Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT).  First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs.  This guidance marked a significant shift in the regulation of LDT as FDA has chosen not to exercise regulatory oversight or enforcement over LDTs. In statements released to media outlets, the FDA suggests the delay is in part “to work with stakeholders, our new Administration, and Congress to get our approach right.”  This decision was in stark contrast to FDA’s consistent position to finalize the regulations before the current Administration hands over power at noon on January 20, 2017.

The decision to not finalize the guidance drew praise from congressional republicans. House Energy and Commerce Chairman Fred Upton (R-MI) and Commerce, Manufacturing and Trade Subcommittee Chairman Dr. Mike Burgess (R-TX), lauded the move saying “[the] committee has consistently believed that applying medical device regulations to LDTs via non-binding guidance documents is not the best approach.”  Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN) also supported FDA’s decision. Not all stakeholders were pleased by the decision, however.  The American Cancer Society Cancer Action Network said in a statement, “without such regulation, patients and their providers may not be able to have confidence in the quality and veracity of test results to make critical decisions.”

Delaying this guidance may have marked its demise. A deal on 21st Century Cures legislation is rumored to be nearing completion, which may obviate the need for, and/or outright prevent, the finalization of the LDT guidance. If “Cures” doesn’t end it, there likely is little chance that the still republican-controlled 115th Congress will support the guidance.  Moreover, it is unlikely that the incoming Secretary of Health and Human Services will move forward with the draft as written.

Given the critical importance of LDTs, the Cooley team will continue to closely monitor regulatory and legislative developments in this area.

Posted by Vince Sampson