Cell and gene therapies are the next frontier in medicine and promise long-sought hope for people living with incurable and fatal conditions. As their promise increasingly becomes reality, the FDA’s gatekeeping role is important.
To truly serve the people who need these medications, the FDA must be a good-faith partner and deploy the tools my fellow congressional lawmakers and I helped secure.
We are finally beginning to realize the results of decades of cell and gene therapy investments, fostered by repeated bipartisan legislation to help advance the scientific technology capable of addressing diseases at the DNA level. Despite signs of progress and a strong commitment from FDA leadership to improve its readiness for these cutting-edge therapies, the agency remains far off pace. Its risk-averse approach and culture that’s slow to adapt to new science could become a curse for many patients and the scientific field as a whole, with investment in biotech chilling in recent quarters.
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