Clinical Research on Illegal Dispensing of Controlled Substances
Tuesday, July 7, 2015
By: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Shelby RootOn July 2, 2014, the Administrator of the Drug Enforcement Administration (DEA) denied a DEA research registration application of an Arkansas clinical research company. The DEA found that the individual who would be primarily responsible for ordering and storing controlled substances was "surprisingly unaware" of the requirements imposed by the Controlled Substances Act (CSA) and DEA regulations. To read a past blog on the consequences of clinical research fraud and misconduct, click here.Background Information on Moore Clinical Trials, L.L.C.Moore Clinical Trials, L.L.C. is owned and operated by Ms. Greta B. Moore. Prior to opening, Ms. Moore worked as a respiratory therapist and later as a Clinical Research Coordinator. During her past work experiences she did not work with controlled substances personally.Ms. Moore marketed the facility to contract research organizations (CROs). During this time, Dr. Brian Nichol was hired to perform clinical research. Dr. Nichol was previously suspended by the Arkansas Medical Board for pre-signing controlled substances, and was convicted of health care fraud, according to reports. On March 30, 2011, the facility and Dr. Nichol entered into a contract with Quintiles, to provide clinical trials of a schedule II controlled substance.Application to the DEA as a Researcher in Controlled Substances.The case began on March 15, 2011, when Ms. Greta B. Moore submitted on behalf of Moore Clinical Trials, an application for a DEA Certificate of Registration as a researcher in schedules II through V. In her application she stated she would be the primary person responsible for ordering and storing controlled substances, and that she had prior experience researching with controlled substances. Eventually, DEA investigators discovered she had no prior experience with handling controlled substances. To read a past blog on some of the implications of clinical research misconduct, click here.The DEA informed Ms. Moore that her application was denied because the facility lacked a state license and experience in dispensing controlled substances. Eventually, the DEA asked Ms. Moore to withdraw her application, but she refused to do so. In response, the DEA filed a Show Cause Order on August 8, 2011. Moving Forward with Illegal Clinical Trials.Despite the Order to Show Cause, Ms. Moore moved forward with clinical trials at the facility. She purchased television commercials seeking patients to participate in the study and placed participants into study groups. To conduct this study, Dr. Nichol ordered the controlled substances, received them at his registered office, and dispensed them to participants at Moore Clinical Trials.Ms. Moore later testified at an administrative hearing in September 2012 that she was unaware that transportation to her unlicenced clinical trial site was illegal. Moreover, she testified regarding her inadequate records, that she did not know the record-keeping requirements for dispensing controlled substances. She stated her forms were incorrect because it was eleven o'clock at night when she completed the forms.Drug Enforcement Administration's Decision.Under the Controlled Substance Act, the Attorney General may deny an application for registration if she believes such registration would be inconsistent with the public interest. Moreover, an applicant's candor during an investigation and failure to accept responsibility for its misconduct is an important factor. Therefore, due to Ms. Moore's failing to acknowledge misconduct and accepting responsibility for Moore Clinical Trial's record-keeping violations, the DEA administrator denied the application.The Administrative Law Judge decided that evidence had been presented that showed Ms. Moore may be able to comply to controlled substance laws and regulations if an appropriate course was taken. The evidence included her willingness to comply with the CSA regulations, including installing an alarm, timely presenting information to investigators, and efforts to create compliant records. Although the Attorney General agreed with this statement, the administrator found that the evidence was diminished by Ms. Moore aiding and abetting Dr. Nichol's violations of federal law. Comments?
What are your thoughts on the DEA's decision and order? Please leave any thoughtful comments below.Contact a Health Care Attorney that is Experienced in the Representation of Clinical Research Fraud and Misconduct.
The Health Law Firm and its attorneys have experience in representing researchers, investigators, academicians and clinicians who are the subject of clinical research fraud and misconduct. The Health Law Firm and its attorneys also have experience in representing students, employees, researchers, investigators and “whistle blowers” who report such matters including those who become the victim or reprisals and retaliation by the person against whom the report is made.To contact the Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com
.Source:Office of Diversion Control. "Moore Clinical Trials, L.C.C.; Decision and Order." (July 11, 2014). From:http://www.deadiversion.usdoj.gov/fed_regs/actions/2014/fr0711.htm
About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620. Shelby Root is a summer associate at The Health Law Firm. She is a student at Barry University College of Law in Orlando. Keywords: Drug Enforcement Administration, DEA, defense attorney, defense counsel, Office of Administrative Law Judges, ALJ, Clinical Trial Agreement, CTA, clinical investigations lawyer, misconduct in science, investigational misconduct, defense lawyer, Controlled Substance Act, CSA, Show Cause Order, DEA registration, Contract Research Organization, CRO, research facility, health law, health care law, health law attorney,The Health Law Firm, administrative hearing, controlled substances class, controlled substances database, The Health Law Firm reviews
"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.Copyright © 1996-2015 The Health Law firm. All rights reserved.
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