Advocacy - Lab Advocate
On Friday, November 18, the Food and Drug Administration (FDA) informed Congress and the healthcare community that it would not finalize the draft guidance on laboratory developed tests (LDTs) prior to the new Trump Administration taking office. This is a near-term victory for the physician and clinical laboratory groups concerned that the proposed policy, if implemented, would result in many clinical laboratories discontinuing LDTs.
When announcing its decision, the FDA stated that it will outline a new “risk-based approach in the near future.” Given President-elect Trump’s call for reduced federal regulation, and congressional threats to stop the FDA from advancing this policy initiative, it is unlikely the agency will move forward with policy changes to LDT oversight without legislative authorization.
Over the past few years, AACC has urged Congress to develop a more flexible regulatory approach. AACC has met with lawmakers and staff to express its concerns regarding the impact of the draft guidance on test innovation and patient access to invaluable LDTs. As part of its advocacy efforts, AACC developed and circulated on Capitol Hill an alternative LDT regulatory approach to replace the FDA’s one size fits all model.
The 115th Congress is likely to discuss LDTs after it convenes in January. Key leaders, such as Rep. Fred Upton (R-MI) and Senator Lamar Alexander (R-TN), chairs of the respective oversight committees, have already indicated support for a legislative fix to the LDT issue. AACC will remain engaged in this process as Congress, government agencies and other stakeholders seek to find a reasonable solution.