Lawmakers push FDA oversight of lab tests

Democratic senators are pressing the Obama administration to give the Food and Drug Administration (FDA) authority to regulate laboratory tests used to detect high-risk conditions like cancer and Lyme disease.

Sen. Ed Markey (D-Mass.) and other lawmakers wrote to the Office of Management and Budget (OMB), asking it to quickly release a draft guidance allowing the FDA to regulate so-called Laboratory Developed Tests (LDTs), used to diagnose serious diseases.

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In the past, the FDA said it wouldn’t regulate such tests because they were simple and only used to diagnose low-risk or rare diseases. However, over the years, the tests have become more sophisticated and are now being used to diagnose high-risk diseases.

“Because these more advanced LDTs are a staple of clinical decision-making and are being used to diagnose, high-risk, but relatively common diseases, it is imperative that they perform as they are expected,” the lawmakers wrote.

“Incorrect results mean that patients either will not seek out the care and therapy that is needed, or will be subject to treatments that do not work or are harmful.”

The letter to OMB is also signed by Sens. Elizabeth Warren (D-Mass.), Richard Blumenthal (D-Conn.), Sherrod Brown (D-Ohio) and Dick Durbin (D-Ill.).

The OMB and the Office of Information and Regulatory Affairs must review the FDA's regulatory policies, and the lawmakers say the guidance on lab tests has been delayed.

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.

The guidance would allow FDA to tell the medical industry what tests it will regulate, and how those tests need to be manufactured and used to ensure safety.

“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.

“The risk-based framework we have under development will ensure that diagnostics used in cancer treatment will provide medical professionals with a critical baseline for confidence in the tests they order for their patients.”