The 21st Century Cures Act—Will It Take Us Back in Time? (Reply)

In this exchange, supporters of the 21st Century Cures Act argue that it does not lower FDA standards but rather enables the use of new evidence tools like biomarkers and real-world data, while the authors reply that the bill’s provisions could authorize the FDA to rely on less rigorous data, particularly for antibiotic approvals and surrogate endpoints, potentially undermining patient safety.