Hamburg Highlights FDA Commitment to Personalized Medicine at PMC Annual Luncheon


When Dr. Margaret (Peggy) Hamburg delivered the Sixth Annual State of Personalized Medicine Address at the National Press Club on February 25, she impressed and energized the audience by announcing the Agency’s intent to release draft guidance on companion diagnostic regulation by the end of 2010.

As the PMC contends and she noted to the audience, for innovations to occur in personalized medicine, FDA needs to outline clear expectations and standards for approval.

According to Hamburg, FDA intends “to clarify our expectations for the kinds of clinical trials and levels of confidence needed to satisfy us that a test is accurate and that it can be used to help shape clinical judgments.…We also are working internally to make sure we have a common understanding across all centers and throughout the agency about the kind of evidence needed when a test result is being used to shape a drug trial, or drug approval or relabeling.  We also intend to make sure the communication line between sponsors and CDER and CDRH is clear, and that sponsors get consistent advice about how to take the next step in development.

We expect to have this guidance finished by the end of the year.”

She also promised that FDA would be flexible, collaborative, open, and clear throughout this process.   Hamburg concluded her remarks by sharing her enthusiasm and commitment for reducing regulatory barriers at FDA for personalized medicine.

Dr. Hamburg has clearly outlined sound goals – to articulate clear procedures and requirements within and among FDA centers for the approval of personalized medicine products– and a sound way to achieve them –through an open and collaborative process.  PMC members are excited by this commitment and are equally committed to working with her to this end since achieving these goals represents a necessary step in assuring that our regulatory processes are appropriately designed for the science of personalized medicine.

The full text of Dr. Hamburg’s speech is available here:

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