FDA announces permanent debarment orders for clinical trial misconduct

Today’s Federal Register announces the permanent debarment by FDA of two individuals who worked for the Lee Research Institute in Lenexa, KS, in response to felony convictions arising from clinical trial misconduct.

The site PI, Dr. Wayne Spencer, and Lisa Jean Sharp, Lead Clinical Research Coordinator (who was also the site’s Director of Clinical Trials) were found guilty earlier this year of violating the Federal Food, Drug & Cosmetic Act. Both admitted falsifying records and enrolling participants who did not meet eligibility criteria for a trial of an investigational allergy medication.

The debarment order effectively ends the clinical research careers of Dr. Spencer and Ms. Sharp, who are now prohibited from “providing services in any capacity to a person with an approved or pending drug product application”. Fines can be imposed for working in violation of a debarment order, or for knowingly using the services of an individual who has been debarred. Additionally, the agency can refuse to review applications submitted by or with the assistance of individuals who have been debarred.

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