Hamburg’s announced resignation follows the agency’s most productive year for personalized medicine novel new drug approvals
WASHINGTON (Feb. 5, 2015)
Following Margaret Hamburg’s announcement that she would step down as FDA commissioner, the Personalized Medicine Coalition (PMC) applauded her dedication to advancing personalized medicine.
"Her commitment to personalized medicine was second to none,” said PMC President Edward Abrahams.
Hamburg’s announcement follows the release of a PMC analysis revealing that more than 20 percent of the novel new drugs approved by FDA in 2014 were personalized medicines. The effort was guided by PMC’s definition of personalized medicine -- product labels needed to refer to a specific biomarker that can play a role in treatment decision making, either whether or not to treat, or how to treat, for an individual patient.
In her letter announcing her resignation, which was posted on FDA’s website, Hamburg stated that FDA has “ushered in the era of personalized medicine across all of our medical product centers,” noting the growing percentage of recent approvals that have involved targeted therapies.
About the Personalized Medicine Coalition:
The Personalized Medicine Coalition (PMC), 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, visit www.personalizedmedicinecoalition.org.