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Source: United States House of Representatives – Congresswoman Diana DeGette (First District of Colorado)

WASHINGTON, DC – U.S. Rep. Diana DeGette (D-CO), chair of the House Energy and Commerce Committee’s Oversight and Investigations panel – which directly oversees the Dept. of Health and Human Services and the Food and Drug Administration – sent a letter today to HHS Secretary Alex Azar raising serious concerns over the agency’s decision to allow laboratory-developed tests, or LDTs, for COVID-19 to be used throughout the country without FDA review. 

The letter – which DeGette sent along with U.S. Reps. Frank Pallone Jr. (D-NJ) and Anna Eshoo (D-CA) – comes in response to the FDA’s recent announcement that it will no longer be reviewing laboratory-developed tests to determine their accuracy for detecting COVID-19, even if the lab that developed the tests requests such a review.

The FDA’s decision to no longer review the tests to ensure their reportedly came directly from Azar, who President Trump appointed to run the nation’s health agency.

“For months, the Administration has failed to take responsibility for developing and implementing a national [COVID-19] testing strategy, which has resulted in uncontrolled spread of the virus and continuous supply chain problems,” DeGette and others wrote.  “We now believe you have once again committed a grave error in overruling objections of career scientists at [FDA] by announcing that HHS would allow marketing of [LDTs] without FDA review. This new policy, which was made without prior notice or warning, could lead to numerous faulty tests on the market, raising serious concerns about the reliability of tests used to detect COVID-19.”

Until now, the FDA has historically required laboratories to seek authorization prior to marketing tests it develops during a public health emergency, such as the ongoing COVID-19 pandemic. 

According to an article that two top FDA officials – Jeff Shuren and Timothy Stenzel – recently published in the New England Journal of Medicine, many of the laboratory-developed tests the FDA has reviewed for COVID-19 have had performance problems or were poorly validated. 

The officials also noted that out of the 125 Emergency Use Authorization requests the agency has received for such tests, FDA identified problems with 82.

“We are disappointed that rather than follow this safer, more constructive approach, political leadership at HHS has chosen a reckless path, removing the requirement for LDTs to receive any review by FDA prior to their use during the worst pandemic of our lifetimes,” the lawmakers wrote.  “This decision will increase the chances of false negative results, endangering countless lives, and weakening our understanding of COVID-19 as we head into fall and winter.”

To read the full letter, click HERE.

MIL OSI USA News