Pennsylvania residents suffering from terminal illnesses will be allowed to try experimental therapies yet to receive full approval under the U.S. Food & Drug Administration’s lengthy review process.
Gov. Tom Wolf signed House Bill 45 (HB 45) into law by on October 11, making Pennsylvania the 38th state to enact a “right-to-try” law.
The new law takes effect on December 10. After that date, Pennsylvania residents suffering from terminal illnesses can legally access experimental medical therapies still under FDA review, such as drugs, medical devices, and other biological products, under state law. The FDA still retains legal authority over these drugs, pending the outcome of legislation currently under consideration in Congress.
Elizabeth Stelle, director of policy analysis at the Commonwealth Foundation, says the new law allows treatment options for patients otherwise without hope.
“The bill gives individuals with terminal diseases the ability to try drugs that have not been approved by the FDA but have been through initial safety screening,” Stelle said. “The bill gives manufacturers the option to make these treatments available. Under current laws, this would be illegal.”
HB 45 gives Pennsylvania residents more control over their health care, Stelle says.
“The right-to-try bill is a smaller microcosm of the larger problem in healthcare, which is that consumers and doctors have been largely stripped of their freedoms to choose what kind of care they want to receive, and how and when they want to receive it,” Stelle said. “This bill repairs a small fraction of that.”
HB 45’s sponsor, state Rep. Bob Godshall (R-Hatfield), says getting the new law passed was personal fight for him.
In 2004, Godshall was diagnosed with terminal bone marrow cancer. FDA rules discouraged doctors from prescribing stem cell treatments. Godshall insisted on receiving treatment, knowing the risks involved.
“I was declared terminal 12 years ago,” Godshall said. “The oncologists told me I had a year or two left to live. If I didn’t know about this 14 years ago, I would have been long gone, and we wouldn’t have had this conversation today. I can’t blame the medical community. It was a serious situation. If they suggest something and it doesn’t work, they could be liable.”
Godshall says the new law solves the liability problem.
“The right-to-try [bill] prevents that from happening,” Godshall said. “They can suggest things that might work but don’t have FDA approval.”
‘Right for Pennsylvania’
Godshall says the right-to-try law is all about putting people back in charge of their own health care.
“It’s right for Pennsylvania, and it’s right for a lot of people,” Godshall said. “It gives them a chance to save their lives, if they are willing to take the responsibility for themselves.”
‘Most Rewarding Bill’
HB 45 is the most important bill he’s ever proposed, Godshall says.
“This is the most rewarding bill I’ve ever passed, because it can help people,” Godshall said.