The Association for Diagnostics & Laboratory Medicine (formerly AACC) opposes FDA ruling on laboratory developed tests; urges FDA to involve all stakeholders in modernization of laboratory developed test regulation in order to improve patient care

WASHINGTON — Statement attributable to: Octavia Peck Palmer, PhD

President, Association for Diagnostics & Laboratory Medicine (formerly AACC)

“We at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) strongly disagree with the Food and Drug Administration’s (FDA’s) decision to issue a final rule placing laboratory developed tests under duplicative FDA authority, in addition to these tests’ current regulation under the Centers for Medicare & Medicaid Services (CMS). We agree with the FDA that laboratory developed tests have evolved since the CMS regulations for them were first implemented and that it would benefit patients to modernize these standards. However, the best way to achieve optimal patient health is not through unilateral rulemaking, but by having a broader dialogue that involves all stakeholders, including CMS and the expert lab directors who oversee the high-complexity labs where laboratory developed tests are created. Only by having a collaborative discussion can we craft thoughtful and sensible updates to laboratory developed test regulations that advance patient safety while also safeguarding patient access to these essential tests.

“As it stands, the FDA’s rule would limit patient access to laboratory developed tests. For example, a provision in the rule will phase out the agency’s general enforcement discretion approach for laboratory developed tests over the course of 4 years. After this phaseout, the FDA will require laboratory developed tests to meet the agency’s regulatory standards. However, this timeframe is unrealistically fast. The FDA does not currently have the bandwidth to regulate laboratory developed tests and 4 years is not enough time for the agency to hire the staff needed to take on this additional responsibility. As a result, once the phaseout period ends, labs will be faced with significant delays in getting FDA authorization for their laboratory developed tests. This in turn will lead to patients not getting the diagnoses and care they need.

“The FDA’s final rule also proposes grandfathering in laboratory developed tests that were first performed prior to the rule’s date of issuance, which would exempt these tests from the agency’s regulatory requirements. While we appreciate the intent of this provision to permit continued access to these tests, we are concerned that if enacted, it may have unintended consequences, such as stifling innovation. The clinical laboratory community has historically been quick to respond to changing clinical needs. However, the grandfathering provision may discourage labs from modifying their laboratory developed tests or introducing new and better testing services to replace grandfathered tests, since the new tests would then be subject to additional oversight.

“These are just our initial concerns about the FDA’s rule — concerns that can’t be effectively addressed until the FDA engages in a true collaborative discussion with the whole laboratory community. We strongly urge the agency to bring up this issue with the Clinical Laboratory Improvement Advisory Committee (CLIAC) — which is comprised of a wide variety of stakeholders and therefore serves as a good venue for discussing changes to the current laboratory standards — and we look forward to working with the FDA and CLIAC to update laboratory developed test regulation so that it mproves patient care rather than hindering it.” 

To speak to Dr. Peck Palmer about this issue, please contact Molly Polen, ADLM Senior Director of Communications & PR, at [email protected] or 202-420-7612.

About the Association for Diagnostics & Laboratory Medicine (ADLM)

Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.