Scott Gottlieb, MD, President Donald Trump's nominee for commissioner of the US Food and Drug Administration (FDA), said at his Senate confirmation hearing today that he would put public health ahead of the many drug and medical device makers he has led, advised, and invested in over the years.
"FDA decisions are a matter of life and death," Dr Gottlieb told the Senate Health, Education, Labor and Pensions (HELP) Committee. "I don't want to do anything that shakes the public's confidence in the agency."
Vowing to be guided only by science, Dr Gottlieb also disagreed with Trump on the discredited link between childhood vaccinations and autism. The president has floated the idea of forming a safety commission to study whether vaccine ingredients, or the schedule of shots, causes autism.
Dr Gottlieb, a father of three, said he understood the concerns that parents have about "putting products into otherwise healthy children." However, exhaustive studies have found no causal relationship between vaccines and autism, he said. "At some point, we have to accept no for an answer."
Dr Gottlieb came into the confirmation hearing as another Trump nominee valued for his extensive industry experience and support of more streamlined government regulation. Republican members of the Senate HELP Committee remarked that it is a plus that the hospitalist has been a board director or advisor for drug companies such as GlaxoSmithKline, Tolero Pharmaceuticals, and Glytec, and a healthcare consultant for venture capital firm New Enterprise Associates, among other private sector roles.
They also touted his previous senior leadership in the FDA during the George W. Bush administration, his study of health policy at the conservative American Enterprise Institute, and his recovery from Hodgkin's lymphoma.
"You know first-hand how medical treatments affect patients and families," committee chair Sen. Lamar Alexander Jr (R-TN) said to Dr Gottlieb during the hearing.
However, Sen. Patty Murray (D-WA), the ranking Democrat on the committee, said she was troubled by Dr Gottlieb's "unprecedented financial entanglements with the industry he would regulate."
Other Democrat senators also raised that point, despite Dr Gottlieb's attempt to disentangle himself before the meeting. He had informed the US Office of Government Ethics that, if confirmed, he would resign from about a dozen industry posts, sell off healthcare investments, and recuse himself from decisions relating to some 20 companies and institutions for 1 year.
Dr Gottlieb told lawmakers that he would not be an industry puppet. "I'm going to work hard to preserve my integrity in this role, and the integrity of the FDA," he said. "I'm going to be guided by the science, and the expertise of the career staff, and what's good for patients."
Safety Versus Speed — a False Dichotomy?
Dr Gottlieb also tried to allay fears that he favored faster FDA approval of drugs and medical devices at the expense of patient safety. "We should reject a false dichotomy that it all boils down to a choice between safety and speed," he said in his opening statement. He also made the pro-safety point that "we also save lives when we keep bad things from happening."
Sen. Elizabeth Warren (D-MA) pressed the nominee on that point. Warren cited a 2012 National Affairs article by Dr Gottlieb — a prolific author — in which he traced the modern FDA product review culture to the decision in the early 1960s by one staffer to block the approval of thalidomide, which had caused thousands of birth defects in Europe. Dr Gottlieb wrote that the thalidomide episode "fostered the idealization of the lone reviewer championing an issue of safety against the prevailing orthodoxies, especially when it meant taking on corporate interests."
However, "in so heavily prioritizing one of its obligations — the protection of consumers — the FDA has sometimes subordinated and neglected its other key obligation, which is to guide new medical innovations to market," he wrote.
Warren asked Dr Gottlieb, "Do you think the FDA puts too high a priority on championing safety, and protecting unborn babies and other consumers?"
"Absolutely not, senator" replied Dr Gottlieb, adding that primary focus of the National Affairs article was the problem, in his opinion, of the FDA attempting to regulate the practice of medicine because it was losing confidence in the decision-making ability of physicians.
The Senate HELP Committee is expected to vote later this month on whether to send Dr Gottlieb's nomination to the full Senate for a final decision.
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Medscape Medical News © 2017
Cite this: Trump's FDA Pick Vows Scientific Integrity at Hearing - Medscape - Apr 05, 2017.