Biologics

House GOP Probes Covid ‘Political Interference’ at FDA

Republican leaders of the House Select Committee on the Coronavirus Pandemic are asking FDA for information, communications, and transcribed interviews addressing possible political interference in Covid-19 vaccine and booster approvals. “According to new internal FDA communications,” the lawmakers wrote (contains link to letter) to FDA commissioner Robert Califf, “it appears the Biden administration may have bypassed, compressed, and possibly compromised the longstanding process for awarding a full biologics approval to a vaccine. This effort may not have been to save lives, but concernedly to provide cover for implementing and enforcing vaccine mandates across the country.”

The letter cites internal agency communications showing that Marion Gruber, the former director of the CBER Office of Vaccines Research and Review, expressed concerns about the Biden administration wanting to cut corners to fast-track the vaccine approval and “was sidelined by political leadership.”

The lawmakers say a Gruber email “points to evidence that the Biden administration chose to sideline experts and fast-track full approval of the Covid-19 vaccine, sacrificing thoroughness and veracity, to establish a precedent for vaccine mandates. This is unconscionable.”

The representatives ask FDA to provide:

all documents and communications regarding a meeting to discuss review of Pfizer/BioNTech’s BLA for Comirnaty, Covid-19 mRNA vaccine that occurred on 7/19/21, including but not limited to a memorandum prepared by Drs. Marion Gruber and Philip Krause from 7/15/21;
all documents and communications, including with the CDC and the Executive Office of the President (EOP) regarding review of Pfizer/BioNTech’s BLA for Comirnaty, Covid-19 mRNA vaccine;
all documents and communications, including with the CDC and EOP, regarding increased evidence of association of mRNA vaccines and the development of myocarditis or pericarditis;
all documents and communications, including with the CDC and EOP, regarding or referring to mandating vaccines; and
all documents and communications regarding the departure of Drs. Marion Gruber or Philip Krause from FDA.

They also ask for transcribed interviews with principal deputy commissioner Janet Woodcock, CBER director Peter Marks, Gruber, and Krause.

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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