As the FDA works away on final guidance for regulating LDTs, various professional groups unhappy with the course of the FDA have put together and hurried their own proposals up to Captiol Hill. The Diagnostic Testing Working Group (DTWG) has had their proposal drafted into legislation which has already been revised once in the House Energy and Commerce Committeee, while proposals from the College of American Pathologists (CAP) and the Association of Molecular Pathology (AMP) have been presented to both the Senate and the House. Various other groups, including the American Medical Association (AMA) and the American College of Medical Genetics (ACMG), have either signed on in support of one of these proposals or are independently lobbying Congress as well.
What chance do these organizations have at persuading Congress to step in and change the course of LDT regulation?
Here to help us parse through these options and get a sense of congressional reception is Scott McGoohan, the new Director of Science and Regulatory Affairs at BIO. Scott says that all of the proposals fit into “three buckets:”
First, there’s the guidance that the FDA is working on which will bring regulatory oversight to thousands of tests which heretofore have not been regulated.
Second, there’s the CAP and AMP proposals which call for the modernization of CLIA which will include increased oversight of laboratory developed tests. These proposals reserve a small set of high risk tests for FDA oversight.
And third, there’s the DTWG who are hoping to get Congress to establish a new center at the FDA for all in vitro diagnostics.
One thing is for sure, says Scott. Whichever proposal wins out, “the general sense is that there will be a change coming with increased regulatory standards for laboratory developed tests.”
Scott joins BIO at a very busy time in Washington for biotech policy. The House has passed the 21st Century Cures Initiative and the Senate Help Committee is doing active work on their health innovation agenda.
“It is an incredible time [in Washington] and an incredible opportunity for transformative regulatory change,” says Scott.
Certainly not all regulatory change is transformative, as Scott reminds at the conclusion of today's show with a story about a crazy bill in Wisconsin.