Leading an Agency that ‘Very Few Politicians Love’
In her first interview since leaving her position as FDA commissioner, Margaret Hamburg says that one of the challenging things in her years on the job was that “we didn’t have a lot of advocates on the Hill. Often, even the White House really was a little bit suspect about what FDA was and what was our value.”
In a lengthy discussion with Boston Globe Media’s Stat published online, Hamburg underscored the importance of protecting the agency from politicization. “FDA frequently finds itself working at the interface of science, healthcare, public health, and politics,” she said. “This can be precarious terrain, and I was determined to make sure that science and evidence were always our compass and our guide.”
Asked about her biggest accomplishments, Hamburg said she arrived at FDA at a time of low morale within the agency and decreased respect, appreciation, and support of it from outside. There had been a series of crises, congressional hearings, and harsh media stories, she recounted. “We were able to reenergize the agency,” she said. “We opened ourselves up, engaged with stakeholders, and enhanced confidence. I refocused the agency on its mission as a science-driven, evidence-based regulatory agency with a public health mission, strengthening science but also enhancing opportunities for collaboration at various academic institutions.”
Hamburg brought Robert Califf, now the commissioner, into FDA’s number two spot in 1/2015. She said the challenge for him in his new position is that he doesn’t know how long he will be in place. “Of course, you never know how long you will be in a job like that,” she said. “He needs to think both about what the things are that absolutely need to get accomplished before this administration ends, as well as never forgetting the long-term issues.” She added that given Califf’s relatively short experience with the many FDA components, he has had and will continue to have a “steep learning curve.”
The former commissioner expressed surprise that some Democrats opposed Califf’s nomination over his industry ties. “In fact, he’s never actually worked in industry, but his programs have been supported by industry dollars,” she explained. “The world is changing and most academic research centers get money from companies to do clinical trials.”
In other portions of the interview, Hamburg criticized a proposal from Sen. Ted Cruz (R-TX) to require FDA to approve life-saving products for which there is a medical need if the drugs have already been approved in Europe, Canada, or other trusted countries. “I think that would be an extremely dangerous world,” she said. “FDA makes science-based decisions, they look at the data. Congress is not an appropriate body to be assessing whether a drug or a medical device should be approved.”
She also called on the drug industry to “really address how it can assure the public that it’s looking out for the needs of the patients first and foremost. I don’t think they help themselves showing their Viagra ads during the Super Bowl. It’s mystifying to me how they went from being one of the most admired industries in America to now.”