Bowling Green Today

U.S. Senator Rand Paul (R-KY) has sent 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). According to Senator Paul, the rule would impose the FDA's medical device regulatory framework on healthcare providers, causing unnecessary disruptions to patient care.

In his letter, Senator Paul argues that 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 have stated 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 also reaffirmed by the General Counsel of the U.S. Department of Health and Human Services.

Senator Paul points out 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 ultimately omitted from legislation. He argues that the proposed rule threatens to usurp the lawmaking role assigned to Congress by the U.S. Constitution.

Furthermore, Senator Paul highlights the potential disruptions to patient care that could result from the proposed rule. He references the initial restrictions on clinical laboratories during the COVID-19 pandemic when the FDA enforced emergency use authorizations for all LDTs. This led to a delay in testing and a recall of the CDC's test kit, leaving the U.S. without authorized tests as the virus spread undetected. Senator Paul quotes the Deputy Director of the White House Office of Pandemic Preparedness and Response Policy, who acknowledged that "diagnostics were clearly the elephant in the room of what went wrong."

Senator Paul also raises concerns about the consequences of granting the FDA authority over LDTs. He argues that subjecting all LDTs to FDA approval could lead to outdated tests that miss more patients over time. 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.

It is important to note that 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 in the 116th and 117th Congress as an alternative to the overburdensome VALID Act. The VITAL Act aims to remove unnecessary government barriers to make tests quickly and widely available in health emergencies.

In conclusion, Senator Rand Paul is urging the FDA to rescind its proposed rule on Laboratory Developed Tests, citing concerns about the agency's authority, potential disruptions to patient care, and adverse consequences for patients. He calls for Congress to continue its work in establishing a modern oversight framework for laboratory testing services.

Click this link to access more information: https://www.paul.senate.gov/dr-rand-paul-urges-fda-to-rescind-overburdensome-proposed-rule-on-laboratory-developed-tests/