WASHINGTON – U.S. Senator Sam Brownback today introduced the Access, Compassion, Care and Ethics for Seriously-ill Patients Act, or ACCESS Act, which would reform the Food and Drug Administration’s approval system for treatments for terminally-ill patients.

The ACCESS Act will reform the current accelerated access approval system for drugs, biological products, and medical devices, to create a new three-tiered approval system that is responsive to the needs of terminally-ill patients.

“Congress must address the needs of terminally-ill patients who are afflicted with cancer and other life-threatening diseases,” Brownback stated. “Unnecessary barriers and ethical dilemmas currently prevent terminally-ill patients from gaining access to potentially life-saving investigational treatments. The use of placebo-only and no treatment arm controlled studies for these patients is questionable on both scientific and ethical grounds.”

Under recent trends in FDA clinical trial approvals, some patients suffering from serious, life-threatening diseases are being denied access to potentially life-saving treatment options. The FDA Advisory Committees currently have minimal representation of patient advocates who represent the interests of seriously-ill patients.

Brownback continued, “The decision for terminally-ill patients to take an investigational drug should be between the physician and the patients, not government bureaucrats.”

This legislation would ensure that seriously-ill patients who have exhausted all other treatment options have access to investigational treatments that have shown promise, and would also ensure that dying patients will not be forced to participate in a clinical trial and be given a placebo or sugar pill if another reasonable treatment exists. The bill would ensure that patients have a stronger voice in the FDA’s Accelerated Approval Advisory Committee, the committee that makes recommendations on accelerated approvals for treatments for life-threatening diseases.

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