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Terminally Ill Patients in Two States May Bypass FDA to Access Experimental Drugs

Oklahoma and North Dakota may become latest right-to-try states

AP
• April 16, 2015 11:12 am

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Two states may soon join 13 others in passing so-called right-to-try bills, which would give terminally ill patients access to experimental drugs not yet approved for the market by the Food and Drug Administration.

The governors of Oklahoma and North Dakota will decide soon on the legislation.

House Bill 1074 was headed to Gov. Mary Fallin’s desk in Oklahoma, and had yet to be received by her office as of late Wednesday, according to a spokesman for the governor, who said that the bill would be reviewed once it was received.

Fallin will have five days from when it reaches her office, excluding Sunday, to review the bill, the spokesman said. Fallin will then decide to approve or veto the legislation.

The Oklahoma Right to Try Act was sponsored in the House by State Rep. Richard Morrissette (D.) and in the Senate by State Sen. Rob Standridge (R.), a pharmacist.

The legislation would allow doctors to prescribe medicines being used in clinical trials to terminally ill patients.

The bill in North Dakota was still awaiting Republican Jack Darlymple’s signature as of Wednesday night, according to the Goldwater Institute, which has led a national campaign to promote the passage of right-to-try legislation.

Starlee Coleman, a senior policy adviser at the Goldwater Institute, said that Darylmple is expected to sign the legislation.

"We do expect him to sign it, as the bill sponsor hasn’t heard that his office has any concerns," said Coleman.

Darylmple’s office did not respond to a request for comment by the Washington Free Beacon.

"Right now, if a terminally ill person wants to try a drug being used in a clinical trial that they were not allowed to enroll in, they have to go through a months-long FDA approval process," said Coleman.

"But Americans shouldn’t have to ask the government for permission to try to save their own lives. They should be able to work with their doctors directly to decide what potentially life-saving treatments they are willing to try," Coleman said.

Coleman said that the bill empowers patients and doctors. "This is exactly what Right To Try does—it removes barriers that prevent doctors from providing the care they were trained to give and puts treatment decision-making back in the hands of patients and their doctors," she said.

The 13 states that have right-to-try laws currently in place are Arizona, Arkansas, Colorado, Indiana, Louisiana, Michigan, Mississippi, Missouri, Montana, South Dakota, Utah, Virginia, and Wyoming.

Right to try is also in play in 20 other states, in various stages of the legislative process.

"In almost every state where right to try has passed, it passed with unanimous, bipartisan support. Lawmakers from coast to coast, left and right, agree that when a person is fighting for their life, they shouldn’t have to fight the government too," Coleman said.

California’s right-to-try bill passed unanimously out of the state assembly’s health committee recently. It was introduced by Assemblyman Ian Calderon (D.).

"Currently, FDA regulations do allow for expanded access to investigational treatments for those patients with serious or immediately life threatening diseases or conditions," said Calderon in a press statement. "However, the application process can be long and cumbersome and sometimes takes up to several months to gain access to treatment. The terminally ill do not have the luxury of waiting. Not when they have weeks or months left to live."

California’s bill was re-referred to the Assembly Committee on Business and Professions two days on Tuesday.

Two bills were recently introduced in New York in the Senate and Assembly. The right-to-try bill introduced in the Assembly earlier this month has now been referred to the health committee.

A North Carolina bill was referred to the Committee for Health two days ago.

Terminally ill patients across the country have come out in favor of the law, including in states such as Illinois and Alabama.

Gov. Gary Herbert (R.) of Utah signed a right-to-try bill late last month, and patients there embraced the potentially life-saving law.

John Johnson, the chairman of Overstock.com, was on hand for the ceremonial signing. He recently set up the nonprofit Right to Try Foundation in Utah to help terminally ill in the state pay for the experimental medicines. Insurance companies are not required to cover experimental treatments.

Published under: FDA, Health Care