Table 1. Policies Promoting Innovation and Access to New Prescription Drugs.

Policy	Supervising agency	Goal	Scope
Medicaid Drug Rebate Program	CMS	Increase patient access to prescription drugs while ensuring preferred pricing benefits	Applies to FDA-approved outpatient drugs, with few enumerated exclusions such as drugs “used for cosmetic purposes”3
Accelerated approval program	FDA	Enable drugs meeting unmet medical needs to reach the market more quickly	Applies to products intended to treat a “serious or life-threatening disease,” where the product has an “effect on a surrogate endpoint that is reasonably likely to predict clinical benefit”4

Abbreviations: CMS, Centers for Medicare & Medicaid Services; FDA, US Food and Drug Administration.