IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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REGULATIONS & STANDARDS The Long and Winding Road to FDA Regulation of LDTs Te role of lab-developed tests has increased substantially since FDA frst mentioned regulating them 21 years ago. BY JEFFREY N. GIBBS Over the years, FDA's regulation of in vitro diagnostics (IVDs) has raised many policy issues. Some are short-lived and quickly resolved, such as the creation of the Analyte Specifc Reagent (ASR) regulation, and the subsequent guidance which curtailed the distribution of ASRs. Other policy issues have remained open for decades. Te regulation of laboratory developed tests (LDTs) falls into the latter category. FDA frst asserted it could regulate LDTs in 1992. Tat assertion was controversial then, and is at least as controversial today. During this 21-year period, there have been prolonged lulls, where the issue remains unresolved but simply does not receive much attention. At other times, the issue fares up. Tis is one of those times, as highlighted by the July 7, 2013, editorial in the New York Times saying, "Regulations are long overdue." It is uncertain how this issue ultimately will be resolved. Looking at past regulatory initiatives, though, does provide some insight. So, too, does looking at a seemingly unrelated arena: FDA's eforts to regulate pharmacy compounding. Background Laboratories, of course, were in existence well before 1976. Te Medical Device Amendments of 1976 were silent on the subject of regulating laboratories. Congress explicitly conferred authority on FDA to regulate devices used by laboratories, but the statute said nothing about FDA regulating laboratories themselves. In 1988, Congress did enact legislation aimed at laboratories: the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Tis legislation, which amended a much weaker existing law, created an elaborate regulatory structure for laboratories. While the impact of CLIA on FDA's authority to regulate laboratory tests has been debated, it is clear that the 1988 legislation did not bestow regulatory authority over laboratories to FDA. Te frst mention of FDA's power to regulate laboratories appeared in an unexpected source: a draft FDA compliance policy guide regarding the regulation of Research Use Only (RUO) products. Although the focus of the docu- ment was RUO products, FDA inserted a comment, almost as an aside, that it could regulate LDTs. (At the time, LDTs were more commonly called "home brews." Because of its negative connotation, the term has been replaced by LDTs.) Te issuance of the draft guidance prompted a citizen petition, which I fled on behalf of some laboratories challenging FDA's claim that it could regulate LDTs.1 Te petition challenged FDA's assertion on a variety of grounds. After this burst of activity, quiescence reigned for fve years. Ten, in 1996, FDA published the proposed ASR regulation. Although the ASR proposal itself only covered products sold to laboratories, FDA reasserted in the preamble its authority to regulate laboratories.2 At the same time, FDA said it would exercise enforcement discretion and not regulate these tests.3 Te following year, FDA fnalized the ASR regulation4 and FDA denied the citizen petition. Although FDA reafrmed its asserted authority to regulate LDTs in the ASR rulemaking, another lull followed. Ten, in 2006, FDA issued a new draft guidance, this one directed squarely at laboratories. Creating one of the clunkier acronyms, this draft guidance proposed regulating a subset of LDTs given the name In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). Under this draft policy and a similar one issued in 2007, FDA proposed regulating LDTs that utilized complex, "black box" algorithms.5 A fundamental premise underpinning the IVDMIA proposal was that LDTs were, in fact, devices subject to FDA's jurisdiction. Te IVDMIA proposal engendered considerable opposition, and eventually was quietly shelved. Tis was not the only instance in which FDA asserted authority over specifc LDTs in this time period. A Jeffrey N. Gibbs is director at Hyman, Phelps & McNamara, P.C., in Washington, DC. He can be reached via e-mail at jgibbs@hpm.com. 1 0 IVD TEC HNOL O G Y | FA L L 2013 magenta cyan yellow black ES320554_IV1309_010.pgs 09.19.2013 01:55 UBM

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