Laws Spreading That Allow Terminal Patients Access to Experimental Drugs
Earlier this month, Arizona voters approved a referendum that allows terminally ill patients to receive experimental drugs and devices. It’s the fifth state to approve a “right-to-try” law this year. Supporters say the laws give dying patients faster access to potentially life-saving therapies than the Food and Drug Administration’s existing “expanded-access” program, often referred to as “compassionate use.” But critics charge they’re feel-good laws that don’t address some of the real reasons patients may not receive experimental treatments. The legislatures in Colorado, Louisiana, Michigan, and Missouri also passed right-to-try laws this year as part of a nationwide effort spearheaded by the conservative Goldwater Institute, which hopes to get right-to-try laws on the books in all 50 states. The measures generally permit a patient to get access to an experimental drug after it’s passed through phase 1 of a clinical trial, the initial testing in which a drug is given to a small group of people to evaluate its safety and side effects.
Between 2009 and 2013, the FDA received roughly 1,000 expanded-access applications annually and approved virtually all of them. Among other things, the FDA considers the severity of the patient’s condition and whether other avenues of treatment have been exhausted. Some patient advocates and policy experts say that while the FDA process could be sped up, they support the agency’s continued oversight because of its critical role in ensuring drug safety and effectiveness.
Source/more: Kaiser Health News
David Wingate is an elder law attorney representing clients in Frederick and Montgomery Counties, Maryland.