A couple weeks ago, I expressed some skepticism on whether LDTs would ever be regulated by FDA. Now I'm a little concerned that I may turn out to be too much of a cynic on this topic.
Today Congresswoman Louise Slaughter (NY's 25th District) issued a public letter to the White House's Office of Management and Budget (OMB) urging the office to release the LDT guidance documents FDA submitted back in 2010. I have to admit I was shocked by this event. Even during the last round of LDT discussions, this sort of public request from politicians did not occur.
While FDA is gaining some traction on this issue, the American Clinical Laboratory Association (ACLA) is working to proactively bat the issue down again. ACLA sent FDA a Citizen Petition requesting that FDA refrain from issuing any draft guidance or rules that purport to regulate LDTs as medical devices. Although much of the legal reasoning supporting the ACLA's position is fairly dated, I applaud their enthusiam.
I'm still not taking any bets or preparing to kick any footballs yet ... but I will stay closely tuned in to the discussion. I'm impressed that Dr. Gutierrez and other folks at FDA have managed to bring this issue back into the light.