Department of Health and Human Services June 12, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Dr. Mary E. Sawaya a.k.a. Marty Sawaya (Dr. Sawaya) 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. Sawaya was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and conduct otherwise relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Sawaya failed to request a hearing. Dr. Sawaya's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Dr. Allyn M. Norman for 5 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. Norman was convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product or otherwise relating to the regulation of drug products under the act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Norman failed to request a hearing and, therefore, has waived his opportunity for a hearing concerning this action.