FDA Speeding Approval Process, Continued User Fees Needed

The U.S. Food and Drug Administration (FDA) has been chronically plagued with understaffing, an ever expanding workload and criticism over how long the agency takes to issue approvals. And the new President has created a new woe: the threat of deep budget cuts. So far, the agency has been able to deflect the chopping block. And recent reports suggesting improvements in times required for drug and medical device approvals provide more welcome news—not just for the agency but the entire life sciences industry.

Drug Approvals
A correspondence published on April 6 in the New England Journal of Medicine adds some welcome context to the FDA’s long lead times for approvals by comparing them to the situation in Europe. According to the correspondence, for new therapeutic agents that were approved between 2011 and 2015, the regulatory reviews by the FDA were, on average, 60 days shorter than those by the European Medicines Agency (EMA).

The authors say the speed of the U.S. regulatory review process will likely face scrutiny again as Congress debates reauthorization of the Prescription Drug User Fee Act, which is set to expire this October. To inform this debate, the authors, led by Nicholas S. Downing, M.D., from Brigham and Women’s Hospital in Boston, assessed all new therapeutic agents that had been approved by the FDA or the EMA between 2011 and 2015 and compared the median total review times between the agencies.

The researchers found that over the four years studied:

• The FDA approved 170 new therapeutic agents versus the 144 approved by the EMA;

• The FDA’s median total review time was 306 days, significantly shorter than the 383 days median total review time of the EMA;

• Among the 142 therapeutic agents that were approved by the FDA and EMA (with at least one of the approvals occurring during the study period), results were similar with median total review times of 303 days and 369 days, respectively.

Medical Device Approvals
There was also positive information on the medical devices front. The source: the regulatory consultancy firm Emergo’s (Austin, Texas) recently released 2017 report reviewing medical device applications submitted to the FDA from 2012 to 2016. While not exclusive to diagnostic products, the report offers some insights for the diagnostics industry.

In 2016, the number of devices that received 510(k) clearance fell to 2,957, the lowest number since 2010. The company says this decline in clearances is “entirely attributable” to fewer American companies submitting devices to the FDA. For products cleared by FDA internal review, it took, on average, 177 calendar days from submission to clearance in 2016.

“The FDA—like many other regulatory authorities—has become much stricter about clinical evidence and testing requirements, thus lengthening the overall path to clearance,” Emergo writes in the report. “Most companies can plan on waiting about six months to get the green light from FDA, although that varies by device.”

The report also found that 58 percent of devices cleared in 2016 did so within six months of submission.

FDA Sources Say User Fees Fuel Progress
The results from both of these reports echo the FDA’s own analysis. In recent testimony before the House Committee on Energy and Commerce regarding reauthorization of the Medical Device User Fee Amendments (MDUFA), Jeff Shuren, M.D., FDA’s director of the Center for Devices and Radiological Health, credited the user fee program for reducing FDA decision times. He testified that the FDA has made “substantial progress” and said that in 2015 it took on average 133 days to reach a decision on a Section 510(k), an 11 percent decrease over five years.

Shuren also said that the FDA’s workload continues to increase about 10 percent every year, in part because of the increasing complexity of innovative medical devices and because of the need to use real-world evidence in post-market surveillance. As a result of this increasing workload, even if the Trump administration’s proposed cuts to regulation and staffing are made, the agency will still need the medical device user fees to continue to speed the review process.

Takeaway: Recent analyses shows the FDA is making progress to speed the regulatory review process across product types and the agency plans on continued need of user fees for continued improvements in review speed.