Oct. 04, 2017
HARRISBURG – A bill by Rep. Robert Godshall (R-Montgomery), which would permit eligible patients with terminal illnesses to use investigational drugs, biological products and devices not yet approved by the U.S. Food and Drug Administration (FDA), passed the last major hurdle on its way to the governor’s desk. By a unanimous vote,
House Bill 45 passed the House on concurrence today after undergoing minor Senate amendments.
The FDA approval process for investigational drugs, biological products and devices in the United States aims to protect patients from premature, ineffective and unsafe medications and treatments. However, three rounds of clinical trials can take as long as 15 years, leaving many to die while awaiting treatment. Godshall’s bill would permit a manufacturer to make these products available to eligible patients after the products successfully complete the first phase of clinical trials.
“Faced with certain death, terminally ill patients do not have the luxury of time and have likely exhausted all other available options,” said Godshall. “If they want to try medications that have not completed the rigorous FDA testing and approval process, they should be permitted to do so. House Bill 45 would give them that choice.”
About 12 years ago, Godshall faced a similar choice. He was diagnosed with multiple myeloma – a deadly form of blood cancer - and told he had about a year to live. Doctors advised him that a bone marrow transplant might extend his life, but at age 72, he was already seven years beyond the medically approved cutoff date for that procedure. They warned Godshall that the odds were against him surviving the surgery. Believing he had nothing to lose, Godshall chose to go ahead with the surgery and signed a stack of waivers to assume all responsibility.
The bone marrow transplant sustained him until a new medication came along to control his cancer. Godshall said his “right-to-try” legislation would give other terminally ill patients the same opportunity that he and patients in 37 other states have - another chance at life.
Under House Bill 45, physicians would not be held liable for recommending experimental products to their terminally ill patients, nor would the bill create a private cause of action against the manufacturers that make the drugs. While the bill does not require insurers to cover these products, they may do so at their own discretion. The bill is now awaiting the governor’s signature.
Representative Bob Godshall
53rd District
Pennsylvania House of Representatives
Media Contact: Donna Pinkham
717.260.6452
dpinkham@pahousegop.com
BobGodshall.com