RFK Jr. Pledges Faster FDA Pathways for Rare Disease Treatments
Kennedy Says U.S. Must Remain Global Leader as FDA Considers Streamlining Rare Disease Drug Approvals
Health and Human Services Secretary Robert F. Kennedy Jr. announced Thursday that the FDA will pursue new strategies to speed up the approval process for rare disease therapies and remove barriers delaying their entry to market.
Speaking at an FDA-hosted meeting on cell and gene therapies, Kennedy emphasized the urgency of regulatory reform, stating, “We are going to continue to figure out new ways of accelerating approvals for drugs and treatments that treat rare diseases, and we’re going to make this country the hub of biotechnology innovation.”
The event brought together researchers, industry leaders, and FDA officials, including Dr. Vinay Prasad, the newly appointed head of the FDA’s Center for Biologics Evaluation and Research. Prasad, whose appointment sparked concern among drug developers over stricter approval standards, assured attendees that he would act quickly to greenlight promising treatments.
Several panelists warned that without a more agile approval process, the U.S. risks falling behind countries like China in the race to develop advanced therapies.
“The path to approval is seen as so arduous,” said Dr. Carl June of the University of Pennsylvania. “If firms feel there is no credible way to get new products approved here, they will simply relocate trials overseas or abandon them. We cannot afford that exodus.”
Story originally appeared on Reuters
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