GAO confirms basis for industrys frustration with FDA

Coming from Congress’ independent, nonpartisan Government Accountability Office (GAO), the title says it all: “FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer.”

According to the GAO’s summary of the 59-page report, released March 28, the FDA has gotten substantially slower at giving an up or down decision on manufacturers’ 510(k) applications.

GAO also looked at the agency’s performance with premarket-approval applications and found it “inconsistent.”

On the bright side, FDA met two key performance goals. Each year from 2005 through 2010, the agency reviewed more than 90 percent of 510(k) submissions within 90 days. For all three years the second goal was in place, FDA reviewed at least 98 percent of 510(k) submissions within 150 days.

The problems came when the agency asked manufacturers to submit additional information. “FDA review time excludes this waiting time, and FDA review time alone is used to determine whether the agency met its performance goals,” the report points out.

Factoring in the holdup time these requests created, GAO found that total review times expanded from 100 days in 2005 to 161 days in 2010—an increase of 61 percent.

The report comes two months after medical device manufacturers agreed to pay FDA double the user fees they had been laying out—$595 million over the next five years, up from $295 million over the past five years—in exchange for speedier and more predictable reviews at the hands of a larger review staff. In March, the White House’s Office of Management & Budget signed off on the agreement, bringing the latest iteration of the Medical Device User Fee & Modernization Act (MDUFMA) closer to replacing the current user-fee structure when it expires Sept. 30—or so it seemed.  

On March 29, Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) released a joint statement that seemed to raise a flag over industry sending more money to FDA at a time when its performance on timeliness is on a conspicuous downswing.

“This report makes clear that reporting only on the user fee performance goals negotiated by industry and the FDA does not paint a full picture of FDA’s performance,” they said. “GAO’s report shows that FDA’s final decisions on devices are taking longer due to more review cycles and requests for additional information. If Congress fails to ensure consistent oversight and transparency at FDA, we risk continuing to drive medical innovation and job creation overseas and jeopardizing American patients’ access to the most cutting-edge medical therapies and advances.”

The next day, Burr and Coburn were among the members of the Senate Committee on Health, Education, Labor & Pensions who made those points directly to Jeffrey Shuren, MD, director of the FDA’s Center for Devices & Radiological Health, in a hearing on the GAO report. No transcript or online recording was available at press time.

The GAO report notes that the issues most commonly raised by stakeholders in the device-review process include insufficient communication between FDA and stakeholders throughout the review process, a lack of predictability and consistency in reviews, an increase in time to final decision and inadequate assurance of the safety and effectiveness of approved or cleared devices.

“FDA is taking steps—including issuing new guidance documents, enhancing reviewer training and developing an electronic system for reporting adverse events—that may address many of these issues,” according to the report. “It is important for the agency to monitor the impact of those steps in ensuring that safe and effective medical devices are reaching the market in a timely manner.”

The report summary concludes by pointing out that, in commenting on a draft of the report, the Department of Health and Human Services (HHS), which oversees the FDA, “generally agreed with GAO’s findings and noted that FDA has identified some of the same performance trends in its annual reports to Congress. HHS also called attention to the activities FDA has undertaken to improve the medical device review process.”