Biologics

Scalise, Comer Ask FDA About Biden Booster Shot Push

House Republican whip and Select Subcommittee on the Coronavirus Crisis ranking member Steve Scalise (R-LA) and House Committee on Oversight and Reform ranking member James Comer (R-KY) say they are concerned that the Biden White House is pressuring career FDAers to recommend Covid-19 vaccine booster shots before there is research showing they are necessary. In a 9/14 letter to FDA acting commissioner Janet Woodcock, the two write that “President Biden, instead of following the science, is attempting to distract from his numerous crises by playing politics and moving out ahead of FDA and the Centers for Disease Control when it comes to the science on coronavirus vaccine booster shots.”

The letter says the “political manipulation and pressure to interfere with the science by President Biden’s White House reportedly contributed to the decision of two top career scientists, Marion Gruber and Phil Krause, who were key in the vaccine process, to leave FDA. They felt that FDA was being sidelined by the Biden administration and ‘what finally did it for them was the White House getting ahead of FDA on booster shots.’”

Scalise and Comer ask FDA to provide:

all documents and communications relating to the study and implementation of a booster shot option for mRNA vaccine recipients;
all documents and communications between FDA and the White House relating to booster shots;
all documents and communications related to President Biden’s 8/18 announcement that booster shots would be available for Americans beginning 9/20;
all documents and communications relating to any effort by political appointees or White House personnel to review, revise, edit, delay, or prohibit publication of information related to booster shots;
all documents and communications related to the departure of FDA scientist Marion Gruber;
all documents and communications related to the departure of FDA scientist Phil Krause; and
all documents and communications relating to any adverse employment action taken or considered against any employee, official, or contractor of the federal government for actions taken in the course of their employment related to the science of Americans receiving booster shots.

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