An aide to Sen. Lamar Alexander, R-Tennessee, said the Obama administration made no such rule change. The aide, Taylor Haulsee, said the Obama administration did propose that the Food and Drug Administration have more oversight over approving diagnostic tests, but that did not go through.
“There has not yet been significant regulatory reform of diagnostics passed by Congress,” Haulsee said.
Alexander served as chairman of the Senate Committee on Health, Education, Labor and Pensions while those changes were being considered during the Obama administration.
A policy expert at the Association of Public Health Laboratories agreed with Haulsee’s assessment.
When asked about Trump’s remarks, Peter Kyriacopolous, chief policy officer at the association, said: “We aren’t sure what rule is being referenced.”
He added that “there was an intense interest from FDA to pursue regulation of lab-developed tests during the Obama administration, but it never occurred. FDA did a lot of work on this, but there never was a final rule that came out of all that work.”
The White House did not offer a comment when asked to explain why the President said it was an Obama-era decision.