Opinion: STAT+: A court decision on lab-developed tests sets a dangerous precedent
An under-the-radar court ruling may be among the most significant harbingers of the crises to come for the FDA and public health.
It’s no secret that the new administration has upset normal operations at the Food and Drug Administration: Thousands of employees have been terminated, more than three dozen senior officials are gone, day-to-day operations ranging from communicating product recalls to the public to inspections of food and drug facilities have been upended, and approvals of new products and technologies have been delayed and shelved.
Yet amid all the challenges of today, an under-the-radar court ruling may be among the most significant harbingers of the crises to come for the agency and public health.
On March 31, Judge Sean Jordan of the Eastern District of Texas struck down the FDA’s final rule that established the agency’s regulatory framework for ensuring the safety and effectiveness of laboratory-developed tests (LDTs). This decision, which asserts that the FDA does not have responsibility for the authorization and oversight of LDTs, removes established guardrails for diagnostic safety and accuracy that protect patients, and sets a dangerous precedent for public health.
