Biologics

House Covid Report Hits FDA, Others

David McFarland

— 1 min read
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The House Select Subcommittee on the Coronavirus Pandemic has issued its final 550-page report that generally praises actions taken under the Trump administration and criticizes actions taken by the Biden administration. A committee statement (including a link to the full document) says “After Action Review of the Covid-19 Pandemic: The Lessons Learned and a Path Forward” is the single most thorough review of the pandemic conducted to date.

The statement’s report highlights says that FDA “rushed approval of the Covid-19 vaccine in order to meet the Biden administration’s arbitrary mandate timeline.” It notes that two FDA scientists warned colleagues about the dangers of rushing the vaccine approval process and the likelihood of adverse events. “They were ignored,” the statement says, “and days later the Biden administration mandated the vaccine.”

The report praises the Trump administration’s Operation Warp Speed to encourage the rapid development and authorization of the vaccines, saying it “helped to save millions of lives.” But it also says that contrary to what was promised, the Covid-19 vaccine “did not stop the spread or transmission of the virus.”

Other findings that reference FDA in the full report are:

  • the need to ensure that U.S. companies communicate with FDA more efficiently and to establish a system where companies are able to quickly adjust their manufacturing;
  • the need for the U.S. to reduce its reliance on other countries, particularly China, for pharmaceuticals and medical supplies;
  • FDA and other public health officials falsely implied that ivermectin was only for horses and cows;
  • the Biden administration sidelined senior scientists after they expressed concern regarding the rapid pace of review of Pfizer’s biologics approval application;
  • FDA officials refused to rebut allegations that the Biden White House was involved in the Pfizer biologics approval application;
  • the Vaccine Adverse Event Reporting System, co-managed by FDA and the Centers for Disease Control, is insufficient and not transparent;
  • existing vaccine safety systems may be missing important safety signals, especially related to neurological conditions;
  • the use of off-label prescriptions was unjustly demonized and further eroded the doctor-patient relationship; and
  • the lack of supply chain diversity exacerbated economic and business recovery.

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