The FDA lacks consistency in review times for medical device pre-market approval applications, missing most goals for submissions marked "expedited," according to report by the Government Accountability Office.
"For FYs 2003 through 2010, FDA met most of the goals for original PMAs but fell short on most of the goals for expedited PMAs," according to the GAO report. "In addition, FDA review time and time to final decision for both types of PMAs generally increased during this period."
The report became a bone of contention for at the Senate Health, Education, Labor & Pensions committee hearing this week as Sen. Richard Burr (R-N.C.) grilled FDA devices chief Dr. Jeffrey Shuren over the findings.
The panel convened to discuss the latest iteration of the Medical Device User Fee & Modernization Act, which would double the fees med-tech pays for FDA review in exchange for meeting certain performance goals.
Burr was skeptical of the agency’s intentions to meet new time-frames for 510(k) and PMA applications, saying he’s heard the same promises before.
"Comments were made 5 years ago and they haven’t been met," Burr said. "A doubling of user fees isn’t going to make sure the agency meets its goal."
"FDA needs adequate, stable funding to manage a device program that can approve or clear safe and effective products for patient without delay, and only timely reauthorization of a medical device user fee program that both FDA and the medical device industry support can assure such funding," the Dept. of Health & Human Services wrote in a response to the GAO report.
The FDA met performance goals for original PMA submissions in 4 of the 7 years the goals were in place, but missed goals for "expedited" submissions, those intended to treat or diagnose life-threatening or debilitating conditions and address an unmet medical need, in 5 of those years.
Although PMAs were the main concern, the report also found that 510(k) submission times had increased 61%, from an average of 100 days to 161 days between 2005 and 2010, although the FDA still met performance goals for those applications.
HHS generally agreed with the findings, having highlighted some of the same trends in its annual report to Congress, but noted that total time metrics rest on both FDA and the medical device industry meeting their respective goals.
"The total time to a decision (FDA review time plus the time it takes a sponsor to provide requested information) has increased, yet FDA’s performance in meeting its goals is by and large strong," HHS wrote. "Since the total time to decision includes the time industry incurs in responding to FDA’s concerns, FDA and industry bear shared responsibility for the time increase and will need to work together to improve performance on total time to decision."