Posted on March 5, 2020
WASHINGTON, March 5, 2020 — United States Senator Lamar Alexander (R-Tenn.) today released the following statement regarding a CNN story related to the Administration’s response to coronavirus:
“President Trump and Commissioner Hahn are accurate when they say that in the last week the Food and Drug Administration changed its policy to allow more and faster diagnostic testing for the coronavirus so that more labs around the country can conduct these necessary tests. Yesterday, CNN asked whether Congress had changed the rules regarding diagnostic testing and my staff answered that it had not. But that has nothing to do with the fact that the FDA in the last week changed its policy to allow more and faster diagnostic testing for the coronavirus so that more labs around the country can conduct these necessary tests.”
Below is the reporter’s question submitted to Alexander’s press office, followed by Alexander staff’s response:
Years ago, Sen. Alexander was instrumental in the consideration of changing certain regulations about laboratory testing.
As far as we can tell from the attached article and other sources, those proposed changes did not go through. Could you tell us if we have that right?
Unfortunately, we’re on a tight deadline. Would you be able to answer quickly? It’s hopefully easy – just wondering if these proposals passed or not.
No problem and you’re correct, there has not yet been significant regulatory reform of diagnostics passed by Congress.
So you have, here’s some information on the Health committee hearing on FDA guidance when it came out: https://www.help.senate.gov/hearings/laboratory-testing-in-the-era-of-precision-medicine
In 2016, Sen. Alexander had a legislative proposal to reform laboratory developed tests. That proposal did not pass Congress.
In an effort to help a reporter accurately report the news, staff informed the reporter that no proposals to change laboratory developed tests had been passed by Congress. Nowhere in the brief email exchange are Trump, Obama, or FDA regulatory policy mentioned.
It was surprising to see a story published indicating that Alexander staff disagreed with the president’s statement about a new FDA policy to expedite testing of the Coronavirus and that our office had weighed in on differences between the Obama Administration and the Trump Administration regulatory policy on laboratory developed tests.