The Limits of FDA's Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing
Symposium: Emerging Issues and New Frontiers for FDA Regulation, 70 Food and Drug Law Journal 259-287 (2015)
30 Pages Posted: 22 Aug 2014 Last revised: 26 Aug 2015
Date Written: August 26, 2015
The U.S. Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation sequencing, to the agency’s Part 812 investigational device exemption (IDE) regulation. Late in 2014, the agency published two draft guidances that would treat laboratory-developed tests (LDTs) as in vitro diagnostic (IVD) devices that FDA can regulate. Many of the high-throughput DNA sequencing products and services used in genomic research are LDTs. This article is motivated by concern that intrusive FDA regulation of genomic research has the potential to: (1) slow the progress of genomic discovery; (2) interfere with scientific inquiry and suppress investigators’ and clinicians’ speech in ways incompatible with the First Amendment to the U.S. Constitution; and (3) upset longstanding Congressional and FDA policies on federalism that respect the primacy of States to regulate the practice of medicine. Genome sequencing — for reasons explained in this article — blurs the line between categories of IVD research that FDA traditionally has regulated and categories of research that FDA traditionally has not regulated. This blurring creates a risk that FDA may overstep its proper authority to regulate fundamental genomic and medical research. This article surveys the legal limits of FDA’s authority to subject research to its IDE requirements. Section 1 explains that FDA has authority to regulate clinical investigations of devices, but is not authorized to regulate investigations that merely use devices to expand medical knowledge or to conduct fundamental research, unless special circumstances apply. Section 2 discusses five special circumstances that can expand or limit FDA’s authority to regulate a specific clinical investigation, and Section 3 offers a practical example. Section 4 explores concerns that arose in recent years about risks to human subjects in a certain type of investigation known as sponsor-investigator studies. In response to these concerns, FDA has suggested that it can regulate such studies in ways that threaten to expand FDA’s regulation of research at academic medical centers beyond its proper scope. These concerns, while valid in some academic research contexts, seem inapposite in the setting of genomic research programs funded by responsible entities such as the National Institutes of Health (NIH). Moreover, FDA’s regulations do not appear to support the proposition that FDA can regulate sponsor-investigator studies more expansively than it regulates other studies. Section 5 explores specific ways that NIH, clinical investigators, and FDA might work together to rationalize FDA’s regulation of NIH-funded genomic research.
Keywords: FDA, gene sequencing, high-throughout sequencing, Part 812, IDE, research
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