As detailed earlier this year, legislators in numerous states will introduce “right to try” bills in 2015 that give critically ill patients access to medications that have not been approved by the FDA. Kansas, Tennessee, Utah, and Wyoming have already filed bills or announced intentions to do so. These “right to try” laws have already been approved in five states: Arizona, Colorado, Louisiana, Missouri, and Michigan.
On April 7, 2015, the Oregon state House became the latest legislative body to pass a bill that would nullify in practice some of the FDA rules that prevent terminally ill patients from accessing treatments. In a unanimous 59-0 vote, House Bill 2300 (HB2300) would give terminally ill patients access to medicines that have not been approved by the FDA.
Currently the federal Food, Drug, and Cosmetic Act (FDC Act) prohibits general access to experimental drugs. Under the expanded access exception of the FDC Act (21 U.S.C. § 360bbb), however, patients with serious or immediately life-threatening diseases are allowed access to experimental drugs after receiving express FDA approval. All human test subjects using the exemption must be informed that the drug is being used for investigational purposes and the consent of the subjects or their representatives must be obtained, except when an investigator deems it not feasible or contrary to the best interest of the subject. The Oregon bill would bypass this expanded access program. Insurance companies would not be required to cover the drug or complications that arise from using it under “right to try.”
Highlights of HB2300:
- Only patients with a prognosis of one year to live would be eligible for the “right to try.”
- Children under 15 would be denied the right to try in all circumstances.
- Investigational product must have passed Phase I clinical trials and be currently active in subsequent phases.
- No civil or criminal liability exists for acts or omissions of acts related to administering a treatment.
- Licensing boards, health care facilities, or professional organizations/associations cannot impose discipline or sanctions for administering treatment.
Other states’ “right to try” bills have passed without the eligible patient and age restrictions above. For patients and providers wanting the “right to try,” the wait is on for the Oregon state Senate to approve the bill and submit it to the governor.