FDA Refuses to Remove Alleged Misinformation from COVID Shot Labeling
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A group of drug safety advisors and academics is speaking out against a decision by the Food and Drug Administration (FDA) to amend the labeling for the Pfizer and Moderna mRNA inoculations for COVID-19.
The labeling for the shots is “obsolete” and fails to warn the public about harms, an op-ed in The Hill stated on June 9.
“Product labeling should be informative and accurate, not promotional. The law requires it, and following the law shouldn’t be optional,” wrote Peter Doshi, Ph.D., an associate professor, and Linda Wastila, Ph.D., a department chair, both at the University of Maryland School of Pharmacy, and Kim Witczak, a drug safety advocate.
On January 31, the op-ed authors and the Coalition Advocating for Adequately Labeled Medicines (CAALM) submitted an FDA Citizen Petition (petition) requesting updates to the labeling on the mRNA COVID shots.
The FDA denied virtually all petition requests in its response on April 18.
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