Long-Awaited Announcement from the FDA on LDTs

FDA v LDTOn July 31, 2014, the FDA gave Congress notice that in the next 60 days it would be announcing draft guidelines on the regulation of laboratory developed tests (LDTs). This topic has been discussed on the Genomics Law Report frequently for years. [You can access the previous coverage here].

The “Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” mark a large expansion of FDA regulatory activity into industry practices that have been–depending on your perspective on the scope of the agency’s regulatory power—enjoying the FDA’s discretionary forbearance from regulation or taking place just outside of FDA’s regulatory reach. Indeed, aside from a few “it has come to our attention” letters in Summer 2010 and the second, more forceful warning letter issued to 23andMe in Fall 2013, the FDA has not taken action against companies providing individuals with direct-to-consumer (DTC) access to their personal genetic/genomic information.

The FDA’s notice to Congress does indicate that at least some LDTs are not going to be caught up in the FDA’s forthcoming LDT framework, including those used solely for law enforcement purposes and certain LDTs used for transplantation. Not surprisingly, the FDA indicates it will apply its risk-based classification of medical devices to evaluate LDTs. Does this notice signal that the ultimate regulatory regime is finally in sight? Well, some of the provisions even in this draft guidance (not finalized guidance) would take almost a decade to implement. The FDA suggested it wouldn’t have descriptions of what it generally considers to be Class I, II, and III (the risk-based medical device categories) LDTs for 18 months after the guidance is finalized. Likewise, enforcement of the premarket review requirements for Class II LDTs is scheduled to be phased in gradually (>5 years after the finalized guidance) and only after the FDA has completed implementing the requirements for Class III LDT premarket reviews (which it estimates would take ~4 years after finalized guidance).

It will be necessary to be patient once more, await the Federal Register notice of the Draft Guidance in a few weeks, and then consider the actual requirements proposed. However, it is interesting at this stage to highlight one point of the FDA’s notice to Congress. The FDA buried this gem in footnote 4:

“FDA generally does not exercise enforcement discretion for direct-to-consumer (DTC) tests regardless of whether they meet the definition of an LDT provided in this guidance. Therefore, the enforcement policies in this guidance do not apply to DTC tests, and the FDA’s usual enforcement policies apply to DTC tests.”

Huh? The FDA does not generally exercise enforcement discretion for DTC genetic tests? To “exercise enforcement discretion,” in FDA jargon, is to choose not to regulate something that the agency might have the authority to regulate. So the FDA is saying here—hold on for a jarring double negative—that it does not choose not to regulate DTC tests, and that, consequently, DTC tests fall under “usual enforcement policies”? The FDA asserting authority over DTC tests and reconsidering its enforcement discretion is one thing, but rewriting the regulatory history is quite another.

There are countless reasons why this footnote is historically inaccurate. If this were true, why would so many publications call for FDA oversight of DTC tests? And, in response to all those scholarly publications, why would the FDA not have issued a simple corrective comment on its website saying, “Hey idiots, these are regulated. Here’s how”? If DTC genetic tests were regulated under “usual enforcement policies” all this time, why would the topic be listed by the FDA on its B-List for draft guidance in FY2014? Why would legal scholars debate the shift in language from the 2010 letters to the 2013 letters on whether DTC genetic tests are “medical devices”? Why would other scholars complain that we’ve been anxiously tapping our feet awaiting rules on the regulation of DTC genetic tests that were thought to have been ready in 2012? Why would the National Human Genome Research Institute website indicate, “The Food and Drug Administration (FDA) has the authority to regulate genetic tests, but it has to date only regulated the relatively small number of genetic tests sold to laboratories as kits.” Why would SACGHS, in direct contradiction to the FDA’s latest statement, report in 2010 that the “…FDA generally exercises enforcement discretion for most LDTs, including DTC genetic tests developed as LDTs?”

Let’s reserve judgment until the actual draft guidance is published in the Federal Register. Until then, we can all learn at least one important lesson from the FDA’s announcement: always read the footnotes.

Additional coverage:
Turna Ray. “FDA Outlines to Congress its Long-Awaited Approach toward LDT Regulation.” GenomeWeb Daily News. 31 July 2014. Available at http://www.genomeweb.com/clinical-genomics/fda-outlines-congress-its-long-awaited-approach-toward-ldt-regulation

Matthew Herper. “FDA To Regulate Thousands Of Cancer, Genetic, And Other Diagnostics.” Forbes.com. 31 July 2014. Available at http://www.forbes.com/sites/matthewherper/2014/07/31/fda-to-regulate-thousands-of-cancer-genetic-and-other-diagnostics/

PR Newswire. “ACLA Expresses Concern with FDA Guidance on Laboratory Developed Tests (LDTs).” MarketWatch. 31 July 2014. Available at http://www.marketwatch.com/story/acla-expresses-concern-with-fda-guidance-on-laboratory-developed-tests-ldts-2014-07-31

Francis S. Collins. “Statement on FDA’s Proposed Oversight of Laboratory-Developed Tests.” 31 July 2014. http://www.nih.gov/about/director/07312014_statement_fda.htm

Andrew Pollack. “F.D.A. Acts on Lab Tests Developed In-House.” New York Times. 31 July 2014 http://www.nytimes.com/2014/08/01/business/fda-to-regulate-lab-developed-test-kits.html?partner=rss&emc=rss&_r=0