ACCESS Act
Latest action · Jun 17, 2008 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJun 12, 2008
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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 "medically accepted indication" 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.
Cosponsors 7
Members who signed on, in the order they did. All signed on Jun 12, 2008.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-IN | Dan Burton | Original | Jun 12, 2008 |
| D-TX | Eddie Bernice Johnson | Original | Jun 12, 2008 |
| D-MD | Elijah E. Cummings | Original | Jun 12, 2008 |
| D-CA | Hilda L. Solis | Original | Jun 12, 2008 |
| D-MI | John Conyers, Jr. | Original | Jun 12, 2008 |
| D-TX | Sheila Jackson Lee | Original | Jun 12, 2008 |
| R-IA | Tom Latham | Original | Jun 12, 2008 |
Actions 3
Everything that happened, newest first.
- Jun 17, 2008Referred to the Subcommittee on Health.
- Jun 12, 2008Introduced in House
- Jun 12, 2008Referred 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.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 3046 | ACCESS Act | Identical bill | May 21, 2008 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Clinical trials
- Commerce
- Department of Health and Human Services
- Drug approvals
- Drug industry
- Drugs
- Executive reorganization
- Federal advisory bodies
- Government Operations and Politics
- Health
- Law
- Medical supplies
- Medical technology
- Medicare
- Patients' rights
- Product safety
- Products liability
- Science, Technology, Communications
- Social Welfare
Text 1
Each version as it was printed, newest first.
- Jun 12, 2008Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.