FDA asks stakeholders to join PDUFA talks by 17 August
The US Food and Drug Administration (FDA) on Monday called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Prescription Drug User Fee Act program by 17 August 2020.The monthly periodic consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin the following month.
The call comes as FDA prepares to kick off the negotiation process with its first public PDUFA reauthorization meeting later this month, as the current user fee agreement is set to expire in September 2022.
“FDA believes that consistent stakeholder representation at these meetings will be important to ensure progress in these discussions,” FDA writes, noting that stakeholders may request to join the consultations at a later date as well. Interested stakeholders are instructed to designate one or more representative from their organization to prepare for and attend the meetings.
During the previous PDUFA VI negotiations, FDA held six stakeholder discussion meetings and 70 meetings with industry between September 2015 and February 2016 before agreeing to the set of goals that would be baked into the PDUFA reauthorization under the Food and Drug Administration Reauthorization Act of 2017.