Medical Device Daily Washington Editor
ROCKVILLE, Maryland – The March 22 meeting on the Medical Device User Fee Modernization Act (MDUFMA) produced no final decisions on the FDA's approach to the legislation, but two officials at the Center for Devices and Radiological Health (CDRH) indicated that the agency's interest in further investments of scarce resources to drive down the amount of time consumed by premarket approval (PMA) decision cycles is ebbing sharply.
Industry complaints regarding review times were predictably part of the ingredients of the meeting, but an alternate view on the advisability of speeding up product approvals also made its way into the mix. The agency is leaving the docket open for comment at present and will meet again for further discussion in autumn.
Before detailing the agenda for this meeting, Mark Barnett, CDRH's assistant director for education and communication, said that when the agency's goals under MDUFMA first found their way onto paper, all involved knew that the proposed turn-around times for PMA and 510(k) review “would be challenging.”
Linda Kahan, the deputy director of CDRH, remarked that industry had hoped that MDUFMA would lead to faster, more predictable reviews and that the agency hoped that a restructured process would move the process along even when deficiency letters came into the process.
The agency has met some of the objectives involving approval times, but PMAs have not met with the success that 510(k) filings have. Kahan said that the CDRH was concerned about the possibility of “unintended consequences for companies and for public health” where the PMA objectives were concerned. She also added that the agency assumed it would obtain a substantial boost in revenues for approval work, but that last year's Medical Device User Fee Stabilization Act “actually reduced the monies” the agency received toward that end.
Kahan said that “the agency believes it is on track” to make 510(k) filings come out on the schedule described in MDUFMA (75% of decisions within 90 days), but that the target turn-around on PMAs was a more distant objective. She said that the agency “does not believe it makes sense to devote more resources” to meet the more ambitious of the PMA goals of handing out a decision on half of PMA filings within 180 days, the so-called “stretch” goal.
Kahan told Medical Device Daily that the parallel objective of issuing a major deficiency letter within 150 days left the agency and companies only 30 days to hash out issues raised in deficiency letters. Kahan also told MDD that “our concern is that being forced to make a decision will result in more products not being approved” because the earlier deadlines could force the agency and the sponsor into inefficient filing work.
Donna-Bea Tillman, the agency's director of the Office of Device Evaluation, said that despite the problems with PMA filings, “we are meeting or exceeding nearly all the agreed-upon” goals enumerated in MDUFMA. She noted that 510(k) filings came through the system on an average of 109 days in 2001 and 86 days in 2005, but that PMAs were in the pipeline an average of 294 days in 2004, leaving CDRH well short of the objective of getting 50% through within 180 days by FY 2007.
According to Tillman, the agency has not finished compiling the FY 2005 data, but “we expect to see the same kind of decrease” in turnaround times as were observed between FYs 2003 and 2004. However, she noted that the earlier timeline for the first deficiency letter forced CDRH to issue more such letters for PMA filings. These deficiency letters jumped from 51% for FY 2002 PMAs to 68% two years later.
“We do not intend to implement the PMA stretch goal in 2007,” Tillman remarked during the meeting. She told Medical Device Daily that “stretch goals are incompatible with cycle and decision goals” for the reasons cited above.
Representatives of the Advanced Medical Technology Association (AdvaMed; Washington) and the Medical Device Manufacturers Association (Washington) offered their comments, mostly to highlight the failings of FDA in bringing performance up to MDUFMA snuff, but Diana Zuckerman of the National Research Center for Women & Families (Washington) had a somewhat different take on the ambitions embodied in MDUFMA.
Zuckerman congratulated the FDA on the improved turnaround on 510(k) filings despite her concern that the recent recall of contact lens solution by Bausch & Lomb (Rochester, New York) could have been averted by closer FDA scrutiny at the plant where the product was manufactured. As for whether the agency is sufficiently staffed to handle the complexities of modern medical devices, she noted that “we don't think the problem is with the expertise,” in that the FDA typically has access to sufficient talent to deal with complex filings.
However, Zuckerman expressed concern about the pressure “to move more quickly” than many at the FDA would like. She cited the thalidomide episode as an example of a rushed approval process, pointing out that the FDA's skepticism saved potentially thousands of American children from the damage wrought by the drug.
Zuckerman told MDD that “using other resources to meet PMA review times [as embodied in MDUFMA] would be a bad idea.”
Mark Brager, director of communications for AdvaMed told MDD that AdvaMed members believe that “FDA occasionally uses deficiency letters to stop the review cycle for problems that do not rise to the level of a serious deficiency.” He also commented that “it is difficult to understand why FDA cannot comply with the [PMA] goals” given that the agency had agreed to these goals in advance.