I have been warning about the FDA’s power grab over lab developed tests. Lab developed tests have never been FDA regulated except briefly during the pandemic emergency when such regulation led to catastrophic consequences. Catastrophic consequences that had been predicted in advanced by Paul Clement and Lawrence Tribe. Despite this, for reasons I do not understand, the FDA plan is marching forward but many other people are starting to warn of dire consequences. Here, for example, is the executive summary from a letter by ARUP Laboratories, a non-profit enterprise of the University of Utah Department of Pathology:

ARUP urges the FDA to withdraw the proposed rule:

• The FDA proposal will reduce, an in many cases eliminate, access to safe and essential testing services, particularly for patients with rare diseases.
• Laboratory-developed tests are not devices as defined by the Medical Device Amendments of 1976, nor are clinical laboratories acting as manufacturers.
• The FDA does not have the statutory authority to regulate laboratory-developed tests.
• The FDA does not have the authority to regulate states, or state-owned entities. This is particularly relevant for the proposed rule regarding academic medical centers.
• The FDA’s regulatory impact analysis is flawed in its design, source information, methods. and conclusions, and it systematically overestimates purported benefits of the proposed rule and dramatically underestimates its cost to society, the healthcare industry, and the ability to provide ongoing essential laboratory services to patients.
• The proposed rule would significantly limit the ability of clinical laboratories to respond quickly to future pandemic, chemical, and/or radiologic public health threats.
• The proposed rule would not be easily implementable, and it would create an insurmountable backlog of submissions that would hinder diagnostic innovation.
• The proposed rule limits the practice of laboratory medicine.
• The FDA has not evaluated less restrictive, easily administered alternatives, such as CLIA reform. This is particularly relevant for common test modifications used in most hospital and academic medical center settings.”

Here is the American Hospital Association:

…we strongly believe that the FDA should not apply its device regulations to hospital and health system LDTs. These tests are not devices; rather, they are diagnostic tools developed and used in the context of patient care. As such, regulating them using the device regulatory framework would have an unquestionably negative impact on patients’ access to essential testing. It would also disrupt medical innovation in a field demonstrating tremendous benefits to patients and providers.

Here is Mass General Brigham, a non-profit hospital system, affiliated with Harvard, and the largest hospital-based research enterprise in the United States:

…we are concerned with the heavy regulatory burden of this proposal. In implementing any regulatory structure, policymakers must consider if the benefits outweigh the costs. Given that FDA predicts 50 percent of tests would require premarket review, and 5 percent will require premarket approval, we have serious concerns that the costs may outweigh the benefits. Given that many LDTs are hospital-based and will never be commercialized, hospitals will have little incentive or ability to develop future LDTs under this proposed rule as they will have little to no opportunity to offset the costs associated with these new regulatory requirements. We are concerned that the regulatory burden could have significant implications on responsible innovation especially for LDTs targeting rare conditions, or public health emergencies.

Two U.S. public lab directors personally reached out to me to ask me amplify the warning. Consider it amplified!

Today is the last day for public comment. Get your comments in!