FDA hints relaxed rules are coming for rare disease gene therapy
The Trump administration’s impact on gene therapy was a topic of discussion at the recent FDA “Cell and Gene Therapy Roundtable.” Researchers, advocates, and industry executives gathered to share their thoughts on what the FDA should know about this innovative field.
The meeting was described as unusual, with many panelists unsure of the agenda or goal. Despite the lack of specifics, guests from academia, advocacy, and industry were given the opportunity to provide brief statements on cell and gene therapy. This segment lasted for two hours, with no clear resolutions or promises emerging.
Health Secretary Robert F. Kennedy Jr., NIH Director Jay Bhattacharya, and CMS Administrator Mehmet Oz also made statements during the event. However, their speeches left little time for further discussion, with only 10 minutes remaining by the end.
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Overall, the Trump administration’s stance on gene therapy remains uncertain, as further details and decisions are still pending. Researchers and stakeholders in the field are eagerly awaiting more concrete guidance and policies from the government to shape the future of gene therapy in the United States.
