By: Andrew Moss and Laurie Lenkel
Like many Federal agencies, FDA has a robust ombudsman program that addresses concerns and complaints from regulated industry and the public. At FDA, most product evaluation centers house their own ombudsman staff that address center specific issues. The FDA Office of the Ombudsman, as part of the Office of the Commissioner, provides this function for the agency as a whole.
While some think of an ombudsman as a type of court of last resort or legal adviser, the FDA Office of the Ombudsman rather acts primarily as a counselor or informal mediator. An ombudsman may be called upon by interested parties to provide guidance and assistance at any stage in a dispute, complaint, or other problem that relates to the work of the agency—not only when a matter reaches an impasse. Addressing problems early can often aid in their resolution.
The FDA Office of the Ombudsman employs some basic guiding principles that allow it to serve in this mediating role:
- Neutrality—we engage in matters free from bias and independently from the agency components involved;
- Transparency—we strive to be as clear and open as possible about the steps we are taking to provide assistance and about what we can and cannot do to help;
- Confidentiality— we maintain the confidentiality of all information provided consistent with applicable laws and regulations.
The FDA Office of the Ombudsman handles inquiries about the resolution of consumer complaints as well as inquiries from regulated industry regarding, among other things, agency action or delays in action, compliance activities, import issues, and actions of FDA field offices. We play an important role in assisting small businesses. Although small businesses are generally subject to the same regulations as any other entity, we can help to draw attention to the special needs and concerns of these companies. If nothing else, we can help small businesses to understand messages from the agency and to better communicate with FDA offices and staff, thereby helping companies to satisfy FDA requirements, which are designed to protect consumers and patients.
The tools we use to assist individuals and companies vary from situation to situation. Sometimes we help them to better understand actions taken by FDA. At other times we can be helpful in calling attention to and moving forward action that has been delayed. In many instances, we are able to facilitate a productive meeting between key FDA officials and the interested party to discuss and help move toward resolution of issues of concern.
A new role for the FDA Office of the Ombudsman is in shepherding the consideration of scientific disputes raised by FDA employees that are not resolved elsewhere and rise to the level of the Commissioner, the head of the FDA. While there are often multiple legitimate ways to view different findings and to make regulatory or policy decisions, FDA is committed to the integrity of the underlying science and a science-based approach to its decision making, and places great value on ensuring that divergent scientific opinions are fully and fairly heard. Any FDA scientist can first raise a scientific dispute or disagreement within the center where they work through well defined processes, with the final arbiter being the Director of that FDA center. However, if they are ultimately not satisfied that their views have been fully heard and considered by the Center, they can bring the matter to the Office of the Commissioner via the FDA Office of the Ombudsman for review of the process.
Whatever the issue, question, or problem, the FDA Office of the Ombudsman stands ready to provide guidance and assistance. We are here to help. And if we can’t directly assist you in a given matter, we will identify the FDA component that can. You can contact us anytime at email@example.com, or visit us on the web.
Laurie Lenkel is Ombudsman and Andrew Moss is Deputy Ombudsman in FDA’s Office of the Commissioner