Kenny Shade, Debarment Specialist, Division of Enforcement, Office of Strategic Planning and Operational Policy, Office of Partnership and Operational Policy, Office of Regulatory Affairs (ORA), Food and Drug Administration

I have worked at the FDA for 15 years. I am Kenny Shade, and I joined ORA in 2009 as a debarment specialist.
ORA’s core mission is to protect consumers and public health. My office uses its statutory authority to exclude bad actors that are responsible for misdeeds from participation in FDA-regulated industry.

My legal authority as ORA’s debarment specialist comes from Section 306 of the Federal Food, Drug, and Cosmetic Act (21 USC 335a). This authority allows the Agency to take administrative and remedial actions often based on a criminal conviction that prohibits participation in certain aspects of the food, drug, or device industry.

Debarment is an effective tool that FDA uses to protect the public because these bad actors cannot work in any capacity for firms whose work is regulated by FDA. If they do the firm and the individual are subject to substantial civil penalties.

Individuals, firms, corporations, partnerships, and associations can be debarred but, in most cases, individuals are debarred. The period of debarments can vary and shall not be less than one year but generally are not more than 10 years. In certain cases, if an act leading to a subsequent debarment occurs within 10 years after the original debarment the debarment shall be permanent.

ORA maintains a debarment list for food importations and drug product applications on FDA’s website so that industry can determine if individuals or firms have been debarred.
 
Prior to coming to the Agency, I worked as a registered nurse for the Department of Veterans Affairs. An FDA reviewing physician heard me mention that I would like a job that lets me use both my medical background and legal background. The physician suggested that I contact the Chief of the Project Management Staff at the Center for Drug Evaluation and Research (CDER), FDA regarding a position, which I did. I joined FDA as regulatory health project manager in the Division of Antiviral Drug Products, CDER. I worked in that position until 2009 when I accepted the position as the debarment specialist in ORA.

This newly created position was established to centralize FDA debarment activities under ORA. After I accepted the position, I successfully reviewed and addressed potential debarment cases and was honored in May 2011 as the second recipient of the Agency’s Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health. I felt especially proud of this accomplishment because Dr Kelsey was the first recipient of this award in 2010.

Dr Kelsey, an FDA medical officer was responsible for the review of new drug applications, a legal requirement in which manufacturers had to provide evidence of a drug’s safety before it could go to market in the U.S. One of the first drug applications she was assigned after joining FDA in 1960 was for thalidomide, which was already available in dozens of countries around the world. Dr Kelsey, despite constant pressure from the company refused to approve the application because of its inadequate evidence. Approximately a year later researchers linked thalidomide to severe birth defects in thousands of babies born in western Europe. The drug was never marketed in the U.S. and the impact of the near disaster helped pass a pending bill fundamentally changing drug regulation, the 1962 Drug Amendments.

I felt especially proud of this accomplishment as the second recipient of the award because Dr. Kelsey was the first recipient of this award in 2010.

I am Kenny Shade and #IAmORA.