WASHINGTON — A key Food and Drug Administration program to quicken medical device approval by allowing third-party review was expected to attract several hundred companies when it was launched last summer. So far, it's had eight.
Both FDA and the industry say that is because the only devices the agency made eligible for third-party approval, which costs more but is in theory quicker, are for simple devices for which there had been no review backlog at FDA.
Some industry officials charge that FDA wanted the program to fail, and put it in place only to avert much tougher congressional legislation last year.
But FDA staffers dispute that, and said they wanted to start slowly because they did not want to put the public at risk from bad devices.
FDA plans to broaden the program to make about 60 medium-risk devices eligible in about a month, but high-risk devices are likely to be ``out of bounds'' for third-party review, said Eric Rechen, a policy analyst in the office of device evaluation. About 250 mostly low-risk devices are eligible now.
Michael Friedman, FDA's lead deputy commissioner, told Congress last month that ``there are legitimate, serious questions as to whether such a system would work in this country — such as whether the capacity exists in this country for such reviews, whether it would provide the same quality control, and whether private reviews could be independent.''
But device makers consider third-party review the ``most essential provision'' of FDA reform, said Jeffrey Kimbell, executive director of the Medical Device Manufacturers Association in Washington.
Industry officials argue that the slow pace of device approval contributes to companies moving production overseas and seeking regulatory approval there. European countries use third-party approval, but FDA officials say the programs are too new to judge how well they have worked.
FDA officials say management changes have eliminated the backlog for many devices that existed in the early 1990s, and they noted that the approval time for new devices, which require an extensive review, has decreased by 30 percent during the past three years. The average review time last year was 110 days, down from 184 days in 1994, FDA said.
``A lot of the cry has seemed to subside,'' Rechen said. ``If it takes an average of 90 days to get a clearance, most people are happy if they know how long it will take.''
While review times for lower-risk devices have improved, Kimbell said the approval process for high-risk and new devices has worsened. For new devices subject to pre-market approval, for example, average approval time is 780 days, four times that required by law.
FDA review time does not indicate the number of days from submission to approval, but rather the number of days FDA works on an application. The clock stops when the agency asks for more information, Rechen said.
Kimbell says the FDA sometimes asks for more information when it nears the end of a 90-day decision cycle: ``I've got a syringe manufacturer who spent 21/2 years getting his device approved. How many 90-day cycles is that?''
FDA interest in third-party review is picking up because the agency's budget crunch is forcing it to rethink its operations, said James Benson, executive vice president for technology and regulatory affairs at the Health Industry Manufacturers Association in Washington.
The FDA unit that reviews devices is ``seriously planning'' on losing 25 percent of its 1,000 staff members over the next few years, Rechen said. Agency officials have told Congress that could reverse recent device approval gains.