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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

Energy and Commerce Committee Releases White Paper, Seeks Feedback on LDTs

December 12, 2014—As part of  its 21st Century Cures initiative, the House Energy and Commerce Committee released a Dec. 9 white paper seeking stakeholder feedback on key issues surrounding the Food and Drug Administration (FDA) plan to regulate laboratory developed tests (LDTs), particularly regarding an appropriate role for Congress in the discussion.

The request comes after the Energy and Commerce Subcommittee on Health held a Sept. 9 hearing in response to the guidance offered by the FDA [see Washington Highlights, Sept. 12]. Solicited feedback will be used in preparation for a discussion draft anticipated to be released under the 21st Century Cures initiative, sometime in 2015. 

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.”

The committee is specifically seeking feedback regarding definitions of the current classification system and what is subject to regulation by the FDA; risks, safety, and effectiveness associated with tests and how more accurate and efficient tests can be incentivized; and several questions regarding overall regulatory oversight.

Comments are due to the committee no later than Jan. 5, 2015.

Contact:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559
Email: dbmoore@aamc.org

Len Marquez
Director, Government Relations
Telephone: 202-862-6281
Email: lmarquez@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org