Biologics

FDA Denies ICAN Pertussis Labeling Petition

FDA has denied a 10/28/2020 petition submitted by the Informed Consent Action Network (ICAN) asking that the agency require all manufacturers of acellular pertussis-containing vaccines to amend their labeling and package inserts to state that the vaccines do not prevent infection and transmission of pertussis. “Your petition does not persuade us that a revision to the labeling is needed,” the agency denial letter says. “Your proposed labeling revision is not required by statute or regulation and we are not convinced by your arguments that the change is necessary for the safe and effective use of the vaccines.”

The letter says it is important to note that FDA vaccine licensure standards do not require a demonstration of the prevention of infection or transmission. “A vaccine can meet the licensure standard if the vaccine’s benefits of protecting against disease outweigh the vaccine’s risks for the licensed use,” it says. “There is no requirement that the vaccine also prevent infection with the pathogen that can cause the disease or transmission of the pathogen to others.”

The pertussis vaccines that have been licensed by FDA are for preventing pertussis disease, the letter says, and not for preventing infection by B. pertussis.

FDA says ICAN supports its petition with assertions about what vaccinated individuals may believe about the protection afforded by vaccination. “However,” the letter says, “assertions regarding what some vaccinated individuals may believe is not evidence that there is any widespread misconception about the protection provided by vaccines.”

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