By Emma White | UM Legislative News Service, University of MT School of Journalism
HELENA – A bill to create a regulatory framework for licensed experimental medical treatment passed the first vote in the House on April 24, with bipartisan support and opposition.
Senate Bill 535 piggybacks on the “Right to Try” Act passed by the 2023 Montana Legislature, which states that all patients may use experimental treatments that have only passed stage one of FDA trials if they wish to.
Rep. Ed Buttrey, R-Great Falls, said the bill will allow for medical innovation in Montana by providing the necessary framework for the 2023 bill to be acted upon, and for Montanans to access experimental treatment.
“By allowing treatments prior to the completion of phase two and phase three trials, which are all about the efficacy of the treatments, we can get access for Montanans to innovative therapies many years before the therapies are available through standard medical care,” Buttrey said.
But Rep. Kathy Love, R-Hamilton, opposed the bill, saying she worried about the ethical implications of bypassing parts of the FDA trial process.
“FDA clinical trials have stepped phases,” Love said. “There’s also usually an institutional review board that plays a crucial role in overseeing clinical trials, reviews, and approves the study’s protocol to ensure that it meets ethical standards and complies with regulations. This bill doesn’t provide for that.”
Buttrey noted that the first phases of trials for these treatments do provide oversight. SB 535 passed the preliminary vote 57-43, and awaits the final House decision before moving to the governor’s desk.
Emma White is a reporter with the UM Legislative News Service, a partnership of the University of Montana School of Journalism, the Montana Broadcasters Association, the Montana Newspaper Association and the Greater Montana Foundation. White can be reached at emma.white@umconnect.umt.edu.
