“DEA Decisions: In the Matter of Moore Clinical Trials, L.L.C.”
DEA Chronicles 08/13/14 By Shannon F. O'Boye
In the Matter of Moore Clinical Trials, L.L.C (July 11, 2014) DEA last month denied the DEA research registration application of an Arkansas clinical research company, finding that the person who would be primarily responsible for ordering and storing controlled substances had a “shocking” lack of knowledge of the fundamental requirements imposed by the Controlled Substances Act and DEA regulations. The case began in March 2011 when Greta B. Moore submitted a registration application on behalf of Moore Clinical Trials, the clinical research company she founded. At the time, Ms. Moore had won a contract to participate in a long-term safety study that focused on the use of a Schedule II controlled substance. Moore Clinical Trials’ application came under scrutiny from DEA diversion investigators because, among other things, Ms. Moore had no prior experience with handling controlled substances. She had previously worked as a respiratory therapist and as a clinical research coordinator on clinical trials that did not involve controlled substances. DEA eventually asked Ms. Moore to withdraw her application and, when she declined, an Order to Show Cause to deny the application as inconsistent with the public interest was filed on August 8, 2011. Despite the Order to Show Cause, Ms. Moore forged ahead with Moore Clinical Trials’ work on the long-term safety study. She aired TV commercials and placed qualified participants into the study. She also brought on a DEA-registered doctor, Brian T. Nichol, who had previously been suspended by the Arkansas Medical Board for pre-signing controlled substances prescriptions and had been convicted of felony health care fraud in federal district court. She would later testify, at the administrative hearing in September 2012, that she believed that Dr. Nichol could order the controlled substances, receive them at his office, and then dispense them to research participants at Moore Clinical Trials, which was an unregistered location. She stated that she never asked the DEA diversion investigators with whom she was communicating about her application whether the doctor could lawfully transport the drugs from his registered location to her company’s office. She also testified about inadequate records that she had created just weeks before the administrative hearing: “I’m sorry . . . but I don’t know anything about the true nature of creating these records. My intent in creating these records was simply to have [the DEA Group Supervisor] affirm to me that I was on the right track. . . .So my main concern . . . was to attempt to be compliant with the DEA, so I’m simply creating forms, not for the DEA. I didn’t realize that the DEA was going to get these forms. The reason that the forms are not correct is because it was eleven o’clock at night when I did the forms.” She went on to testify that she did know the record-keeping requirements for dispensing controlled substances, “but, as a compliant person, I’m more than happy to learn what is required as a DEA registrant, because I am prepared to do whatever needs to be done, as I do my clinical research, because there are requirements that are required there as well. So after I learn what is required . . . I’m fully prepared to be compliant.” DEA Administrator Michele M. Leonhart called it “shocking” that even at the time of the hearing, Ms. Moore still lacked knowledge of several of DEA’s fundamental requirements. Despite the testimony and other evidence, the ALJ recommended that Moore Clinical Trials’ application be granted on condition that Ms. Moore take a course in handling controlled substances. While the ALJ concluded that Ms. Moore was responsible for signing for one controlled substances shipment when she was not registered to do so, the ALJ found that Ms. Moore was not responsible for the many controlled substances violations committed by Dr. Nichol. The ALJ said he was an independent contractor to whom Moore Clinical Trials only offered “a facility in which to conduct research.” Administrator Leonhart rejected the ALJ’s opinion and reasoning, calling it “counterfactual” and reflecting “a stunning misunderstanding of the CSA.” The Administrator held that Dr. Nichol’s controlled substances violations should be imputed to Ms. Moore and her company because they aided and abetted his violations and that the violations “were clearly intentional”. The Administrator further held that Ms. Moore and her company failed to maintain records as required by the CSA; that Ms. Moore failed to accept responsibility for the dispensing and record-keeping violations; and that Ms. Moore lacked candor in her testimony regarding the dispensing violations. For all of these reasons, Administrator Leonhart, in her July 2, 2014 order, held that Moore Clinical Trial’s registration would be inconsistent with the public interest and denied the application.