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PMC Analysis Reveals Record-Breaking Month for Personalized Medicine at FDA

PMC’s Amy M. Miller: Ethically and Scientifically ‘No Going Back’

WASHINGTON (July 31, 2015)


A new analysis from the Personalized Medicine Coalition (PMC) reveals that July was a record-breaking month for personalized medicine at FDA, with the agency approving four new indications for personalized medicine products. In the analysis, which was published on the Coalition’s blog, Education & Advocacy, PMC Executive Vice President Amy M. Miller, Ph.D., says the field is “turning a corner,” noting the implications of that for ongoing health care policy conversations, including the current debate on drug costs.

“Policymakers throughout the health care system have to play catch up, because ethically and scientifically there is no going back,” she writes. 

The blog explains that the successful month is only the latest development in a clear trend for the field, as 20 percent of FDA’s 2014 approvals were personalized medicines. Miller speculates that this percentage will be matched or exceeded this year. 

“I encourage all the field’s stakeholders to work together toward ensuring that personalized medicine makes us healthier, because, as FDA’s recent decisions make clear, personalized medicine is no longer just a hypothetical paradigm,” she writes. 

“It is our current reality.” 

Read the analysis


Chris Wells
Phone: 202-589-1755

About the Personalized Medicine Coalition:
The Personalized Medicine Coalition, representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information about PMC, please visit

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