Dr. Margaret A. Hamburg, commissioner of the U.S. Food and Drug Administration, will resign at the end of March after nearly six years on the job, according to an FDA-wide email sent Thursday morning. FDA’s Chief Scientist Dr. Stephen Ostroff will serve as acting commissioner when Hamburg steps down, according to her email.
“Since joining the agency in 2013, and most recently serving as FDA’s Chief Scientist, 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,” Hamburg said.
From reducing trans fat in processed food to protecting consumers from counterfeit drugs, Hamburg has credited the agency with spearheading several life-saving measures during her tenure. Part of the success, she noted, comes from a “dramatically increased” budget, which went from about $2.7 billion in fiscal year 2009 to almost $4.5 billion in fiscal year 2015.
“As commissioner, my goal has been to shape and support an FDA that is well- equipped to meet the challenges posed by scientific innovation, globalization, the increasing breadth and complexity of the products that we regulate, and our new expanding legal authorities,” Hamburg said. “We can honestly say that our collective efforts have improved the health, safety and quality of life of the American people.”
One theme to Hamburg’s tenure has been giving consumers better information about the products they buy. Some of the FDA’s changes in food safety include a push to stay ahead of potential outbreaks in foodborne illness before they happen and better regulation of “gluten free” labeling on baked goods, pasta and other goods. The commissioner also oversaw an effort to reduce trans fat in processed food and an updated to the ubiquitous “nutrition facts” label seen on food packaging.
More recently, the FDA has been finalizing its new rules to make calorie counts available on chain restaurant menus and vending machines.
Fast-tracking good drugs, catching bad drugs
Hamburg praised the FDA for better oversight of the drug supply chain to ensure that counterfeit and contaminated drugs don’t reach consumers. And for medical breakthroughs, the agency has been working to fast-track the review process for “novel” drugs — new drugs that haven’t yet been screened by the FDA.
“We just had another strong year for novel drug approvals, with most of these drugs being approved on or before their PDUFA [Prescription Drug User Fee Act] goal dates and most being made available to patients in the United States before they were available to patients in Europe and other parts of the world,” Hamburg said.
Nearly half of the novel new drugs approved in 2014 received an expedited review. Those approved drugs include treatments for rare types of cancer, hepatitis C, type-2 diabetes and several new vaccines.