ACCESS Act

referredUnited States· United States Congress· EN

Introduced

21 May 2008

Last action

21 May 2008 · Introduced

Status

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summary

Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met. Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device that is reasonably likely to predict clinical benefit to a patient suffering from a serious or life-threatening condition. Requires the Secretary to establish: (1) the Accelerated Approval Advisory Committee; (2) a new program to expand access to investigational treatments for individuals with serious or life threatening conditions and diseases; and (3) a demonstration project under the Medicare program to pay for drugs, biological, products, and devices approved under this Act. Amends title XVIII (Medicare) of the Social Security Act to revise the definition of "medically accepted indication" to provide for coverage of a covered Part D drug based on the sponsor's or organization's determination that the drug is for a medically accepted indication. Requires the Secretary to consider the clinical judgment and risks to the patient from the disease or condition in evaluating the safety and effectiveness of drugs, biological products, and devices that treat serious or life-threatening diseases or conditions, including the evaluation of nonstatistical information. Requires any committee evaluating investigational drugs, devices, or biological product applications to have at least two patient representatives as voting members.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

21 May 2008
Introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral
21 May 2008
Introduced
Sponsor introductory remarks on measure. (CR S4625)
Source: IntroReferral
21 May 2008
Introduced
Introduced in Senate
Source: IntroReferral

Votes

No vote records are attached yet.

Versions

Introduced in Senate · 21 May 2008 · Download file

Documents

3 official files

Introduced in Senate (text)

View file Download file

This file cannot be previewed here. Use View or Download.

Leesvertaling

Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

Vertaal naar

Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Introduced in Senate (text)
Introduced in Senate · EN · 21 May 2008
View Download Open at official source
Introduced in Senate (PDF)
Introduced in Senate · EN · 21 May 2008
View Download Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in Senate
summary · EN · 21 May 2008
Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Related records

related to → ACCESS Act

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/110th-congress/senate-bill/3046
Open data entity: https://api.congress.gov/v3/bill/110/s/3046
us · 110-s-3046 · source updated 21 January 2026