WASHINGTON – The U.S. Food and Drug Administration (FDA) issued its long-awaited proposal on October 3 for overseeing laboratory developed tests—medical tests that are created and used within a single lab, and often developed to fulfill unmet clinical needs. AACC is concerned that this guidance could hinder the ability of labs to provide physicians with the vital information they need to treat patients, and has joined the American Medical Association (AMA), American Hospital Association (AHA), and 48 other major healthcare organizations in requesting that FDA withdraw the draft guidance documents and re-issue them through the rulemaking process required under the Administrative Procedures Act.

Laboratory developed tests enable the clinical laboratory community to respond quickly to the world’s changing healthcare needs, such as during global health crises like HIV and SARS when laboratory developed tests were the first tests created to diagnose these conditions. There are also many rare diseases and health disorders for which no FDA-authorized test exists and that labs can only diagnose by designing laboratory developed tests. In recent years, however, the number and complexity of laboratory developed tests has increased dramatically, and laboratory developed tests are now competing with FDA-approved tests without clinical studies to support their safety or effectiveness. In response to this trend, FDA has proposed clearing or approving certain laboratory developed tests to ensure that they do not give incorrect diagnoses that result in patient harm.

After reviewing FDA’s draft guidance detailing this proposal, AMA has written a letter that AACC, AHA, and numerous other major healthcare organizations have signed urging the agency to withdraw this guidance and resubmit it through notice and comment rulemaking as required under the Administrative Procedures Act. Using the current guidance process, FDA does not have to publicly respond to comments nor conduct an economic impact analysis of the proposal—both of which inform policymakers and stakeholders as to the basis and consequences of FDA’s actions. In contrast, the Administrative Procedures Act’s rulemaking process recommended in the letter would require the agency to respond to all concerns with its proposed laboratory developed tests oversight, and undertake an economic impact analysis to assess the estimated burden this oversight would place on physicians, clinical laboratories, and hospitals.

“Laboratory developed tests play a significant role in getting patients essential medical care by providing timely, accurate, quality diagnoses when an existing test does not meet current clinical needs,” said AACC CEO Janet B. Kreizman. “AACC fully supports AMA’s recommendation that FDA re-issue its laboratory developed tests draft guidance in compliance with the Administrative Procedures Act’s notice and comment rulemaking process. This will help to ensure that any changes in the regulatory oversight of these important tests are only made after the agency considers input from the broad array of healthcare stakeholders that will be affected.”

AACC will soon release an official statement detailing the association’s position on and recommendations for the regulation of laboratory developed tests.

About AACC

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.