UPDATE 12/2/2016: On December 1, 2016, Andrew Yogmour, legislative aide to state Rep. Robert Sprague (R-Findlay) told Health Care News, “Yesterday, the Senate made a change regarding clinical trials. Instead of attempting to qualify in the patient’s resident or adjoining county, language was included that changed the provision to within 100 miles.”
UPDATE 12/1/2016: House Bill 290 was passed out of the Senate Health and Human Services Committee on November 30, 2016, and awaits further action by the Senate.
The fate of a bill that would allow terminally ill patients to try investigational drugs under Ohio law depends on whether the state Senate approves the right-to-try legislation during its lame duck session scheduled to end on December 28.
The Ohio House of Representatives approved the legislation, House Bill 290, by a vote of 96–1 in April. The bill will not carry over into the 2017 session, which begins on January 2.
Adopting HB 290 would make Ohio the 33rd state to pass right-to-try legislation permitting terminally ill patients to use investigational drugs, products, or devices that have passed Phase I of clinical trials and are awaiting full approval by the U.S. Food and Drug Administration (FDA).
Only patients who cannot access or are denied entry to a clinical trial in their county or an adjacent county for their terminal illness would be eligible under the bill. These patients would be eligible for treatment under HB 290 if they determine with their physician an investigational treatment offers the best chance of survival, compared to FDA-approved treatments, for a progressive neurological disorder, musculoskeletal disorder, cancer, or other illness likely to kill them within 12 months, the bill states.
The bill would limit the liability of doctors who recommend treatment or treat eligible patients except in cases of “willful or wanton misconduct.”
‘They Should Have Access’
State Rep. Robert Sprague (R-Findlay) says the bill would give terminally ill patients a fighting chance.
“This legislation is meant to save lives,” Sprague said. “When people are fighting an illness that will eventually result in death, they should have access to potentially lifesaving treatment options.”
A terminally ill patient whose physician recommends a treatment currently in clinical trials should not be kept waiting by FDA, Sprague says.
“If a promising treatment is still under consideration by the Food and Drug Administration, it should not take federal approval or acceptance into a clinical trial for terminally ill individuals to gain access,” Sprague said. “Individuals and their physicians should have the opportunity to try these treatments, especially when they have exhausted all other options.”
Free-Market Cost Control
An Ohio right-to-try law would decrease testing and development costs for companies bringing new drugs to market, Sprague says.
“One of the reasons for the incredibly high cost of pharmaceuticals is the incredibly expensive clinical trial method of approval that is required to reach the market,” Sprague said. “This needs to be reformed and streamlined long-term to help reduce the cost of these drugs.”
Satya Thallam, chief economist for the U.S. Senate Committee on Homeland Security and Governmental Affairs, says state right-to-try laws and analogous federal legislation currently pending would empower patients who have no other way to extend their lives.
“This approach is absolutely consistent with free-market principles but particularly with providing more individual agency and liberty in decision-making, in this case about assuming risks when an individual, their doctor, and a company believe the expected benefits are sufficient,” Thallam said.
Letting Doctors Be Doctors
Fully implemented right-to-try legislation would shift the burden of quality assurance from the federal bureaucracy to the health care system itself, Thallam says.
“[It] places more of the heavy lifting of sorting effective and ineffective therapies on the complex medical ecosystem and market and away from a central regulatory agency,” Thallam said.
Sprague says HB 290 would restore to patients and doctors the authority to make crucial health care decisions.
“Right-to-try laws take some of the decision-making from the government and place important medical decisions in the hands of patients and the medical community,” Sprague said. “It enables manufacturers, along with treating physicians, to offer potentially revolutionary solutions for some of the worst health issues.”
Jordan Finney ([email protected]) writes from Boise, Idaho.
Josh Thomas, “Federal ‘Right to Try’ Act Would Help States Bypass FDA to Treat Terminally Ill,” Health Care News, The Heartland Institute, June 2016.
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