In a recent STAT News opinion piece, BIO President & CEO John F. Crowley calls for strategic FDA reform to accelerate rare disease therapies while preserving regulatory expertise. He cautions against deep staffing cuts, stating, “If the FDA and other agencies lose their most knowledgeable employees…patients in need will suffer.”
Crowley highlights recent FDA progress, such as the Rare Disease Innovation Hub, which has “allowed multiple programs in the rare diseases that were stuck at the FDA for many years to finally move forward.” He emphasizes that reforms should focus on “trimming redundancies, upending bureaucracies, enhancing a patient-focused culture, and utilizing state-of-the-art regulatory science.”
He urges the administration to modernize regulatory pathways without compromising…
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