Old Drugs, New Cures Act

HR 8267, the "Old Drugs, New Cures Act," creates a process for drug manufacturers to request "priority research drug" status for existing medications (approved over 10 years ago) being studied for new medical uses that address significant unmet needs. To qualify, the new use must target diseases affecting at least 33% of Medicare/Medicaid beneficiaries, as defined by claims data. If designated, these drugs are excluded from specific Medicaid and Medicare pricing rules that typically apply to "line extensions" or "best price" calculations. This change directly affects drug manufacturers seeking to study older drugs for new indications and impacts how Medicare/Medicaid programs calculate drug pricing for these medications.