IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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REGULATIONS & STANDARDS more. Tis event galvanized FDA into action. Te agency scrapped its draft policy in favor of a series of inspections of dozens of pharmacies, the issuance of numerous Form 483s and several warning letters, and advocating new legislation. Tis tragedy also spurred Congress to craft new legislation. As of this writing, the Senate Health, Education, Labor and Pensions Committee has reported out legislation that would substantially revamp FDA's regulation of pharmacies. Te House is working on its own version. Tese events illustrate an important factor: the impact of unforeseen events on policy. In October 2012, nobody anticipated that FDA regulation of pharmacy would become one of the most prominent regulatory issues for both FDA and Congress. Yet the NECC contamination completely changed the landscape. It is likely that nothing will occur that will similarly upset the political calculus for LDTs. Yet, such a contingent event could occur, although its form could be very diferent. For example, the event could be learning that an LDT yielded erroneous results, harming patients. Or, it could involve an LDT that plays such a profoundly positive role at a critical moment that it causes any FDA regulatory initiative to lose momentum. In sum, the pharmacy example illustrates two principles that are likely to apply to FDA's regulation of LDTs. First, there is likely to be litigation, which will be prolonged and complicated. Tere may be multiple court cases, some with conficting outcomes. While the litigation is ongoing, the regulatory status of LDTs would be unsettled. Second, the regulatory, legal, and political landscape can change quickly due to an unexpected external event. A single high visibility incident can overwhelm reasoned analyses of law and policy, at least at the political level and in the media. NECC illustrates how unanticipated events can shake up the political, legal, and regulatory landscape in unpredictable and profound ways. Why LDTs? Te topic of LDT regulation can be addressed at numerous levels, ranging from statutory construction and the Administrative Procedure Act to the efect on innovation and patient care. One of the many questions is why do so many companies choose to introduce assays as LDTs rather than kits. I have spoken with many laboratories and IVD companies that weighed the two options and then elected the LDT route. Te reasons for that choice may difer, but it is generally predicated on more than the cost or the time it takes to go through the FDA process. One of the recurring concerns is that the FDA process, as currently constituted, simply does not match well with modern laboratory assays. For example, an increasing number of LDTs utilize next generation sequencing (NGS). FDA still has not laid out a clear path forward for NGS assays. A company that has developed an NGS assay or instrument it wants to distribute will fnd this uncertainty itself to be a barrier; in the case of LDTs, there is no similar uncertainty. Te inability to accommodate change is another drawback of the FDA regulatory system. Companies that have developed new assays know that the assay will evolve, for example, to identify more mutations or to update an algorithm. Te FDA regulatory system does not do a good job accommodating these dynamic tests. Rather, the regulations are geared toward more static products. Te requirements for submitting new 510(k)s or PMA supplements to make changes are ill-suited for the many novel, rapidly evolving tests that are being ofered in laboratories or are under development. Another factor is the review process itself. One can debate whether the current data requirements are "least burdensome," or whether the review process asks too many questions of lesser importance, or whether there are too many "surprise" questions during the review process. Tere can be no real debate, though, that the increasing data requirements combined with the uncertainty over what data will be needed and the infexibility in allowing product changes has led many companies to opt for LDTs. As FDA considers its approach to LDTs, it would be worth considering what steps could be taken to make the 510(k)/PMA process a more reasonable and predictable— and, hence, more attractive—option. Improvements in the review process would be welcomed not only by companies weighing their options, but also by IVD kit manufacturers who have no choice but to undergo the FDA review process. Conclusion In the 21 years since FDA frst mentioned regulating LDTs, the laboratory industry has grown signifcantly and the role of LDTs has increased. Many widely used diagnostic tests are ofered as LDTs. As a practical matter, this complicates FDA's eforts to regulate LDTs. How the issue will be resolved is anyone's guess. However, it is likely that this topic will generate debate and controversy for many more years. References 1. Citizen Petition from Jefrey N. Gibbs, Hyman, Phelps & McNamara, P.C. (Docket No. FDA 1992-0405)(Oct. 2, 1992) 2. 61 Fed. Reg. 10,484 (March 14, 1996). 3. 62 Fed. Reg. 62,243 (November 21, 1997). 4. Letter from D. Bruce Burlington, Director, CDRH, to Jefrey N. Gibbs, Hyman, Phelps & McNamara, P.C. (Aug. 12, 1998). 5. FDA, Draft Guidance for Industry, Clinical Laboratories, and FDA Staf: In Vitro Diagnostic Multivariable Index Assays (Sept. 7, 2006); FDA, Draft Guidance for Industry, Clinical Laboratories, and FDA Staf: In Vitro Diagnostic Multivariable Index Assays (July 26, 2007). 6. 75 Fed. Reg. 34,463 (June 17, 2010). 7. Vauren Satena, Lawmakers Press OMB to Release Lab-Developed Test Draft Guidance, Gray Sheet, Aug. 19, 2013. 8. Prof'ls and Patients for Customized Care v. Shalala, 56 F.3d 592 (5th Cir. 1995). 9. Tompson v. W. States Med. Ctr., 122 S. Ct. 1497 (2002). 10. United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla.), Med. Ctr. Pharmacy v. Mukasey, 536 F. 3d 383 (5th Cir. 2008). IVD 1 4 IVD TEC HNOLO G Y | FA L L 2013 magenta cyan yellow black ES320552_IV1309_014.pgs 09.19.2013 01:55 UBM

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