If your question isn’t addressed here, please contact the ORA ombudsman.
An ombudsman —also known as ombudspersons, ombudsman, ombudsmen, or ombuds— are confidential, impartial, and independent conflict management professionals in universities, government organizations, healthcare organizations, and other organizations. The origin of the word is Swedish, and it literally translates to “representative.” Ombudsmen are uniquely qualified to resolve conflicts and to serve as conduits for change through their ability to bring significant and repetitive issues to management’s attention in a safe and confidential way, particularly with sensitive or controversial issues. The ORA ombudsman listens nonjudgmentally to all concerns while helping external and internal stakeholders evaluate their choices and explore options for resolution.
The ombudsman strives to enhance communication between ORA and external stakeholders and to improve transparency in the agency’s compliance and investigation activities. The ORA Ombudsman Program brings an impartial perspective, maximizes opportunities for collaboration with internal and external stakeholders, while focusing on the advancement, efficiency, and effectiveness of ORA operations. Think of the ombudsman as a conflict resolution mechanism informal alternative who can preserve the confidentiality of sensitive information, assist in the development of sustainable outcomes, and refer you to helpful resources as needed. Keep in mind that your options for resolution might be limited by statutory, regulatory, or administrative timeframes.
The ORA Ombudsman Program is an external-facing program, but one which assists internal and external stakeholders. This means that the ombudsman is available to facilitate resolution between ORA staff and all stakeholders, including other FDA staff, other government agencies at all levels, FDA-regulated industries, law firms, importers, consumers, and trade, professional, and consumer organizations.
The ombudsman will listen to your complaints, questions, and comments regarding (but is not limited to):
- Import detentions and refusals;
- Concerns about facility inspections;
- Interactions with district offices or ORA personnel;
- Interactions with the Office of Criminal Investigations; and
- ORA laboratory analytical findings and review.
Yes, the ombudsman does not conduct formal investigations and will not make binding decisions or direct change of any regulatory outcomes. The ombudsman does not advocate on behalf of any stakeholder during administrative or judicial proceedings. During ongoing compliance and inspection evaluations, the ombudsman is not a substitute for communicating directly with the ORA program staff, and the ombudsman cannot overturn ORA decisions. The stakeholder’s primary contacts at ORA remain in the program offices, and the ombudsman is available to provide conflict resolution services when the stakeholder has exhausted all other resources.
To ensure independence, the ORA Ombudsman operates outside of the enforcement program management channels, which allows the ombudsman to maintain neutrality. As necessary, the ombudsman provides feedback to the Office of the Associate Director for Regulatory Affairs and enforcement program management while keeping individual inquiries confidential. The ombudsman will make every effort, per The International Ombudsman Association Code of Ethics & Standards of Practice, to ensure confidentially.
Yes, and very important ones. The ombudsman reserves the right to report imminent risk of serious harm to self and/or others, and it remains the ombudsman’s own interpretation whether a risk actually exists. Additionally, the ombudsman has the discretion to report federal program fraud and abuse, or any issue that legally requires ORA to act. These are strict exceptions to the ombudsman’s pledge of confidentiality. See The Use of Ombuds in Federal Agencies, recommendation #5, of the Administrative Conference of the United States for constrains related to confidentiality.
No. Confidentiality is critical to the ombudsman. The ombudsman requires no formal introductions and, in addition to the contents of conversations, your personal information may remain private. You have the option of submitting your concerns anonymously, but keep in mind that when doing so the ombudsman’s ability to facilitate resolution will be limited. The best way to submit an anonymously concern, is to call the ombudsman at 1-844-871-4536 or write to ORA Ombudsman Program, U.S. Food & Drug Administration, 10903 New Hampshire Avenue, Building 31, Room 3533, Silver Spring, Maryland 20993.
The ombudsman receives and responds to reported concerns about an ORA process, policy, or procedure. The primary function of the ombudsman is to be a resource for guidance to address conflicts between ORA and its stakeholders. The ombudsman facilitates authentic stakeholder dialogues without barriers, fear of retaliation, or bias. This resource allows stakeholders to view ORA as fair, ethical, and trustworthy.
The main goal of the FDA Complaint Coordinator is to receive complaints related to regulated products or issues involving manufacturers, distributors, or importers of an FDA-regulated product. Stakeholder assistance staff within ORA provide information or technical support about ORA-related systems.
FDA complaint coordinator or other stakeholder assistance staff may refer individuals to the ombudsman. Similarly, when the ombudsman receives questions or requests for technical support or information, they will suggest referral to the most appropriate staff.
Yes, you can expect a response within two business days. In rare circumstances, the ombudsman may exercise discretion on whether to act on a concern stated in an inquiry. Some exceptions are matters in litigation, inquiries that include profanity or other inappropriate language, or matters where the ombudsman is included as a part of large group in a spam-like email.
The ombudsman process is usually initiated by a breakdown in communication requiring informal resolution. Mediation is a specific process for conflict resolution and is normally initiated by an arbitration request. Many ombudsmen are trained as mediators and often use mediation skills and techniques as one of many approaches to dispute resolution.
The ombudsman will close an inquiry after finding a solution, when the inquirer no longer requests assistance, after exhausting all viable options, or when a formal process is initiated and concluded. Common outcomes of closed inquiries are defined in the most recent ORA Ombudsman Annual Report.
If you are unsatisfied with the outcome of your inquiry, you may contact the FDA Ombudsman.
Contact ORA Ombudsman
Toll free 844-871-4536