VALID Act Possible to Take the Stage in 2023 – What Does that Mean for Me?
The highly debated Verifying Accurate Leading-edge IVCT Development (VALID) Act was first introduced in June of 2021 aiming at reforming the way in vitro diagnostic tests (IVDs) are regulated.
Proponents of the bill claim current CLIA and state regulatory oversight ensure testing quality, but are insufficient in evaluating the clinical validity for the ailments the IVDs are said to detect. On the other hand, opponents of the bill agree regulatory changes for IVDs are needed, but the proposed legislation creating a risk-based framework overseen by the FDA may outright prevent many labs from developing innovative and quick-to-market tests.
A History of the VALID Act
The FDA, under the Medical Device Amendments Act of 1976, has regulatory oversight of IVDs making them subject to a whole suite of FDA requirements. However, as a matter of enforcement discretion, the FDA has chosen not to take broad steps to regulate LDTs. This stance largely changed in 2014 after it issued guidance opting to take greater regulatory responsibility for LDTs. While significant objection surrounding feasibility caused the draft guidance to be withdrawn shortly thereafter, interest in the FDA’s role in LDTs quickly increased.
After a failed attempt by the FDA, Representatives Diana DeGette (D-Col.) and Rep. Larry Bucshon, M.D. (R-Ind.) introduced, as an amendment to the Federal Food, Drug and Cosmetic Act in 2021, the VALID Act. Despite bipartisan and bicameral support, several industry stakeholders including the American Society for Clinical Pathology (ASCP), American Association of Clinical Chemistry (AACC), and the National Independent Laboratory Association (NILA) have heavily criticized the bill.
At the end of 2022 the VALID Act was excluded from the year-end omnibus spending package finalized in late December. At the time, this indicated an indeterminate delay in the bill being passed. With many celebrating the delay, the NILA has recently reported the bill is expected to be reintroduced to the House of Representatives as early as this Spring. The bill as it currently stands will require sponsorship in the Senate.
Additionally, staff within the FDA has indicated that the VALID Act may move to be attached to the Pandemic and All Hazards Preparedness Act set to be renewed later this year. Regardless of the feasibility of this move, the FDA has clearly displayed its intention to exercise its power over LDTs.
Case study : VALID Act potential impacts on Microbiology Labs
As outlined by the American Society for Microbiology, clinical microbiology laboratories extensively rely on LDTs with a change in the regulatory environment having wide-reaching impacts on patients. Microbiologic testing for infectious diseases (ID) via LTDs are one tool in the overall diagnosis of a patient and are not used independently. These tests are, however, critical in identifying pathogens, determining its drug resistance, and prescribing and monitoring effective treatments.
Furthermore, given the countless known and novel infectious diseases clinical microbiology labs may encounter, LDTs are the only way to rapidly develop the requisite diagnostic tools. Indeed, during the COVID-19 pandemic, LDTs faced redundant regulatory hurdles to achieve emergency approval already implemented in laboratories with CLIA certification.
Microbiology, Toxicology, and several other laboratories may face similar hinderances under the proposed VALID Act.
Where does this leave us?
Laboratories around the US have been critical to the development of innovative, lifesaving testing under the incumbent regulatory environment. While individuals on both sides of the VALID Act believe further oversight could support the safe introduction of LTDs to the market, the current VALID Act has many laboratorians concerned; including those of us at Colaborate.
With the potential re-introduction of the Bill as early as the Spring, we’ll be monitoring the impacts it has on the industry and on our clients. Should the VALID Act be passed, and an overly burdensome regulatory approval process be implemented, we believe many smaller labs who previously created LTDs will no longer have the funding required to meet the new requirements.
With that said, our lab consultants believe laboratories who effectively anticipate and navigate the oncoming regulatory changes can maintain a strong and profitable laboratory. Those who do not may face greater expenditures on compliance, increased competition, or even look to engage in a merger or acquisition with another laboratory.
All of us here at Colaborate are here to help you navigate the healthcare regulatory environment. Should you have any questions on how the VALID Act may impact your laboratory, we’d be happy to provide a free laboratory assessment.