Dr. Margaret Hamburg will be stepping down from her position as commissioner of the U.S. Food and Drug Administration after being appointed by President Obama nearly six years ago.
Hamburg has overseen initiatives including personalized medicine, disease control, medical device and drug approval, food safety and tobacco control. Reuters reported that the news comes from a person briefed on the matter and that a formal announcement from The White House will be made Friday.
Reuters reported that in a note to staff, Hamburg said it was “with very mixed emotions” that she planned to step down at the end of March and that her tenure as FDA chief “has been the most rewarding of my career.”
It isn’t clear who would replace her yet, but Dr. Robert Califf, cardiologist and researcher from Duke University, was recently appointed by the agency to oversee drug, medical device and tobacco policy. He could be a likely contender.
For now, the FDA’s chief scientist, Dr. Stephen Ostroff, will temporarily fill her spot.
Hamburg has had a significant influence on things like improving nutrition by requiring restaurants to label calories and limiting trans-fats, as well as having a major focus on increasing patient engagement with the FDA patient network.
Under her leadership the FDA also dealt with health issues like the rise of antibiotic-resistant bacteria, the emergence of electronic cigarettes, the abuse of opioid painkillers and the Ebola outbreak, among other things.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Many things could be changing soon for the FDA following her resignation as Congress looks to speed up new drug development even more and the potential for a new agency combining the food safety aspects of the FDA with the U.S. Department of Agricultural could be in the future.
