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), urging the agency to reverse its proposed rule on Laboratory Developed Tests (LDTs). In the letter, Senator Paul expresses his concerns about the FDA's attempt to impose its medical device regulatory framework on healthcare providers who develop and perform LDTs as part of their professional practice. He argues that this proposed rule would exceed the FDA's statutory authority and conflict with the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which have successfully regulated LDTs for decades.

Senator Paul highlights the legal interpretation that laboratory-developed testing services are not devices and, therefore, fall outside the FDA's jurisdiction. He references 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." This legal interpretation was also reaffirmed in a memorandum by the General Counsel of the U.S. Department of Health and Human Services.

Furthermore, Senator Paul points out that Congress has twice rejected proposals to grant the FDA authority over LDTs. He mentions the VALID Act of 2021, which aimed to shift the regulation of all in vitro clinical tests to the FDA. However, this policy was omitted from legislation passed by Congress to fund the government, indicating that ongoing discussions about modernizing the federal government's approach to regulating laboratory testing services are still taking place.

Senator Paul raises concerns about the potential disruptions to patient care that could arise from the FDA's proposed rule. He refers to the initial months of the COVID-19 pandemic when the FDA enforced emergency use authorizations (EUAs) for all LDTs for SARS-CoV-2. The FDA's restrictions on clinical laboratories conducting testing led to a shortage of authorized tests, causing delays in detecting the spread of the virus. The proposed rule fails to address these consequences and does not provide a comprehensive analysis of its potential societal and economic costs.

Additionally, Senator Paul warns that subjecting all LDTs to FDA approval could lead to outdated tests and delays in patient care. He cites the example of a melanoma drug and its companion test, where the FDA-approved test failed to identify patients who would respond to the drug. He emphasizes that the FDA's expertise in assessing drugs and devices may not readily translate to LDTs, and the lengthy product reviews required for each update or improvement could hinder patient access to timely and accurate testing.

In conclusion, Senator Paul urges the FDA to rescind its proposed rule on LDTs, allowing Congress to continue its efforts to establish a modern oversight framework for laboratory testing services. He has long advocated for removing unnecessary government barriers to make tests quickly and widely available in health emergencies, as demonstrated by his introduction of the VITAL Act in the 116th and 117th Congress. This act aims to protect doctors, healthcare workers, and patients from unnecessary federal regulations that hindered the response to the COVID-19 pandemic.

The FDA has yet to respond to Senator Paul's letter, but his concerns highlight the ongoing debate surrounding the regulation of laboratory developed tests and the need for a balanced approach that ensures patient safety while allowing for innovation and timely access to 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/