Cavaleri refers to this ‘rush’ being ‘pushed hard by Azar and US GOV.’ Under the Trump administration, Alex Azar, former pharmaceutical executive was the United States Secretary of Health and Human Services (HHS) from 2018-2021. The FDA is an agency that falls directly under the HHS.
It’s worth noting that when Azar was former president of Lilly USA LLC, a division of Eli Lilly, drug prices skyrocketed under his leadership. The pharmaceutical company was also embroiled in a class-action lawsuit under his tenure where it was accused of exploiting the drug pricing system to increase profits for its insulin drug. Of course, this doesn’t necessarily mean this executive was complicit in any way, but the timing is noteworthy.
Cavaleri’s email speaks to the extent of how politics (and the US government) was driving the FDA’s regulatory process, making sure it was going at ‘warp speed’. And of course, on that note Trump’s Operation Warp Speed was to ensure all vaccine development records would be shattered. The intentions were undoubtedly good given the outbreak of the worst pandemic in a century.
However, across the Atlantic in Europe’s regulatory agency tension mounted as the pressure to accelerate deadlines made the air and general mood tense—the pressure and anxiety was palpable in the reviewed email exchanges.
Persons of high integrity and clarity as to their roles and commitments as stewards of public health emerged. For example, one individual demonstrated palpable concern over accelerated timelines to ensure they would meet the ‘deadline’ for vaccine authorization at the expense of a robust assessment. He was Noel Wathion, at the time the EMA’s deputy executive director, but who has since retired. This EMA official importantly pointed out, ‘We are speeding up as much as possible, but we also need to make sure that our scientific assessment is as robust as possible. Let’s not forget the responsibility/accountability attached to the recommendation to the EC to grant a CMA.’
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