3.0.0 4732 2023-01-11T13:16:27Z 2023-01-11T13:16:27Z House H HR 2010-03-02 111 hswm00 Ways and Means Committee House Standing hswm02 Health Subcommittee Referred to 2010-03-08T18:11:28Z Referred to 2010-03-02T17:32:50Z hsif00 Energy and Commerce Committee House Standing Referred to 2010-03-02T17:32:49Z 2010-03-08 hswm02 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2010-03-02 Referred to House Ways and Means IntroReferral H11100 2 House floor actions hswm00 Ways and Means Committee 2010-03-02 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. IntroReferral H11100-A 9 Library of Congress 2010-03-02 Referred to House Energy and Commerce IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2010-03-02 Introduced in House IntroReferral Intro-H 9 Library of Congress 2010-03-02 Introduced in House IntroReferral 1000 9 Library of Congress W000794 Rep. Watson, Diane E. [D-CA-33] Diane Watson D CA E. 33 N B001149 Rep. Burton, Dan [R-IN-5] DAN BURTON R IN 5 2010-03-12 False L000111 Rep. Latham, Tom [R-IA-4] TOM LATHAM R IA 4 2010-03-16 False M001137 Rep. Meeks, Gregory W. [D-NY-6] GREGORY MEEKS D NY W. 6 2010-03-17 False F000030 Rep. Farr, Sam [D-CA-17] SAM FARR D CA 17 2010-03-25 False H001039 Rep. Hall, John J. [D-NY-19] John Hall D NY J. 19 2010-04-13 False R000409 Rep. Rohrabacher, Dana [R-CA-46] DANA ROHRABACHER R CA 46 2010-05-19 False C001078 Rep. Connolly, Gerald E. [D-VA-11] Gerald Connolly D VA E. 11 2010-09-14 False Health Administrative remedies Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health care coverage and access Medical research Medicare Health 00 2010-03-02 Introduced in House 2010-05-13T19:44:34Z Compassionate Access Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) 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.

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.

]]> Compassionate Access Act of 2010 Display Title Compassionate Access Act of 2010 Official Title as Introduced 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 House IH Short Titles as Introduced Compassionate Access Act of 2010 Introduced in House 2010-03-02T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr4732ih/xml/BILLS-111hr4732ih.xml 2010-03-08 Referred to the Subcommittee on Health. 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.