GDUFA II: FDA Prefers A ‘Manageable Number of High-Impact Changes’
This article was originally published in The Pink Sheet Daily
Executive Summary
Negotiations for generic drug user fee reauthorization open with FDA saying it doesn't want a large number of small tweaks that will increase program complexity.
FDA wants to make significant, but feasible, changes to the generic drug user fee program as part of its reauthorization rather than too many small tweaks.
Agency officials told industry representatives during the first GDUFA II negotiating session that multiple small changes likely would complicate program operations.
“A fundamental goal for GDUFA II is to align with industry on a manageable number of high impact changes rather than a large volume of low-impact changes that add complexity to the program without meaningful public health benefit,” the agency said in minutes of the Oct. 7 meeting, which lasted five hours.
The agency and industry also agreed to “use GDUFA I as a foundation for negotiating GDUFA II, as opposed to renegotiating GDUFA I,” according to the minutes. Another session was scheduled for Oct. 21.
Limiting program complexity also was a tenet of the GDUFA I talks, in part because the agency wanted to devote as many resources as possible toward generic drug review and facility inspections (Also see "Generic User Fee Waivers Created In Draft House Bill, Breaking FDA-Industry Agreement" - Pink Sheet, 19 Mar, 2012.).
And as the Office of Generic Drugs shows increasing productivity in its ANDA review and approval process, FDA likely does not want to slow that progress by making many more system changes for GDUFA II.
OGD experienced many growing pains as a result of its new responsibilities under GDUFA. The office also made a number of changes to fix communication and other problems that developed when new systems were implemented (Also see "FDA/Generic Communications Plan Restoring Best Of Past Practices" - Pink Sheet, 18 Dec, 2014.).
FDA said in the minutes that it “framed lessons learned from implementing GDUFA I” and talked about the “challenge of bridging the gap between its negotiated GDUFA I commitments on the one hand and stakeholder expectations on the other.”
ANDA approvals have increased dramatically in the last few months as new staff and operational changes have taken hold. Industry is concerned about the applications still pending, however (Also see "ANDA Approval Improvements Reveal Just How Big The Backlog Is" - Pink Sheet, 12 Oct, 2015.).
FDA counters that it is exceeding expectations when it comes to the statutory generic drug backlog and that among all the applications without formal review goals, the trend is improving (Also see "Generic User Fees: FDA Goes On Backlog Offensive" - Pink Sheet, 16 Oct, 2015.).
FDA and industry officials are working on an agreement to reauthorize GDUFA before it expires at the end of September 2017.
In the months leading up to the start of the talks, some in industry have indicated reauthorization is not assured, although it would seem that the generic drug program could not continue in its current state without fee revenue (Also see "GDUFA II? Mylan Lawyer Questions User Fee Law’s Future Absent FDA Progress" - Pink Sheet, 27 Apr, 2015.).
Industry Still Formulating Priorities
Both sides intend to discuss broad issues first.
Industry still was creating its “priority list of proposals,” according to the minutes. Its GDUFA II challenges, needs and priorities were expected to be discussed during the Oct. 21 meeting.
There already have been calls by some stakeholders that fees should be reduced, in part because of the large fee carry-over balance that the agency has accumulated (Also see "FDA's GDUFA War Chest Grows, And Industry May Look For Lower Fees" - Pink Sheet, 8 Jun, 2015.).
FDA said it wants to establish a subgroup focused on small business issues. The minutes indicated that the agency’s small business subgroup proposal also would be discussed during the Oct. 21 meeting.
Stakeholders have indicated that GDUFA fees are unaffordable for many small business owners and that a fee waiver should be created.
Among the arguments in favor of the waiver is that it would make it easier for more generic drug manufacturers to enter the market.
In some cases, GDUFA fees can cost more than the value of the generics business the companies are waiting to land (Also see "GDUFA II: Facility Fees Might Be Deferred Until ANDA Approval" - Pink Sheet, 15 Jun, 2015.).
FDA Outnumbers Industry In The Room, But Not At Table
FDA had seven people participating in the talks, along with 10 supporting staff.
Not among them was OGD Director Kathleen Uhl, who recently returned to work after a medical leave (Also see "FDA Generic Office Director Uhl Returns From Medical Leave" - Pink Sheet, 21 Sep, 2015.).
Industry had 13 participants, including six from the Generic Pharmaceutical Association, two from the Society of Chemical Manufacturers and Affiliates’ Bulk Pharmaceuticals Task Force, and one from the European Fine Chemicals Group.
The Pharma and BioPharma Outsourcing Association, a new trade group in the negotiations, sent four participants (Also see "GDUFA II Negotiations: Contract Manufacturers Gain Seat At Table" - Pink Sheet, 6 Jul, 2015.)).
Among the GPhA representatives was Keith Webber of Perrigo Co. PLC, who is a former acting OGD director and assistant director of the Office of Pharmaceutical Science (Also see "FDA's Generic Drugs Office Faces Transition As Director Buehler Departs" - Pink Sheet, 8 Mar, 2010.).
GPhA also sent two supporting staffers to the session.