Warren Goes After Gottlieb Regarding Drug Safety At his April 5, 2017, Senate Hearing, Dr. Scott Gottlieb, President Trump’s nominee for FDA Commissioner, responded to Massachusetts Senator Elizabeth Warren’s concern about his commitment to FDA’s basic safety mission.
Senator Warren cited Gottlieb’s comments about how the thalidomide “episode” had a lasting effect on the FDA’s work. The comments appeared in a 2012 article titled “Changing the FDA’s Culture.” Relevant excerpts from that article include:
“The thalidomide episode also had a more subtle influence on the way the FDA goes about its work: It focused the agency’s attention on a certain category of risks in which the problems are latent, meaning they do not become manifest until many months, and perhaps years, after exposure to a drug.”
“This is more or less how the FDA understands its own review culture – as devoted to averting risks and protecting the public, and as being very good at doing so. This devotion comes with some downsides, to be sure: 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.”