IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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REGULATIONS & STANDARDS Two days later, the American Clinical Laboratory Association (ACLA) fled a 19-page citizen petition with FDA contesting FDA's jurisdiction over LDTs. In taking that step, ACLA raised multiple issues, including lack of statutory authority, impact on healthcare, burden to the laboratory industry, and complicating the laboratory regulatory oversight scheme. Te ACLA petition joins two other petitions relating to LDTs that have long been pending at FDA, one submitted in 2006 by the Washington Legal Foundation and one submitted in 2008 by Genentech, as well as a 2009 letter from AdvaMed recommending a framework for regulating all diagnostic tests. To date, no proposal has been publicly released. As of the date of this article, the draft document apparently is under review at the Ofce of Management and Budget.7 Tere are conficting reports as to the likely outcome of this increasingly politicized review. What's Next? Based on statements by multiple FDA ofcials, it remains clear that the agency both believes it has the authority to regulate LDTs and it would like to invoke that power against some subset of LDTs. It is equally clear that the laboratory industry is adamantly opposed to being regulated by FDA. Te IVD industry is itself conficted. Some IVD companies support FDA's eforts, believing that the current system does not create a level playing feld between kits and LDTs. Other IVD manufacturers have purchased their own laboratories or entered into collaborations with laboratories. Other companies have introduced LDTs, with the goal of later distributing an FDA-regulated version. If FDA were to proceed to try to regulate LDTs and Congress did not intervene, it is a virtual certainty that the matter would wind up in court. Mounting a successful attack against a proposed framework or a draft guidance would present some challenges. FDA may be able to defend those documents on procedural grounds, such as lack of fnal agency action, or lack of "ripeness." However, if the agency were to proceed and adopt a fnal policy, the laboratory industry and other potential plaintifs would be able to marshal an array of strong legal and policy arguments in any lawsuits. Te legal landscape could quickly become murky, simply by the fling of litigation. In trying to predict how this might unfold, examining FDA's attempts to regulate pharmacy compounding is instructive. For years, FDA and the compounding industry have been involved in litigation. Te frst suit was fled shortly after FDA issued its initial pharmacy compliance policy guide in 1992,8 and there have been multiple court cases since then.9 Te upshot is that FDA's authority to regulate compounding has been called into question. Indeed, two federal courts reached diferent conclusions in two diferent lawsuits as to whether the 1997 federal compounding legislation was even in efect. FDA developed the theory that all compounded drugs were unlawful. A district court ruling rejected FDA's theory that all drugs compounded by pharmacies were illegal, while other courts arguably reached the contrary conclusion.10 FDA has maintained that all compounded drugs were unapproved drugs, but that it would exercise enforcement discretion if certain criteria were met. Although FDA apparently has not made the same explicit sweeping statement for LDTs, the rationale behind FDA's position here apparently leads to the same conclusion: if LDTs are devices, then they are technically violative unless they are exempt or covered by a 510(k) or PMA. While the district court ruling in the pharmacy case was later rendered moot, some of that court's logic would likely be invoked in a lawsuit against LDT regulation. Te end result has been confusion as to what rules applied to pharmacies. FDA has told Congress that its eforts to regulate pharmacies had been stymied by the legal uncertainties. Analogously, any FDA efort to regulate LDTs would also confront a series of legal challenges. It would be surprising if any fnal agency document that purported to set out policy was not the subject of one or more lawsuits. In addition, if FDA were to take enforcement action against a laboratory, by seeking an injunction against a laboratory for performing an LDT, for example, that action could also be contested. Tat is, even if the broad policy withstood a legal assault, the outcome might be diferent in a case brought against a laboratory where that policy was applied to specifc facts. Te net efect of litigation would be to create confusion about the applicable law. If lawsuits are fled, they will probably take years to resolve because they would raise complex legal, regulatory, and policy issues. Based on the pharmacy precedent, the ensuing uncertainty would create difculties for FDA, laboratories, investors in laboratories, and other afected parties, to the public's detriment. Te pharmacy example may be relevant in another way, as well. FDA's eforts to regulate pharmacies—and Congress's interest in regulating pharmacies—languished for many years. FDA had been working on a policy guide to clarify and modestly strengthen its policy on permissible compounding. Tis long-deferred policy was nearly ready for release when in the fall of 2012, the New England Compounding Centers (NECC), a Massachusetts pharmacy, compounded and distributed contaminated drugs. Te drugs reportedly killed dozens and harmed scores Analogously, any FDA effort to regulate LDTs would also confront a series of legal challenges. 1 2 IVD TEC HNOLO G Y | FA L L 2013 magenta cyan yellow black ES320553_IV1309_012.pgs 09.19.2013 01:55 UBM

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