Bowling Green Today

WASHINGTON, D.C. - U.S. Senator Rand Paul (R-KY) has called on the U.S. Food and Drug Administration (FDA) to withdraw its proposed rule on Laboratory Developed Tests (LDTs). In a letter addressed to Dr. Robert Califf, Commissioner of Food and Drugs at the FDA, Senator Paul expressed his concerns about the proposed rule and its potential consequences for healthcare providers and patients.

The proposed rule aims to impose the FDA's medical device regulatory framework on health care providers developing and performing LDTs as part of their professional practice. However, Senator Paul argues that this exceeds the FDA's statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA) and conflicts with the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which have successfully governed LDT regulation for decades.

In his letter, Senator Paul cites legal experts who affirm that the FDA lacks the authority to regulate LDTs without specific legislation granting them such authority. He also highlights that Congress has twice considered and twice rejected proposals to grant the FDA the authority to regulate LDTs. Despite ongoing debates on how to modernize the federal government's approach to regulating laboratory testing services, the proposed rule threatens to usurp the lawmaking role assigned to Congress by the U.S. Constitution.

Furthermore, Senator Paul warns that the proposed rule could result in disruptions to patient care, similar to what was experienced during the early months of the COVID-19 pandemic. He recalls how the FDA's enforcement of emergency use authorizations (EUAs) for LDTs for SARS-CoV-2 initially restricted clinical laboratories from testing, leaving the U.S. without authorized tests as the virus spread undetected. The potential consequences of the FDA having authority over LDTs during the pandemic are not addressed in the proposed rule, raising concerns about the completeness of the agency's impact analysis.

Senator Paul also emphasizes that the proposed rule could have adverse consequences for patients. He cites the example of a melanoma drug and its companion test, which were both FDA-approved but failed to identify patients who would respond to the drug. This experience highlights that the FDA's expertise in assessing drugs and devices may not readily transfer to LDTs. Subjecting all LDTs to FDA approval could lead to delays in updates or improvements, potentially leaving many patients without timely access to accurate testing.

In conclusion, Senator Paul urges the FDA to rescind its proposed rule so that Congress can continue its work to establish a modern oversight framework for laboratory testing services. He has been a vocal advocate for protecting doctors, healthcare workers, and patients from unnecessary federal regulations on laboratory testing services. In previous congressional sessions, Senator Paul introduced the VITAL Act as an alternative to the overburdensome VALID Act, aiming to remove unnecessary government barriers that slowed the response to the COVID-19 pandemic.

As discussions on how to regulate laboratory testing services continue, it remains to be seen how the FDA will respond to Senator Paul's call to reconsider the proposed rule on LDTs.

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/