Terminally ill patients in Michigan may soon have a new avenue to pursue unproven treatments.
The State House Health Policy committee Tuesday approved "right-to-try" legislation. The state Senate has already approved the legislation, which tries to give patients a better chance of getting drugs or medical devices that show promise, but have not been fully tested.
The law does not require doctors to prescribe experimental drugs or insurance companies to pay for them.
The committee heard from Terry Kalley, whose wife is a stage-four cancer patient.
“Denying a person the right to access drugs that might save their own life flies in the face of our due process rights embedded in the Constitution,” Kalley told the committee.
Lucy Caldwell is with the Goldwater Institute, which is lobbying state governments to pass similar legislation. She admits they don’t know what the side effects of these experimental drugs will be.
“But we know we are taking about a pool of patients for whom the side effect of not taking one of these medications is certain. And that’s death,” says Caldwell.
Critics say right-to-try laws give dying patients false hope. Supporters say given a choice of no hope and some hope, terminally ill patients should be allowed to make their own choice.
The Food and Drug Administration has not taken a position on the right-to-try bills. But the agency defends the lengthy drug approval process which can take many years.
The FDA issued a written statement saying that terminal patients have had and continue to have options that seek access to experimental drugs and medical devices.
FDA allows the vast majority of Expanded Access requests it receives to proceed. These requests usually are made by the individual patient’s treating physician, although they also can be made by the company. A company developing an experimental therapy may also request access for intermediate size patient groups or under a treatment protocol if the patients do not meet the criteria for a clinical trial. It is important to note that FDA cannot require a company to make its experimental drug available to patients however; the agency stands ready to work with companies that are interested in providing access to experimental drugs. FDA’s oversight of this process provides important protections for individual patients, while also ensuring the collection of the data needed to support FDA approval of safe and effective therapies.
The legislation is on its way to the state House floor; it has already cleared the state Senate.
Three other states have already passed right-to-try laws.
