…At any rate, the NEJM article describes four bills as having been introduced in the U.S. Congress in 2007 to expedite approval of follow-on protein products. None reached the floor. The article cheerfully concludes “despite failures of the bills… [they] collectively represent important first steps that should help stimulate further discourse… and signal an end to the de facto permanent patent that a recombinant protein therapeutic currently enjoys.” In the meantime, its a hard knock life for persons with ultra-rare disorders. (photo credit: dishevld 2007)
Studies of Translation in Ethics and Medicine