In our last year-end blog post on diagnostic devices and products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020 with regards to laboratory-developed tests (LDT) and clinical laboratory testing in general during a COVID-19 public health emergency (see this previous post here). We highlighted at the time an August 2020 Trump administration order prohibiting the FDA from requiring a pre-market review for any LDT unless the agency goes through formal regulatory procedures. We also hypothesized that although âthe regulatory framework and policies surrounding LDTs ââwill be a major subject of debate in 2021â¦ there will be no rapid resolution of these issues, either at the legislative policy level. or agencies, in the short term and that LDTs ââwill likely remain in a gray area of ââFDA regulation and policy for the foreseeable future. “
As of mid-year, our previous statements hold true and clinical labs offering LDTs ââcontinue to operate with some degree of uncertainty as to whether and how the FDA intends to regulate these diagnostic offerings. The Biden administration, under the leadership of Health and Human Services (HHS) Secretary Xavier Becerra, has not taken positive steps to reverse or waive the previous administration’s August 2020 announcement, although that the policy statement appears to have been removed from the HHS website. where it originally appeared. (The statement had not been officially published in the Federal Register.And while several members of Congress and public health advocates have called on Secretary Becerra to clarify the current regulatory landscape for LDTs ââand “restore” power to the FDA, to date neither the department nor the FDA has her – even have not made a statement one way or the other. the other concerning the thinking of the new administration concerning the surveillance of LDTs.
Perhaps they think this will be the year when Congress finally comes to a compromise solution that is achievable for all stakeholders in this complex debate – from the laboratory community to the kits based on it. in vitro diagnostic manufacturers (IVDs), pathologists and clinicians looking for solutions for their patients at the agency. To be fair, furthermore, other groups have also communicated to the HHS Secretary that constantly changing application statements and fragile legal bases for the FDA to exercise jurisdiction over lab-developed tests is not the way. the most prudent or practical to establish federal regulatory policy on such an important segment of the health care economy. Groups with this view continue to push for a comprehensive legislative solution, which appears to come closer to reality as the volatile situation continues and clinical laboratories still lack the certainty necessary to confidently plan future business operations. and research and development of diagnostic tests.
On June 24, 2021, bipartisan members of the House and Senate reintroduced a revised version of the Advanced IVCT Development Accurate Verification Act (VALID), following its initial introduction in March 2020 during the previous session of Congress. We have summarized the first iteration of the VALID law, which aims to reform federal oversight regimes for LDT and IVD products, in a previous article (see here). The general framework of the proposed new system for the regulation by the FDA of In vitro clinical tests (IVCT) have not been redesigned in the 2021 version of the bill compared to the 2020 version; however, there are several important changes to the proposed legislative solution that all stakeholders will consider and debate over the coming months. Some of the most important changes are as follows:
The provisions of the technology certification program have been broadened so that more types of tests are eligible for commercialization through this new route, and procedural improvements have been made based on feedback from the clinical laboratory community. For example, the FDA would be required to implement the technology certification program through the development of advice and comment rules, rather than through agency guidelines, and certification orders would expire after 4 years with the possibility of being renewed. The previous version would have given the FDA the discretion to set an expiration period for such orders as long as it did not exceed 4 years.
The date of entry into force of the new IVCT regulatory system has been clarified and the current version of the legislation sets this date at 4 years after the date of enactment of the bill. The previous version did not have a clear effective date because it was drafted in relation to the federal government‘s fiscal year, so the law would have come into force between 3 and 4 years after its enactment.
The FDA would also be asked to issue final rules to implement the various provisions of the VALID Act within 2 years of its enactment, and as noted above for the technology certification program, rule making by the FDA. agency rather than guidance would be required for all substantive elements of the new IVCT regulatory system. These administrative improvements may have been made in response to the August 2020 HHS announcement that revoked all previous FDA guidelines regarding LDTs ââand ordered the agency to regulate laboratory-developed diagnostics only after following the process of developing notification and comment rules more arduous. .
With bipartisan and bicameral attention to this long-standing thorn on the FDA side, and public awareness of the importance of clinical laboratory testing intensely heightened in the wake of the COVID-19 pandemic, legislative reform appears more likely than ever.
Â© 1994-2021 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC All rights reserved.Revue nationale de droit, volume XI, number 194