(American Greatness)—Biotech advancements often face delays due to bureaucracy, hindering the development of necessary therapies. Now is the time for us to overhaul the archaic procedural measures, including the Food and Drug Administration’s (FDA) outdated policies and procedures. If we continue to permit bureaucracy to impede the advancement of science, then people will continue to die waiting for therapeutic advances—and that is unacceptable.
With over 30 million Americans suffering from rare diseases, 95% of whom lack approved treatments, time is of the essence. FDA approvals typically take a decade and require extensive funding, plagued by linear reviews and outdated standards. These patients have no options.
Our understanding of diseases and technologies has advanced substantially over the past decade, but FDA regulations haven’t changed much. It’s imperative that our regulatory policies align with our scientific potential.
To modernize the FDA, three key changes are crucial. First, regulatory guidelines must reflect current scientific progress. The last major update occurred over 30 years ago, while technologies like AI and gene editing have significantly advanced. Current standards often rely on outdated methods, such as in vitro testing over AI predictions and animal testing for human antibodies, which lack scientific logic. Regular guideline reviews are essential to align with technological advancements.
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