Annapolis, MD—A law protecting the right of terminally ill patients to access medicines that have passed Phase 1 of the FDA approval process but are not yet on pharmacy shelves has been passed unanimously by the Maryland State House and Senate. The Maryland Right To Try Act, HB 584, was sponsored by State Delegate Karen Lewis Young (D) and State Senator Bryan W. Simonaire (R). Right To Try allows doctors to prescribe to terminally ill patients medicines being safely used in clinical trials.
“This legislation gives those who have terminal illnesses, with no other treatment options left, one more chance,” said Delegate Lewis Young. “It will give them hope but, more importantly, it could give them life. Treatments that have passed the safety phase of trials, but have not yet received final FDA approval, which can take up to 10-15 years, may be made available to the terminally ill."
“In a bipartisan effort, Maryland has passed legislation that gives people hope where they have no hope,” said Senator Simonaire. “This bill provides hope to the 97% of people that are unable to participate in clinical trials. Time is not on the patient’s side, but this legislation helps give the patient a fighting chance of survival."
Right To Try laws have been already adopted in 34 other states: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maine, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, and Wyoming. The law was introduced in the other 16 states this year and is pending approval from the Governor of Washington state. The national bipartisan effort to give terminally ill Americans access to investigational medications is being led by the Goldwater Institute.
“Millions of Americans will die this year from terminal illnesses for which there are treatments and cures in the FDA approval pipeline; but it doesn’t have to be that way,” said Darcy Olsen, CEO of the Goldwater Institute. “We congratulate Delegate Lewis Young and Senator Simonaire, and all of their colleagues, on their work to get promising treatments in the hands of people who need options today.”
About 40,000 women with breast cancer will hear from their doctor this year that there are no treatment options left. But there are 22 pioneering breast cancer treatments waiting for the FDA’s green light; some of them are already available and saving lives in Europe. The FDA has a process that allows people to ask permission to access investigational medicines, but only approximately 1,300 people a year receive help. Others die while waiting on their approval.
“Patients shouldn’t have to beg the federal government for permission to try to save their own lives. If you were on a sinking ship, would you pass on the only available lifeboat because the government hadn’t certified it yet? No. You’d say, put the lifeboat in the water. Right To Try gets the lifeboats in the water,” said Olsen.
Right To Try is limited to patients with a terminal disease that have exhausted all conventional treatment options and cannot enroll in a clinical trial. All medications available under the law must have successfully completed basic safety testing and be part of the FDA’s on-going approval process.
Read more about the bureaucratic structure of the FDA that keeps promising treatments out of the hands of terminal patients in this Goldwater Institute report, Dead on Arrival.