Pharmacy Law: Subpoena Power of DEA Called into Question

Investigations by the Drug Enforcement Administration were stalled when a state board of pharmacy refused to supply information from its prescription drug monitoring program.

Issue of The Case

When a state has assigned responsibility for maintaining its Prescription Drug Monitoring Program (PDMP) to the State Board of Pharmacy and the US Drug Enforcement Administration (DEA) presents administrative subpoenas to the Board to obtain prescribing records, must the state agency comply and supply the information in question?

Facts of The Case

Representatives of the DEA were conducting 3 investigations for which they requested information from the state agency that operates the PDMP database of controlled substance prescribing and dispensing information by presenting an administrative subpoena. The first was an investigation regarding allegations that a prescriber based in the state was involved with prescribing controlled substances over the Internet, whereas the second was with regard to use of a prescriber’s DEA registration number “by persons not authorized to use that number for the treatment of patients the registrant did not personally examine.” The third focus was on a physician assistant who was allegedly issuing prescriptions in the state “under an expired DEA registration number from another state.”

An administrative subpoena is an official order compelling the recipient to provide a governmental agency with information.

In this case, the specific type of order was a subpoena duces tecum, ie, an order to produce documents or to show cause why the documents need not be produced. This differs from a subpoena ad testificandum, which is an order requiring a person to appear and testify. In this situation, the Board of Pharmacy refused to supply the information and the DEA filed a petition in federal court seeking a court order to enforce the subpoena.

The Board responded that it had indeed informed the federal agency that it did not intend to respond to the subpoena, but it had also indicated that it “would respond after a court order requesting it to respond.” The Board’s position was based on wording of the state statute creating the PDMP that restricted access to information in the database to certain specified individuals or groups—Board staff administering the program, a prescriber or pharmacist requesting information about a current patient, practitioners engaged in monitoring a patient’s drug use, or law enforcement officials, “so long as the information is specific to an individual and is part of a bona fide investigation and the request is accompanied by a court order or subpoena.”

The position of the Board was that the wording “specific to an individual” limits requests to be honored to those that are addressing medication use by a specific patient. Further, requests such as those from the DEA that are prescriber-specific are not authorized by the statute and release of such information by Board staff members would open the possibility of fines being levied against that person. Thus, it was the position of the Board that the state statute did not authorize the Board to provide the information in question without a court order.

The Court’s Ruling

The petition was considered by a US magistrate judge, an official of a federal court appointed by the judges of that court to assist with discharging their duties and responsibilities. The magistrate judge recommended to the US District Court that the petition filed by DEA be granted and the Board be directed to supply the specified information.

The Court’s Reasoning

The magistrate judge pointed out that federal law confers on the attorney general, the leader of the US Department of Justice within which DEA falls administratively, broad authority “to require the production of any records…which the Attorney General finds relevant or material to the investigation.” The magistrate judge did note that a person who receives a subpoena may challenge that administrative request before complying, as was done here. However, when that challenge is considered by the court, the factors to be weighed include that the subpoena was issued for a purpose approved by the US Congress, that the subpoena was issued following appropriate procedures, and that the information being sought is relevant to the investigation. It was noted that the challenge mounted by the Board was not based on any of these 3 reasons; rather, the Board was pointing to wording in a state-level statute. Further, even if the interpretation of the state statute by the Board were appropriate and correct with regard to the phrase “specific to an individual,” such a restrictive reading of the statute would present an obstacle to the federal agency’s efforts to complete its investigation. This runs afoul of the Supremacy Clause of the US Constitution, which dictates that the US Constitution, federal treaties, and federal statutes are the “supreme law of the land.” If there is a conflict between federal and state law, the former is to prevail. PT

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.