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Proposed LDT Rule is The Biggest Impact Event of 2023 in FDA Regulatory Space
(Thursday, December 14, 2023) There were many developments at the FDA last year such as the approval of multiple cell and gene therapy products, the first CRISPR product approval, the formal end of the pandemic, the rise of remote inspections, and the retirement of the legendary Janet Woodcock. However, the one action by the FDA that would likely have a major impact on healthcare in general and the diagnostic industry, in particular, for years is the move by the FDA to propose a rule to abolish the Lab Developed Tests (LDT). FDA has been toying with various plans, ideas, and suggestions to regulate LDTs formally for the last 20 years. All its attempts were rebuffed by an industry that has grown from a few specialized labs doing sophisticated tests about 20 years ago to more than 17,000 labs offering more than 100,000 tests for all kinds of diagnostic applications, from the most complex tests to tests that look and feel like conventional tests but do not seek formal approval/clearance from the FDA. The issue came to a head during the pandemic when the FDA wanted to regulate LDTs for Covid-19 but was reversed by the Secretary of Health and Human Services. It became clear to the FDA that it has few friends in its quest to regulate LDTs. So, it decided to go at it alone and proposed a new rule to regulate LDTs. The proposed rule is much more conservative than what FDA had proposed in the past and has been put on a fast track to be finalized. There is a strong resistance to the proposed rule. The comments docket has received almost 7,000 comments and multiple parties have promised litigation to stop it. The strong public opposition almost guarantees an extended fight that likely will end in the Supreme Court. And there will be a political fight as well. Perhaps that’s why the FDA took such a hardline for the proposed rule. This seems like a Hail Mary pass by the FDA to either win this debate or to possibly get out of the way, for good. Either way, the year 2023 will be remembered as a year when the FDA took its gloves off to regulate LDTs. Whether it succeeds is a story for another time. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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