NEWS

4/20/2016

Members of Congress Approve Language To Delay FDA Oversight Of LDTs

Yesterday, the House Appropriations Committee approved report language requesting that the FDA suspend its Guidances on the oversight of LDTs as an accompaniment to the legislation passed to fund and direct programs under the Food and Drug Administration (FDA).  The language passed – in spite of active opposition from leading Democrats on the Committee and several patients advocacy and diagnostic manufacturing groups – asks that the FDA shelve its Guidances and work with Congress to pass legislation that would create a new pathway for the regulation of LDTs:

“The Committee directs the FDA to suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner.”

The FDA is expected to release final LDT oversight Guidances within the next two months, before final passage of the Appropriations Bill in the Fall. While this language does not explicitly prohibit the FDA from finalizing its Guidances, it is an important step towards delaying the agency’s efforts, as members of Congress are now on record opposing the FDA taking unilateral action on this issue. 

Next, the Senate will separately take up consideration of the Appropriations Bill to fund and direct FDA programs and policies.  During this time, NILA will continue to engage appropriators in an effort to get the Senate to adopt language requesting that the FDA suspend its LDT Guidances.

NILA appreciates the efforts of all members who reached out to their Congressional Representatives to encourage their support for the LDT report language.  We will continue to follow this issue and update you as the Appropriations process continues.