Recently, FDA commissioner Margaret A. Hamburg, MD, announced that she was stepping down at the end of March. One of the longest-serving FDA commissioners, Hamburg started in the position in May of 2009. Her job has been demanding and intense, dealing with everything from the rollout of the Affordable Care Act, to tobacco control, to food safety, to reacting to the Ebola epidemic in West Africa, to antibiotic-resistant bacteria, to the recurrence of once-thought eradicated measles.

Hamburg has made significant contributions to the regulation of food, medicine, and devices, using science as the basis for better regulatory decisions. She was instrumental in the FDA’s new spirit of openness. In fact, medical device companies at the recent AdvaMed meeting spoke often about how the FDA has become more responsive, streamlining processes and approvals.

In 2014, FDA approved 51 new drugs and biologics, the most in almost 20 years. In an FDA blog post, Hamburg said it’s “a testament…to FDA’s innovative approaches to help expedite development and review of medical products that target unmet medical needs.”

FDA is about to enter into negotiations with the pharmaceutical and medical device industries regarding user fees. This brings new resources to the agency to allow it to hire more staff to review new product applications, as well as accountability in adhering to specific timelines for product review to ensure timely patient access to innovative new technology.

One of the things that may change would be the agency’s name and focus. A bill introduced in Congress at the end of February, the Safe Food Act of 2015, would strip FDA of its authority to regulate food products, combining its food safety functions and those of the U.S. Department of Agriculture, and transferring that combined responsibility to a newly created agency, the Food Safety Administration, whose sole job would be to regulate food.

Having heard Hamburg speak at several meetings, I have always found her to be well-spoken, expressive, and tireless in her strong leadership and championing of public health and safety. I wish her all the best as she decides her future. At the time of this writing, no one is certain who will take her place. Theories abound, and by the time you read this, the replacement will likely be chosen. One thing is certain, change is inevitable.

Beth G. Sisk


Medical Design Briefs Magazine

This article first appeared in the March, 2015 issue of Medical Design Briefs Magazine.

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