Proposed bill would allow terminally ill to try experimental drugs

SACRAMENTO – Assemblyman Ian Calderon introduced Assembly Bill 159, which would allow terminally ill patients to seek an investigational drug, product, or device from a product manufacturer when other treatment options have been exhausted. “Terminally ill patients do not have the luxury of waiting for the FDA to grant compassionate use or participating in the lengthy process of clinical trials,” said Calderon. “AB 159, the ‘Right to Try’ Act, gives terminally ill patients a chance to try potentially life-saving treatments when all other options have been exhausted. It removes barriers for patients who need to immediately obtain those treatments, and protects physicians, hospitals, and manufacturers from retribution.”

The FDA’s compassionate use program allows terminally ill patients expanded access to investigational drugs and devices. Although the FDA approves most compassionate use requests it receives, it often takes doctors and patients weeks or months to navigate the process.

For terminally ill patients, the waiting period can be a matter of life and death, Calderon said.

“Patients suffering from a terminal illness should be able to exercise a basic freedom – to preserve their own life,” stated Calderon. “A ‘Right to Try’ Act in California would allow patients access to medications that have passed basic safety testing and have the potential to save or extend their life.”

AB 159 would deny the Medical Board of California and the Osteopathic Medical Board of California the ability to take any disciplinary action against the license of a physician for providing investigational treatment, provided that the prescription is consistent with medical standards of care.

The measure would also authorize, but not require, a health benefit plan to provide coverage for these drugs, products or devices for terminally ill patients.

Furthermore, an official, employee, or agent of the state would be prohibited from blocking an eligible patient’s access to an investigational treatment.

Similar measures have passed in other states in recent years. In Arizona, the “right to try” ballot initiative (Proposition 303) in 2014 was supported by an overwhelming majority of voters (78%-22%). The same type of measure passed the Colorado, Michigan, Missouri and Louisiana legislatures with bipartisan support.

 

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Published: Jan. 29, 2015 - Volume 13 - Issue 42