Last month, during his address
to Congress, President Donald Trump promised to overhaul what he described as the “slow and burdensome [drug] approval process” within the US Food and Drug Administration (FDA).
But while he delivered the comments with the bravado and populist rhetoric that have become the hallmark of his discourse, both in the public and on social media, he surprised a number of political and media observers alike when he announced
on March 10, 2017 his intention to nominate Scott Gottlieb, MD, as the next commissioner of the FDA. Although the response to the pick from political pundits in the press has thus far been far from uniform, most seem to agree that Dr. Gottlieb is a “conservative” choice—in every sense of the term.
Indeed, Dr. Gottlieb is decidedly not the kind of Washington “outsider” President Trump has gravitated toward during his first 2 months in office.
An internist and hospitalist, Dr. Gottlieb was a deputy commissioner at the FDA under President George W. Bush. More recently, he has served as a fellow at the American Enterprise Institute, a conservative think tank.
Although his nominee is not likely to substantially overhaul a drug approval process that, according to President Trump in his speech to Congress, “keeps too many advances… from reaching those in need,” at least on Day 1, the choice has been met with the same disparate opinions from various corners of the media as all of the new administration’s cabinet and/or agency picks.
In its report on the announcement, for example, CNN
noted Dr. Gottlieb’s “deep ties to the pharmaceutical industry” in the first paragraph, and linked to his profile page
on LinkedIn, which highlights his role as a venture capitalist who specializes in the biotech sector. CNN, like NPR and media/technology news site Vocativ
—which used the headline “Trump’s FDA Pick Scott Gottlieb Is A Big Fan Of Big Pharma”—quoted Michael Carome, MD
, director of the Public Citizen’s Health Research Group, who has decried Dr. Gottlieb’s “unprecedented web of financial ties and conflicts of interest.” Similarly, pharma/biotech news site Fierce
went with the headline “Trump picks industry favorite Gottlieb to run FDA.”
Yet, in a more balanced analysis, business news site MarketWatch
, part of the Dow Jones network, noted that President Obama’s choice to head the FDA, Robert Califf, also had ties to industry, and he was ultimately approved by a Congress then controlled by Democrats. And to another extreme, an editorial
by the conservative Washington Examiner
described Dr. Gottlieb as being “on the side of the little guy,” writing that “regulation often serves to protect big business from competition, harming the consumer.”
That may be a bit much, but it is worth noting that President Trump is hardly the first to suggest the need for an accelerated approval process for novel therapies and/or vaccines for rare and/or troubling infectious diseases that currently lack effective treatments and/or prophylaxis. In fact, clinicians at the front lines caring for patients and populations affected by these diseases have for years been calling
for balanced reforms that allow for novel products to come online faster—importantly, however, without comprising safety standards and while still keeping a watchful eye on the companies that manufacture them. We saw this recently in efforts to control spread of the Zika virus
This is not to say Dr. Gottlieb is a good choice for the FDA—or a bad one. Rather, it is a reminder that clinicians, regulators, and politicians whose views span the political spectrum have for some time now been demanding at least some of the same reforms President Trump has been promising. Although we are always right to view political appointees with some skepticism, let us not lose sight of the ultimate mission here: to improve public health.
Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous healthcare-related publications. He is the former editor of Infectious Disease Special Edition.
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