3.0.0 3046 2020-02-10T17:01:58Z 2020-02-10T17:01:58Z Senate S S 2008-05-21 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2008-05-21T19:01:53Z Access, Compassion, Care, and Ethics for Seriously Ill Patients Act 110 6270 HR 2008-06-17 Referred to the Subcommittee on Health. Identical bill CRS 2008-05-21 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2008-05-21 Sponsor introductory remarks on measure. (CR S4625) IntroReferral B00100 9 Library of Congress 2008-05-21 Introduced in Senate IntroReferral 10000 9 Library of Congress B000953 Sen. Brownback, Sam [R-KS] SAM BROWNBACK R KS N C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA 2008-05-21 True C001057 Sen. Coleman, Norm [R-MN] Norm Coleman R MN 2008-05-21 True S000709 Sen. Specter, Arlen [R-PA] ARLEN SPECTER R PA 2008-05-21 True I000024 Sen. Inhofe, James M. [R-OK] Jim Inhofe R OK 2008-05-21 True S001141 Sen. Sessions, Jeff [R-AL] Jeff Sessions R AL 2008-09-18 False Health Clinical trials Commerce Department of Health and Human Services Drug approvals Drug industry Drugs Executive reorganization Federal advisory bodies Government Operations and Politics Law Medical supplies Medical technology Medicare Patients' rights Product safety Products liability Science, Technology, Communications Social Welfare Health 00 2008-05-21 Introduced in Senate 2008-08-29T14:26:36Z 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.

]]> Access, Compassion, Care, and Ethics for Seriously Ill Patients Act Short Titles as Introduced Access, Compassion, Care, and Ethics for Seriously Ill Patients Act Short Titles as Introduced ACCESS Act Display Title Access, Compassion, Care, and Ethics for Seriously Ill Patients Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. Introduced in Senate 2008-05-21T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s3046is/xml/BILLS-110s3046is.xml 2008-05-21 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.