New FDA triage website will improve dialogue with patient advocacy groups

Dec 6, 2017
New FDA triage website will improve dialogue with patient advocacy groups

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is developing a web-based triage system to make it easier for patient advocacy groups to contact the agency with drug development inquiries.

Announced at a public workshop with rare disease groups on October 30, the website is in response to a growing amount of contact between patient advocacy groups and the FDA which has led to increasing time constraints on CDER officials.

Acting as a triage tool, the website will create a more formal and efficient system for organizations to ask questions of and arrange meetings with the agency.

“There will be a website where you can put what is the goal of your meeting, who do you want to meet with, what are your specific questions and the PASE [Professional Affairs and Stakeholder Engagement] staff will then determine what is the most appropriate avenue, what would be the most appropriate type of engagement with CDER,” said Associate Director for Medical Policy in CDER’s Office of Translational Sciences, Laurie Muldowney.

Patient involvement still welcome

Although allowing for a more formal contact process with the FDA, Muldowney emphasized that the website will not stand in the way of groups directly contacting specific FDA divisions. “Most divisions are also willing to meet with patient groups on an ad hoc basis. These would be organized with the division.”

Muldowney emphasized the importance of these meetings, particularly when in developing trial endpoints or developing outcome assessment tools.

“We have a number of these meetings throughout clinical development,” said Muldowney. “[FDA staff] actually really welcome patient involvement.”

New FDA triage website will improve dialogue with patient advocacy groups

Stakeholder Engagement is a function within Corporate Affairs at Astellas that focuses on creating, building and maintaining third-party relationships. We serve as a conduit between Astellas and external stakeholders to help improve patient outcomes, improve access issues and address patients’ unmet needs head on.