GDUFA Stakeholder Deadline May Come After Negotiations Conclude
This article was originally published in The Pink Sheet Daily
Executive Summary
Generic drug user fee reauthorization talks remain on schedule and are expected to last about four months.
FDA decided to give stakeholders eight additional months to decide to participate in monthly GDUFA negotiation updates in part to allow groups who develop an interest in the pertinent issues to join as talks advance.
Generic drug user fee program reauthorization talks still are expected to begin in the fall, the agency said in an Aug. 12 email to “The Pink Sheet” DAILY.
The information came a day after a Federal Register notice released for public inspection Aug. 11 indicated that the deadline for stakeholders to tell the agency of their intentions to participate in monthly meetings on the GDUFA talks had been extended from Aug. 14 to April 30, 2016.
FDA will begin negotiating with industry representatives to renew the user fee program in the coming weeks. GDUFA launched in October 2012 (Also see "GDUFA Performance Goals For Fiscal Years 2013-2017" - Pink Sheet, 12 Dec, 2011.).
Federal law requires FDA to conduct monthly meetings with stakeholders during negotiations to keep them updated and gain perspectives on relevant issues.
The agency said in the email that it extended the deadline for stakeholders to tell the agency of their intentions “for purposes of transparency and inclusion, to make sure that stakeholders who may develop an interest in the issues going forward get an opportunity to participate.”
Even though deadline extensions are common, the move raised questions about whether the GDUFA negotiation schedule had changed (Also see "GDUFA Stakeholder Deadline Extended; Are Talks Delayed?" - Pink Sheet, 11 Aug, 2015.).
Is Goal To Finish By May 2016?
FDA said formal notice of the start of the talks has not been released.
Once they do begin, talks are anticipated to last about four months, John DiLoreto, executive director of the Society of Chemical Manufacturers and Affiliates’ Bulk Pharmaceutical Task Force, one of the industry groups negotiating the renewal, said in an interview.
Given that, April 30, 2016 could in fact be very close to the goal for the agency to have the GDUFA reauthorization agreement finalized.
Talks in 2011 to create the inaugural generic user fee program lasted more than six months, about two months longer than expected (Also see "ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five" - Pink Sheet, 12 Sep, 2011.).
FDA said the April 2016 date “is a placeholder for purposes of facilitating patient and consumer group involvement in the stakeholder meetings,” but may change.
GDUFA, along with user fee programs for prescription drugs, biosimilars and medical devices, will expire Oct. 1, 2017 if not renewed by an act of Congress.
FDA and industry negotiate agreements to continue the programs, which are sent to Congress for approval. GDUFA and BsUFA were created and PDUFA and MDUFA reauthorized in the 2012 FDA Safety and Innovation Act (Also see "FDASIA Is Signed, Not That White House Wanted Anyone To Notice" - Pink Sheet, 16 Jul, 2012.).
Negotiation Prep Ongoing
Allowing additional groups to join stakeholder meetings after the talks have started should be a benefit, in part because priorities may change during the process.
Industry and FDA now are gathering data and fine-tuning their proposals for GDUFA improvements.
Several potential changes for GDUFA II already have emerged, but it is possible something seemingly not controversial could raise concerns among outside stakeholders.
As a matter of course, once the FDA-industry agreement is finalized, it is not changed by Congress, although members typically add other mandates to the bill.
The Generic Pharmaceutical Association, European Fine Chemicals Group and SOCMA again will negotiate on behalf of industry.
They will be joined by a new group for this round, the Pharma and Biopharma Outsourcing Association, which represents contract manufacturers (Also see "GDUFA II Negotiations: Contract Manufacturers Gain Seat At Table" - Pink Sheet, 6 Jul, 2015.).
Industry has been concerned about the lack of improvement in ANDA review times since GDUFA launched. But FDA has reported an increase in approvals over the last several months, which may be a positive sign (Also see "ANDA Approvals Continue To Accelerate As FDA Breaks Monthly Record" - Pink Sheet, 7 Aug, 2015.).
Manufacturers also want to add a small business waiver to the program, potentially for those looking to enter the generic business (Also see "GDUFA II: Facility Fees Might Be Deferred Until ANDA Approval" - Pink Sheet, 15 Jun, 2015.).
In addition, there are concerns that some GDUFA fees are too high (Also see "FDA's GDUFA War Chest Grows, And Industry May Look For Lower Fees" - Pink Sheet, 8 Jun, 2015.).
PDUFA Talks, Stakeholder Meetings Starting Soon
FDA also is looking for interested stakeholders for meetings related to the PDUFA reauthorization.
The agency said the docket for stakeholders to announce their interest will close Aug. 28. Monthly meetings are expected to begin in late September and continue as long as negotiations are ongoing.
Groups that miss the deadline but still want to participate will be allowed to join, FDA said.
“If other representatives of patient and consumer advocacy groups indicate to us the desire to join the process sometime after the docket closes we would ask that they also plan to continue to participate in every monthly stakeholder meeting,” according to the agency email.
The brand industry will be considering whether changes should be made to the NDA and BLA review system, which for PDUFA V was lengthened to encourage more first-cycle approvals and mid-review interaction between sponsors and reviewers.
FDA and industry also are looking for ways to better incorporate patient experience data in clinical trials (Also see "PDUFA VI: Price Tag For Patient Experience Data Validation May Go Up" - Pink Sheet, 18 Jun, 2015.).
And there have been requests for joint drug and device negotiations related to combination products (Also see "Will Combination Products Join The User Fee Family?" - Pink Sheet, 29 Jun, 2015.).