Many public health experts say cheap, widely available at-home COVID-19 tests would help Americans safely return to normal activities and help control the spread of COVID-19. These tests are still hard to come by nearly two years into the pandemic, however, due to the pace of FDA authorizations and manufacturing bottlenecks, Kaiser Health News reported Nov. 22.
The FDA has authorized more than 400 COVID-19 tests for emergency use, including 12 over-the-counter rapid tests. The agency receives about 100 emergency use submissions for COVID-19 tests per month, most of which are not at-home tests. In total, the FDA has received more than 4,500 emergency use applications or requests related to testing, agency spokesperson Jim McKinney told Kaiser Health News.
While a March analysis found the agency's review time for emergency use applications has improved since the pandemic started, the FDA said it cannot work any faster as it balances the need to ramp up the nation's rapid testing capacity with the need to ensure the safety of any test that hits the market.
"The FDA carefully weighs the known and potential risks and … benefits of emergency use authorization for COVID-19 diagnostic tests based on sound science," Mr. McKinney told the publication.
Material and worker shortages are also causing manufacturing delays that keep the price of at-home tests high, Kaiser Health News reported. At present, costs range from $14 for a two-pack to more than $50 a test.
Last month, the White House announced a $1 billion investment to increase the nation's rapid testing supply, building on a $2 billion investment announced in September. The federal government said it expects to quadruple the nation's rapid at-home test supply by December.