Oct 15, 2018

Safety Versus Speed — Drug and Device Approval Options

Robert Graboyes Senior Research Fellow

Safety is relative, and whatever quantum of safety we achieve comes with its own perils. The federal government, through agencies like the Food and Drug Administration, strives for — but cannot guarantee — patient safety. There’s a terrible tradeoff between relative safety and opportunities to save the dying, heal the sick, and relieve those in pain. Ban a drug, or take years approving it, and those it could help may suffer.

At present, FDA policy applies uniformly to the entire population. Once a drug is approved, everyone can get it (perhaps with a licensed provider’s signature). Before approval, no one... 

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