Memo to the FDA: Thanks, But We’ve Got This


March 2, 2015 4:59PM

Last week, Virginia became the 6th state to pass Right to Try legislation through both chambers of its legislature, making it the latest in a plethora of states expected to enact this groundbreaking law. This law gives terminally ill patients the right to access experimental medication that has passed Phase I of III in the Food & Drug Administration’s (FDA) process. Following the example of Colorado, Michigan, Missouri, Louisiana, and Arizona, Virginia and its likely predecessors in the Right to Try movement are sending a strong message to the FDA: adapt or move out of the way. Reading the writing on the wall, the FDA responded to the groundswell of public pressure and bipartisan popularity of Right to Try earlier this month by reducing the amount of paperwork required to complete the application process for its compassionate use program— a clause that functions as an appeals process for terminally ill patients seeking advanced access to investigational medicines still ensnared in the 3-Phase approval process. Previously, physicians petitioning for access on behalf of a patient were required to devote over 100 hours of their time towards completing the necessary paperwork. With the newly announced change, doctors can now submit the paperwork much more quickly. Problem solved, right? Wrong. And while this is an encouraging sign that the FDA understands it must reform or be reformed, in this case— it’s just too little, too late. Unfortunately, the FDA is still missing the point. Five states haven’t signed Right to Try into law simply in response to outrage over the hours required for doctors to submit compassionate use petitions on behalf of their patients—though it was certainly outrageous. Rather, Right to Try asserts the ability for states to be more efficient at responding to the immediate needs of their citizenry. Despite this positive change to the compassionate use permissions’ process, an application still must be examined by an internal review board (IRB) before access to the intended medication is ever granted. The FDA claims the IRB must respond within 30 days, but if they encounter questions regarding the patient’s information, they can return the application to the patient and physician, and put another 30 days on the clock. ‘Round and ‘round she goes… Tennessee is poised to be the next state that puts an end to this inhumane carnival ride. Rep. Jon Lundberg and Sen. Joey Hensley have filed Right to Try legislation, which is up for its first vote tomorrow in House Health Subcommittee. Terminally ill Tennesseans deserve to hope as far as the horizons of innovation may take them, uninhibited by the whims of Washington bureaucrats.