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Improving The Fda Approval Process, Anup Malani

Anup Malani

The FDA employs an average-patient standard when reviewing drugs: it approves a drug only if is safe and effective for the average patient in a clinical trial. It is common, however, for patients to respond differently to a drug. Therefore, the average-patient standard can reject a drug that benefits certain patient subgroups (false negative) and even approval a drug that harms other patient subgroups (false positives). These errors increase the cost of drug development – and thus health care – by wasting research on unproductive or unapproved drugs. The reason why the FDA sticks with an average patient standard is …