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HR 4732 111th Congress House 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

Compassionate Access Act of 2010

Introduced: March 2, 2010 See on congress.gov
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 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 8, 2010
Referred to the Subcommittee on Health.
Mar 2, 2010
Introduced in House
Mar 2, 2010
Referred to House Ways and Means
Mar 2, 2010
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.
Mar 2, 2010
Referred to House Energy and Commerce
 Plain-English summary Congressional Research Service

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.

What's happening now March 8, 2010

Referred to the Subcommittee on Health.

 Committees of jurisdiction 3
 Cosponsors 1
All 1 Democratic 1