What’s next for the FDA, after Commissioner Hamburg steps down in March?

Last week, U.S. Food and Drug Commissioner Dr. Margaret Hamburg announced she would step down at the end of March.

Hamburg, one of the longest-serving FDA commissioners, has been quoted saying “the honest truth is that I had never expected to stay this long.”

She was nominated by President Obama in 2009 and has overseen public health initiatives including tobacco control and food safety.

Rachana Pradhan, a health care reporter for Politico, joined Pulse host Maiken Scott this week to talk about Hamburg’s career and the implications of this news.

Pradhan says the FDA has undergone many significant changes under Hamburg’s leadership over the last six years.

“One of the biggest things that comes to mind is overhauling our food safety system,” she said. “Currently what’s underway is the biggest overhaul since the 1930s.”

Hamburg has proposed measures to ban trans-fats, or at least reduce them, and require restaurants to post calorie counts on menus. She also played a role in developing what is called the breakthrough pathway.

“The main motive of that is to make it so that drugs and devices are approved faster. Often times, they’re meant for getting products approved that would really help people who have very serious, even life-threatening issues.”

Hamburg’s agency came under fire in 2012, following a deadly meningitis outbreak that was linked to a Massachusetts compounding pharmacy.  

“Another controversial issue is the approval of the Plan B birth control pill to be over the counter. That decisions was made in 2013 to make the pill available to all ages over the counter without a prescription. Before that, it was only available over the counter for women ages 17 and older.”

Oberserves point to one potential successor of Hamburg’s as Dr. Robert Califf, a prominent cardiologist and Duke University researcher. He was recently appointed as the FDA’s deputy commissioner for medical products and tobacco.

“Califf had been floated as a possibility in 2008 to head the FDA but the reason he was passed over was because of his close ties to the pharmaceutical industry, which the FDA regulates.”

Dr. Stephen Ostroff, the FDA’s chief scientist, will serve as acting commissioner when Hamburg leaves at the end of March.