News Feature | September 12, 2014

Congressional Leaders Question FDA Decision To Regulate LDTs

By Nick Otto

Congressional leaders this week grilled FDA officials on the agency’s legal authority to regulate lab-developed tests (LDTs), asking if new requirements would trigger additional costs to laboratories, and whether the FDA itself had the necessary resources to take on the task.

Following the agency’s earlier notice to legislators of its intent to issue draft guidance outlining regulatory requirements that developers of LDTs will have to meet to ensure that they are marketing accurate and reliable devices, the House Energy and Commerce Committee’s subcommittee on health held a hearing to question industry experts on what LDT makers should expect.

In testimony, the FDA’s Center for Devices and Radiological Health director Jeff Shuren continued to defend the agency’s reasoning of including LDTs in the agency’s notification process, in lieu of the standard registration process, as it provides companies with the opportunity to avoid the Affordable Care Act’s unpopular medical device tax.

“The option allows FDA to collect and analyze the notification data that advisory panels will need in order to advise the Agency on appropriately classifying and prioritizing LDTs based on risk,” Shuren added in his written testimony.

Meanwhile, Andrew Fish, executive director of AdvaMedDx, threw his support behind the FDA’s efforts to regulate LDTs.

The current regulatory regime for diagnostic tests creates gaps in oversight “with respect to patient safety and public health regarding the use of LDTs,” Fish wrote in his testimony. “Maintaining two very different oversight mechanisms for tests that are the same from the perspective of patient safety is bad public policy, provides an opportunity to use tests in clinical settings without sufficient clinical data, and stifles investment in high quality products that can stand up to FDA review.”

Other witnesses testifying before the subcommittee included: Christopher Newton-Cheh, on behalf of the American Heart Association; Charles Sawyers, immediate past president of the American Association for Cancer Research; Alan Merz, president of the American Clinical Laboratory Association; and Kathleen Behrens Wilsey, the co-founder of the Coalition for 21st Century Medicine.

Current FDA regulations only apply to diagnostic tests if they are developed and sold by device makers as diagnostic kits, “regardless of whether they were developed by clinical laboratory companies for in-house testing or by manufacturers for use in kits,” Bloomberg notes.

The agency made the announcement of regulating LDTs earlier this summer with some Democratic senators lauding the FDA’s initiative.