Improved Access to Affordable Medications Act

[AI summary unavailable — showing source text] Improved Access to Affordable Medications Act This bill modifies provisions relating to the ability of generic drug manufacturers to obtain samples of brand-name drugs for purposes of generic drug development. Under current law, brand-name drug manufacturers must provide sufficient quantities of their products on commercially reasonable, market-based terms to generic drug manufacturers upon request for purposes of generic drug development. Brand-name drug manufacturers are subject to civil actions if they fail to do so. The bill modifies provisions relating to this requirement and the criteria needed for related civil actions, such as specifying that generic drug manufacturers may use certain delivery services to make their requests. Additionally, under current law, generic drug manufacturers must obtain authorization from the Food and Drug Administration (FDA) in order to request sufficient quantities of brand-name drugs that are subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to ensure safe use (ETASU). The bill requires the FDA to approve an authorization request within 60 days (rather than 120 days), if testing and development does not involve human cl…