US lawmakers again propose diagnostics reform bill

US House lawmakers have re-introduced a bill that would give the Food and Drug Administration (FDA) explicit authority to regulate certain laboratory-developed tests (LDT). The agency has long sought to regulate such tests that are currently overseen by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).

Reps. Larry Bucshon, R-IN, and Diana DeGette, D-CO, reintroduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act on 29 March, arguing it would limit duplicating work between the two agencies and ensure uniform standards are met.

“As a doctor, I know just how critical it is that patients and their doctors have test results that they can rely on,” Buschon said in a statement. “Even the slightest discrepancy can have drastic effects on a patient’s wellbeing.”
FDA has long used its enforcement discretion to refrain from regulating most LDTs because they have typically been simpler tests for low-risk conditions and were not mass manufactured. In recent years, however, the agency has argued that many LDTs have become more complex, are meant to accurately diagnose serious diseases, and are being mass manufactured and sold across the country.

In the final days of the Obama administration, FDA published a guidance to use a risk-based approach to oversee LDTs; the guidance was pulled by the Trump administration. Then-FDA Commissioner Scott Gottlieb said the issue needed to be legislated by Congress and has since been lobbying lawmakers to pass the VALID Act.

While FDA Commissioner Robert Califf has said he would consider rulemaking to ensure the agency has authority to regulate LDTs, he has also said he would prefer it if Congress explicitly gave the agency authority to do so. Elizabeth Hillebrenner, associate director for scientific and regulatory programs at FDA’s Center for Devices and Radiological Health (CDRH), recently said the agency has already started the rulemaking process to ensure it has the authority to regulate LDTs (RELATED: Califf: FDA may use rulemaking for diagnostics reform if VALID isn't passed, Regulatory Focus, 25 October 2022).

Despite the importance FDA has put on getting Congress to act, it did not include diagnostics reform in the legislative asks included in its FY2024 budget request (RELATED: FDA seeks 10% boost in Biden’s FY 2024 budget, Regulatory Focus, 9 March 2023).

The VALID Act came close to passing a couple of times last year during budget negotiations on the Hill. While there was bipartisan support for the diagnostic reform bill, Rep. Cathy McMorris Rodgers, R-WA, chair of the House Energy and Commerce Committee, successfully fought to keep it out of the FY 2023 budget, industry sources told Focus. She argued that the bill would put undue burdens on academic medical centers (RELATED: US FDA sees boost in FY23 budget proposal but no diagnostics reform, Regulatory Focus, 20 December 2022).

The medical device lobby group AdvaMed has been a supporter of giving FDA the explicit authority to regulate LDTs.

“Modernization of the regulation of all LDTs and IVDs under a single, diagnostic-specific regulatory framework under the Food and Drug Administration is needed to foster innovation, embrace scientific advances, and ensure consistency in development, accuracy and reliability of all tests, for the advancement of patient care and public health,” said Zach Rothstein, executive director of AdvaMedDx, AdvaMed’s diagnostics division.

In a request for information (RFI) to lawmakers earlier this year, AdvaMed highlighted diagnostics reform as one of its top priorities.

“We urge Congress this year to move the legislative process forward to improve and pass the [VALID Act] to close existing gaps in regulation of diagnostic tests,” the group said. “The bipartisan VALID Act would modernize the regulatory framework applicable to all diagnostic tests, providing much-needed clarity, while enhancing the availability of high-quality, innovative tests to improve patient care and public health.”

“By closing gaps in regulation, the VALID Act would give confidence to patients and providers in the quality and performance of all tests, regardless of where the tests were developed,” the group added.

In the past, the main opposition to diagnostics reform has been from the American Clinical Laboratories Association (ACLA) who have argued FDA regulation of LDTs would be too burdensome for some manufacturers and laboratories and would lead to patients being deprived of diagnostic tests. The group says that it has long held the position that any LDT regulation must be done through legislation and has helped develop the VALID Act (RELATED: AdvaMed, ACLA working on 11th hour bid for diagnostics reform in FY23 budget, Regulatory Focus, 15 December 2022).

“In 2022, while ACLA did not take a position on the VALID Act, the association worked constructively with bipartisan co-sponsors of the VALID Act, committees of jurisdiction in Congress, FDA and private sector stakeholders to provide technical assistance around key provisions of the legislation, significantly improving the substance of the bill to protect access and innovation for patients,” said ACLA President Susan Van Meter. “ACLA stands ready to provide expertise and technical assistance to Representatives Bucshon and DeGette, who have reintroduced the VALID Act, and to Congress broadly.”

US lawmakers again propose diagnostics reform bill

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