FDA Takes “Several Months” to Approve Manufacturers’ “Rapid” Test Applications

(p. A1) As rising Covid-19 infections stoked demand for tests across the U.S. in December, California-based LumiQuick Diagnostics Inc. shipped 100,000 rapid tests to a hospital customer—in Germany.

LumiQuick didn’t receive authorization from the Food and Drug Administration to sell Covid-19 tests domestically after waiting several months for a decision.

Some public-health experts said the relatively strict review process is part of a broader failure by U.S. officials and manufacturers to make and distribute enough rapid tests to track the pandemic adequately. Nearly two years into the pandemic, people have struggled to find tests during the holiday season as infections surge again, fueled by the highly infectious Omicron variant.

. . .

(p. A4) “We’ve never gotten the testing situation well instituted in our country,” said Ezekiel Emanuel, co-director of the Healthcare Transformation Institute at the University of Pennsylvania, and a former member of the Biden administration’s disbanded coronavirus advisory board.

. . .

Some U.S. manufacturers said the FDA’s slow review of new rapid tests discouraged them from making products that they weren’t sure they would be able to sell in the U.S. “Without approval we cannot commit,” said Frank Wang, chief executive officer of BioMedomics Inc., a North Carolina manufacturer that applied for authorization in March. The company has sold some tests outside the U.S.

Another test maker, Kaya17 Inc., said it has been waiting on FDA approval for months. “The FDA has to up their game and move faster,” said Sulatha Dwarakanath, the company’s CEO.

For the full story, see:

Austen Hufford and Brianna Abbott. “Slow Test Approvals Blamed for Shortage.” The Wall Street Journal (Friday, Dec. 31, 2021): A1 & A4.

(Note: ellipses added.)

(Note: the online version of the story has the date December 30, 2021, and has the title “Covid-19 Rapid Test Shortages Tied to Slow Federal Action.” The online version says that the title of the print version is “Tests in Short Supply as Approvals Lag.” But my print version (probably the Central Edition) has the title “Slow Test Approvals Blamed for Shortage.”)

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