ACCESS Act

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

1. 12 June 2008

   Introduced

   Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

   Source: IntroReferral

2. 12 June 2008

   Introduced

   Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

   Source: IntroReferral

3. 12 June 2008

   Introduced

   Introduced in House

   Source: IntroReferral

4. 12 June 2008

   Introduced

   Introduced in House

   Source: IntroReferral

5. 17 June 2008

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 12 June 2008 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 12 June 2008

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 12 June 2008

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 12 June 2008

  Open at official source

  Leesvertaling

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

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

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

Sponsors

• Rep. Watson, Diane E. [D-CA-33] · D · Sponsor
• Rep. Burton, Dan [R-IN-5] · R · Sponsor
• Rep. Latham, Tom [R-IA-3] · R · Sponsor
• Rep. Johnson, Eddie Bernice [D-TX-30] · D · Sponsor
• Rep. Solis, Hilda L. [D-CA-32] · D · Sponsor
• Rep. Jackson Lee, Sheila [D-TX-18] · D · Sponsor
• Rep. Cummings, Elijah E. [D-MD-7] · D · Sponsor
• Rep. Conyers, John, Jr. [D-MI-13] · D · Sponsor
• · hswm00 · Standing
• · hsif00 · Standing

Related records

• related to ← ACCESS Act