Montana, Arkansas Senate Unanimously Approve Bills To Let Ailing Patients Bypass FDA Drug Restrictions

This week, the Montana Senate unanimously passed Senate Bill 142, also known as a “Right To Try” bill. SB 142 would allow terminally ill patients to use experimental drugs or treatments not yet approved by the Food and Drug Administration (FDA).

If the bill becomes law, an “investigational drug, biological product or device” under the guidance of a health care provider would be allowed as treatment if the eligible patient:

  • has a terminal illness that is recognized by the patient’s health care provider
  • considered all other treatment options currently approved by the FDA
  • received recommendation from the patient’s health care provider for experimental treatment
  • has given written informed consent for such treatments
  • has provided documentation from their health care provider that those requirements have been met

An experimental treatment is defined in the bill as a “drug, biological product or device” that “has successfully completed phase 1 of a clinical trial but has not yet been approved for general use by the United States food and drug administration and remains under investigation in a United States food and drug administration-approved clinical trial.”

The bill, introduced by Republican Sen. Cary Smith, also provides protection for health care providers who would administer experimental treatments. Section 8 of the bill prohibits licensing boards from revoking, suspending, or taking other retaliatory action against a health care provider’s license based on a provider’s recommendation to an eligible patient regarding experimental treatments. The Department of Health and Human Services is also prohibited from taking action against a health care provider based on advocating experimental treatments. State officials would be not be allowed to stop an eligible patient from pursuing these treatments.

Montana is one of many states that have pursued such legislation. Senate Bill 4 (SB 4), a bill that is nearly identical to Montana’s SB 142, was passed unanimously on Thursday by the Arkansas Senate and has been referred to the state’s Public Health, Welfare, And Labor Committee. Michigan, Colorado, Missouri, and Louisiana have passed similar “right to try” bills. Last November, voters in Arizona passed Proposition 303 with over 70% supporting the “right to try.” New Hampshire introduced a “right to try” bill, HB 446, in January.

While the FDA offers a chance for patients to seek “expanded access” to investigational drugs, their process requires patients to apply for approval from the agency. “Right to try” bills that have been considered and passed throughout the country could signify that terminally ill patients prefer making important treatment decisions with their health care providers without being required to wait for FDA approval.