Bowling Green Today

Dec 5, 2023

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

In the letter, Dr. Paul states 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 and previous legislative debates to support his argument that the FDA lacks the authority to regulate LDTs without specific legislation.

Dr. Paul also raises concerns about the potential disruptions to patient care, drawing parallels to the initial months of the COVID-19 pandemic when the FDA enforced emergency use authorizations (EUAs) for all LDTs for SARS-CoV-2. He highlights the FDA's initial restrictions on testing and the recall of the CDC's test kit, which left the U.S. without authorized tests as the virus spread undetected. He emphasizes the importance of diagnostics in pandemic response and suggests that the proposed rule fails to address the consequences of the FDA having authority over LDTs.

Furthermore, Dr. Paul argues that the proposed rule would have adverse consequences for patients. He cites a past example where an FDA-approved companion test for a melanoma drug failed to identify patients who would respond to the treatment. He suggests that subjecting all LDTs to FDA approval would lead to delays, outdated tests, and potential harm to patients who cannot afford to wait for lengthy product reviews.

In conclusion, Dr. Paul 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.

Dr. Paul has been a vocal advocate for protecting doctors, healthcare workers, and patients from unnecessary federal regulations on laboratory testing services. His proposed VITAL Act, introduced in both the 116th and 117th Congress, aims to remove government barriers that slow the response to health emergencies such as the COVID-19 pandemic.

This letter serves as another example of Dr. Paul's efforts to ensure that healthcare providers can continue to develop and perform LDTs as part of their professional practice without unnecessary regulatory burdens. As the debate around laboratory testing services continues, it remains to be seen how the FDA will respond to Dr. Paul's concerns and the ongoing discussions in Congress.

Contact:

Press_Paul@paul.senate.gov

202-224-4343

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/