Bowling Green Today

U.S. Senator Rand Paul (R-KY) has called on the Food and Drug Administration (FDA) to rescind its proposed rule on Laboratory Developed Tests (LDTs), citing concerns about the potential negative impact on healthcare providers and patient care. In a letter to Dr. Robert Califf, Commissioner of Food and Drugs at the FDA, Senator Paul expressed his grave concerns about the overreach of the FDA's regulatory framework on LDTs.

The proposed rule would impose the FDA's medical device regulatory framework on healthcare providers who develop and perform LDTs as part of their professional practice. Senator Paul argues that this exceeds the FDA's statutory authority and conflicts with the current regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which have successfully governed LDT regulation for decades.

In his letter, Senator Paul referenced a white paper co-authored by Paul Clement, the former Solicitor General of the United States, and Professor Laurence Tribe of Harvard Law School, which states 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 legal interpretation was reaffirmed in a memorandum by the General Counsel of the U.S. Department of Health and Human Services.

Senator Paul also highlighted the fact that the proposed rule was not included in recent legislative discussions and debates about modernizing the federal government's approach to regulating laboratory testing services. He argues that the FDA's attempt to impose this rule undermines the lawmaking role assigned to Congress by the U.S. Constitution.

Furthermore, Senator Paul expressed concerns about the potential disruptions to patient care that could result from the proposed rule. He referenced the initial response to the COVID-19 pandemic, when the FDA's enforcement of emergency use authorizations for LDTs led to restrictions on testing and a recall of the CDC's test kit. This left the U.S. without authorized tests as the virus spread undetected. Senator Paul argues that giving the FDA authority over LDTs could lead to similar disruptions in the future.

The proposed rule also raises concerns about the potential impact on the healthcare sector. Under current regulations, CLIA governs certified laboratory entities, many of which are housed at prestigious academic institutions and staffed by leading researchers. The proposed rule would effectively transfer the LDT market to large medical device manufacturers and other companies, potentially consolidating the clinical laboratory market and preventing providers from offering testing services.

Senator Paul concludes his letter by urging the FDA to rescind the proposed rule so that Congress can continue its work to establish a modern oversight framework for laboratory testing services.

This is not the first time Senator Paul has taken a stand on this issue. Since 2019, he has been fighting to protect doctors, healthcare workers, and patients from unnecessary federal regulations by the FDA on laboratory testing services. In the 116th and 117th Congress, he introduced the VITAL Act as an alternative to the overburdensome VALID Act. The VITAL Act aims to remove unnecessary government barriers that slow down the availability of tests in health emergencies, such as the COVID-19 pandemic.

Senator Paul's call to rescind the proposed rule highlights the need for careful consideration of the potential consequences and impact on healthcare providers and patient care. As discussions about modernizing the regulation of laboratory testing services continue, it is essential to strike a balance between ensuring safety and promoting innovation and accessibility in the healthcare sector.

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