Biden administration moves to make at-home COVID-19 tests more available

The Biden administration announced on Monday its plan to make rapid, at-home COVID-19 tests cheaper and more available through an accelerated Food and Drug Administration (FDA) authorization process.

The National Institutes of Health (NIH) plans to commit $70 million from the American Rescue Plan to boost the number of over-the-counter at-home COVID-19 tests on the market. 

Under this strategy, the Department of Health and Human Services (HHS) plans to prioritize FDA authorization applications for COVID-19 tests from companies that “have the potential for manufacturing at significant scale.”

“The goal is to accelerate the availability of more high-quality, accurate and reliable over-the-counter tests to the public as quickly as possible,” HHS said in a release. 

Working with the FDA, the NIH’s Independent Test Assessment Program intends to select manufacturers capable of producing high volumes of COVID-19 tests and urge them to bring tests to the U.S. market to open up options for Americans, including potentially more affordable choices. 

Experts from the FDA, NIH, HHS and the Centers for Disease Control and Prevention aim to analyze and conduct studies on these tests and cooperate with companies to collect the necessary data for an FDA emergency authorization application.

The investment will help provide the FDA with the “precise data needed to make authorization decisions quickly,” NIH Director Francis Collins said. 

The FDA has also issued recommendations to streamline the authorization process for companies whose tests are currently approved for repeated serial testing to get these tests endorsed for single-use without requiring more data.

Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, said the streamlined policies will help attract more companies to the U.S.

“The most important step recently has been the money that the government has pumped into and continues to put into testing,” he said. “I think … the actions today are complementary to that and can expedite the assessment of candidates for over-the-counter tests.”

HHS Secretary Xavier Becerra said in a statement that cheaper COVID-19 tests could be “key to bringing peace of mind to our families, especially as we approach winter.”

“As we pursue our path out of this pandemic under President Biden, we will continue doing everything we can to keep people safe and healthy,” he said.

The announcement comes weeks after the White House declared the U.S. is on track to quadruple its at-home rapid test supply by December. 

The need for testing is also expected to jump once the administration’s vaccinate-or-test rule goes into effect for businesses with at least 100 employees.

Last month, Biden requested the Department of Labor develop mandates that unvaccinated workers get a COVID-19 test at least once a week.

Experts have previously called on the administration to improve the accessibility and affordability of rapid, at-home tests, saying the lack of available tests hinders the country’s pandemic response.

Last week, the FDA gave an emergency use authorization for a rapid, at-home test to the company Celltrion DiaTrust for its antigen test.

Updated on Oct. 26 at 8:49 a.m.