Healthcare organizations are uniting in opposition to the U.S. Food and Drug Administration (FDA) proposal for overseeing laboratory-developed tests (LDTs)—medical tests created and used within a single lab and often developed to fulfill unmet clinical needs. The American Association for Clinical Chemistry (AACC) recently expressed concern that the FDA guidance could hinder the ability of labs to provide physicians with the vital information they need to treat patients, and it has joined the American Medical Association (AMA), American Hospital Association (AHA), and 48 other major healthcare organizations in signing a letter requesting that FDA withdraw the draft guidance documents and re-issue them through the rulemaking process required under the Administrative Procedures Act.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 of the basis and consequences of FDA’s actions. In contrast, the Administrative Procedures Act’s rulemaking process 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.
LDTs enable the clinical laboratory community to respond quickly to the world’s changing healthcare needs, such as during global health crises such as HIV and SARS; LDTs 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 LDTs. In recent years, the number and complexity of LDTs has increased dramatically, and they are now competing with FDA-approved tests without clinical studies to support their safety or effectiveness. It is in response to this trend that FDA has proposed clearing or approving certain LDTs to ensure that they do not give incorrect diagnoses that could result in patient harm. The healthcare organizations acknowledge this issue, but do not approve of FDA’s proposed policy. Read FDA’s draft guidance.
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