Biologics

Marks Warns of Growing Anti-Vaccine Stance

Former CBER director Peter Marks, who recently resigned due to pressure from the Trump administration over vaccines, told Time in a 4/8 interview that he was seeing “an increasing anti-vaccine tone” before he left. “I was hoping to work through it, but it was very clear to me that they just didn’t want to work through it.”

In response to growing anti-vaccine sentiment, Marks told Time he had been developing a proposal aimed at addressing public concerns. His four-point plan included improving clarity in vaccine labeling, holding public listening sessions, initiating independent studies by the National Academy of Medicine, and overhauling the adverse event reporting system to make it more transparent.

Marks notes that the leadership change at HHS and FDA coincides with a resurgence of measles in the U.S. The outbreak has already claimed the lives of two children and led to hundreds of infections. “I was so disturbed when I heard about the second measles death in a child that I used profanity with a reporter without realizing it,” Marks said. “This is absolutely needless.”

Marks emphasized the proven safety and efficacy of the measles vaccine, telling Time it is one of the most effective immunizations available. “Measles vaccine is not associated with death, encephalitis, autism, or long-term adverse effects,” he said. “It saves lives.”

Marks remarks coincide with concerns that have arisen around Kennedy’s reported appointment of vaccine critic David Geier to review safety data on other vaccines. Geier's past work linking vaccines and autism has been widely discredited by scientists and dismissed by the courts.

As the measles outbreak continues and public confidence in vaccination wavers, Marks’ resignation likely signals a potentially troubling shift in the nation’s approach to public health.

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