A recent survey shows concern from US laboratories about patient access to laboratory developed tests (LDTs) if the US Food and Drug Administration (FDA) goes ahead with its proposal to regulate such tests. Many have said they would have to react to new regulation by withdrawing tests from the marketplace.
Nearly 85% of respondents to an ARUP Laboratories survey on the impact of the FDA's proposed rule were either "extremely concerned" or "very concerned" about the impact of the proposed rule on patient access to essential testing and innovation, the financial and personnel resources required to comply, and the FDA's ability to implement the proposed rule.
The survey is the largest exploration of the impact of the proposed rule on clinical laboratories to date. Of 503 respondents, only 41 (8.2%) support the FDA's proposed rule. A total of 83.9% of respondents believe the proposed rule will negatively impact their laboratories, whereas only 3% believe they have the financial resources to pay FDA user fees, which can be as high as $483,000 for ‘high-risk’ premarket authorisation submissions. Additionally, nearly 61% of participants said they would likely remove tests from their laboratory menus if the proposed rule were enacted, and an additional one-third of respondents were not yet sure what they would do.
"This survey shows there is profound concern within the clinical laboratory community about the proposed rule and its negative impact on patient care," said Jonathan Genzen MD PhD, ARUP's Chief Medical Officer and Senior Director Of Governmental Affairs. "If laboratories cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients."
A detailed exploration of the survey results and the issues surrounding the proposed rule for labs and patients can be found in a manuscript authored by Genzen and colleagues, linked here and publicly available on medRxiv, a health sciences preprint server.
