People wait in line as city workers hand out take-home COVID-19 tests in lower Manhattan.
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- Former Biden advisory member Dr. Celine Gounder told “Meet the Press” the FDA has “dragged its feet” in authorizing rapid antigen tests.
- She said shifting guidelines from the CDC and FDA are contributing to public confusion around prevention of the omicron variant.
- The FDA is required to authorize rapid tests before the CDC can recommend their use to quickly detect contagious individuals.
Dr. Celine Gounder, a former advisory board member to the Biden Administration, is speaking out about how organizations like the US Food and Drug Administration are contributing to public confusion around COVID-19 guidelines.
Speaking on NBC’s “Meet the Press” on Sunday, Gounder said that while the CDC has issued unclear guidance in recent weeks on how to prevent the spread of the omicron variant, there are “many other parties that contributed to this issue” — namely the FDA.
“The FDA under both the Trump and Biden administrations has really dragged its feet on authorizing these rapid antigen for the purpose of assessing ‘are people contagious or not,” Gounder said on Sunday.
The CDC recently faced criticism for shifting its recommended isolation time periods, changing its guidance from 10 days to five days at the end of December. On Tuesday, the CDC said the “best approach” is to use a rapid antigen test toward the end of an isolation period, but stopped short of requiring a negative test to end isolation.
Similar to vaccines, the use of antigen tests to determine contagiousness must be authorized by the FDA before the CDC can formally include it in its isolation guidelines. Experts are advocating for rapid antigen tests as a good measure of whether a person is infected with COVID and contagious, Gounder said on Sunday, but the FDA has not yet approved them for that purpose.
“We have real world evidence that the rapid antigen tests are a good measure of contagiousness but the FDA has not authorized them for that purpose,” Gounder said on “Meet the Press.”
Still, the FDA has made significant moves in the fight against COVID in the past two months, including authorizing pills from Pfizer and Merck to treat COVID-19 and approving the vaccine booster shot for children ages 12 and up.
Gounder also pointed out that the White House and private manufacturers could have been better prepared for the holiday season by place a large volume order of rapid test in advance to create a “stabler demand.”
President Biden announced plans in late December to provide 500 million free at-home COVID tests to help fight the Omicron surge, but Americans are still struggling to find COVID tests, as they scour empty shelves at pharmacies or navigate lengthy lines at testing sites.
“The one and only thing you can count on is that the recommendations and guidelines are going to change over time,” added Gounder.