The Biden administration “pressured” the Food and Drug Administration (FDA) to “change its procedures, cut corners, and lower agency standards” in order to quickly approve the Pfizer COVID-19 shots and allow the implementation of mandates, a House Judiciary subcommittee interim report exposed last week.
The Administrative State, Regulatory Reform, and Antitrust subcommittee, chaired by Rep. Thomas Massie, R-KY, also revealed that, amid concerns the Pfizer products were causing injuries to young Americans who were otherwise healthy, federal agencies “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)” shots.
“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,” Massie explained in a press statement introducing the report.
The report was titled “Politics, Private Interests, and the Biden Administration’s Deviation from Agency Regulations in the COVID-19 Pandemic.”
The 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,” the subcommittee’s statement continued.
“During the pandemic, politics overruled science at the government institutions entrusted with protecting public health,” Massie said:
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 report asserts that the Biden campaign and later the Biden administration turned the COVID pandemic into a highly-charged political tool:
[F]rom the beginning of the pandemic, the Biden-Harris campaign sought to politicize and undermine the federal COVID-19 response, for apparent political reasons. As a candidate, then-former Vice President Biden questioned all efforts to return the country to normal. He recommended mandating social behaviors and called into question COVID-19 testing and mobilization efforts in the federal response. Effectively calling into question research being done at the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the National Institutes of Health (NIH) to address the crisis, then-Senator Kamala Harris said she would not trust President Trump that a vaccine developed during the Trump Administration was safe.
In the wake of the 2020 presidential election, however, the Biden administration “flipped to not only endorsing and taking credit for rolling out a vaccine—the one it had impugned during the campaign—but also they later sought to mandate that Americans take the vaccine.”
In January 2021, Biden appointed Janet Woodcock to be acting FDA commissioner as the administration pushed to use the COVID pandemic as a means to control Americans’ behavior. Under her leadership and that of Dr. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research (CBER), “the agency cut corners in its usually rigorous BLA [Biologics Licensing Application] process to brand the Pfizer EUA vaccine as the only fully licensed ‘safe and effective’ COVID-19 vaccine on the market at the time.”
During a recent interview with the New York Times, Woodcock – who retired in February – admitted some Americans who took the shots experienced “serious” and “life-changing” effects.
“I’m disappointed in myself,” Woodcock said. “I did a lot of things I feel very good about, but this is one of the few things I feel I just didn’t bring it home.”
The administration “pressured agencies to go beyond their legal authorities” and “ignored risks revealed in the initial release of the EUA vaccine and required that the vaccine be given to the military and federal employees,” the subcommittee’s report continued:
The Biden Administration encouraged agencies and states to use liberty-taking tactics not supported by science (such as universal mask mandates, vaccine mandates, social-distancing mandates, school closures, and censorship) and to force Americans to take the vaccine.
The subcommittee’s key takeaway:
This episode is an example of the administrative state engaging in dangerous behavior beyond its authority and without accountability. Dr. Marks testified that he believed his actions were justified because people wanted more confidence in the vaccine, but by ignoring warnings, his actions served to reduce confidence in the entire FDA approval program. Dr. Marks testified that he was justified in his decisions made in July 2021 because of increases in COVID-19 deaths, but the data at the time show lower levels of hospitalizations and deaths. Reflecting on the FDA’s handling of the vaccine approval process three years later, now-former Acting FDA Commissioner Woodcock said she is “disappointed in [her]self” and her involvement as it relates to vaccine-related injury as the FDA did not do enough to address this important concern.
The subcommittee’s report was published days before the U.S. Supreme Court released its decision in Loper Bright Enterprises v. Raimondo, which overturned Chevron v. Natural Resources Defense Council, a precedent that “had allowed unelected bureaucrats and federal agencies to play a quasi-legislative role without oversight from elected officials in Congress,” as CatholicVote reported Friday.
In light of the High Court’s landmark ruling, attorney and education/culture analyst Jane Robbins, co-author of “Deconstructing the Administrative State: The Fight for Liberty,” commented to CatholicVote on the intersection of the subcommittee’s interim findings in its investigation of the Biden administration’s liberal use of the FDA, a federal agency, to achieve its political goals, and the Supreme Court’s far-reaching decision.
“Clearly, federal ‘public health’ agencies were motivated more by politics than by public health in their disastrous response to COVID-19,” Robbins said:
But they knew that the Chevron doctrine would probably protect their policies against court challenges – even if, as the House committee is discovering, those policies were corrupt from the beginning. With Chevron now kaput, Congress must continue to press on this COVID debacle, clean the stables, and reclaim the policy-making authority it relinquished long ago. We desperately need a new era of government accountability.
