‘The Power Of Persuasion’: FDA Ombudsman Discusses Her Role

Ombudsmen within the US Food and Drug Administration can play a powerful role in resolving disputes between industry and agency staff. But the position holds no official power beyond “the power of persuasion,” according to Laurie Lenkel, who has been the FDA’s chief ombudsman since 2003.

Lenkel spoke during a 30 August webinar sponsored by the Alliance for a Stronger FDA.

The longtime ombudsman, who came to the role from several years in the FDA’s drug center and prior work for drug and device firms, said the lack of an enforcement role is sometimes a disappointment to firms that interact with the FDA’s ombudsman’s office.

“Sometimes I get a company, usually small companies that come and they argue their case, they want to show me how aggrieved they've been, perhaps thinking that I'm going to say, ‘Oh yes, that's terrible. Let's fix that right away.’  Well, that's not what we do,” she said. “We can help get their point across if it's not been clearly stated. We can help them get their voice heard. But we have no particular power.”

So what can companies do to ensure that help is as effective as possible?

Sponsors need to understand something about FDA structure, Lenkel said. While Lenkel is the ombudsman for the FDA itself, some centers within the agency have separate ombudsmen. These officials don’t have any reporting relationship to each other or the FDA ombudsman’s office; instead, they work “collaboratively,” she said.

The chief ombudsman recommended that companies or other stakeholders who desire ombudsman intervention begin by approaching the relevant center’s ombudsman before escalating to her office.

They should also prepare a summary of the issue, who they have spoken with, and what the outcome has been. Sometimes companies approaching the ombudsman enter the process with an attorney, which Lenkel said can be “a good thing” because attorneys normally know the regulations and how to present the issue.

Smaller Companies Make Up Bulk Of Work

Smaller companies tend to be most likely to reach out to the FDA with questions because they have fewer resources or regulatory staff, Lenkel said. And because there are more small companies in the device sector than there are in other FDA-regulated industries, the ombudsman’s office deals with more concerns from the Center for Devices and Radiological Health than from other centers.

Devices also play a role in the longest-lasting disputes that land on Lenkel’s desk, which tend to involve combination products. Disputes over whether a product should be regulated as a drug or device can drag on for years, with the longest in her memory taking about six years before an agreement was reached.

Whether it involves a device or not, Lenkel explained that a typical interaction with the ombudsman’s office goes something like this: A company tells the office that they’ve been working with a review division for years and it isn’t going anywhere.

The office gets in touch with someone from the review division, who may say in turn that they’ve been trying to explain a regulatory issue to the company for years and aren’t getting through.

“As I see it, our job is to try to bring them closer together to clarify what is needed, what has been submitted, and to get this route to communicate better,” Lenkel said.

The ombudsman’s office will then discuss the company’s options of using the FDA’s formal appeals process, or having the office organize a meeting between the company and the regulators involved. What she often finds in those discussions is that the company isn’t clear on what the agency wants or expects.

“I've gone into meetings where the agency has very professionally stated its position, for example, a meeting where a company was trying to determine what type of test and what type of protocol to have,”
she explained. “And so, the agency said, ‘Well, we have guidance on this and we suggest X, Y, and Z.’ So, the company said, ‘Okay, but can we do A, B and C?’ Now, it's guidance. That's not a regulation. So, the agency said, ‘Yes, if you reach the same endpoint.’

“After the meeting, I said to the company, ‘You can [do A, B and C], but it's probably in your best interests to follow the recommended pathway.’”

After that, the company may continue to communicate with the agency until an agreement is reached. Sometimes the company wants Lenkel’s office to remain involved for the sake of neutrality; sometimes “they just go off on their own.”

In those situations, she may not know whether a product ever gains authorization. She can only hope that the final decision is in the interest of public health – either by bringing a helpful new product to market, or by blocking a product that is dangerous or ineffective.