Douglas M. Hargrave; Denial of Hearing; Final Debarment Order

The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Dr. Douglas M. Hargrave (Dr. Hargrave), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Hargrave for 2 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Hargrave was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Hargrave's debarment, FDA has considered the relevant factors listed in the FD&C Act. Dr. Hargrave has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.