May 2021: We've been hearing about a new era in laboratory test regulation since 2010, with multiple episodes (in one episode, FDA was going to take on national LDT regulation unilaterally).
The VALID Act amounts to reform of both packaged kit (IVD) test regulation and risk-based regulation of what have traditionally been LDTs. It was introduced in the prior Congress (March 2020; from 2020 see trade journal here, here, law firm Mintz Levin here; response of ACLA here). Favorable stance toward VALID from the Pew Foundation in January 2021, here.
Meanwhile, the smaller and feistier VITAL Act, from Sen. Rand Paul, would prohibit FDA regulation of LDTs. There's a pop-up of news on that front in May 2021.
VITAL 2021; AMP Support
VITAL is re-introduced in May 2021 - ClinicalOmics here, MedTechDive here.
May 18, 2021
See also something I missed a few weeks ago - on May 18, 2021, both AMP and the Association of Pathology Chairs (APC) weighed in with a press release supporting VITAL and urging its passage. "The VITAL Act of 2021 would enhance transparency, preserve innovation, and ensure widespread patient access to essential medical services." See 2-page PDF here.
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| Support for Rand Paul's VITAL Act, Keeping FDA Away from LDTs |
Back to the Larger VALID Act Proposal
AdvaMed and others support the VALID Act. CAP noted its 2020 version was better than prior versions, with less overlap of FDA and CLIA. (Both quoted in LabPulse, 2030,
here.) But AACC was quite opposed; quoting LabPulse, "The American Association for Clinical Chemistry (AACC) believes the VALID Act "introduces new and redundant regulatory hurdles" for labs for many diseases and conditions that are not public health emergencies, according to a March 6 [2020] press statement. The AACC sees the VALID Act as imposing new and duplicative regulations on labs, as well as "cost-prohibitive" user fees for labs that develop tests for nonemergency applications."
May 21, 2021
On May 21, 2021, ACLA sent a detailed 3-page letter to Secr Becerra on HHS LDT policy -
here. It's worth reading; it emphasizes the role of LDTs in the COVID response, and that FDA on its own doesn't have authority to regulate LDTs. Beyond that, ACLA generally supports legislative improvements to be worked out among the stakeholders, and ACLA mentions VALID by name, but not VITAL.
Economics of VALID
Last month I had the chance to be a middle author on a paper on the costs of VALID under alternate scenarios; Hsiao et al., J Clin Oncol Oncology Practice,
here.
The FDA's big push to regulate LDTs came under the Obama administration, 2008-2016, while the FDA's disputed regulation of Covid LDT tests came under the Trump administration, which had quashed the FDA 2014-2016 effort. Now under Biden, clearly the different stakeholders are lining up in the ring and expecting new discussions and potentially, new actions.
June 24, 2024
The VALID Act is re-introduced for the new 2021-2022 term -
here.
