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Hahn addresses EUAs, transition to approvals in conversation with RAPS members

Posted 17 November 2020 | By Michael Mezher 

Hahn addresses EUAs, transition to approvals in conversation with RAPS members

Real-world data has proven useful in demonstrating the performance of COVID-19 diagnostics, but has not always lined up with the data submitted to support the emergency use authorizations (EUA) of those product. That was one message Stephen Hahn, MD, US Food and Drug Administration (FDA) commissioner brought to RAPS members during a conference call on Tuesday.
“The real-world application of these tests differs from the science and data that are used for us to make this decision, and that’s by necessity. We didn’t have the luxury of spending five years to develop a point-of-care test for COVID-19,” Hahn said, noting that such data can inform changes to the agency’s recommendations.
Hahn’s remarks were made in an interview with Jethro Ekuta, incoming RAPS board chair and vice president, global regulatory affairs at Alexion Pharmaceuticals Inc., and Carol Cooper, RAPS board member and founder and principal of CM Cooper and Associates.
“This group understands, perhaps as well as any, the importance of FDA and the difference that effective regulations can make in helping meet the needs of patients and consumers,” Hahn said in his opening remarks. “I think you appreciate how the application of regulatory science benefits the public by helping to speed the development and approval of safe, high quality medical products, and I think you recognize that this role has been incredible magnified during this public health crisis.”
Hahn called the pandemic a “painful period” and noted the strain it has put on the agency. “We’ve seen basically a doubling of our workload during the pandemic, and as we’re seeing moving forward, an increase in the number of cases in the US and around the world. We realize that’s not going to end anytime soon,” he said.
Addressing some of the criticisms lodged against the FDA during the pandemic, Hahn stressed that none of the agency’s decisions have been motivated by political interference and emphasized the uncertain and shifting nature of the PHE. “Data changes, information changes and the FDA must change its decision-making,” he said, adding that the agency has updated or revoked some of the EUAs issued so far.
(RELATED: Harvard professors call on FDA to maintain review standards amid COVID-19, Regulatory Focus 15 April 2020; FDA revokes EUA for hydroxychloroquine, chloroquine, Regulatory Focus 15 June 2020; Lawmakers, experts raise questions after convalescent plasma EUA, Regulatory Focus 25 August 2020; Hahn pledges no politics in COVID vaccine decisions, Regulatory Focus 23 September 2020).
With the first EUA requests for COVID-19 vaccines expected in the coming days, Hahn said the agency will approach those decisions in the same way, with the understanding that vaccines will be broadly deployed and given to healthy people. “That changes the risk-benefit calculus with respect to a therapeutic versus a vaccine,” he said.
Within the last two weeks, both Pfizer and Moderna have reported preliminary data from Phase 3 trials of their COVID-19 vaccine candidates showing more than 90% efficacy. Both companies are expected to request EUAs for their vaccines shortly. (RELATED: NIH director: Efficacy for co-developed Moderna vaccine nears 95%, Regulatory Focus 16 November 2020).
Noting those impending EUA requests, Hahn reiterated his oft-repeated pledge that “FDA will not approve or authorize any COVID-19 vaccine until our career scientists have poured through the data and made sure that such an authorization or approval meets the statutory standard.”
By sticking to its standards, Hahn said the agency will foster public confidence in the products it approves or authorizes. “This confidence is so important as we begin a national vaccine campaign, hopefully in the near future.”
Hahn also pointed to the steps announced today to increase transparency around EUA decisions as another way to increase trust and address vaccine hesitancy. (RELATED: FDA commits to data transparency in COVID EUAs, Regulatory Focus 17 November 2020).
“Although the process has been compressed, no corners have been cut with respect to development and the clinical trials we’re now going to be looking at, hopefully in the near future, have anywhere from 35-44,000 people in each of those clinical trials, so the amount of information that we’ll have is very, very robust,” Hahn said, stressing the agency’s commitment to convene an advisory committee meeting to review each COVID-19 vaccine EUA request that comes in.
But just because a vaccine is on the horizon does not mean things will return to normal any time soon. “We are not out of the woods with respect to this pandemic. It is absolutely important that while we see the great hope associated with what’s been reported publicly with these two vaccines, and hopefully more on the way, we cannot, cannot abandon our simple but very important public health message around mitigation,” Hahn said.
Post-PHE era
Hahn also discussed the agency’s plans for the post-PHE era and how it will approach the plethora of products currently being used under EUAs.
“At some point the current public health emergency will end and we will move into a new stage of the pandemic response. We recognize that this change is coming—hopefully coming sooner rather than later—and that the subsequent return to normal operations by manufacturers will require and involve a period of adaptation and adjustment,” Hahn said.
Hahn said that FDA has spent a lot of time evaluating an approach to the transition from emergency to normal operations. “We anticipate that that won’t happen in a snap, that we will give a transition period of time for this to occur and we will be publishing guidance … to help address that,” he said.
“As long as the PHE is in place, these EUAs will stay in place. Our intention is to provide a guidance which we hope to publish relatively soon regarding the pathway forward for all medical products … we want to be able to provide a roadmap so that developers know what criteria we’ll be using to transition from an EUA to an outright approval,” Hahn said, noting that the agency has already been in contact with many companies on what they need to bridge the gap.


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