PHOENIX, Ariz. (Jan. 22, 2019) – A bill introduced in the Arizona House would allow patients to access stem cell treatments not yet given final approval by the FDA, nullifying some FDA regulations in effect.
A coalition of four Republicans filed House Bill 2121 (HB2121). The legislation would allow patients with a chronic disease or terminal illness to access and use investigational stem cell treatments. HB2121 includes language to legally protect physicians who recommend investigational stem cell treatments.
“Notwithstanding any other law, the Arizona medical board and the Arizona board of osteopathic examiners in medicine and surgery may not revoke, fail to renew, suspend or take any action against a physician’s license pursuant to title 32, chapter 13 or 17 based solely on the physician’s recommendations to an eligible patient regarding accessing or using an investigational stem cell treatment if the care provided or recommendations made to the patient meet the standard of care and the requirements of this article.”
The proposed law also prohibits any state or local government agency or employee from interfering with an eligible patient’s access to an experimental stem cell treatment.
HB2121 builds on and expands the Arizona Right to Try law, which authorizes terminally ill patients to access experimental treatments not yet approved by the FDA. Notably, HB2121 doesn’t limit access to experimental stem cell treatments to terminally ill patients, but creates a process for patients with chronic illnesses to access such treatments as well.
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 last year after 40 states enacted laws allowing terminally ill patients to effectively bypass the FDA and try experimental treatments without federal permission.
HB2121 goes a step further, specifically authorizing experimental stem cell treatments in Arizona without regard to FDA regulations and expanding access beyond terminally ill patients.
This expansion of Right to Try demonstrates an important strategic point. Passing bills that take a step forward sets the stage, even if they are limited in scope. Opening the door clears the way for additional steps. You can’t take the second step before you take the first.
WHAT’S NEXT
At the time of this report, HB2121 had not been referred to a committee. Once it receives a committee assignment, it will have to pass by a majority vote before moving forward in the legislative process.
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