The Washington Legal Foundation (WLF), a public-interest law and policy center, has challenged FDA’s authority to regulate laboratory developed tests (LDTs), as well as FDA’s proposed method of changing its regulations governing analyte specific reagents (ASRs), which are components of LDTs. LDTs are commonly referred to as "home brew" assays.
At the center of debate are two draft guidance documents FDA issued on September 7, 2006: (1) Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays (the IVDMIA Draft Guidance); and (2) Draft Guidance for Industry and FDA Staff: Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (the ASR Draft Guidance). Earlier this month, WLF filed comments pointing out the illegalities of both draft guidance documents.
Laboratories are regulated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988. LDTs, which are developed by and used in a particular laboratory, have not been regulated by FDA. In the IVDMIA Draft Guidance, however, FDA creates a new category of LDTs, and declares that IVDMIAs are medical devices subject to FDA regulation. At a Febryary 2007 FDA public meeting, WLF asserted that FDA’s regulation of IVDMIAs as medical devices is contrary to law. Independent of the IVDMIA Draft Guidance, in September 2006, WLF filed a citizen petition requesting that FDA not regulate LDTs as medical devices. The petition raises many legal issues not addressed in the IVDMIA Draft Guidance.
In response to the ASR Draft Guidance, WLF argues that FDA’s proposed regulatory activity violates the Administrative Procedure Act and the First Amendment. The ASR Draft Guidance introduces new characteristics that products must have in order to be considered an ASR. WLF’s comments point out, however, that these characteristics are not included in, and actually conflict with, FDA’s existing regulations. WLF argues that the ASR Draft Guidance represents a substantive change to FDA’s regulations, and that these changes can only be made through notice and comment rulemaking. Additionally, WLF asserts that the ASR Draft Guidance violates the First Amendment rights of ASR manufacturers by restricting commercial speech.
WLF and numerous other stakeholders have submitted comments on both draft guidance documents.