As Part of Effort to Prepare 21st Century Cures Legislative Discussion Draft, House Committee Seeks Comment on FDA Proposed Framework to Regulate LDTs

December 12, 2014

By Jamie K. Wolszon & Jeffrey N. Gibbs

The House Energy & Commerce Committee, which has jurisdiction over FDA, has issued a “white paper” announcing that as part of its efforts to prepare a draft discussion legislative package in early 2015 related to the overall 21st Century Cures Initiative, that it seeks input on specific questions related to the FDA Laboratory-Developed Test (LDT) proposed Framework.  This key House panel is also seeking “advice on what role Congress should play in addressing any other related issues.” The white paper requests comments by January 5, 2015.  We previously reported on the overall 21st Century Cures initiative here, here, and here.  

The white paper states: “The committee understands that FDA’s approach has led to a number of important questions about administrative process and policy.  In addition to questions about the framework proposed, we are aware that the agency’s release of the guidance documents has served as a catalyst for broader conversations about the overarching need to modernize governmental oversight of these unique and increasingly important medical products.  As the 21st Century Cures initiative proceeds, with preparations for a discussion draft early in the New Year, the committee appreciates all interested stakeholders” input on the issues.”  The administrative process issues referenced here likely refer to calls for the agency to use notice-and-comment rulemaking instead of guidance to issue the framework.  We previously reported that in November 2014, several laboratory and medical groups and laboratory directors sent FDA Commissioner Margaret A. Hamburg a letter arguing that if the agency proceeds with the framework, it must do so through notice-and-comment rulemaking. 

The specific issues related to FDA oversight of LDTs that the panel seeks comments on include: how to draw lines “separating the practice of medicine, the actual conduct of a diagnostic test and the development and manufacturing of diagnostic tests;”  what constitutes a “device” in the context of LDTs; how FDA will define risk; the applicability of pre-market review standards for kits to LDTs; the potential role of pre-market controls in easing premarket review; when a supplemental premarket submission is required for a modification; what constitutes labeling for an LDT; potential overlap between the Clinical Laboratory Improvements Act of 1988 (CLIA) and FDA regulation, particularly in the area of quality systems; how to address tests for rare disorders; grandfathering provisions; and incentives to encourage development of new tests. 

In the white paper, the Committee notes that its health subcommittee held a September 9, 2015 hearing on the issue of FDA regulation of LDTs.  We previously reported that at the hearing, which lasted for hours, several members of the subcommittee questioned FDA Center for Devices and Radiological Health (CDRH) Director Jeff Shuren at length. 

January 2015 promises to be an interesting time for the regulation of LDTs.  As we previously reported, FDA will hold a public meeting to discuss the draft guidances on January 8-9, 2015 at the National Institutes of Health (NIH) campus in Bethesda Maryland.  FDA identified specific topics for each session during that upcoming meeting.  It is unclear whether presenters could make a general comment that they oppose the very concept of FDA regulation of LDTs.  Consistent with prior FDA statements, FDA is looking for feedback on its framework and not whether there should be FDA regulation of LDTs at all.  However, the white paper calls for comments “on what role Congress should play in addressing any other related issues,” which could include comments that the agency should not regulate LDTs at all.  While FDA is not receptive to a “do not regulate” message, Congress may be receptive to this message.