Posted 11 November 2020 | By
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 negotiations, Regulatory 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 misuse, Regulatory Focus 2 October 2020; FDA seeks comment on plan to increase REMS transparency, Regulatory Focus 5 November 2020).
For PDUFA VII, FDA said its goals for REMS will be to improve on design planning, clarify expectations, and to enhance review efficiency and transparency.
With regards to the agency’s Sentinel Initiative, FDA said it wants to build on progress made during PDUFA VI with the “hope of making Sentinel a national resource.” FDA also presented on recent Sentinel-related activities and said that it met all its Sentinel-related commitments under PDUFA VI on time.
Last month, Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research, hinted that the agency would like to see more funding from Congress to support Sentinel. “We have to think about continuing to invest in postmarket safety. We have to think about the fact that Sentinel, which was mandated by Congress, is still largely supported by user fees … this is another area where we think there are some opportunities when it comes to budget priorities,” she said. (RELATED: Top CDER officials discuss budget priorities, staffing and COVID, Regulatory Focus 16 October 2020).
Manufacturing and inspections
The manufacturing and inspections workgroup also met twice, with industry taking the lead in presenting issues it would like to focus on during the negotiations.
Those issues include enhancing premarket and postmarket communication, increasing understanding of the decision framework around inspections and streamlining quality-related regulatory submission content.
While industry raised those topic areas and issues, they and FDA acknowledged that some of the topics presented may be addressed through “existing work streams.”
During the second meeting, FDA and industry agreed to a set of topic areas and a schedule for the remainder of the negotiation process and industry presented on communications. Industry specifically raised information requests issued during the review process and mid-cycle meeting communications as prime targets to address in PDUFA VII.
“Industry provided insight on the issues with these types of communications and provided examples of how improved communications would allow for more efficient processes for their firms,” FDA writes. The two sides also agreed to review lessons learned and practices from the COVID-19 pandemic and how they could be carried forward in the next user fee agreement.
FDA
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 negotiations, Regulatory 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 misuse, Regulatory Focus 2 October 2020; FDA seeks comment on plan to increase REMS transparency, Regulatory Focus 5 November 2020).
For PDUFA VII, FDA said its goals for REMS will be to improve on design planning, clarify expectations, and to enhance review efficiency and transparency.
With regards to the agency’s Sentinel Initiative, FDA said it wants to build on progress made during PDUFA VI with the “hope of making Sentinel a national resource.” FDA also presented on recent Sentinel-related activities and said that it met all its Sentinel-related commitments under PDUFA VI on time.
Last month, Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research, hinted that the agency would like to see more funding from Congress to support Sentinel. “We have to think about continuing to invest in postmarket safety. We have to think about the fact that Sentinel, which was mandated by Congress, is still largely supported by user fees … this is another area where we think there are some opportunities when it comes to budget priorities,” she said. (RELATED: Top CDER officials discuss budget priorities, staffing and COVID, Regulatory Focus 16 October 2020).
Manufacturing and inspections
The manufacturing and inspections workgroup also met twice, with industry taking the lead in presenting issues it would like to focus on during the negotiations.
Those issues include enhancing premarket and postmarket communication, increasing understanding of the decision framework around inspections and streamlining quality-related regulatory submission content.
While industry raised those topic areas and issues, they and FDA acknowledged that some of the topics presented may be addressed through “existing work streams.”
During the second meeting, FDA and industry agreed to a set of topic areas and a schedule for the remainder of the negotiation process and industry presented on communications. Industry specifically raised information requests issued during the review process and mid-cycle meeting communications as prime targets to address in PDUFA VII.
“Industry provided insight on the issues with these types of communications and provided examples of how improved communications would allow for more efficient processes for their firms,” FDA writes. The two sides also agreed to review lessons learned and practices from the COVID-19 pandemic and how they could be carried forward in the next user fee agreement.
FDA
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PDUFA VII: FDA, Industry take up manufacturing, postmarket issues - Regulatory Focus
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