Advocacy - Lab Advocate
On September 20, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing, “Laboratory Testing in the Era of Precision Medicine,” which explored the potential impact on precision medicine of the Food and Drug Administration (FDA) draft laboratory developed test (LDT) guidance. The agency proposes to regulate LDTs through its medical device review process. Many groups and individuals have raised concerns about this approach, including HELP Chair Senator Lamar Alexander (R-TN).
In opening remarks, Chairman Alexander suggested that the adoption of the FDA guidance would result in the “double regulation” of LDTs, since the Centers for Medicare and Medicaid Services already regulates LDTs under the Clinical Laboratory Improvement Amendments (CLIA). He added that the costs and regulatory burdens associated with the policy may force many healthcare institutions to stop performing LDTs. If implemented, the “biggest loser,” according to the Chair, would be “Americans who stand to benefit from the rapid pace of science and discovery.”
Two witnesses agreed with Senator Alexander’s concerns. David Klimstra, MD, representing Memorial Sloan Kettering Cancer Center, testified his institution performs nearly 350 LDTs that are invaluable for detecting cancer and ensuring that patients receive the right therapies “as first-line treatments.” He expressed concern that the “costs of FDA regulations, along with the delays they will entail, would simply prevent” his institution from continuing to provide these tests.
Similarly, Karen Kaul, MD, PhD, representing NorthShore University Health System in Chicago, stated that LDTs are continually being updated to reflect new scientific knowledge. She suggested that many LDTs going through the medical device review process would be obsolete “at the time of FDA approval.” Dr. Kaul supported maintaining CLIA as the primary vehicle for regulating LDTs, since labs have “a long history” of operating under the standards and the process “allows a greater flexibility and faster responsiveness to new tests” than the FDA model.
AACC shares the concerns of Chairman Alexander and the witnesses. AACC reiterated its support for upgrading the CLIA regulations to address concerns regarding LDT oversight. The association has also endorsed legislative efforts to suspend FDA work on the final FDA guidance pending congressional action. AACC will continue to work with legislators and other professional societies to ensure that laboratory professionals can continue to provide high quality, vital LDTs to their patients.