During the COVID-19 pandemic, the Atlantic lambasted the US Food and Drug Administration for moving too slowly to approve vaccines with the provocative headline “The Death Toll of Delay.” Not long before, National Public Radio had run a piece titled “One-Third of New Drugs Had Safety Problems After FDA Approval.” As the agency tries to move safe and effective drugs as quickly as possible to patients who need them, it also needs to maintain the diligence and rigor necessary to prevent harms. Two experts look at the pace of FDA approvals and argue whether the agency is getting it right.