U.S. Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg has announced her plan to resign at the end of March 2015. She has held the post for nearly six years and is one of the longest-serving FDA commissioners in recent history.
Along with advancing various public health initiatives, including personalized medicine, Dr. Hamburg's tenure was marked by several accomplishments in the regulation of medical devices. One of these was the publication of the Unique Device Identification (UDI) System final rule, which regulates the tracking of medical devices. Also under her watch, the average number of days for premarket review of new medical devices dropped by a third since 2010, prompting an increase in premarket approval (PMA) of high-risk device applications.
The Advanced Medical Technology Association (AdvaMed) praised the commissioner for her service and contribution in improving the regulation of the industry. “It was under her leadership that the historic Medical Device User Fee Agreement III (MDUFA III) was struck, bringing significant new resources, accountability and improvements to the device review process,” Janet Trunzo, senior executive VP for technology and regulatory affairs at AdvaMed, said. “In addition, she was a key advocate to strengthen oversight for certain laboratory-developed tests which have become far more complex and critical to patient care and medical decision making. We wish her continued success.”
Dr. Hamburg told Reuters that her decision to step down was prompted by difficult work demands and the length of time she has served at FDA. Her resignation comes at a critical time for the agency, as it is poised to enter into negotiations with the medical device and pharmaceutical industries concerning user fees, notes the Regulatory Affairs Professionals Society (RAPS).
Dr. Stephen Ostroff, currently serving as the FDA's chief scientist, will serve as acting commissioner upon Dr. Hamburg's resignation. Dr. Robert Califf of Duke University is a likely candidate for the permanent replacement, reports The Wall Street Journal. Dr. Califf was recently appointed by Dr. Hamburg as deputy commissioner for tobacco and medical products and has been previously considered for the top FDA position.