Opinion: Flawed FDA safety requirements are hamstringing a highly effective treatment for severe schizophrenia

For medications with serious safety concerns the Food and Drug Administration mandates a Risk Evaluation and Mitigation Strategy (REMS) “to help ensure the benefits of the medication outweigh its risks.”

Sixty-three medications currently have REMS programs, 57 of which require “elements to assure safe use.” For providers and pharmacies, these elements often mean becoming certified to prescribe and dispense the medication, as well as using online systems to verify that patients are complying with the safety requirements. For patients, they can range from monthly pregnancy tests for the anti-acne medicine Accutane to periodic vision monitoring for the anti-seizure medication vigabatrin to — until recently — in-person dispensing from a certified provider instead of a pharmacy for mifepristone, a drug used to end early pregnancy.

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