HHS Secretary Alex Azar accused of overruling FDA on COVID-19 test quality reviews

pharmafile | September 16, 2020 | News story | Research and Development COVID-19, FDA, US, USA 

Allegations have emerged accusing US Health and Human Services Secretary Alex Azar of overruling the FDA over the review of COVID-19 testing kits amidst a pandemic which has so far killed almost 200,000 Americans.

Seven officials working for the administration both currently and in the past have alleged that the HHS Secretary moved in late August to revoke the FDA’s ability to evaluate the quality of “lab-developed” tests for a range of diseases including COVID-19, as reported by Politico. The move is intended to increase flexibility for health labs to make tests available through the market.

FDA Commissioner Stephen Hahn had opposed the move because of the risks posed by the availability of unverified and potentially inaccurate tests during an ongoing pandemic, which could mean it complicates the US’ ability to respond to the virus’ spread.

Four of the officials corroborated that this disagreement even led to “screaming matches” between the Commissioner and HHS Secretary, while Director of the Center for Devices and Radiological Health Jeffrey Shuren was locked out of meetings leading up to the policy decision.

These claims were dismissed by HHS Chief of Staff Brian Harrison, who said that: “Every interaction between the secretary and commissioner has been highly professional.”

In a statement, Harrison defended the policy change: “Primarily, it was our lawyers advising us that this requirement was illegal,” explaining the decision to neuter the FDA’s review powers. “Additionally, everyone would agree that at the beginning of a pandemic we need to maximise the development of quality diagnostics as fast as possible.”  

However, a review published this month in The New England Journal of Medicinerevealed that 82 of 125 tests submitted to the FDA were found to present “design or validation problems”, while the agency was forced in April to recall a number of inaccurate tests that had hit the market. 

Matt Fellows

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