Medical Device Daily Washington Editor
Les Weinstein has held down the job of ombudsman at FDA’s Center for Devices and Radiological Health (CDRH) since its inception, and probably has heard just about everything in his seven-plus years on the job.
Weinstein has fielded calls from private industry, consumers, healthcare providers and more. But lucky for him, he doesn’t hear from Congress very often.
In his recent annual report, which covers calendar year 2006, Weinstein concentrates mostly on numerical data – that data showing no large trend lines up or down — and he gave Medical Device Daily a closer look at the story behind some of the numbers.
As the device industry knows all too well, the Office of Device Evaluation (ODE) has consistently led the CDRH offices in total complaints, but the ODE’s share of complaints is tailing off (see tables, below).
Weinstein said that this “might have to do with user fees and the performance goals [CDRH staff members] have to meet,” pointing out that a tally of the reasons for complaints shows that time of product review turnaround is a smaller problem of late.
“Most of the timeliness issues have to do with ODE,” Weinstein told MDD.
Weinstein’s report notes that on three occasions in 2006, companies applied to go before a dispute resolution panel, with two getting the go-ahead.
That number is up from zero for each of the two previous years. One such request was filed in 2003, but the report for 2005 says that the hearing was postponed indefinitely.
Weinstein said that the three dispute resolution requests in 2006 probably constituted “a statistical aberration.”
He noted that a dispute panel sided with the company in a 2001 hearing and said, “I thought, at that point, I’d be getting a lot more” such requests. However, he said that such panels are “very expensive and resource-intensive” for companies, which takes some of the edge off industry’s appetite for that avenue of appeal.
“The message that I’ve been giving is that [a dispute resolution meeting] should be a last resort,” Weinstein said. He added that the most recent panel sided with the agency, a fact perhaps making companies less likely to request a panel.
He said he has fielded no requests for a dispute panel meeting so far this year.
Asked if the issues between FDA and industry are getting tougher to resolve, Weinstein said that the most recent 81% rate of resolution “was much higher” than in the previous two or three years. “Maybe that’s an indication that they’re not so far apart” on most of the issues.
Weinstein said he receives “only two or three contacts a year” from foreign device makers. In this area, he said he does not see “an upward trend, and I thought I would,” given the growth of the device industry in other nations.
“It could be that they’re not aware of” the ombudsman’s office,” he said, as one explanation for this.
“The thing that strikes me the most is how constant the number of complaints is from year to year,” Weinstein said, adding that the total “seems to be around 120, plus or minus a few.”