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.