Medical Device Daily Washington Editor

The Center for Devices and Radiological Health (CDRH) recently published its Ombudsman's Annual Report for calendar year 2005, and while the numbers suggest a lot about what the ombudsman office does, they do little more than hint at the work that stands behind the report.

Les Weinstein took the job of CDRH ombudsman in 2000 when it was first established, and the unflappable Weinstein has been able to survive in that position despite the various divides he encounters – unflappability obviously being one of the key skills for building bridges.

“I have to be a very good listener and maintain my neutrality,” he told Medical Device Daily – in an interview following release of the report – another important skill that ensures he hears and understands both sides of every story.

As someone obliged to beat the drum of communication, Weinstein walks the talk. He reports having made about 25 presentations at various CDRH offices “in order to tell them what an ombudsman does,” an effort that has paid dividends in the form of cooperation.

Just as important has been his two decades of work at CDRH before taking the ombudsman's office, serving as the director of international relations and external affairs at CDRH.

“I am familiar with the program issues that come up, and I know who to get in touch with,” he says, in order to move disputes along to the next step. Others at the agency “are extremely responsive,” he adds, and his prior agency experience has been pivotal.

Additionally, he pushes out into the field, making numerous presentations to meetings of device manufacturers, encouraging them to contact him if they come to loggerheads with CDRH.

Weinstein is a graduate of Brown University (Providence, Rhode Island), and as a senior wrote a paper on comparative national government ombudsman systems. He then earned a law degree from George Mason University (Fairfax, Virginia), with a focus on the field of mediation.

Expanding on the 2005 report from his office, Weinstein said that oftentimes he is a company's first contact with the FDA.

“There are some companies that call me that are very small, and it may be the first time they have interacted with FDA.” He says these companies are usually looking to seek PMA or 510(k) approvals and “might have no idea – I view my role as helping them through the process.”

More experienced and larger firms are often “more savvy, but the issues are often similar. On the other hand, some of these firms may have hit an impasse with a particular office,” he says.

According to the report, there were 114 calls to the ombudsman's office in calendar year 2005, off slightly from the previous year's 125 calls (see Table 1). Weinstein says he does not get many from outside the U.S., but that those “seem to have increased a little bit.”

Unlike the numbers of U.S. complaints virtually none of the calls from overseas are from consumers.

Weinstein said that complaints were those calls involving those dissatisfied with turn-around on applications or unhelpful employees whereas a dispute usually dealt with a difference of opinion regarding an FDA ruling. The “other” category involves calls requiring only clarification or an answer to some minor question.

As for the jump in ombudsman interactions over the past three years compared to 2001 and 2002, Weinstein says he can't pinpoint a particular reason for this.

Interestingly, he says that he does not feel the somewhat controversial provisions of the user fee act – or other aspects of MDUFMA – have been a primary driver of the increase in calls.

While he is doing no more of these presentations now than in the first couple of years on the job, he says the cumulative effect may be driving the number of complaints to his office. And, “Most of these calls have to do with 510(k)s because there are 5,000 of these a year.”

As for calendar year 2006, he reported total calls to date at 61.

The majority of the calls for each of the five years have been about the Office of Device Evaluation (ODE), but the ratio of those has fallen from 65% in 2001 to 52% four years later (see Table 2).

“Donna Tillman [director of ODE] is excellent at making decisions within 30 days,” but firms can also appeal to the center director, “and there seem to be more of those appeals than in the past,” Weinsten says.

And he reports receiving few calls, if any, concerning reclassification petitions.

“That seems to be a whole different process and I am not involved in it,” he says.

Complaints about the Office of Compliance (OC) have also been inching down since 2001, when 27% of the calls Weinstein dealt with addressed OC. In 2005, the figure was 22%.

“I think that what might be at play is that if the complaint involves the district office, I refer those calls to the ombudsman in the Office of the Commissioner because Office of Regulatory Affairs does not have its own ombudsman.”

However, some of those calls do land in his lap, though his purview is not global to the agency's regulation of devices. For instance, “there are a lot of important questions that should go to the district office because they are responsible for detention,” Weinstein says. District offices do not have ombudsmen per se, but rather small business coordinators, who sometimes refer complaints to him.

On the other hand, he says that many who work in district offices are unaware of the work of his office.

The numbers regarding unresolved complaints at the end of the year have bounced around quite a bit. In 2001, 38% of the total complaints were still outstanding on Dec. 31, and 46% had yet to be hashed out 365 days later. That figure dropped in 2003 to 36%, but was up to 44% in 2005.

Weinstein attributes this phenomenon to MDUFMA.

“Since the advent of MDUFMA,” he says, “there have been a lot more appeals for PMAs and 510(k)s than in the past.

As a general perspective, Weinstein suggests that his value to both callers and the agency is his openness and availability.

“They know that I'm part of the process and it's no big deal to contact me,” Weinstein says.