News Feature | July 11, 2014

Senators Urge Approval Of FDA Laboratory-Developed Test Draft Guidance

By Nick Otto


Five Democratic senators are urging the U.S. Office of Management and Budget (OMB) to approve draft guidance developed by the FDA to better regulate laboratory tests used in the detection of common ailments.

Lawmakers, including Massachusetts Sens. Ed Markey and Elizabeth Warren, wrote to the OMB asking it to “take prompt action in releasing draft guidance on the regulation of laboratory developed tests (LDTs),” which are used to diagnose maladies like cancer and Lyme disease. The letter to the OMB is also signed by Sens. Richard Blumenthal (D-Conn.), Sherrod Brown (D-Ohio), and Dick Durbin (D-Ill.).

As time has progressed and technology has improved, LDTs have been used more frequently to detect widespread illnesses, according to Law360.

The primary issue addressed in the letter to the OMB, as described by Bloomberg, is that while most lab-developed tests (LDTs) “are simple and low-risk,” there are some that can be a bit more technical and, if misused, could lead to patient harm via misdiagnosis. 

After the FDA decided in 2010 that lab tests were becoming more sophisticated and popular, the agency decided to step in to develop new regulations aimed at the medical industry, which it sent to OMB for approval, as Genomics Law Report notes.

“The Agency is working to make sure that the accuracy and clinical validity of high-risk tests are established before they come to market,” said FDA Commissioner Margaret Hamburg, during a medical industry conference last year.

Support, however, doesn’t come from both aisles. In 2011, Rep. Michael Burgess (R-Texas) introduced a bill that would ban the FDA from regulating genetic diagnostic testing, according to a Patent Docs’ blog. His opposition stemmed from the idea that greater regulation would “cripple innovation.”