ACCESS Act

[AI summary unavailable — showing source text] Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to replace the current fast track product approval process with a multi-tiered approval process for any investigational drug, biological product, or device. Provides for expedited approval for a drug, biological product, or device for a serious or life-threatening condition, with additional conditions such as additional studies, limits on advertising and promotional materials, and expedited withdrawal procedures. Requires the Secretary of Health and Human Services to: (1) establish the Accelerated Approval Advisory Committee to issue recommendations to the Secretary on applications submitted by a sponsor of such a drug, product, or device; (2) prohibit placebo-only or no-treat-only concurrent controls in clinical investigations with respect to any life-threatening condition or disease where reasonably effective, approved, alternative therapies exist for the specific indication; (3) establish a program to encourage the development of surrogate endpoints and biomarkers that are reasonably likely to predict clinical benefit for serious or life-threate…