Access, Compassion, Care, and Ethics for Seriously Ill Patients Act

Bill: 110-hr-6270
Sponsor: Rep. Watson, Diane E. [D-CA-33]
Introduced: 2008-06-12 in the House
Policy area: Health
Subjects: Clinical trials
Commerce
Department of Health and Human Services
Drug approvals
Drug industry
Drugs
Executive reorganization
Federal advisory bodies
Government Operations and Politics
Law
Medical supplies
Medical technology
Medicare
Patients' rights
Product safety
Products liability
Science, Technology, Communications
Social Welfare

Summary:
action_date: 2008-06-12
text: 
Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services 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.

Amends title XVIII (Medicare) of the Social Security Act to revise the definition of &quot;medically accepted indication&quot; to provide for coverage of a covered Part D drug based on the sponsor's or organization's determination that the drug is for a medically accepted indication.

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.


Legislative actions:
action_date: 2008-06-17
text: Referred to the Subcommittee on Health.
action_date: 2008-06-12
text: 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.
action_date: 2008-06-12
text: 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.
action_date: 2008-06-12
text: 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.
action_date: 2008-06-12
text: Introduced in House
action_date: 2008-06-12
text: Introduced in House