Woodcock: High Prices Create Problems For Entire Accelerated Approval Program
Acting FDA commissioner suggests a primary reason for outrage over accelerated approvals is the high costs of certain medications despite their unproven clinical benefits, an issue that is outside of the agency’s purview. Health policy experts says FDA shouldn’t be left off the hook that easily.
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Because Medicare and Medicaid do not reimburse based on indication, it would be hard to target specific accelerated approvals for pricing discounts. This could penalize drug manufacturers even if the accelerated indication represents a minor share of the drug’s use, researchers say.