BioCentury
ARTICLE | Politics & Policy

Colorado governor signs compassionate use bill into law

May 20, 2014 12:56 AM UTC

Colorado Gov. John Hickenlooper signed into state law legislation that would allow eligible terminally ill patients access to investigational products that have completed a Phase I trial but have not been approved by FDA. Under the law, drug manufacturers may provide the product with or without receiving compensation. The law does not address promotion of investigational products for compassionate use but does include liability protection for health care providers and investigational drug manufacturers.

The "right to try" movement is gaining traction among state and federal lawmakers. Similar bills are moving through the legislatures of at least three other states: Arizona, Louisiana and Missouri. At the federal level, the Compassionate Freedom of Choice Act (H.R. 4475) would allow manufacture, importation, distribution and sale of investigational products outside of a clinical trial for terminally ill patients without restriction by or reporting to FDA. The bill -- which provides liability protection for both manufacturers and health care providers -- was referred to the health subcommittee of the U.S. House of Representatives Energy and Commerce Committee. ...