May 26, 2022 – Congress is preparing to act on the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which, if enacted, would impact our profession by establishing a federal regulatory framework for the oversight of laboratory-developed tests (LDTs).
Earlier this week, at the request of the Senate Health Education, Labor and Pensions (HELP) Committee, the College of American Pathologists provided feedback on the latest version of this bill. These comments represent the third time over the past four years that the CAP has provided a formal response to the congressional authors of the VALID Act. All our responses, including the most current, are available here, on Laboratory-Developed Test Oversight, for your review.
In our letter, we outline specific provisions of the current version of the VALID Act that we support. In addition, we provide recommendations to improve the bill. I acknowledge that other pathology and laboratory associations oppose the VALID Act and are lobbying to block this legislation. Considering the political realities in Washington today, we at the CAP have an honest difference of opinion with some other respected laboratory organizations. Today, I will lay out the reasons why we are advocating to continue to improve the bill rather than to block it from consideration.
We believe the VALID Act is the only viable piece of legislation addressing the LDT issue. In addition, we believe it is very likely the VALID Act will eventually be enacted into law. The VALID Act is a bipartisan and bicameral bill. It is the product of over four years of multistakeholder input. This deliberative process has provided all stakeholders, including all pathology and laboratory organizations, the opportunity to provide guidance. In the current form, the VALID Act contains many provisions that are similar to policy the CAP has advocated for regarding the regulation of laboratory tests since 2009. Importantly, the current version includes explicit protections for pathologists and our ability to practice medicine without infringement from the Food and Drug Administration (FDA).
No legislation is perfect. However, the latest version of the VALID Act includes provisions that will allow us to meaningfully influence the enforcement and execution of the legislation through the regulatory process.
Our May 22, 2022 letter cited specific provisions in the VALID Act the CAP supports while also noting areas that require improvement. Below is a summary of what the latest version of the bill, if enacted, would do.
- It would create a risk-based system of oversight utilizing tiers (low-, moderate-, and high-risk) to target FDA oversight.
- It would exempt all existing LDTs from FDA premarket review. Any LDT you are using today would not be subject to FDA review unless there is a safety concern for patients.
- It would utilize mitigating measures to shift LDTs into lower tiers of regulation. These measures would include such practices as appropriate labeling, performance testing, submission of clinical data, clinical studies, and posting information on a website.
- It would offer exemptions from the FDA premarket review process. These exemptions would include LDTs in the low-risk category, low-volume tests, modified tests, manual interpretation tests, and humanitarian tests.
- It would prohibit the FDA from infringing on the practice of medicine.
- It would direct the FDA not to create regulations that are duplicative of regulation under CLIA.
- It would require the FDA to conduct public hearings on LDT oversight.
- It would establish an effective date five years after passage.
- It would establish a process by which user fees would be established via negotiations between the agency and the industry. The process includes that the fees would be subject to Congressional approval.
As we noted in our letter about the bill, we at the CAP share concern regarding the impact user fees may have on the ability of laboratories to continue to develop laboratory developed tests. However, the current legislation would not establish specific fees and any fees would need to be approved by Congress in a future FDA user fee authorization bill after years of public input.
The Political Landscape as We See It
As noted, we at the CAP have a different view on the political realities in Washington on this issue than other laboratory groups. First, we believe that any solution legislated by Congress must take into consideration the input from multiple stakeholders, most notably patients. We continue to stay at the table with the broader group of stakeholders to ensure our voice is heard. And while some may think the VALID Act goes too far, many patient advocate groups believe it doesn’t go far enough and are actively pushing for more restrictive LDT oversight. Indeed, these groups are frustrated that strengthening the oversight of LDTs has taken so long.
We are not done with the VALID Act. We expect the VALID Act will be formally acted upon by the Senate HELP Committee soon. We at the CAP will continue to represent your interests and oppose harmful policies while still navigating the political realities of this debate. We also remain committed to working with other laboratory groups to ensure the government gets it right.
You will hear more from us on LDT oversight as news develops. We will continue to work with policymakers to influence the final product and work to ensure patient safety, allow for continued industry innovation, while mitigating burdens on pathologists and laboratories.
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Emily E. Volk, MD, FCAP, is president of the College of American Pathologists and chief medical officer at Baptist Health Floyd, New Albany, Indiana. She is also an associate professor of pathology at the University of Louisville.