WASHINGTON – Today AACC sent formal comments to the Food and Drug Administration (FDA) addressing FDA’s proposal for oversight of laboratory developed tests. AACC shares FDA’s goal of improving the safety and effectiveness of these crucial tests, but recommends that the agency protect patient access to the tests by limiting its oversight to high risk laboratory developed tests. AACC additionally recommends that the agency broaden its criteria exempting tests for rare diseases from its review process, and re-evaluate its proposal to require the discontinuation or FDA review of tests that fulfill unmet clinical needs once the agency clears or approves a similar commercial test.
There are many rare or new medical conditions for which no commercial test exists, and clinical laboratories have traditionally filled this void by creating medical tests in-house, known as laboratory developed tests. These tests fulfill a broad range of healthcare needs, from screening newborns for treatable genetic disorders to testing during the ongoing Ebola outbreak.
Laboratory developed tests are currently regulated by the Centers for Medicare and Medicaid Services (CMS) through an oversight process that AACC believes is sufficiently rigorous. In recent years, however, the number and complexity of laboratory developed tests has increased dramatically, leading FDA in October 2014 to release draft guidance proposing that high- and moderate-risk laboratory developed tests should go through the agency’s clearance or approval process. Under the agency’s proposed oversight framework, low-risk laboratory developed tests would also be subject to registration and listing with the agency, as well as adverse-event reporting.
After reviewing FDA’s draft guidance, AACC recommends that FDA limit its involvement with laboratory developed tests to joint oversight of the high-risk category with CMS. While FDA’s draft guidance does include plans to exempt certain tests for rare diseases from the review process, AACC believes the criteria for exemption are too narrow. If implemented, the FDA’s proposed criteria would exclude almost all newborn screening tests from the rare disease category. AACC is also concerned by FDA’s proposal to discontinue or review a test fulfilling unmet needs once a commercial test for the same condition is FDA-approved or cleared. This approach could stifle innovation and potentially diminish the quality of care given, because in many instances the laboratory developed test may be the more accurate test.
AACC and FDA share the goal of optimizing outcomes for patients whose conditions warrant the use of laboratory developed tests. To this end, AACC strongly recommends that the agency’s approach include gathering data on the laboratory developed tests that labs currently use before making decisions regarding its planned oversight framework.
“There seems to be a misunderstanding that laboratory developed tests are unregulated because the FDA is only using its ‘enforcement discretion’ for them,” said AACC CEO Janet B. Kreizman. “Laboratory developed tests are actually subject to a variety of oversight mechanisms at the federal and state levels and by professional accreditation organizations. AACC is concerned that duplicative, costly federal oversight could result in many laboratories discontinuing these tests, and patients not getting the proper care because a commercial test does not exist to meet their needs.”
Read AACC’s comment letter here.
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 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 breaking laboratory science. Since 1948, AACC 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.