During an interview with the Alliance for a Stronger FDA on Aug. 30, 2023, Laurie Lenkel, JD, Director, FDA Office of the Ombudsman, provided an overview of the functions of the office, how it interacts with stakeholders, and what success looks like.

Here we provide key takeaways from the interview, which was co-moderated by Wayne Pines, President of Healthcare, APCO and Alison Bodor, President & CEO, American Frozen Foods Institute.

The Office of the Ombudsman is located in the Office of the Chief Scientist, within the Office of the Commissioner. (There are no reporting lines between the ombudsman’s office and the ombudsmen located within the Centers, although they do collaborate as needed.) The ombudsman is responsible for addressing complaints and assisting in resolving disputes between companies or individuals and FDA.

The three-person staff in the Office of the Ombudsman operates under three main tenets: independence, neutrality and confidentiality. Neutrality is key, she said; her office does not take sides on a particular issue or dispute but works to bring both sides together.

Lenkel emphasized that her office does not have any power or authority to change FDA decisions or require that staff do anything; rather, she focuses on the “power of persuasion” and ensuring each side’s voices are heard. For example, the office often focuses on convincing FDA and the company to come to the table again, to continue talking.

“We listen more carefully than perhaps others in the agency have an opportunity to do,” she said. “We just try to get people to talk, and to listen to both sides.”

Requests for involvement by the ombudsman may come from both internal FDA staff or external stakeholders; however the majority of requests originate externally. The office addresses approximately 400 cases per year. And while there is no “typical case,” she cited as an example of the types of cases she receives: A company may come to her and say “We’ve been working with this review division for two years, and every time we do something, they tell us to do something else.” Then when her office contacts the review division, and they say “We’ve been telling them for two years what to do, they just don’t listen.” In these types of cases, “we have this huge disconnect, and as I see it, our job is to try to bring that closer together, to clarify what really is needed, what really has been submitted, and to get this group to communicate better.”

The largest percentage of cases the Office of the Ombudsman engages in involve foods (CFSAN, the Center for Food Safety and Applied Nutrition), because the Center lacks an ombudsman. CDER has a “long-standing, robust ombudsman program,” and “most other centers” (although not all) have them. Of the Centers that have an ombudsman, she sees most issues coming primarily from CDRH, most likely because there are more small companies in the device area compared to drugs and biologics.

While her office occasionally receives a question from a large company, most inquiries come from mid- to small-sized companies, which she said reflects the fact that they have fewer resources available and perhaps smaller Regulatory staffs. She also receives inquiries involving “emerging technologies” in CBER.

Her office also “deals a lot with issues involving the Office of Regulatory Affairs (ORA), either inspection issues or import issues.” ORA has an ombudsman, but the large number of cases and tight deadlines (“fast-moving cases”) sometimes necessitate getting the Office of the Ombudsman involved.

In terms of resolving cases, “we don’t have wins or losses” per se, she said, and she may not know the outcomes of particular cases. As she brings companies and FDA division staff together for further discussions, in some cases they continue to involve her office, but in others, the two parties continue discussions on their own, “which I consider a win.”

For anyone who is planning to reach out to the ombudsman, she recommends they use the dedicated email inbox for that purpose and include: a brief summary of the issue; who at FDA the company has spoken with; and what the outcome was.

For those Centers that have an ombudsman, she recommends companies reach out to that ombudsman first, then come to her office if they’re still in need of assistance.