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COVID-19 pandemic will accelerate change at US FDA – Commissioner Hahn

SNL ImageSome of the measures the U.S. Food and Drug Administration has taken during the coronavirus pandemic to speed products to patients are likely to stick permanently, while the outbreak will accelerate other policy changes regulators have long sought, the agency's commissioner said.

"A major strength of the FDA is not just in our response to the crisis but our ability to learn from the work that we do and apply that experience in the future," Commissioner Stephen Hahn said. "The entire FDA team has now seen firsthand that we needed to take a critical look at some of our processes and policies."

Hahn said he has instructed the agency's staff to identify the lessons learned from the COVID-19 pandemic and what adjustments may be needed — "not just to manage this or future emergencies, but how to permanently make FDA more efficient in carrying out our regulatory responsibilities."

The FDA has issued over 100 emergency use authorizations since COVID-19 first reached the U.S., Hahn said during a June 1 telebriefing hosted by the Alliance for a Stronger FDA.

Most of those emergency authorizations have been for COVID-19 diagnostic or antibody tests, the commissioner noted.

"That's been done at an incredibly fast pace," said Hahn, who was sworn in as commissioner in December 2019, just weeks before COVID-19 entered the U.S. "We're constantly reevaluating those authorizations to modify them as more data become available."

Revising FDA decisions when new scientific data and information are available should not be actions that are criticized, Hahn said.

"I think that's something to embrace because we know that in a fast-moving pandemic and outbreak like COVID-19, one must make the best decisions possible with the data that you have, but one must also be willing to revisit those decisions and change them," he said.

Real-world evidence

The FDA has taken a fresh look at how to design and conduct clinical trials, Hahn said.

"We knew in a pandemic we needed to get answers more quickly," he said.

One area Hahn said he had "great hopes for in the future" is the use of real-world evidence by drugmakers and the FDA to support regulatory decisions.

"This is an interest of the agency and has been for some time," he said.

The FDA has stepped up its leverage of modern, rigorous analyses of real-world evidence from electronic health records, insurance claims, patient registries and laboratory results, Hahn said.

"There are some very important lessons there for us, because real-world evidence has the potential to provide a wealth of rapid, actionable information to better understand disease, describe and measure immunity, understand the operating characteristics of tests and to actually assess the medical product supply chain to mitigate potential shortages," he said. "I commit to you that we will continue to use real-world evidence."

Hahn said the FDA would develop an approach "so that we can maintain our rigor around the scientific adjudication and decisions for medical products," which he said would build more confidence in the use of real-world evidence.

Regulatory independence

Under President Donald Trump's edict through the Operation Warp Speed initiative to have a COVID-19 vaccine ready for Americans by the end of the year, Hahn said the FDA anticipates having to make some risk-benefit decisions if a company submits a marketing application to the agency.

While the FDA has provided flexibility to companies, it will not cut corners, he said.

"I want to promise you that FDA will not shirk its responsibility regarding the safety and efficacy of vaccines and therapeutics and we will use all available evidence and data to make that decision," Hahn said.

Part of that, he said, was ensuring that the FDA maintain its regulatory independence from the Warp Speed project.

The head of the FDA's drug center, Janet Woodcock, has stepped aside as director to work with the Warp Speed team full time on the initiative's efforts to accelerate COVID-19 drugs, Hahn noted. Woodcock will not be involved in any of therapeutic regulatory decisions while she is working with Warp Speed, he said.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, has left the Warp Speed initiative to ensure his regulatory independence, Hahn added.

In April, Marks had predicted some of the changes Hahn talked about during the June 1 briefing, particularly with vaccine development.

"I can't actually predict how it will look differently at this time," Marks said during an April 17 telebriefing. "Like everything else, it won't be exactly the same after COVID-19 as it was before COVID-19."