poses an “imminent danger to public health
The relevant federal statute defines “imminent danger to the public health and safety” as meaning that the DEA can show “a substantial likelihood
of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.”2
The court issued a prompt ruling that the DEA had not demonstrated that the immediate suspension of the pharmacy’s registration was necessary to prevent “imminent danger to public health and safety.”3
The Court's Reasoning
It was noteworthy that the federal judge deciding the case pointed out very early in his opinion that he was personally familiar with the effects of opioids on the community from his decades of work with defendants on supervised release who desperately need treatment.
That gave the jurist a very valuable perspective to bring to his deliberations on the matter.
The judge also identified early on that the relevant federal statutes conferred on him the authority to dissolve the “extraordinary action by a government agency of suspending registration without due process.”
However, after emphasizing that “judicial review of an agency decision is limited to the information in the record before the agency at the time it made its decision,” he stated that in this matter “the administrative record is not just inadequate; it is nonexistent.”
The court opinion continued: “Here, the DEA fails to show an ‘imminent danger to public health and safety.’ This standard requires more than mere surmise of abuse and diversion of a controlled substance. Simply demonstrating an unquantified risk of illegal drug use is not a finding of imminent danger. The DEA has not pointed to a single instance
of violation of the law. The DEA does not even contend that a specific patient abused or diverted Subutex or Suboxone. The DEA simply offers what it sees as a suspicious pattern of the filling of lawful prescriptions for medication designed to treat opiate addiction.”
The judge’s conclusion was that “the agency has not found facts determining an ‘imminent danger to public health and safety.’”
The court issued a decision dissolving the Order of Immediate Suspension.
Joseph L. Fink III, JD, BSPharm, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.