Senate Health Leadership Reacts to FDA Laboratory Developed Test (LDT) Oversight

Reproduced with permission from Daily Report for Executives, 183 DER (Sep. 21, 2016). Copyright 2016 by The Bureau of National Affairs, Inc. (800-372-1033) <>

GOP Senator Blasts FDA’s Plans for Regulating Lab Tests

Bloomberg BNA
By Michael D. Williamson
September 21, 2016

“The American Clinical Laboratory Association (ACLA), which represents the lab industry and has been staunchly against the FDA’s plans for LDTs, outlined 10 key principles to guide any reforms to oversight of the tests, according to a letter the group sent the committee’s leaders.

In its letter, the group restated that LDTs aren’t medical devices and shouldn’t be regulated by the FDA as such. In addition, the federal government should implement any new framework for LDTs through notice and comment rulemaking, not guidance documents, the ACLA said.”

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Health Panel Examines Lab Test Oversight

CQ Roll Call
By Joe Williams
September 20, 2016

“At a Senate Health, Education, Labor and Pensions hearing on Tuesday, Sen. Lamar Alexander, the panel’s chairman, said FDA oversight of lab tests would reduce patient access to innovative testing and impose added costs for academic researchers.

Alexander noted that FDA’s draft guidance proposed that lab developed tests that are currently under CMS oversight be submitted to FDA for approval before they can be used.” 

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Alexander Says FDA’s “Double Regulation” Could Halt Tests Americans Need For Treatments, Cures

The Chattanoogan
September 20, 2016

“U.S. Senator Lamar Alexander on Tuesday said that under the FDA’s proposal to regulate laboratory-developed tests, which Senator Alexander pointed out are already regulated by an arm of the Centers for Medicare and Medicaid Services, ‘the biggest loser, it seems to me, would be Americans who stand to benefit from the rapid pace of science and discovery.'”

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Alexander Floats Separate Agency For LDT Oversight To Avoid Regulatory Duplication

Inside Health Policy
By Erin Durkin
September 20, 2016

“Meanwhile, the American Clinical Laboratory Association wrote to the committee applauding lawmakers for holding the hearing and outlining key principles for any new statutory framework.

ACLA asserted that LDTs are not medical devices and should not be regulated as such. LDTs introduced prior to enactment of a new framework must be grandfathered from any premarket review or design control requirements, and laboratories must be granted a reasonable transition period after enactment, the group said.

ACLA also insisted that statutory and regulatory provisions developed under a new framework should be designed to avoid duplication of oversight of test development and laboratory operations to ensure continued patient access to clinical laboratory services.”

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