Here’s what’s come in on Scott Gottlieb’s nomination as FDA Commissioner since my post last week.
From the New England Journal of Medicine: a scathing commentary observes that “Gottlieb’s background places the agency, and the public, in a difficult position.” Two reasons: (1) “His previous experience in academic medicine, applied science, and government service is threadbare.” (2) “Gottlieb has been enmeshed in highly remunerative relationships with the biopharmaceutical industry, including sitting on various corporate boards…Gottlieb seems unlikely to have earned his corporate-board perches with scientific expertise.”
From Politico: Gottlieb says he will recuse himself–for one year (that’s all?)–from some (not all?) agency decisions dealing with more than 20 drug companies. This is because he is a board member or adviser to those companies or funds them through his venture capital roles. Here is his financial disclosure form.
From StatNews: More details on Gottlieb’s financial entanglements with drug companies: “Gottlieb’s critics argue that his expansive resume creates a conflict-of-interest minefield that could cast doubt on the FDA’s decision making.”
From the New York Times:
Dr. Gottlieb, a resident scholar at the American Enterprise Institute, has also been a prolific writer and public speaker, criticizing the agency’s approach. “In so heavily prioritizing one of its obligations — the protection of consumers — the F.D.A. has sometimes subordinated and neglected its other key obligation, which is to guide new medical innovations to market,” Dr. Gottlieb wrote in 2012 in National Affairs, a conservative-leaning political journal.
Also from the New England Journal of Medicine: A commentary discusses the challenges faced by an FDA Commissioner having to do with evidence for drug efficacy, drug development, and drug prices. It concludes: “All these challenges require a strongly resourced FDA working at the cutting edge of regulatory science. A commissioner who is able to advocate for such a vision, which includes less dependence on industry funding, will bring the agency into the 21st century.” Will someone so closely tied to the drug industry fit this description?
Concerns about Gottlieb center on his financial ties to the drug industry.
But what about food?
A reader reminds me about pre-election promises to get rid of the FDA Food Police.
From The Hill, September, 2016: