FDA Commissioner Margaret Hamburg resigns

Margaret A. Hamburg, MD, resigned this week after six years as FDA Commissioner, an agency spokesperson confirmed with Healio.

Stephen M. Ostroff, MD, has been appointed acting commissioner, according to a letter penned by Hamburg to FDA employees.

Margaret A. Hamburg

Hamburg, 59, is the former health commissioner of New York City, and a graduate of Harvard Medical School. She previously worked for the NIH, and was the youngest person elected to the IOM in 1994.

“As you can imagine, this decision was not easy,” Hamburg wrote. “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.”

During her six-year tenure, the FDA created a modernized food safety system, approved numerous novel medications, and took steps to combat death and disease caused by tobacco.

Hamburg tackled the compounding pharmacy arena following a meningitis outbreak in 2012, and fought to bring Plan B contraceptives over-the-counter in 2013.

In 2014, the FDA approved 51 novel drugs and biologics – the most in 20 years, according to Hamburg’s latest FDA Voices blog entry.

In her letter, Hamburg highlights the agency’s efforts to expedite new drugs, including those for rare types of cancer, hepatitis C, type 2 diabetes and idiopathic pulmonary fibrosis, in addition to vaccines.

“On the medical device side, the average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010,” Hamburg wrote. “The percentage of pre-market approval (PMA) device applications that we approve annually has increased since then, after steadily decreasing each year since 2004.”

Hamburg also noted the implementation of the Family Smoking Prevention and Tobacco Control Act which led to nearly 240,000 inspections, more than 12,100 warning letters to retailers and launched new campaigns to prevent and reduce tobacco use among youth.

“As hard as it is to leave this Agency, I am confident that the leadership team that we have in place will enable FDA to capitalize on, and improve upon, the significant advances we've made over the last few years,” Hamburg wrote.– by Samantha Costa