Biologics

Kennedy Wanted Sentinel, BEST Data: Reuters

HHS aide Stefanie Spear, a close associate of HHS secretary Robert F. Kennedy Jr. for many years, has been asking FDA to provide access to its Sentinel and BEST surveillance system data to help the HHS staff conduct studies, including into rates of autism and other conditions among vaccinated versus unvaccinated children. That’s one of the revelations in a Reuters in-depth look at Kennedy’s efforts to dismantle the nation’s vaccine policy.

The report is based on anonymous discussions with 16 people at the White House and in HHS who are familiar with Kennedy’s efforts.

Reuters says the databases Spear and others sought access to are designed to monitor the safety of FDA-approved products after they go into the market. “Access to such systems, which contain sensitive information, is highly restricted even within HHS,” Reuters reports, “typically limited to a small number of career officials and experts.”

The report says FDA initially refused the requests for access “out of concern that Kennedy and Spear were on a ‘fishing expedition’ for information to back up their autism argument.” The report says Reuters was unable to verify whether access to the data was ever granted.

A HHS spokesperson told the news agency that, “With scientists at NIH, FDA, CDC, and universities, we are continuing to conduct studies to better understand vaccine safety and efficacy and to assess how vaccine exposure, timing, and patterns affect health across the lifespan. This work will generate evidence to inform vaccine recommendations.”

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