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Mr. Secretary, Reclassify the Statin
One regulatory stroke could save more American lives than a decade of health campaigns. You have the pen.
Mother Nature herself runs a permanent, double-blind trial: people born with loss-of-function variants in PCSK9 or ANGPTL3 cruise through life with LDLs in the 20–40 mg/dL range and enjoy 30-plus-percent cuts in coronary risk without obvious downside ( 1, 2, 3, 4). In 2021-24 AstraZeneca’s web-app TACTiC studies showed> 96 % concordance between consumer self-selection and clinician judgment for rosuvastatin 5 mg—exactly the “additional condition for non-prescription use” the FDA now invites under its new ACNU rule. Draft guidance that (a) designates low-dose statins as Generally Recognized as Safe and Effective for primary prevention in adults meeting a clear risk threshold, (b) mandates a pharmacist-screened initial sale (à la pseudoephedrine) if you need a training-wheels phase, and (c) sunsets the pharmacist checkpoint after post-market data confirm what two million patient-years already tell us.
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