FDA Speeding Approval Process, Continued User Fees Needed

The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also facing potential budget cuts proposed by the Trump administration. Yet, several recent reports are indicating improvements in the time to approval across drug and device types, which is welcome news to the life sciences industry.

Drug Approvals
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), according to a correspondence published April 6 in the New England Journal of Medicine.

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 FDA—like many other regulatory authorities—has become much more strict about clinical evidence and testing requirements, thus lengthening the overall path to clearance."


The researchers found that the FDA approved 170 new therapeutic agents over the four years, while the EMA approved 144. The FDA’s median total review time was significantly shorter than the EMA’s (306 days versus 383 days, respectively). Among the 142 therapeutic agents that were approved by agencies (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.

Device Approvals
Regulatory consultancy firm Emergo (Austin, Texas) recently released its 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 more strict 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 found that 58 percent of devices cleared in 2016 were cleared within six months of submission.

The results from both of these reports echo the FDA’s own analysis. In recent testimony to the House Committee on Energy and Commerce regarding reauthorization of the Medical Device User Fee Amendments, 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 510(k), an 11 percent decrease in 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 still needs 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.


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