House Passes Godshall Bill to Allow Terminally Ill to Receive Drugs Not Yet Approved by FDA
HARRISBURG -- The House today passed legislation, sponsored by Rep. Robert Godshall (R-Montgomery) to 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).
“The FDA approval process is often too slow to save patients suffering from terminal illness,” said Godshall. “Faced with certain death, terminally ill patients do not have the luxury of time. If they want to try medications that have not completed the rigorous FDA testing and approval process, they should be permitted to make that choice. House Bill 45
would make this possible.”
Eleven years ago, Godshall was diagnosed with multiple myeloma 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 elected 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. Godshall said his “right-to-try” legislation would give other terminally ill patients the same opportunity he had for another chance at life.
“I believe patients who have a terminal illness have a fundamental right to actively pursue the preservation of their own lives,” Godshall said. “My ‘right-to-try’ legislation would give those facing dire circumstances the same opportunity that patients in 31 other states have.”
While 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, the process often takes many years. In the meantime, people die. House Bill 45 would permit a manufacturer to make these products available to eligible patients once the products successfully complete the first phase of clinical trials.
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.
Godshall’s legislation passed by a unanimous vote in the House last session, but the Senate failed to take up the bill. For the sake of those whose lives could be spared, he said he is hopeful the bill will make it through the legislative process and be signed into law this session.
Representative Bob Godshall
Pennsylvania House of Representatives
Media Contact: Donna Pinkham