Biologics

Biden Pressured FDA for Pfizer Covid Vaccine: House Report

A House Judiciary subcommittee interim staff report issued 6/25 claims to detail “how the Biden administration pressured FDA to go beyond its regulatory authority to change its procedures, cut corners, and lower agency standards to approve the Pfizer Covid-19 vaccine and authorize boosters. This approval enabled the Biden Administration to mandate the Covid-19 vaccine, despite concerns that the same vaccine was causing injury among otherwise healthy young Americans.” The report relies on testimony from two former CBER scientists who resigned just before the Pfizer booster received an emergency use authorization (EUA).

A subcommittee news release (includes a link to the report) says former vaccine reviewers Marion Gruber and Philip Krause testified that they felt pressure to cut corners on the vaccine review, which was due to outside pressure to provide immediate approval so that the government could mandate vaccines. “Despite evidence of harms from the EUA vaccine, the Biden Administration sought to fully approve the Pfizer vaccine through the BLA process,” the release says.

The report says the “administrative state” mishandled reports of vaccine injury, despite requirements to actively obtain, synthesize, and report feedback on the safety and efficacy of the EUA vaccine.

“Under the leadership of then-acting FDA commissioner Janet Woodcock, a long-time FDA staffer who the Biden Administration promoted to acting commissioner, and Peter Marks, head of CBER, the agency cut corners in its usually rigorous BLA process to brand the Pfizer EUA vaccine as the only fully licensed ‘safe and effective’ Covid-19 vaccine on the market at the time,” the release says. “Today, former FDA acting commissioner Woodcock says that, as it relates to vaccine-related injury, she is ‘disappointed in [her]self’ and that FDA did not do enough to address vaccine-related injury.”

Subcommittee on the Administrative State, Regulatory Reform, and Antitrust chairman Thomas Massie (R-KY) says that during the pandemic, “politics overruled science at the government institutions entrusted with protecting public health. FDA abandoned its congressional directive to pursue a policy of promoting the vaccine while downplaying potential harms. Exposing and acknowledging mistakes that were made is a necessary step toward restoring integrity and trust in our regulatory agencies.”

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