RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2021 > 2 > FDA's user fee reauthorization talks continue

FDA's user fee reauthorization talks continue

Posted 03 February 2021 | By Kari Oakes 

FDA's user fee reauthorization talks continue

In ongoing negotiations, representatives from the generics drug industry continued their meetings with US Food and Drug Administration (FDA) representatives to discuss the upcoming reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA) program. Additional rounds of meeting were held both before and after the start of the new year.
The meetings are closed to the public, and minutes are sparse on details. However, according to published minutes from the 17 December FDA-industry virtual meeting, FDA laid out how agency workflow is being affected by the increasing numbers of post-marketing changes being submitted through post-approval supplements (PASs) and changes being effected supplements (CBEs). This increase in volume, if it continues, may mean that the agency will need to boost staffing, said FDA.
Controlled correspondences are similarly on the rise, according to the minutes, with one category of products responsible for much of the increase: “FDA indicated that a substantial percentage of these submissions are for complex generic drug products.”
A potential way to consider suitability petitions in a more timely fashion was also floated by FDA, though details were not included in the minutes.
On 14 January 2021, FDA and generics industry representatives held a 4-hour virtual meeting. “Industry introduced a set of proposals around inspections, including follow-up activities after FDA has issued a final classification letter,” according to the minutes. At that meeting, FDA also agreed on technical terminology harmonization “related to the mid-cycle discipline review letters” that industry had previously requested.
Separately, subgroups of FDA and industry working on negotiations for the reauthorization of the Prescription Drug User Fee Act (PDUFA VII) met and published minutes.
On 1 December, a breakout group composed of representatives from FDA’s Center for Biologics Evaluation and Research and representatives from the BIO and PhRMA trade groups met. The chief topic of discussion, according to the minutes, was a proposed from CBER requesting third party support to boost resources for cell and gene therapy work. Specifically, CBER is looking for assistance in boosting and integrating staff resources in support of the rapidly growing field.
The 1 December meeting also reviewed commitment language for each proposal made by industry, spanning topics from patient-focused drug development to evidentiary standards for cell and gene therapy products.
This subgroup met again on 17 December, with a focus on commitment language for CBER’s cell and gene therapy program. These discussions will continue in subsequent meetings, according to the minutes; new commitment language for inclusion of allergenics will also be a topic of future meetings.
Another PDUFA subgroup focused on postmarket processes met virtually for the eighth and ninth times on 2 and 9 December.
Topics discussed at these meetings included risk evaluation and mitigation strategies (REMS) assessments; industry had asked for FDA to speed up its processing of REMS reports. “FDA agreed to take a number of questions on timing and process back to its REMS experts,” according to the 2 December minutes.
More discussion at that meeting focused on FDA’s Sentinel program as it relates to pregnancy safety; Sentinel analytics and health outcomes of interest were also explored. Industry, for its part, is planning to consult with analytics experts to explore how analytics can be used in support of the pregnancy safety project.
In the 9 December meeting, FDA came back with some thoughts about speeding up the REMS process. The conclusion from FDA, according to the minutes, is that more up-front time spent by FDA on REMS work should help speed workflow for the assessment portion of the process. Industry is planning to share these thoughts with its larger PDUFA working group.
The Sentinel discussion continued on 9 December with a look at the PDUFA VI Sentinel budget, with industry planning to review the summary and send any questions to FDA in the interval before the next meeting. Further discussion about the nuts and bolts of analytics methods led to an agreement by industry to take specific questions from FDA back to its analytics experts and send responses to FDA for feedback.
Pregnancy safety was raised again on 9 December. This Sentinel project is one that “FDA is very interested in including in the PDUFA VII post-market commitments,” according to the minutes. Industry saw value in looking at electronic data sources and pregnancy registries to support pregnancy safety efforts. FDA, though it is committed to continuing to work on demonstration projects, will not be able to use PDUFA VI funding for any such new projects going forward.

According to the 9 December minutes, participants agree that the postmarket subgroup is “making good progress… Members expressed satisfaction that the discussions were now focusing on specific aspects of the proposals and specific resource needs.”


© 2022 Regulatory Affairs Professionals Society.