FDA Policy/General

Gottlieb Warns HHS Could Undermine Pediatric Vaccines

Former FDA commissioner Scott Gottlieb is warning that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report on autism to challenge the scientific basis of the nation’s pediatric vaccine program. Speaking on CNBC 9/8, Gottlieb said he believes Kennedy intends to link aluminum salts (commonly referred to as alum), which are used as adjuvants in multiple licensed vaccines, with autism. Such a claim, he cautioned, could destabilize the regulatory foundation of the childhood immunization schedule and force manufacturers to reformulate or decouple combination vaccines.

“That adjuvant is used in about 10 vaccines, there’s no good alternative,” Gottlieb said. “It could force the vaccine manufacturers to try to reformulate the vaccines, decouple them — so instead of having MMR, you have measles, mumps, and rubella separately. It’s gonna cause a lot of people not to get those vaccines.”

Gottlieb, who led FDA from 2017 to 2019, said Kennedy has been “systematic and effective” in advancing his longstanding opposition to vaccines and warned that his position at HHS gives him unprecedented influence. Gottlieb emphasized that his concern stems from the potential regulatory and public health impact of Kennedy’s actions, noting that combination vaccines have been central to maintaining high childhood immunization coverage.

His remarks come amid heightened scrutiny of Kennedy’s leadership at HHS. At a Senate Finance Committee hearing last week, senators from both parties questioned his dismissal of senior CDC staff, restrictions on Covid-19 vaccine access, and cancelation of certain mRNA research programs (see earlier story).

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