3.0.0 6047 2019-11-15T21:21:46Z 2019-11-15T21:21:46Z House H HR 2008-05-14 110 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2008-05-15T16:45:54Z Referred to 2008-05-14T14:04:19Z 2008-05-15 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2008-05-14 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2008-05-14 Introduced in House IntroReferral Intro-H 9 Library of Congress 2008-05-14 Introduced in House IntroReferral 1000 9 Library of Congress J000255 Rep. Jones, Walter B., Jr. [R-NC-3] WALTER JONES R NC B. 3 N J000032 Rep. Jackson-Lee, Sheila [D-TX-18] SHEILA JACKSON-LEE D TX 18 2008-05-21 False Health Access to health care Administrative remedies Clinical trials Department of Health and Human Services Drug approvals Drug therapy Drugs Electronic data interchange Electronic government information Emergency Management Emergency medicine Government Operations and Politics Government paperwork Informed consent (Medical law) Law Pharmaceutical research Science, Technology, Communications Health 00 2008-05-14 Introduced in House 2008-07-31T22:03:30Z Early Access to Treatment Act - Amends the Federal Food, Drug, and Cosmetic Act to require a drug that is not approved for marketing, but that is under clinical investigation for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available, to be made available for treatment use by an individual patient if: (1) the drug is intended to treat such condition; (2) there is no comparable or satisfactory alternative available to treat that stage of the disease; (3) the drug is under investigation in a controlled clinical trial as an investigational new drug or all clinical trials have been completed; and (4) an application for treatment use has been filed with the Food and Drug Administration (FDA) by a licensed practitioner which sets forth the intended use of the drug, an explanation of the rationale for its use, the treatment protocol, statements of the practitioner's qualifications to use the drug and familiarity with its safety and effectiveness, and a notarized statement of the patient's informed consent.

Requires the Secretary of Health and Human Services, within 30 days after an application is filed, to grant permission to the sponsor to furnish such drug to the practitioner under such terms as the sponsor, practitioner, and patient determine to be appropriate, including any agreement to waive liability. Provides for application transmission by telephone or other means of rapid communication and for rapid action on it in an emergency situation.

Requires (current law authorizes) the Secretary to approve an application under the Public Health Service Act for a fast track product determined to have an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit.

]]> Early Access to Treatment Act Short Titles as Introduced Early Access to Treatment Act Display Title Early Access to Treatment Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to mandate early access by desperately ill patients to treatment use of new drugs under clinical investigation for a serious or immediately life-threatening disease condition for whom no comparable or satisfactory drug or other therapy is available. Introduced in House 2008-05-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr6047ih/xml/BILLS-110hr6047ih.xml 2008-05-15 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.