Bowling Green Today

In a recent letter to Dr. Robert Califf, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), U.S. Senator Rand Paul expressed his concerns about the FDA's proposed rule on Laboratory Developed Tests (LDTs). The proposed rule would impose the FDA's medical device regulatory framework on health care providers developing and performing LDTs, which Dr. Paul believes exceeds the FDA's statutory authority and conflicts with the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Dr. Paul, in his letter, cited a white paper co-authored by legal experts Paul Clement and Professor Laurence Tribe, stating that "FDA's novel effort to expand its jurisdiction is foreclosed by the plain text of the FDCA. Congress gave FDA the authority to regulate medical devices, and laboratory-developed testing services are not devices." This interpretation was reaffirmed by the General Counsel of the U.S. Department of Health and Human Services in a June 2020 memorandum.

The proposed rule has faced opposition in Congress as well. The VALID Act of 2021, which would have shifted the regulation of in vitro clinical tests to the FDA, was twice rejected by both chambers of the 117th Congress. Congress chose to omit the VALID Act policies when reauthorizing FDA user fee programs, indicating that the debate on how to modernize the federal government's approach to regulating laboratory testing services is still ongoing.

Dr. Paul also highlighted the potential disruptions to patient care that the proposed rule could cause, drawing attention to the initial restrictions on testing during the early months of the COVID-19 pandemic. The FDA's authority over LDTs during that time led to delays in testing and a lack of authorized tests as the virus spread undetected. The consequences of the FDA having authority over LDTs during the pandemic are not addressed in the proposed rule, raising concerns about its potential impact on patient care.

Furthermore, the proposed rule fails to address the potential societal and economic costs, as well as the burden it would place on the FDA to regulate a vast portion of the health care sector it currently does not regulate. The rule would transfer the LDT market from certified laboratory entities to large medical device manufacturers, potentially consolidating the clinical laboratory market and limiting providers' ability to offer testing services. These potential effects on the health care sector were overlooked in the proposed rule, suggesting an incomplete impact analysis.

Dr. Paul also raised concerns about the adverse consequences the proposed rule could have for patients. He cited the example of a melanoma drug and its companion test, where the FDA-approved test failed to identify patients who would respond to the drug. This experience serves as a reminder that the FDA's expertise in assessing drugs and devices may not easily transfer to LDTs. Subjecting all LDTs to FDA approval could lead to delays and outdated tests, potentially missing patients who need timely diagnosis and treatment.

In conclusion, Dr. Paul urged the FDA to rescind the proposed rule, allowing Congress to continue its work in establishing a modern oversight framework for laboratory testing services. Dr. Paul has been a vocal advocate for protecting doctors, health care workers, and patients from unnecessary federal regulations on laboratory testing services, introducing the VITAL Act as an alternative to the overburdensome VALID Act. The VITAL Act aims to remove unnecessary government barriers to ensure that tests are quickly and widely available in health emergencies, such as the COVID-19 pandemic.

To find out more, go to this link: https://www.paul.senate.gov/dr-rand-paul-urges-fda-to-rescind-overburdensome-proposed-rule-on-laboratory-developed-tests/