Last week, the Ohio House of Representatives sent legislation to Governor Kasich that gives terminally ill patients, with the recommendation of their treating physician, the opportunity to access drugs that are still in the trial period with the United States Food and Drug Administration.
House Bill 290, also known as “Right to Try” legislation, will allow Ohioans who are suffering from a terminal illness to have increased access to investigational drugs, biological products, or devices that have passed Phase I of an FDA clinical trial and will remain in ongoing trials.
“The legislation is a last resort for individuals and their families who feel that their terminal illness has left them nowhere else to turn,” said Rep. Anielski, who sponsored the legislation with Rep. Robert Sprague (R-Findlay). “Allowing those diagnosed individuals the right to try new medications, under the care and supervision of a physician, has the possibility to greatly improve the patient’s quality of life and, in some cases, provide life saving measures.”
Brian Wolf, a local resident of Cuyahoga County and supporter of the bill, said, "Our family is so excited to have been involved in this historical legislation that will give hope to the families who will have a renewed sense of hope by being able to access safe drugs that they wouldn't have otherwise been able to utilize."
Currently, the FDA offers an expanded access program, which allows terminally ill individuals to access investigational medications. However, there are only about 1,000 annual participants and the application process is burdensome.
Under this legislation, patients are eligible to access an investigational drug provided that all approved treatment options have been utilized without satisfactory results. Before beginning treatment, the legislation requires physicians to obtain informed consent and provide treatment information to patients or their legal guardians. Additionally, House Bill 290 provides certain protections for parties that will be involved in the treatment process.
This legislation is not a mandate or requirement for doctors to provide their patients with investigational drugs, but instead creates an opportunity not previously available to physicians and patients.