Colleen Brunetti Testifies Before the FDA
Thanks to a new law, the Food and Drug Administration (FDA) will expand the way it uses patient input during its review and approval of drugs and devices. The FDA plans to select 20 specific disease communities to focus on in 2013. As a first step, they took testimonies in October from representatives of more than 50 disease communities. The FDA nominated PAH as part of this group.
PH patient and PHA Board Member Colleen Brunetti travelled to Washington, D.C., to speak to an FDA panel, arguing for the inclusion of both PAH and organ transplant in the pilot year of the FDA’s new initiative.
Rino Aldrighetti, PHA’s President, submitted written comments as well as letters of support from several of PHA’s partner organizations encouraging the FDA to include both PAH and organ transplant in the program’s first year.
The goal of the patient focused initiative is to help the FDA understand how its approval processes can better meet patients’ needs. For example, the FDA will seek input on the way it assesses risk versus benefit during the approval process for new drugs and devices. After working with 20 disease communities in the program’s first year, the FDA will expand the program in the future. (Watch the next issue of Pathlight for an update!)
We will continue to work closely with the FDA through this and other initiatives to improve the drug and device approval process for the PH community.