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FDA releases plan to wind down COVID EUAs
Volume 7, Issue 12 | March 29, 2023
IN THIS ISSUE
Getting good data from test to user is harder than it sounds
More and faster COVID testing saved lives in nursing homes - and could have saved even more
Two leaders on clean indoor air in schools
Global health organizations press for One Health action
New and Noteworthy
The end of the federal emergency continues: The plan for EUAs
The US Department of Health and Human Services (HHS) issued its plan on how it’s going to wind down all those emergency use authorizations (EUAs) for medical devices that have gone out over the past three years. The critical elements, as far as diagnostics are concerned:
HHS issued three different EUA declarations for medical devices: one for tests, one for “personal respiratory protective devices,” and one for other devices. The agency will give 180 days’ advance notice before it terminates any of these declarations. (The declarations might each be terminated separately, or one or more might be terminated together.)
The agency didn’t explicitly say when those countdowns might start, but it hinted: All of its example scenarios for tests begin with a 180-day warning starting on July 1, 2023.
If the 180 days runs out before the FDA has made a decision about whether or not to approve a certain test, the manufacturer can continue to distribute the test with its EUA labeling - as long as they’ve sent a marketing submission for the test to the FDA and the agency has accepted the submission.
Because we’re talking about government regulations here, there’s obviously a lot of fine print to go with the overview above. For those who prefer to ingest info via slides and talking heads instead of paragraphs with lots of footnotes, FDA is holding a webinar about this guidance on April 18.
Commentary: This guidance is mostly consistent with the FDA’s previous comments on the transition away from EUAs, which is reassuring for companies with products under such authorization. The critical questions moving forward will be:
How quickly will the agency process COVID EUA-to-marketing-approval applications?
Will the bolus of applications from EUAs slow the process for other diagnostic test approvals?
How will the criteria for approval be applied to these tests?
How many of the existing EUA holders will go forward for marketing approval? (We suspect that many will not move forward.)
Lastly and most broadly: Will this process finally usher in a new era of home testing?
FDA: Getting good data from test to user is tough, but they’re working on it
Diagnostics are only useful if the info they provide gets to the folks who need to see and interpret the results. Those folks include not only health-care providers but researchers and public health officers, as well. (We like to call it the “So What” test: What changes as a result of the test’s result?) If chunks of that data don’t get transmitted, or if critical nuances disappear along the way, people’s health suffers and lives may be lost.
The FDA wants the world to know that it’s working to address this problem. Last Friday, it launched new web pages devoted to its Diagnostic Data Program, which has two arms: SHIELD (a long acronym that basically means getting diagnostics data from the test to the user without losing critical info), and Digital Diagnostics, which is trying to figure out how on earth we can effectively capture the data from over-the-counter and point-of-care tests. (The MakeMyTestCount.org website, run by NIH’s RADx program, is a start on the OTC front, but a lot more work clearly needs to be done on this area in general.)
Digital Diagnostics is just getting started - it was birthed out of the skyrocketing popularity of OTC and POC tests for COVID. SHIELD has been around since 2015, so this is not a new problem, but it’s clearly a tough nut to crack.
Oddly, the site references two 2022 articles that show how little the SHIELD program seems to have accomplished thus far: One estimates that lab data maintains between 22 and 68% integrity as it travels from source to user; the other puts the estimate at 59%.
Commentary: The proverbial proof is in the pudding. We applaud the effort - there is no doubt that “diagnostics is a data business with a wet lab on the side.” The question, at least when it comes to Digital Diagnostics, is about participation: What kind of incentives (and/or deterrents) can be put in place so that the data can be populated in a way that makes this system useful.
More and faster COVID testing saved lives - and could have saved many more
A study in the New England Journal of Medicine provided additional confirmation for what we’ve always said: COVID testing saved lives, particularly before vaccines were available. And where there was more testing, more lives were saved: This study found that in US nursing homes, before vaccines were available, doing one more test per staff member per week was associated with 26% fewer deaths among nursing-home residents. Shorter test turnaround (≤2 days as compared with ≥3 days) helped, too.
While that is an important finding, the impact of the tests that were NOT administered is tragic. According to the Washington Post’s analysis of the paper, if 1.1 million more tests had been done on nursing-home staff each week in the US between November 2020 and mid-January 2021, nearly 27,000 nursing-home residents’ lives would have been saved.
Clean indoor air matters. Some places are following up with action.
Commentary: The unsung, non-politicized hero-that-might-have-been of the COVID pandemic was ventilation and clean indoor air. As a primarily indoor species, we humans need to take to heart the lesson that this highly airborne virus taught us: Clean indoor air is as important to our health as clean running water. If you haven’t read it, take a look through the Lancet COVID-19 Commission Task Force’s report on the subject (it’s only three and a half pages long and is mostly bullet points, so you kind of have no excuse not to).
Two very different places, the state of Illinois and the nation of South Korea, have clearly taken at least a bit of the above lesson to heart. According to the Korea Herald, the South Korean government recently passed an updated school health act that “requires the installation of air-cleaning systems and air-quality sensors in classrooms, and allows the use of state funds to cover the costs.” In Illinois, more than 60,000 portable HEPA filters will be distributed to over 3,000 schools, primarily those “serving lower-income communities and counties with elevated air pollution counts.” (The schools won’t include Chicago, because of the quirks of federal funding.) We hope other US states will follow Illinois’ lead - and other countries will follow South Korea’s.
Food for Thought
Global health orgs call for One Health action to avert next health crisis
In a unique and urgent call to action, four global health organizations, the United Nations Food and Agriculture Organization (FAO), the UN Environment Program (UNEP), the World Health Organization (WHO), and the World Organization for Animal Health (WOAH) came together to call for aggressive action to “translate the One Health approach into policy action in all countries.”
What’s the One Health approach? The WHO explains it as “an integrated, unifying approach to balance and optimize the health of people, animals and the environment.” Back in October 2022, these four organizations issued a detailed, 86-page plan detailing exactly how they intend to put One Health into action around the world, with specific deliverables and timelines.
That plan’s action tracks include reducing the risk of zoonotic epidemics and pandemics, improving food safety, decreasing antimicrobial resistance (AMR), and better integrating the environment into the One Health approach, among other items. This week’s call to action focused on the “how,” urging folks in power to do things like “build intersectoral One Health workforces,” encourage and strengthen R&D and information exchange, and increase investment and financing so that One Health projects can be implemented.
Commentary: We don’t believe that we are going too far out on a limb to say that there will be another pandemic. So what can we do? We can maximize prep to minimize risk. In order not to be blindsided, we need to see the pathogen coming, and no one country can do it alone. We hope that the CDC’s One Health Office is well supported and the actions recommended are adopted.
The FDA issued one new de novo device authorization, two new EUAs, 36 amendments to existing EUAs, and no revocations in March. Data is available at TestingCommons.com
Device Classification Under Section 513(f)(2)(De Novo) (1):
New EUAs (2):
COVID Antigen: Biosynchronicity Corporation C-Sync COVID-19 Antigen Test
COVID Collection Kits: Quest COVID-19 Nucleic Acid Test Collection Kit
Amendments to Existing EUA’s (36):
COVID Molecular: 13
COVID Collection Kits: 2
COVID Antigen: 16
Respiratory multiplex (COVID and Flu): 5