WASHINGTON, D.C. – Continuing their crusade against politicization of the COVID-19 drug approval process by the Trump Administration, U.S. Sen. Bob Menendez (D-NJ) and Congressman Bill Pascrell, Jr. (N.J.-09) today have written a new letter to U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn again urging the FDA to be guided by science and not political considerations in helping find a vaccine. In a separate letter, the lawmakers questioned officials at the U.S. Department and Health and Human Services (HHS) on their work on advancing therapeutics and diagnostics for COVID-19.
“In your search for a viable vaccine candidate, we ask that the Food and Drug Administration (FDA) commit to regular agency procedure that demonstrate safety, efficacy, and effectiveness,” Menendez and Pascrell write. “The nation’s health and safety remain in FDA’s hands… We request that you publicly commit to advancing only the most viable of vaccine candidates and to running adequate and well-controlled trials to ensure there is public trust in any eventual COVID-19 vaccine.”
In a second letter sent today, Rep. Pascrell and Sen. Menendez wrote to Dr. Robert Kadlec, the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS) and Dr. Gary Disbrow, the Acting Director of the Biomedical Advanced Research and Development Authority (BARDA) seeking an update on the development of COVID-19 vaccines and answers to fresh inquiries on agency politicization.
“We recognize and appreciate the need for expediency during the ongoing pandemic to provide a vaccine that will allow Americans to return to some semblance of normalcy. However, such expediency must not abandon the core principles of safety, efficacy, and transparency that should be the cornerstones of our collective national efforts on development of COVID-19 vaccines, treatments, and diagnostics. Any decisions regarding the development of vaccines and therapeutics should be based on sound science only, not political pressure or favoritism,” the members write.
On April 8, Sen. Menendez and Rep. Pascrell wrote to the commissioner of the FDA regarding the FDA’s emergency use authorization of hydroxychloroquine and chloroquine as well as the approval for a clinical trial of a stem cell therapy for the treatment of COVID-19. A recent large analysis of hydroxychloroquine in COVID-19 patients in U.S. veterans’ hospitals showed no benefit and even noted that there were more deaths among those given hydroxychloroquine versus standard care.
On April 27, the lawmakers wrote to the HHS Inspector General calling for an investigation of the FDA to determine if its decision-making process has been compromised by political pressure to promote unproven therapies, specifically calling for an investigation into the removal of Dr. Rick Bright as the Director of BARDA.
Sen. Menendez and Rep. Pascrell have been the most active members of Congress shining a light on politicization of the COVID-19 vaccine, treatment, and diagnostic approval process by the Trump administration.