As she steps down after nearly six years as commissioner of the Food and Drug Administration, Dr. Margaret Hamburg said she feels good about where the agency stands, and where it’s going in the future.
“What was important to me as I thought about stepping down was making sure we have the right leadership team in place here,” Hamburg said on the Federal Drive with Tom Temin. “I’m very, very pleased that we have some great new additions to our team on both the food area and medical product area, and a lot of strong leaders who have been here for a while.”
Chief Scientist Dr. Stephen Ostroff, who joined the agency in 2013, will serve as acting commissioner.
“I have every confidence that he will take on this new role with the same energy, dedication and care,” Hamburg said.
Under Hamburg’s leadership, the FDA made big strides in both the food and drug industries. It increased regulation on transfats in processed foods and updated the required nutrition facts on packaging. The FDA, in collaboration with other agencies, has also cracked down on several counterfeit drugs.
The FDA opened up more of its data to the public and stakeholders, creating greater transparency at the agency. The agency is finalizing regulation of “gluten free” labeling on food packages, and making calorie counts available on chain restaurant menus and vending machines.
“I look back and I really feel that so much has been accomplished in key areas. A lot is on track that I think will stay on track and continue to gain momentum,” Hamburg said.
She attributed those successes in part to an increased budget, which went from about $2.7 billion in fiscal year 2009 to almost $4.5 billion in fiscal year 2015.
But her tenure as FDA commissioner wasn’t always smooth sailing. Despite the budget boost, Hamburg said the agency still needs more resources. The FDA should draw more on existing data sources, Hamburg said, such as electronic health records and insurance data.
“The expectations of the public and our Congress are very high on what FDA can deliver,” she said. “The world is much more global. That puts a set of very challenging new demands on us.”
Scandal broke out over the past few years when compounding pharmacies sold contaminated steroids. Compounding pharmacies alter drugs and other products to best suit the needs of a patient, with minimal change to the medicine’s composition and side effects. The pharmacist could, for example, change a pill to liquid form for a patient with difficult swallowing, or eliminate an ingredient that causes patient allergy.
But some compounding pharmacies were acting more like manufacturers, Hamburg said, in which they created products without getting the proper approval from the FDA. To add another wrinkle to the issue, Hamburg said state agencies typically oversee compounding pharmacies, but it was unclear where state oversight ended and federal began.
A number of anti-addiction groups last September asked the Obama administration in September to replace Hamburg, citing the FDA’s approval of a powerful yet addictive painkiller called Zohydro.
“You can’t expect that everyone will like you, but you have to hope that people will respect you and your integrity,” Hamburg said. “It’s absolutely essential to be able to listen, to learn and to respond to the concerns and issues that people raise.”