Bowling Green Today

U.S. Senator Rand Paul (R-KY) has expressed his concerns about the proposed rule on Laboratory Developed Tests (LDTs) by the U.S. Food and Drug Administration (FDA). In a letter addressed to Dr. Robert Califf, Commissioner of Food and Drugs at the FDA, Senator Paul argued that the rule would impose unnecessary regulations on health care providers and disrupt patient care.

The proposed rule would extend the FDA's medical device regulatory framework to health care providers developing and performing LDTs as part of their professional practice. However, Senator Paul believes that this exceeds the FDA's statutory authority and conflicts with the Clinical Laboratory Improvement Amendments of 1988, which have successfully governed LDT regulation for decades.

In a letter to Dr. Califf, Senator Paul referred to legal experts who have argued that the FDA lacks the authority to regulate LDTs without specific legislation granting them such authority. He also highlighted that the proposed rule was omitted from recent legislation discussions on modernizing the federal government's approach to regulating laboratory testing services.

Senator Paul expressed concerns about the potential disruptions to patient care that may result from the proposed rule. He referred to the challenges faced during the early months of the COVID-19 pandemic when the FDA enforced emergency use authorizations for LDTs. The FDA's initial restrictions on testing and the recall of the CDC's test kit left the U.S. without authorized tests, leading to delays in detecting and responding to the spread of the virus.

Furthermore, Senator Paul criticized the lack of mention of these consequences in the proposed rule and the absence of a comprehensive impact analysis. He argued that the rule could have dire and far-reaching consequences by consolidating the clinical laboratory market and preventing providers from offering testing services.

The potential adverse consequences for patients were also highlighted by Senator Paul. He cited a previous experience where an FDA-approved companion test failed to identify patients who would respond to a melanoma drug. He cautioned that subjecting all LDTs to FDA approval could lead to outdated tests and delays in patient care.

In conclusion, Senator Rand Paul urged the FDA to rescind its proposed rule so that Congress can continue working to establish a modern oversight framework for laboratory testing services. He has been a vocal advocate for protecting doctors, health care workers, and patients from unnecessary federal regulations on laboratory testing services.

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/