FDA Policy/General

RFK Jr. Misfires at FDA Headquarters Address

In a further blow to FDA morale, a 4/11 address to the agency’s White Oak, MD staff by HHS secretary Robert F. Kennedy Jr. was filled with unusual statements about the “Deep State” and accusations about employees becoming industry “sock puppets.” The Kennedy address failed on all levels to reassure employees who have been reeling from mass layoffs over the past two months, according to a Politico report based on comments from several anonymous FDA employees and a recording of Kennedy’s remarks.

Speaking off the cuff, Kennedy claimed that the “Deep State” is real, referenced past CIA experiments on human mind control, and touted his work for the Special Olympics but shocked listeners when he said he spent 200 hours in high school working with “Wassaic home for the retarded.” Politico said several employees misheard the reference and thought it was derogatory remark about those with intellectual disabilities and walked out of the rooms where the address was being broadcast.

Kennedy told the FDA staff that “every institution that’s created by human beings” is inevitably captured by powerful interests, and urged FDA employees to take advantage of a four-year period under his leadership during which he promised that HHS would not be subjected to undue influence and would listen to dissidents.

“All of us are subject to those gravities of agency capture,” Kennedy said, challenging the audience to “be conscious of that gravity because it’s going to be pulling you every single day of your career. We want to break away from this so we can make our kids healthy.”

Introducing Kennedy, FDA commissioner Marty Makary urged FDA staff to work together, urging fewer “individual empires” and “less territorialism” between the agency’s medical product Centers, according to Politico. “We want to make it very clear that we believe that the scientists, the reviewers, the inspectors, the officers, the administrative staff — all of the people that support the core mission of the agency — we want to make sure you have all the resources you need to do your job well,” Makary said.

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