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Biden administration announces plan to speed authorization of at-home Covid tests

Government health experts will work with test-makers and guide them through a streamlined FDA process as part of a new $70 million program.

The Biden administration on Monday announced several steps aimed at making rapid, at-home Covid testing more widely available while lowering costs.

The U.S. Food and Drug Administration is streamlining its authorization process, while the National Institutes of Health will spend $70 million on a new program to accelerate test-makers through those regulatory hurdles. The funds will come from the American Rescue Plan, the $1.9 trillion Covid relief package President Joe Biden signed into law in March.

The announcement comes as businesses prepare to implement Biden’s vaccinate-or-test mandate. The administration has for months faced criticism that at-home rapid tests are not widely available and that those on the market are too expensive.

The FDA also said Monday it has issued emergency use authorization to another over-the-counter rapid antigen test by the company Celltrion Diatrust, bringing the total number of rapid, at-home tests available to the public to 10.

The FDA is looking to make over-the-counter Covid-19 tests, like Abbott's BinaxNOW rapid antigen test, more widely available to the public.Julius Constantine Motal / NBC News

To increase that number, the NIH, FDA, the Centers for Disease Control and Prevention and the Department of Health and Human Services will work together to “help identify manufacturers of high-quality tests and encourage them to bring those tests" to market, according to details obtained first by NBC News.

HHS said in a statement that as part of the new program, government health experts will conduct studies on over-the-counter tests and work with the companies “to compile proper data, work towards the right benchmarks for performance and support other needs that will help ensure they are providing the best submissions possible for FDA’s regulatory review.”

“Working hand-in-hand with FDA, NIH will produce the precise data needed to make authorization decisions quickly,” NIH Director Francis S. Collins said in a statement.

HHS Secretary Xavier Becerra said that expanding the nation’s access to affordable, reliable at-home Covid tests “is key to bringing peace of mind to our families, especially as we approach winter.”

In September, Biden announced that he had asked the Department of Labor to issue an emergency rule requiring all employers with 100 or more employees to ensure their workforce is fully vaccinated or require any unvaccinated workers to produce a negative Covid test at least once a week.

That still-unpublished rule is expected to cover an estimated 80 million workers.

This month, the White House announced an additional $1 billion purchase of rapid, at-home coronavirus tests, while the FDA issued an emergency use authorization for a rapid antigen test from ACON Laboratories. Those moves were expected to significantly expand the nation's at-home testing capacity by December, according to the White House.

The White House also said at the time that it was continuing to work on addressing the issue of cost.

A nationwide survey released in February by Hart Research and the Harvard T.H. Chan School of Public Health found that 79 percent of adults would regularly test themselves at home if rapid tests cost a dollar. But only a third would do so if the cost were $25.