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When A Sponsor Wants To Proceed On A COVID Product, US FDA Almost Never Says No

When A Sponsor Wants To Proceed On A COVID Product, US FDA Almost Never Says No

Source : 'The Pink Sheet'

US Food and Drug Administration officials do not appear overly interested in tamping down the unprecedented interest in finding a treatment for the coronavirus, despite the enormous workload it is generating.

In an interview with the Pink Sheet, Robert Temple, FDA Center for Drug Evaluation and Research deputy center director for clinical science, said it is rare that proposals to test potential coronavirus treatments are turned away for lack of evidence, particularly when repurposing that has already been studied or approved for another indication.

“It certainly is true that many of the drugs people are looking at in the hope that they'll have antiviral properties have not much evidence that they're going to be doing that,” Temple said. “But it's still worth trying.”

Jacqueline Corrigan-Curay FDA

“We don't try to stop them,” Temple added. “It's very unusual for us to say, No, you don't have enough evidence to proceed. That would be something very unusual. Unless the drug's really toxic or something.”

One area where the agency does try to influence the direction of research more aggressively is trial design, with a preference towards keeping things simple. (See sidebar.) 

Jacqueline Corrigan-Curay, director of the CDER Office of Medical Policy, who also participated in the interview, said so far there are no visible trends or common concerns among the hundreds of coronavirus proposals submitted.

“I don't think I would say, we have mistakes that we can point to,” she said. “Certainly you want to sort of find what's the most promising new therapeutic to work with and how to get the trials designed in a way that's going to give data that will be informative, and move us forward.”

Corrigan-Curay said that one positive from all the ideas that have made it to the agency is that so many are of sufficient quality that they can open an IND.

Temple said the level of interest is staggering. But Corrigan-Curay would not say the workload is overwhelming. She said many staffers have stepped up to meet many challenges.

“I think the need is being met, to reach out to make sure … we're getting those inquiries to the right people and they're being addressed,” Corrigan-Curay said.

“It'd be hard to identify what we think is a higher priority than getting answers to these questions promptly and properly,” Temple added. “It's hard to think of anything more important.”

FDA officials shifted many staffers and adjusted timelines in order to move as many potential coronavirus treatment proposals and protocols forward as possible. The agency’s Coronavirus Treatment Acceleration Program (CTAP) as of 11 May had approved 144 active trials for therapeutic agents and had another 457 development programs in the planning stages.

The numbers are remarkable, not only for the stakeholder interest, but also for the FDA ability to move the high volume of proposals forward. On 19 April, there were 72 active trials for therapeutic agents and 211 in planning stages. The totals increased 100% and 117%, respectively, in less than a month.

And when CTAP was announced on 31 March, there were 10 potential therapies in active trials and 15 in the planning stages. ("US FDA Greenlighting Dozens Of New Trials For Coronavirus Therapeutics" "Pink Sheet" )

Robert Temple FDA

Indeed, the search for a coronavirus treatment and vaccine quickly became the focus for the FDA soon after the outbreak escalated in the US. 

Even so, Corrigan-Curay and Temple also emphasized that non-coronavirus work at the agency continues, although some things are not moving perfectly.

“It's not as if the agency has shut down everything else to work on this,” Corrigan-Curay said.

The agency has issued guidance for sponsors on how to conduct clinical trials that have been interrupted or altered because of coronavirus. FDA officials recommended sponsors work to limit variability to ensure data collection will be useful for regulatory purposes. ("For COVIDImpacted Trials Investigators Should Practice Remote Assessments Beforehand US FDA Says" "Pink Sheet" )

Other FDA officials have said that some non-coronavirus activity has been shelved temporarily, with guidance development among them. ("Back To Normal US FDA Schedules InPerson Meeting But Pauses NonCOVID Guidance Development" "Pink Sheet" )

And some user fee goals may be missed as work is set aside for pending coronavirus-related issues, but assessments continue to run smoothly, Woodcock has said. ("CDERs Woodcock On COVID19 Missed User Fees Unlikely But Some Work Will Be Set Aside" "Pink Sheet" )

By Derrick Gingery