LANSING—The Michigan Senate Health Policy Committee unanimously approved a measure Wednesday allowing terminally ill patients access to experimental treatments, said sponsor Sen. John Pappageorge, R-Troy.
Senate Bill 991 creates the “Right to Try Act,” which would allow patients to use investigational drugs, biological products or devices that have not yet been approved for general use by the U.S. Food and Drug Administration (FDA).
“Many drugs that could provide effective treatments for terminally ill patients take years to be approved. Unfortunately, some patients don’t have that long,” said Pappageorge, R-Troy. “This bill will give hope to thousands of patients who will have access to life-saving medicines and treatments.”
To be eligible for new treatments and medicine under SB 991, a patient must:
- Have an advanced illness attested to by the treating physician;
- Have considered all other available treatment options;
- Have received a recommendation from their physician to try an investigational drug, biological product or device;
- Have given written informed consent;
- Have documentation from their physician that the patient meets all the requirements; and
- Be under treatment in a hospital only if the hospital approves of the treatment.
Under Pappageorge’s measure, an investigational drug, biological product or device is one that has successfully completed Phase I of the FDA clinical trials process but has not been approved for general use by the FDA. Phase I involves 20 to 80 healthy individuals and looks to the safety of the drug. In Phase I, side effects, levels of toxicity and how the drug is metabolized are studied.
According to the bill, an advanced illness is a disease or medical or surgical condition with significant functional impairment that is not reversible with current FDA approved and available treatments; is expected to result in death or state of unconsciousness; and from which recovery is not expected.
“This legislation is about compassion for patients who have run out of options,” said Sen. Jim Marleau, R-Lake Orion, chair of the Senate Health Policy Committee. “It will give patients an opportunity to try leading-edge treatments and medicines that could save their lives.”
Similar bills supporting Pappageorge’s measure have been introduced in the Michigan House of Representatives by Reps. Gail Haines, R-Waterford, and Nancy Jenkins, R-Clayton.
SB 991 now heads to the full Senate for further consideration.