Regulatory
Both the US and EU rules emphasise increased regulatory oversight of labs. Yet opponents say the FDA is overstepping its bounds.
discretion. So, the laboratory community faces uncertainty. The final rule shows a lack of understanding of the clinical laboratory community and what it needs, as well as a lack of understanding of how LDTs are offered and how such services work.” Critics say that the FDA’s apparent lack of understanding of what laboratories need to sustain testing, plus a lack of detail about modifications and changes to automation, mean that labs do not really understand what they can and cannot do. “If you swap out a piece of equipment, do you need clearance for that modification?” wonders Genzen by way of example. “You need a decision on such things quickly – you can’t wait two years. The FDA must recognise a need to be flexible.”
See you in court? 80,000
The number of LDTs that the FDA estimates are
currently in use, with roughly 8,000 new LDTs introduced each year.
FDA 16
ARUP is among many in the laboratory community supporting the ACLA’s federal lawsuit, which rests on the assertion that the FDA does not have legal authority from Congress over medical testing services – and that regulating these services is therefore unreasonable. “The lawsuit raises serious issues under the so-called ‘major questions’ doctrine,” adds Levine. “The FDA’s position will not be helped by the recent Supreme Court decision in Loper Bright, which says that courts no longer need to give deference to agency interpretations of their own legal authorities.” There’s a financial angle here too. Not all laboratories will be able to afford the cost of compliance with FDA regulations. Some labs will therefore stop offering some or all LDTs, and others could go out of business. The concern is that this will limit the availability of testing, particularly for rare diseases.
The FDA, for its part, acknowledges these outcomes, but believes it has struck the right balance by adopting several broader exceptions – especially
compared to its originally proposed enforcement discretion phase-out policy. “The FDA’s view is that it has always had the legal authority to regulate LDTs as IVDs and laboratories that offer LDTs as IVD manufacturers, but is only now choosing to exercise that authority,” says Levine. “This is the key legal question that will have to be worked out in the courts unless Congress steps in and passes legislation clarifying the issue.” So what happens next? The phase out of enforcement discretion will undoubtedly be highly disruptive and resource-intensive for both laboratories and the FDA. The regulators may well be underestimating the degree of disruption, and overestimating its ability to handle the influx of product applications. Much depends, however, on the upcoming election.
“If the White House changes hands, we may well see the FDA reverse course,” says Levine. “Interestingly, the Supreme Court said one reason that the courts shouldn’t owe deference to administrative agencies is that administrative agencies frequently change their legal interpretations when political control of the executive branch changes hands.” Currently, there is a strong likelihood that’s exactly what happens if Donald Trump prevails in November. Whatever the electoral outcome, at any rate, it seems clear that a proper public conversation about the US’s ideal regulatory framework still needs to happen. For Genzen and others, a mix of the best of FDA and CLIA-oriented rules would be the right outcome, but the nature of the debate has not fostered much collaboration. For now, the FDA seems to have gone as far as it is willing to go voluntarily, and is unlikely to back off from its position unless forced to in court. As so often in the US, then, all eyes are on the judiciary. ●
Medical Device Developments /
www.nsmedicaldevices.com
Gorodenkoff/
Shutterstock.com
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