H.R. 4732 · 111th Congress
Compassionate Access Act of 2010
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Never voted on. It didn't reach a floor vote before the 111th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
WatsonSponsor7 cosponsors · 4 D, 3 R
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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…
What it does: CRS summary · Introduced in House · Mar 2, 2010
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Compassionate Access Act of 2010
Latest action (Mar 8, 2010): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Mar 2, 2010
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.