October 16, 2017

MEGAN MCARDLE: The FDA Needs This Nudge to Speed Along New Drugs: The commissioner is gradually correcting a dangerously overcautious culture.

Drug researcher Derek Lowe has pointed out that in today’s cautious climate, aspirin — good not only for headaches, but for heart attacks — would have “died in the lab,” because it can cause severe gastrointestinal bleeding. Even penicillin, the modern miracle that ushered in an age of safer surgery, safer sex and longer lifespans, would give today’s researchers pause, because of the risk of allergic reactions.

That drug was developed in a different time. It was tested in a slapdash manner — and luckily, penicillin is so amazing that its benefits were obvious even without a rigorously designed trial. If the team that discovered it had tried to follow modern FDA-mandated clinical trial procedures for the drug, its introduction and dissemination would have been seriously delayed. Fewer men would have come home from World War II.

The potential delay of the next penicillin should worry regulators at least as much as the potential horrors of another Thalidomide. But human psychology being what it is, we view sins of omission more benevolently than sins of commission, even if the results are the same. So regulators are likely to worry more about approving a bad drug than about delaying a good one.

No one person, even an agency head, can single-handedly change that sort of tendency, especially when it’s rooted in institutional culture. But they can slowly make headway with decisions about who to advance within the agency.

Faster, please.

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