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PMC Analysis: Personalized Medicines Top 20 Percent of FDA Approvals For Third Straight Year

PMC President: Pharmaceutical industry remains committed to field despite regulatory, reimbursement systems oriented toward traditional medicine

WASHINGTON (January 24, 2017)


new report from the Personalized Medicine Coalition (PMC) shows that in 2016, for the third year in a row, personalized medicines accounted for more than 20 percent of the new molecular entities (NMEs) approved by the U.S. Food and Drug Administration (FDA). PMC President Edward Abrahams said the trend reflects the pharmaceutical industry’s commitment to investing in personalized medicine despite the absence of a business model that ensures success and persistent barriers in public policy that slow the transition from a one-size-fits-all world to one that is based on delivering the right medicine to the right patient at the right time.

"Science shows us that using diagnostic tests to determine which medical treatments work best for each patient produces better outcomes," Abrahams explained. "It also helps some patients avoid ineffective and unnecessary therapy, thereby saving the health care system expense. The pharmaceutical industry is responding to the emerging understanding of treatment heterogeneity by developing personalized medicines, despite the fact that the regulatory pathway for molecular diagnostics remains unclear and reimbursement policies are more often than not still based on statistical averages.”

The report, titled Personalized Medicine at FDA: 2016 Progress Report, lists the six personalized medicines FDA approved in 2016 and underlines that nearly one of every four drugs the agency approved from 2014 to 2016 is a personalized medicine. That ratio is a sharp increase from 2005, when personalized medicines accounted for just 5 percent of NME approvals. In an article published in The Journal of Precision Medicine last year, Abrahams and PMC Board Chair Stephen Eck, M.D., Ph.D., Vice President, Oncology Medical Sciences, Astellas Pharma Global Development, cite data from the Tufts Center for the Study of Drug Development showing that personalized medicines also account for more than 40 percent of all drugs in development.

"The era of personalized medicine is upon us,” Abrahams said. "Now is the time to clear the path by putting in place regulatory and reimbursement policies that support its development and adoption.”

Personalized Medicine at FDA: 2016 Progress Report

Christopher J. 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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