H.R. 6047 · 110th Congress
Early Access to Treatment Act
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Never voted on. It didn't reach a floor vote before the 110th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
JonesSponsor1 cosponsor · 1 D
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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…
What it does: CRS summary · Introduced in House · May 14, 2008
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Early Access to Treatment Act
Latest action (May 15, 2008): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: May 14, 2008
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.