House appropriators direct FDA not to finalize guidance on laboratory developed tests

The House Appropriations Committee yesterday approved report language to accompany its Agriculture Appropriations bill that would direct the Food and Drug Administration to suspend efforts to finalize its draft guidance for laboratory developed tests and work with Congress to pass legislation that "addresses a new pathway for regulation of LDTs in a transparent manner." In comments submitted to FDA last year, AHA said the draft guidance and regulatory framework, which would apply medical device regulations to laboratory developed tests, would reduce patient access to many critical tests and hinder technological and clinical innovation. It said a better approach would be to modernize and enhance the Clinical Laboratory Improvement Amendments. The bill and report language are expected to go to the floor in May. AHA will continue to weigh in with legislators on this important issue.