Drugs

FDA Says Looking at Safety of RSV Infant Therapies

FDA has informed the manufacturers of protective RSV (respiratory syncytial virus) therapies for infants that it will be conducting additional safety evaluations of the therapies following concerns raised by vaccine skeptics. Multiple sources confirmed the agency action to Reuters.

The sources indicated that inquiries by senior FDA staff into the RSV therapies began over the summer, the news service’s exclusive report says.

It reports that then-FDA senior advisor Tracy Beth Høeg started asking safety questions about Sanofi/AstraZeneca’s Beyfortus and Merck’s Enflonsia in June. (Høeg was recently named Acting CDER director following the unexpected and abrupt retirement of CDER director Richard Pazdur, who followed George Tidmarsh, who was dismissed following reports of unethical conduct involving a drug company.)

Reuters reports that an independent Australian journalist, who has been critical of the Covid-19 vaccines, wrote in an 8/17 blog post that the RSV therapies could increase the risk of seizures. The story says several safety studies have found no evidence of a seizure risk.

In a recent telephone call with the three drug companies, agency officials said they should expect further safety questions from the commissioner’s office, Reuters says.

HHS spokesperson Andrew Nixon told the news service that FDA “routinely evaluates emerging safety information and will update product labeling if warranted by the totality of the evidence.” He said the agency is “rigorously reviewing the available data, as it does for all products, to ensure decisions remain rooted in evidence-based science and in the best interest of patients.”

Sanofi said the safety and effectiveness of Beyfortus have been demonstrated in over 50 studies involving more than 400,000 infants, and Merck said it is confident in Enflonsia’s safety.

Reuters quotes scientists who have pushed back against the agency’s probe. “Rolling back RSV availability based on baseless concerns would do harm to American children,” wrote infectious disease physician and Stanford University associate professor Jake Scott in an online publication. “Perhaps more importantly, it would set a dangerous precedent in regard to how America’s scientific advisory committee system might be undermined, or even coopted, by the peddlers of junk science.”

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

Read more

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