FDA Policy/General

Hahn and CDC’s Redfield Dismiss ‘Deep State’ Concerns

FDA commissioner Stephen Hahn and CDC director Robert Redfield 9/23 dismissed notions that a “deep state” operates within their agencies intent on damaging president Trump’s reelection bid. Trump and his political ally and HHS chief spokesman Michael Caputo have recently advanced this conspiracy theory. Caputo is on a 60-day medical leave after being implicated in a scheme to change CDC reports to match Trump’s reelection narrative about Covid-19 and after having a bizarre meltdown on Facebook about the alleged deep state efforts (see earlier story).

Testifying before a Senate Health Education Labor & Pensions Committee hearing 9/23, Hahn diplomatically dismissed the deep state concerns, saying he has 100% confidence in FDA professional employees who have “stood up” to help expedite Covid-19 medical products for Americans and he has complete confidence in their actions to date. For products and vaccines being developed during the pandemic, Hahn said “our career scientists will follow the science and data and rigorous standards and there won't be any politics involved in decisions.”

Redfield, meanwhile, was less tactful, saying he was “disappointed” at “offensive” criticism of his agency over its Covid-19 response — presumably addressing remarks and accusations made by Caputo. “I want to add how disappointed I have been personally when people at HHS made comments that they felt that there was a ‘deep state’ down at CDC,” Redfield said. “These are dedicated men and women that are confronting the greatest public health crisis of our time, working 24/7, over 6,700 of them involved in the outbreak itself, 1,200 deploying, and it’s offensive to me when I hear this type of comment.”

Redfield told the hearing that he was reminded of his 20-year military service where he was never aware of his colleagues' political affiliations, and the same was true of the CDC. “People don't understand the ability to suck energy out of people that are working 24/7 when they get unfairly criticized or unfairly characterized, and really that’s the real harm in all of this,” he concluded.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome