Aug. 20, 2020 – The Food and Drug Administration’s (FDA’s) ability to approve new drugs while juggling new responsibilities during the COVID-19 pandemic appears to be exceeding expectations, with the agency approving 36 novel drugs to date in 2020, an increase from the 24 new molecular entities (NMEs) approved by this date in 2019 (with 48 total NMEs approved last year). Approvals as of this day in 2018 were 31 NMEs (on the way to 59) and in 2017 were 29 NMEs (on the way to 46), so the FDA has approved more NMEs so far this year than during the past several years.
“That the FDA – even when stretched to cover the additional workload resulting from the pandemic – is well ahead of recent years in the pace of approving NMEs is a convincing counter to criticisms heard from some that the approval process is too slow and exacting,” argued Jon Bigelow, executive director of the Coalition for Healthcare Communication. “By perhaps its single most visible metric, 2020 has been a successful year for the FDA,” he said.
Another positive for the FDA is that the third COVID-19 relief bill — the CARES Act – signed into law on March 27, included modernization of the over-the-counter drug monograph process, which the agency had been seeking for years, and established a user fee program to fund it. The COVID-19 relief bills have also included additional funding for FDA activities during the pandemic.
Currently, there is a lot on the FDA’s plate. In late July, the FDA and industry representatives met virtually for the first public meeting in negotiating the seventh Prescription Drug User Fee Act (PDUFA), due to be enacted in 2022. Dr. Stephen Hahn, the FDA’s Commissioner, and representatives of industry have advocated for finding lessons from the current expedited work in developing COVID-19 drugs and vaccines and applying those to the FDA’s process for other drug approvals.
On July 24, the House of Representatives approved $3.2 billion for the FDA in fiscal 2021, representing a $41 million increase in the agency’s budget. That increase in “budget authority” (which excludes revenue from user fees) is smaller than may be justified by the importance of the FDA’s role in the COVID-19 pandemic response, but still is significant in the context of tight limits on non-defense discretionary funds.
However, it is unlikely that a federal budget will be approved before the Sept. 30 deadline, so a Continuing Resolution will be needed. This would lock FDA spending at its 2020 rate until a final 2021 budget is agreed to sometime after the election – which will be challenging in the face of the expanded needs of a continuing pandemic.
Looking ahead, the greatest challenge for the FDA in the coming months is likely to be political rather than budgetary, according to Bigelow. “There will be strong pressure to quickly issue an Emergency Use Authorization for one or more of the COVID-19 vaccine candidates, even before completion of the usual clinical trial process,” he said.
It is worth noting that Russia recently approved a COVID-19 vaccine based on testing in just 76 patients. Commissioner Hahn has vowed that science – and not the upcoming election – will dictate the FDA’s decision. “It is important that the FDA continue to require clear proof of safety and efficacy as it looks at pending products, including those intended for prevention or treatment of COVID-19,” Bigelow noted, adding that efficacy and safety are more important than speed.
“Rolling out an ineffective vaccine (or worse, one with significant adverse reactions) will not halt the pandemic and would set back public confidence in any future vaccination effort against COVID-19,” Bigelow said, “not to mention feeding the broader anti-vaxxer movement and damaging the reputation of both the FDA and the pharma industry.”