Personalized Medicine Education and Advocacy

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FDA: Next LDT Regulation Documents Will Be Final Guidance

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House Energy & Commerce Committee Translates Alternative Proposal into Legal Language

Despite requests for another round of draft documents by PMC and other stakeholders, FDA clarified its intentions to finalize its approach to regulating laboratory-developed tests (LDTs) with the next iteration of guidance publications on the subject during a panel discussion at the 2015 Biotechnology Industry Organization (BIO) Convention. The comments coincided with the release of news that the U.S. House Energy and Commerce (E & C) Committee has converted a proposal from an independent working group into draft legislation.

“I can tell you that our plan is to finalize,” FDA Deputy Office Director for Personalized Medicine Elizabeth Mansfield, Ph.D., told the audience of the personalized medicine track at the Convention, which was organized by PMC and BIO.

Once finalized, alterations to the framework would require Congressional intervention. The recently released draft language from the E & C Committee is based on a proposal from the Diagnostic Test Working Group (DTWG), which includes representatives from both diagnostic kit manufacturers and clinical laboratories. Other alternative frameworks for LDT regulation have been proposed by organizations including the American Medical Association (AMA).

“People understand that LDT regulation is problematic for personalized medicine, and want a solution that will benefit innovations in the field of diagnostics but won’t halt the industry,” PMC Executive Vice President Amy M. Miller, Ph.D., told GenomeWeb.

FDA’s timeline for releasing its final guidance documents is unknown.


Chris Wells
Communications Director
Personalized Medicine Coalition

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