The US Food and Drug Administration (FDA) confirmed media rumours to in-Pharmatechnologist.com today that Margaret (Peggy) Hamburg is stepping down from her role as Commissioner at the end of March.
“My tenure leading this Agency has been the most rewarding of my career, and that is due in no small part to all of you - the dedicated and hard-working people that make up the heart of this Agency,” she said in a memo sent to FDA staff this morning.
Nominated by President Barack Obama and supported by the Senate, Hamburg became the FDA’s 21st Commissioner in May 2009, and is the second longest serving head of the organisation in the modern era.
Dr. Stephen Ostroff, the FDA's chief scientist, will serve as acting Commissioner from April before a new Commissioner is nominated.
“Dr. Ostroff has successfully overseen numerous significant initiatives, while helping to ensure that scientific rigor, excellence and innovation are infused across the Agency. I have every confidence that he will take on this new role with the same energy, dedication and care.”
She also told FDA staff during her tenure the Agency has made great strides in advancing the safety and effectiveness of medical products.
“Some of these important steps include new oversight of human drug compounding and provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.”
Furthermore, she mentioned achievement in speeding up drug development such as the FDA’s breakthrough therapies designation.
“Almost half of the novel new drugs approved in 2014 received expedited review with a combination of breakthrough designation, priority review and/or fast track status.”
Last year the agency approved 51 novel drugs and biologics, the most in almost 20 years.