May. 18, 2016
HARRISBURG – The House Health Committee on Tuesday overwhelmingly approved legislation, sponsored by Rep. Robert Godshall (R-Montgomery), which would permit eligible patients with a terminal illness to use investigational drugs, biological products and devices not yet approved by the U.S. Food and Drug Administration (FDA).
“Patients who are terminally ill do not have the luxury of waiting for FDA approval and they often believe they have nothing to lose,” said Godshall, who found himself in such a situation 11 years ago when he was diagnosed with multiple myeloma and given a year to live. He needed a bone marrow transplant, but was told that, at his age, he might not survive the surgery. He chose to go ahead with the surgery and he is glad he did. The bone marrow transplant sustained him until a new medication came along to control his cancer.
“I was grateful to have a choice,” said Godshall, whose “Right to Try” legislation will give others in dire circumstances the same opportunity that he and patients in 28 other states have. “I believe patients who have a terminal illness have a fundamental right to actively pursue the preservation of their own lives.”
While the process of FDA approval for investigational drugs, biological products, and devices in the United States protects future patients from premature, ineffective and unsafe medications and treatments, the process often takes many years. Meanwhile, people die. House Bill 1104 would permit a manufacturer to make these products available to eligible patients once the products successfully complete the first phase of clinical trials.
Under Godshall’s bill, physicians would not be held liable for recommending experimental products to their terminally ill patients, nor does the bill create a private cause of action against the manufacturers that make them. While the bill does not require insurers to cover these products, they may do so at their own discretion.
House Bill 1104 now goes to the full House for consideration.
Representative Bob Godshall
53rd District
Pennsylvania House of Representatives
Media Contact: Donna Pinkham
717.260.6452
dpinkham@pahousegop.com
BobGodshall.com