PHOENIX, Ariz. (April 26, 2022) – Arizona Gov. Doug Ducey has signed a bill that will expand the state’s “Right to Try” law to allow patients to access personalized treatments that have not received FDA approval.
Sen. Nancy Barto (R) introduced Senate Bill 1163 (SB1163) on Jan. 13 with six Republican cosponsors. The new law expands the state’s “Right to Try” law to allow patients to access individualized treatments based on their genetic makeup, without first getting federal approval
These treatments are tailor-made for each individual. By their nature, they cannot be approved by the FDA in a timely manner. SB1163 would create a process for patients to access these treatments without jumping through FDA bureaucratic hoops
SB1163 builds on the Arizona Right to Try law, which authorizes terminally ill patients to access experimental treatments not yet approved by the FDA.
The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs and treatments. However, under the expanded access provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb, patients with serious or immediately life-threatening diseases may access experimental drugs after receiving express FDA approval. RIght to Try allows terminally ill patients to bypass the expanded access provision and obtain experimental drugs from manufacturers without first obtaining FDA approval.
Congress passed a federal Right to Try law in 2018 after 40 states enacted laws allowing terminally ill patients to effectively bypass the FDA and try experimental treatments without federal permission.
The Goldwater Institute reported the story of the Riley family, exemplifying the potential practical impact of this Right to Try expansion.
“Two of their three young daughters were diagnosed with the rare and fatal genetic brain disease Metachromatic Leukodystrophy (MLD). Because Olivia was already showing symptoms, there was little they could do. However, there was a treatment that could help their youngest—but it was only available in Milan, Italy, due to FDA restrictions. The Rileys had no choice but to raise hundreds of thousands of dollars and move overseas to access the treatment and save their daughter’s life.”
With the enactment of SB1163, people like the Riley’s can access these treatments in their home state.