USA – PDUFA VII: FDA, Industry take up manufacturing, postmarket issues

In the latest meeting summaries released in the ongoing Prescription Drug User Fee Act (PDUFA) reauthorization negotiations, the US Food and Drug Administration (FDA) and industry set out their postmarket and manufacturing and inspections priorities for the next five-year program.
 
The meetings took place in late September and early October, around the same time as other PDUFA reauthorization subgroup meetings focused on premarket, finance and digital health, among other issues, and follow the initial steering committee meetings that set the terms for the months long negotiation process. (RELATED: PDUFA VII: FDA and industry set priorities in first round of negotiationsRegulatory Focus 29 October 2020).
 
Postmarket
 
In the first two postmarket subgroup meetings, FDA proposed two topics to focus on: risk evaluation and mitigation strategy (REMS) assessment modernization and enhancements to the agency’s Sentinel postmarket surveillance system.
 
The focus on REMS comes amid questions over the utility of REMS in curbing opioid misuse and a proposal to make REMS programs more transparent. (RELATED: Report: FDA REMS program ineffective at curbing opioid misuseRegulatory Focus 2 October 2020; FDA seeks comment on plan to increase REMS transparencyRegulatory Focus 5 November 2020)…