Source : Medtech Insight
Top US House Democrats have asked the Department of Health and Human Services (HHS) to reverse a Trump administration policy to stop the Food and Drug Administration from reviewing COVID-19 laboratory developed tests (LDTs).
Energy and Commerce Committee chair Frank Pallone Jr., D-NJ, health subcommittee chair Anna Eshoo, D-CA, and oversight and investigations chair Diana DeGette, D-CO, wrote to HHS secretary Xavier Becerra on 11 May to end the policy instituted by his predecessor, Alex Azar.
“Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliability of diagnostic tests.” – Frank Pallone, Anna Eshoo & Diana DeGette
The FDA in February 2020 issued a guidance stating developers of COVID-19 LDTs would have to file for, and receive an emergency use authorization (EUA) from, the agency. Then, in August, Azar instituted a policy barring the regulatory agency from overseeing LDTs. In response, the FDA under former commissioner Stephen Hahn said it would no longer accept EUAs for COVID-19 LDTs, essentially shutting such tests out of the market. ()
The Trump administration circumvented the issue by handing over regulatory responsibilities for overseeing COVID-19 LDTs to the National Cancer Institute, which in turn contracted out the job to NDA Partners, a third-party contract-development organization.
Since then the HHS has been criticized for hindering the FDA from regulating the products, and stakeholders, including the Pew Charitable Trust, has urged Becerra to reverse Azar’s decision. MT143868
“Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliability of diagnostic tests,” the Democratic leaders said in their letter. “In the midst of a viral pandemic, this responsibility should not be handed off to an obscure federal contractor or a different enterprise within the federal government.”
The congressional leaders note that the decision to stop the FDA from regulating COVID-19 LDTs is still in effect despite objections from agency career scientists and public health experts, and needs to end.
“Access to accurate diagnostic tests is a vital piece of our ongoing effort to stop the spread of COVID-19 and eventually ending the pandemic,” the lawmakers wrote. “We therefore request that you immediately reverse the Trump administration’s shortsighted policy, and restore FDA’s premarket review authority and oversight over COVID-19 LDTs.”
By Ferdous Al-Faruque