UPDATE: Bills create “right to try” experimental drugs

Lawmakers and advocates for people with life-threatening illnesses made a final push Monday to pass legislation giving Virginians the “right to try” experimental drugs and other treatments.

February 25, 2015; 9:01 AM • by Capital News Service

Update #1 — February 25, 2015; 8:56 AM

By Victoria Zawitkowski

Lawmakers and advocates for people with life-threatening illnesses made a final push Monday to pass legislation giving Virginians the “right to try” experimental drugs and other treatments.

“It comes down to one thing,” said Sen. Bill Stanley, R-Moneta. “…The fundamental right to life that is granted to us by our creator, also necessarily encompasses the right to fight for your life, the right to try whatever measure necessary to live.” He spoke at a press conference urging his colleagues to give final approval to House and Senate bills inspired by Josh Hardy, an eight-year-old boy from Fredericksburg who has been fighting cancer.

Stanley introduced Senate Bill 732, which allows terminally ill patients access to experimental treatments when all other options have failed. The bill is awaiting its third and final reading in the House of Delegates.

Stanley’s bill incorporates SB 1149 and SB 1222, which were drafted by Sen. Richard Stuart, R-Westmoreland, and Sen. Bryce Reeves, R-Spotsylvania, respectively.

Stanley has a special motive for sponsoring such a measure: He was 22 when he lost his father to cancer. SB 732 also stems from the ordeal of Josh Hardy, who has battled cancer since he was nine months old. Josh’s family launched the #SaveJosh campaign so he could access an experimental drug called brincidofovir. Josh has been cancer free for two years now.

Aimee Hardy, Josh’s mother, joined legislators at the press conference to urge approval of SB 732 and HB 1750, a companion bill in the House. She said no family should have to go through what the Hardys have experienced.

“You need to not have to go on national TV or beg people to call the company for you or do all these things,” Hardy said. “Everyone should just have the right to try.”

Hardy was initially concerned about the language of SB 732. After working with legislators to make some changes, she feels “much better about it.” “I was very upset [that] they were limiting if you were an inpatient. They were requiring that you do a clinical trial within 100 miles of your home–and if you are critically ill, you can’t move,” Hardy said. “So there were some definite things [about] our experience [that] helped me tell the lawmakers that this is not realistic.”

Del. Margaret Ransone, R-Kinsale, is sponsoring HB 1750, which received a unanimous endorsement from the Senate Education and Health Committee last week and is now before the full Senate. Ransone said that as long as a drug has passed through the first phase of clinical trials, patients should be allowed to request it. “When it comes to end-stage medical treatment, patients should have the right to pursue investigational medications if they have been appropriately informed of the risks and the possible outcomes,” Ransone said.

Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs, endured a situation similar to the Hardys’ but with an unhappy ending for his daughter: Abigail Burroughs died of cancer in 2001 after being denied access to clinical trials for investigational drugs.

Burroughs subsequently launched the Abigail Alliance, which has lobbied for the issue for the past 14 years. He said he is pleased with the progress in Virginia and the country as a whole. “What is so huge about the “right to try” legislation in Virginia and the other states where it’s passed is that it paves the way for changes at the national level,” Burroughs said. “Already because of ‘right to try’ laws being passed and introduced in states, they are really paying attention on Capitol Hill.”

SB 732 and HB 1750 would not require manufacturers to provide experimental drugs to patients and physicians requesting such medicines. And insurance companies would not have to cover the cost of the experimental treatments.

The legislation would let the physician and patient go straight to the manufacturer when time is critical. This would be an option only after all treatment options approved by the U.S. Food and Drug Administration had been exhausted and two doctors agree on use of the experimental drug.

House Speaker Bill Howell of Stafford is a co-sponsor of HB 1750. “I’m glad that the hard work of members in the House and Senate has resulted in legislation that will help Virginians in dire need,” Howell said. “I support this legislation because once all other options have been exhausted, if there’s a treatment that holds promise, we owe it to the patients and their loved ones to let them try.”

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Original — February 09, 2015

By Morgan White

The House of Delegates on Tuesday unanimously passed legislation aimed at making it easier for terminally ill patients to obtain investigational drugs before they have been approved by the U.S. Food and Drug Administration.

House Bill 1750, sponsored by Del. Margaret Ransone, R-Kinsale, was inspired by Josh Hardy, a Fredericksburg boy battling a rare disease.

“This legislation was inspired by the Hardy family’s #SaveJosh campaign, as they fought to get their seven-year-old boy access to a lifesaving treatment that wasn’t yet approved by the FDA,” Ransone said. “Josh eventually got the treatment, and he’s looking forward to celebrating his ninth birthday next month, but this fight isn’t just his and it’s not over. This legislation will give other families who have exhausted all other treatment options the opportunity to access developmental drugs that could save the life of their loved ones.”

Josh’s family sought brincidofovir, which was developed by Chimerix, a biopharmaceutical company in Durham, N.C. The company initially said it couldn’t give Josh the drug because it hadn’t been adequately tested in clinical trials and approved by the FDA. Thanks to a social media campaign that prompted about 17,500 from around the world to sign an online petition, the drug was given to Hardy to help combat an infection.

House Speaker Bill Howell, who represents the Fredericksburg area, agreed with Ransone’s comments.

“I have heard heartbreaking stories from families and patients struggling to get access to a potentially life-saving treatment and sometimes, tragically failing. This legislation will help them in their fight, and I’m proud to support it,” Howell said.

Aimee Hardy, Josh’s mother, was the main force behind the #SaveJosh campaign. She said she was hopeful that the legislation would help families in need of investigational drugs.
“No family should have to suffer a loss if there is a drug in existence that could make a difference,” Hardy said.

Sen. Bryce Reeves, R-Fredericksburg, is sponsoring a companion measure – SB 1222 – in the upper chamber. His bill is awaiting action by a subcommittee of the Senate Education and Health Committee.

Photo by: higlu