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FDA Approves Record Number of Personalized Medicines, Spearheads Six Regulatory Precedents in Field in 2017

Personalized Medicines Now Account for More Than One in Four New Drug Approvals

WASHINGTON (January 30, 2018)


The Personalized Medicine Coalition (PMC) today released a report documenting the record number of new personalized medicines the U.S. Food and Drug Administration (FDA) approved last year, making 2017 the fourth consecutive year that personalized medicines accounted for more than 20 percent of all new drug approvals.

The annual analysis, titled Personalized Medicine at FDA: 2017 Progress Report, shows that FDA approved a record number of 19 personalized medicines — 16 new molecular entities and three gene therapies — in 2017. The report lists a total of six regulatory precedents FDA set last year, as follows:

  1. Record number of 16 personalized medicines approved as new molecular entities
  2. Approval of first three gene therapies
  3. First approval of a tissue agnostic indication for cancer therapy
  4. First authorization for marketing of health-related genetic tests directly to consumers
  5. First approval of a personalized medicine biosimilar
  6. First FDA/CMS joint approval and coverage decision for a next-generation sequencing test 

PMC President Edward Abrahams, Ph.D., said the precedents demonstrate how personalized medicine has reshaped drug development in the decade since 2007, when targeted therapies accounted for less than 10 percent of new drug approvals. An influential article published in 2007 in the Harvard Business Review titled “Realizing the Promise of Personalized Medicine,” for example, suggested that FDA was not yet committed to the paradigm. The pharmaceutical industry, the article noted, was at that time hesitant to develop medicines for smaller patient populations, preferring instead to develop “blockbuster” medications that could earn approval for one-size-fits-all applications. 

This obviously is no longer true, though there remain many obstacles — notably regarding regulation, reimbursement, access and clinical adoption — that complicate the commercialization of personalized medicine products. 

“Despite myriad challenges, the diagnostic and pharmaceutical industries are deeply invested in making health care more effective and efficient by developing products that guide treatments to only those patients who will benefit from them,” Abrahams explained. “As this report shows, FDA is increasingly committed to supporting that effort.” 

Laura Koontz, Ph.D., Personalized Medicine Staff Member at FDA, will discuss FDA’s direction in personalized medicine with PMC members during its next Policy Committee Meeting on February 20, 2018. 

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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