Bowling Green Today

U.S. Senator Rand Paul (R-KY) has written a letter to Dr. Robert Califf, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), expressing his concerns about the FDA's proposed rule on Laboratory Developed Tests (LDTs). In the letter, Senator Paul argues that the proposed rule would impose the FDA's medical device regulatory framework on healthcare providers developing and performing LDTs, causing unnecessary disruptions to patient care.

According to Senator Paul, the proposed rule exceeds the FDA's statutory authority and conflicts with the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which have successfully governed LDT regulation for decades. He cites legal experts who argue 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."

Senator Paul also highlights that Congress has twice rejected proposals to grant the FDA authority to regulate LDTs. He mentions the VALID Act of 2021, which aimed to shift the regulation of all in vitro clinical tests to the FDA, but was omitted from legislation when Congress reauthorized FDA user fee programs. He argues that the proposed rule threatens to usurp the lawmaking role assigned to Congress by the U.S. Constitution.

In addition, Senator Paul raises concerns about the potential disruptions to patient care and delays in testing that could result from the FDA's authority over LDTs. He points to the initial restrictions on clinical laboratories during the COVID-19 pandemic, when the FDA only issued emergency use authorizations for the CDC's test kit, leaving the U.S. without authorized tests as the virus spread undetected.

Furthermore, Senator Paul questions the consequences of the FDA having authority over LDTs during a public health emergency, which are not addressed in the proposed rule. He argues that subjecting all LDTs to FDA approval could lead to outdated tests and delays in identifying patients who would respond to certain drugs. He urges the FDA to rescind the proposed rule so that Congress can continue its work to establish a modern oversight framework for laboratory testing services.

Senator Paul has been a vocal advocate for protecting doctors, healthcare workers, and patients from unnecessary federal regulations on laboratory testing services. He introduced the VITAL Act as an alternative to the overburdensome VALID Act, which aims to remove unnecessary government barriers that slow the response to health emergencies.

In conclusion, Senator Rand Paul is urging the FDA to rescind its proposed rule on Laboratory Developed Tests, arguing that it exceeds the FDA's authority, conflicts with existing regulations, and could have adverse consequences for patient care. He calls for Congress to continue its work in establishing a modern oversight framework for laboratory testing services.

For additional details, please follow this link: https://www.paul.senate.gov/dr-rand-paul-urges-fda-to-rescind-overburdensome-proposed-rule-on-laboratory-developed-tests/