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Sep 15, 2010 (Vol. 30, No. 16)

Regulating Laboratory-Developed Tests

Task Will Require Deft Hand from FDA to Retain Innovation and Patient Access

  • FDA's Public Meeting

    FDA has now abandoned the IVDMIA proposal in favor of a more ambitious objective: regulating LDTs under the medical-device provisions of federal law. In July, FDA held a two-day public meeting to explore various issues relating to LDT regulation.

    In announcing the meeting, FDA explained that enforcement discretion was no longer appropriate for several reasons. FDA cited, among other factors, the greater complexity of tests, and the rise of LDTs offered on a national level. Another factor in FDA’s greater regulatory scrutiny is the growth of genetic tests promoted directly to consumers. FDA officials have called LDTs a “loophole,” used by laboratories to circumvent the FDA process.

    The public meeting attracted significant public interest. Because requests to attend exceeded the 400-plus seating capacity in the original venue, FDA moved the meeting to an auditorium that could hold over 700 people. Many more people watched via a webcast.

    This high degree of interest is not surprising given the significant role LDTs play in the U.S. healthcare system. For example, over 1,800 genetic tests are estimated to be available, but only a handful have been reviewed by FDA. LDTs are playing an increasingly important role in personalized medicine, including companion diagnostics for pharmaceuticals. These tests also are used to identify emerging diseases and to diagnose rare and orphan diseases for which there are no IVDs.

    The development of LDTs has become a large and growing business. Many start-up companies have been formed to offer LDTs; well-established laboratories have also invested heavily in offering innovative tests as LDTs. New LDTs are continually being introduced.

    As LDTs have proliferated, IVD manufacturers have become increasingly troubled by a perceived uneven playing field. While LDTs are exempt from FDA regulation (but not exempt from other types of regulation, including CLIA, state scrutiny, and oversight by professional organizations), assay manufacturers need to go through the FDA review process and comply with FDA’s ongoing regulatory requirements. Other observers have questioned whether LDTs have been adequately tested and clinically validated.

    There are many different companies and organizations that are affected by LDT regulation. Nevertheless, during the FDA two-day meeting, speakers from various perspectives generally agreed that FDA should regulate some LDTs in some manner. There was no consensus, though, regarding the nature and parameters of that process. FDA’s extension of device regulations to LDTs presents many questions. Resolving these will not be easy.

    One legal issue is whether FDA can regulate LDTs simply through a guidance document. At the public meeting, FDA asserted that because it had been exercising enforcement discretion before, the change in policy from nonregulation to regulation would not require rule making.

    Using the guidance document route is far easier and faster for FDA. For example, before issuing a final rule, FDA would need to formally address each significant comment. There is no parallel requirement for guidance documents. Also, rule making does need to analyze economic impact, while guidance documents do not.

    Regulating LDTs will impose a large financial burden on laboratories. Whether FDA is correct regarding the legality of using guidance documents is legally debatable. If FDA’s authority over LDTs is challenged in court, the failure to use formal rules rather than informal guidance should feature prominently in the litigation.

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