Dive Brief:

• The Biden administration came under fire from Democratic and Republican senators during a Tuesday hearing on the federal coronavirus response for not doing enough to increase the availability of COVID-19 tests as cases of the omicron variant continue to surge across the country.   
• Janet Woodcock, the FDA's acting commissioner, said in her testimony that two of the agency’s recent emergency clearances for Roche and Siemens alone may result in up to 400 million more at-home tests available monthly to American consumers by early 2022. However, Sen. Richard Burr (R-N.C.), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, countered that America's testing system is "broken" and the administration is "struggling to buy" the 500 million rapid COVID-19 tests that President Joe Biden last month promised to ship for free to Americans starting in January.  
• Dawn O'Connell, assistant secretary for preparedness and response at HHS, testified that the administration is investing over $3 billion to acquire the 500 million over-the-counter tests, with the initial batch expected to be available this month. Burr criticized the administration for "going to distributors trying to buy their inventory, not to manufacturers." O'Connell, however, countered that initial distributor contracts will soon be followed by deals with as-yet-undisclosed test manufacturers that will quickly ramp up capacity.  

Dive Insight:

Despite recent initiatives announced by the Biden administration, the U.S. continues to struggle with a COVID-19 testing shortage as the fast-rising omicron wave continues to outpace capacity. O'Connell acknowledged in Tuesday's hearing that climbing cases of omicron have "put a significant strain" on America's testing supply.

"There's more work to do," O'Connell testified, noting that the administration will "continue to use the Defense Production Act authorities when needed" to further increase test availability. "We're in the process of procuring the 500 million tests which every American household will be able to order [for free] and have shipped directly to their house. We have completed four contracts so far and have secured 50 million tests."

Among the government contracts granted to distributors last week was a $51.6 million award to Goldbelt Security LLC in Newport News, Virginia, to purchase COVID-19 antigen over-the-counter test kits in support of Biden's goal of distributing 500 million free at-home tests. That contract, and others to distributors, were funded through the American Rescue Plan Act.

"We worked with warehouses to see where additional tests were stored ... and are bringing that capacity to bear for these initial [50 million tests] that are going out, which is why you're seeing contracts with warehouses and not test manufacturers," O'Connell told the senate hearing.   

However, Burr and other senators at Tuesday's hearing criticized the Biden administration for not moving fast enough to secure the tests. 

"We're now three weeks since the President said we're going to buy 500 million tests. We have 50 million currently contracted," Burr said. "We're here to support. What you need, tell us. But don't think that we're just going to sit here and print money without a full accountability of where it has gone."

Sen. Patty Murray (D-Wash.), chair of the Senate HELP Committee, voiced her concerns that despite the U.S. currently producing 300 million rapid at-home tests per month the country is facing serious shortages.

"People are unable to find the at-home tests in pharmacies [and] online, and they are waiting in long lines and often after that waiting days for results," Murray said. "The fact is that it appears the administration simply failed to anticipate our testing needs."

Among the test manufacturers mentioned by Murray during Tuesday's hearing was Abbott Laboratories. Last year, Abbott laid off a total of about 400 workers at two manufacturing sites in Maine, a casualty of an earlier steep decline in demand for the company's COVID-19 tests. The company also closed its Gurnee, Illinois, facility where COVID-19 tests were made, letting go about 2,000 workers. 

Abbott this month said it will manufacture 70 million BinaxNOW rapid tests in the U.S. with plans to increase that output. CEO Robert Ford, who spoke Tuesday at the J.P. Morgan healthcare conference, said that the company is producing more than 100 million tests per month globally. The test maker is seeing a "very big surge" in testing in the U.S. and internationally, Ford said, noting that "it's a challenge to forecast."

The recent emergency authorizations the FDA granted to Roche and Siemens for their respective rapid antigen self-tests were secured through their participation in the NIH Rapid Acceleration of Diagnostics' Independent Test Assessment Program (ITAP). The program was created to help streamline the evaluation and clearance of antigen tests with the potential for large-scale manufacturing.

Woodcock testified on Tuesday that the FDA will continue to prioritize the assessment of authorization requests for at-home antigen tests and expects to "continue shorter review times for such EUA requests due to our partnership with ITAP." Woodcock noted that the Roche and Siemens diagnostics were the first two tests to participate in the program and were authorized in two days or less once the FDA received the final data.

Woodcock told the senators that, so far, the FDA has determined that currently authorized at-home tests "are picking up omicron but right now with less sensitivity than they do some of the other variants."