Nobody Is Safe Until Everybody Is Safe

judiciary.house.gov  |  Today, the House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust, led by Chairman Thomas Massie (R-KY), released an interim staff report titled, "Politics, Private Interests, and the Biden Administration's Deviation from Agency Regulations in the COVID-19 Pandemic" The report details how the Biden Administration pressured the Food and Drug Administration (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. 

"In August 2021, when the Pfizer shots received FDA licensure, and just before the booster received EUA, the top two FDA vaccine reviewers with decades of experience announced they were leaving the agency," said Chairman Thomas Massie (R-KY). "During the pandemic, politics overruled science at the government institutions entrusted with protecting public health. The FDA abandoned its congressional directive to protect citizens from false claims and undisclosed side effects, and instead ignored its own rules 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."

The Subcommittee's investigation also revealed that the administrative state mishandled reports of vaccine injury, despite requirements to actively obtain, synthesize, and report feedback on the safety and efficacy of the Emergency Use Authorization (EUA) vaccine. Two former FDA scientists, Dr. Marion Gruber and Dr. Philip Krause, testified to the Subcommittee 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 Biologics Licensing Application (BLA) process.

Under the leadership of then-Acting FDA Commissioner Dr. Janet Woodcock, a long-time FDA staffer who the Biden Administration promoted to Acting Commissioner, and Dr. Peter Marks, head of the FDA's Center for Biologics Evaluation and Research (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.  Today, former Acting FDA Commissioner Woodcock says that, as it relates to vaccine-related injury, she is "disappointed in [her]self" and that the FDA did not do enough to address vaccine-related injury.

The FDA succumbed to the Biden Administration's pressure to act beyond its authority, which may have long-term impacts on the agency's ability to confidently serve the American public. This poor policy by the Biden Administration reveals many significant problems related to accountability and good decision making in the administrative state that warrant legislative reform. 

Read the full interim staff report and appendix here.