3.0.0 1956 2023-01-13T04:49:35Z 2023-01-13T04:49:35Z Senate S S 2005-11-03 109 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2005-11-03T18:23:50Z ACCESS Act 109 6303 HR 2006-10-02 Referred to the Subcommittee on Health. Identical bill CRS 2005-11-03 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S12355-12357) IntroReferral 2005-11-03 Introduced in Senate IntroReferral 10000 9 Library of Congress B000953 Sen. Brownback, Sam [R-KS] SAM BROWNBACK R KS N I000024 Sen. Inhofe, James M. [R-OK] Jim Inhofe R OK 2005-11-03 True I000055 Sen. Isakson, Johnny [R-GA] Johnny Isakson R GA 2005-12-20 False A000121 Sen. Allen, George [R-VA] GEORGE ALLEN R VA F. 2006-01-25 False S001141 Sen. Sessions, Jeff [R-AL] Jeff Sessions R AL 2006-02-13 False Health Administrative remedies Cancer Chemotherapy Clinical trials Department of Health and Human Services Drug approvals Employee training Federal advisory bodies Federal employees Food and Drug Administration (FDA) Government Operations and Politics Government publicity Governmental investigations Human experimentation in medicine Law Medical ethics Medical research Medical statistics Medical supplies Patients' rights Pharmaceutical research Science, Technology, Communications Health 00 2005-11-03 Introduced in Senate 2006-02-18T14:31:31Z 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-threatening conditions for which there exist significant unmet medical needs; (4) request that the Institute of Medicine undertake a study to identify validated surrogate endpoints and biomarkers, and recommend research to validate surrogate endpoints and biomarkers, that may support approvals for products intended for the treatment of serious or life-threatening conditions or diseases; and (5) give equal weight to clinical judgment and statistical analysis in the evaluation of the safety and effectiveness of new products and not disapprove a product application solely on the basis of a statistical analysis or the rigid use of the 95 percent confidence level convention.

Requires the Food and Drug Administration (FDA) to establish a new program to expand access to investigation treatments for individuals with serious or life-threatening conditions and diseases.

]]> Access, Compassion, Care, and Ethics for Seriously Ill Patients 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 three-tiered 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 IS Short Titles as Introduced Access, Compassion, Care, and Ethics for Seriously Ill Patients Act Short Titles as Introduced ACCESS Act Introduced in Senate 2005-11-03T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109s1956is/xml/BILLS-109s1956is.xml 2005-11-03 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S12355-12357) 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.