Youngstown Daily Legal News

Bill to allow use of unapproved drugs by terminally ill advances

KEITH ARNOLD
Special to the Legal News
Published: December 27, 2016

It's unclear whether a measure that would allow physicians to treat their terminally ill patients using unapproved drugs will proceed to Gov. John Kasich for his signature in the waning days of the 131st General Assembly of the Ohio Legislature.

House Bill 290 recently cleared the Senate unanimously and the members of the House of Representatives subsequently offered unanimous support of amendments to the measure.

It had not been forwarded to the governor's office as of earlier this week.

HB 290 would permit an eligible patient, suffering from a terminal condition, to be treated with an investigational drug, product, or device that has successfully completed the first phase of clinical trials required by the U.S. Food and Drug Administration and remains under clinical investigation but has yet to be approved for general use.

The bill specifically excludes Schedule I controlled substances from use.

"Annually, millions of Americans suffer from a terminal illness," the bill's sponsor, Rep. Robert Sprague, R-Findlay, told members of the Senate Health and Human Services Committee. "Although there are some alternative ways to try new treatments, access to new and potentially life-saving treatment is limited.

"Clinical trials are somewhat rare and qualifying to participate can be extremely difficult."

The bill provides that to be eligible for such treatment, a patient must have a terminal condition, as determined by the individual's treating physician and by one other physician who has examined the individual.

HB 290 defines a terminal condition as any of the following, if irreversible,

incurable, and untreatable through a method of treatment approved by the FDA:

• A progressive form of cancer;

• A progressive neurological disorder;

• A progressive musculoskeletal disorder;

• A condition that, based on reasonable medical standards and a reasonable degree of medical certainty, appears likely to cause death within a period of time that is relatively short but does not exceed 12 months.

"Terminally-ill patients should have the right to choose to attempt non-FDA approved treatments based off how their advanced care unfolds," Ohio State Medical Association Senior Director Tim Maglione. "They should be of their own will and choice, and they deserve the dignity of being allow to try these treatment methods.

"We do not see any detriment in allowing this valuable chance to give physicians another tool with which to treat their patients. This legislation puts this crucial decision back into the hands of those most closely involved with the situation, and of those it affects most directly and personally."

The Ohio State University Comprehensive Cancer Care-James Cancer Hospital and Solove Research Institute joined the state medical association in support of the measure during committee hearings.

"While we support offering options to patients, we also do not want to draw attention and resources away from efforts to develop effective treatments," said Jennifer Carlson, associate vice president for External Relations and Advocacy of the hospital. "Advancements in new treatments only can be achieved through the multi-step clinical trials process, which is conducted in a systematic way to get information regarding the benefits of a new therapy.

"We appreciate the willingness of Sen. (Cliff) Hite (R-Findlay) and the sponsors to include language that would clarify that a patient should first enroll in a clinical trial to treat his or her terminal condition, if the patient is eligible for enrollment and it is available within 100 miles."

HB 290 received broad, bipartisan support in both houses.

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