FDA Debars Two Clinical Investigators Six Years after Fraud Convictions
More than six years after being convicted of fraud, two medical researchers were recently barred from working as clinical investigators by the U.S. Food and Drug Administration (FDA).
The two researchers, Mary Sawaya of Ocala, Fla., and Dr. Allyn Norman of Williamsville, N.Y., were convicted in unrelated cases.
Sawaya, who was convicted in 2003 of the felony offense of making a false statement to a federal agency, was permanently debarred. Sawaya pleaded guilty to charges that she created a medical license by obtaining a copy of a colleague's Florida medical license and altering that license using a photocopy machine to reflect that the license was issued in her name. She then submitted the fraudulent Florida medical license to the sponsor of a clinical trial, for which she was a clinical investigator. The sponsor submitted the license to FDA as part of the drug approval process. When the false license was due to expire, Sawaya once again created a false medical license with a different expiration date and submitted that license to the sponsor.
Sawaya waived her opportunity for a hearing to contend her debarment.
Norman was debarred for five years, resulting from a 2002 conviction of the misdemeanor offense of failure to maintain adequate and accurate records relating to the use of investigational new drugs. The basis of the conviction was Norman's creation and submission of falsified study data in required reports to the sponsor of a clinical trial. Norman failed to conduct the study according to the approved protocol, reported the enrollment of nonexistent subjects in the study and fabricated all of the pertinent study records associated with these subjects.
Debarment is typically applied against clinical investigators who have been convicted of a felony offense under federal law related to development of drug products, but the FDA made an exception in Norman's case after he waived his right to request a hearing to contend the proposed five-year debarment.
Under the debarment, Norman is prohibited from providing services in any capacity to an entity that has an approved or pending drug product application.
Any entity with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the service of a debarred person in any capacity during his or her debarment, will be subject to civil money penalties. If the debarred person, during the debarment period, provides services in any capacity to a drug sponsor with an approved or pending drug product application, the debarred person will be subject to civil money penalties. In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of a debarred person.