FDA’s Move on LDTs is a Power Grab
Tuesday, January 27, 2015
In its pending Framework for Regulatory Oversight for Laboratory Developed Tests (LDTs), FDA is making an audacious and potentially futile power grab.
Futile because however justified by public health concerns, the vehicle the agency has chosen is the legally vulnerable guidance document. Like anything FDA says publicly as an institution, the content of guidance documents is there to be weighed, interpreted, and tested in diverse forums (including courtrooms).
Moreover, the content is currently devoid of regulatory force. Every FDA guidance bears on its first page a boldly boxed statement saying it “represents the agency’s current thinking on this topic. It does not create or confer any rights for or on any persons and it does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statute and regulations.”