Lawmakers Press OMB To Release Lab-Developed Test Draft Guidance

Article preview from "The Gray Sheet" - August 19, 2013

 In a letter to Office of Management and Budget director Sylvia Mathews, nine Democratic representatives urged the release of a draft guidance establishing an FDA oversight structure for laboratory-developed tests. FDA said more than a year ago that the documents were under administrative review.

Lawmakers Press OMB To Release Lab-Developed Test Draft Guidance

Article preview from "The Gray Sheet" - August 19, 2013

It was 2010 when FDA announced its plans to establish a comprehensive regulatory framework for laboratory-developed tests. Some congressional members are now getting impatient for a draft version of the framework.

Nine House Democrats sent a letter to White House Office of Management and Budget director Sylvia Mathews Burwell Aug. 9, urging OMB to release draft guidance that FDA says it has put together on the topic.

“The widespread development and use of a new generation of advanced molecular diagnostics by clinical laboratories without FDA oversight has exposed a significant gap in the regulatory system. Patients and consumers depend on FDA for assurance that the diagnostics, medical devices and therapies used for their care are safe and effective,” the letter states.

Lab-developed tests are those developed and performed as services by a single lab. The offerings have not been subject to oversight, which FDA says is due to its decisions to invoke enforcement discretion, but the labs themselves are regulated under the Clinical Laboratory Improvement Amendments (CLIA).

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