Dr. Makary acknowledged that many Americans have lost faith in public health entities like the FDA. Part of that has to do with the fact that there often appears to be a revolving door between these agencies and major pharmaceutical companies.
The movie Dopesick and other projects about the opioid crisis often reference Curtis Wright, the medical review officer who approved OxyContin while at the FDA and then went on to work for the drug’s maker Purdue Pharma.
More recently, Patrizia Cavazzoni, MD, left Pfizer in 2018 to work for the FDA where she became the agency’s top drug regulator as director of the Center for Drug Evaluation and Research. In January, she departed the FDA and Pfizer announced weeks later that it hired Cavazzoni to replace its outgoing chief medical officer.
Additionally, Scott Gottlieb, MD, who was FDA commissioner from 2017 through 2019 during the first Trump administration, is a member of Pfizer’s board of directors. And the list goes on from there.
“Let’s be honest, a lot of people in the United States feel that the system is rigged. A lot of people feel that the relationship is too cozy between pharma and regulators,” Dr. Makary admitted. “This is an agency that belongs to the American people, so we can work with pharma and, at the same time, ensure that the scientific evaluation process is totally independent.”
That is why one of his first acts as FDA commissioner is aimed at limiting conflicts of interest. “Today we are announcing that we are removing industry members – pharma members – from FDA advisory committees,” Dr. Makary shared. “I was shocked when I learned that employees of Big Pharma companies sit on FDA advisory committees as members of those committees, so we’re going to be replacing them, whenever statutorily possible, with patients and family caregivers.”
The “influence” piece is something he has already experienced firsthand. “When I got this nomination for the job, I cannot tell you how many lobbyists, former members of congress, ‘the swamp’ reached out to me,” Dr. Makary recalled. “I mean, I was in the operating room and the next day I discovered what the swamp was.”
