Generic User Fee Negotiations May Be Falling Behind Schedule
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA and industry look to speed up the talks with GDUFA financial issues still to come.
Generic drug user fee negotiations appear to have slowed, forcing FDA and industry to consider ways to increase productivity with important issues lingering.
Both sides met "to explore strategies for streamlining the negotiation process" on Feb. 3, as well as "lay the foundation for upcoming discussions on financial issues," according to minutes of the meeting.
FDA and industry negotiators talked about how to "accelerate the sharing of information" as part of the streamlining, according to the minutes.
The two sides began meeting more than five months ago (Also see "GDUFA II: FDA Prefers A ‘Manageable Number of High-Impact Changes’" - Pink Sheet, 26 Oct, 2015.).
So far, at least 10 full and four small business subgroup meetings have been conducted.
However, if GDUFA talks were intended to roughly mirror the prescription drug user fee schedule, then negotiations definitely are behind.
PDUFA discussions ended in late January after about four months of talks (Also see "PDUFA Negotiations End, Approval Process Ongoing" - Pink Sheet, 26 Feb, 2016.).
The PDUFA reauthorization calendar assumes the commitment letter will be finalized later this month and then go to the Health and Human Services Department, followed by the White House, for review.
The clearance stage can take months and once completed, the agency must conduct another public meeting before transmitting it to Congress by about January 2017 so it can be incorporated into must-pass legislation.
GDUFA's reauthorization is expected to be part of the same bill next year, so likely would be expected to follow a similar schedule.
FDA officials also have the biosimilar user fee renewal to negotiate. Those negotiations began March 17 (Also see "Biosimilar User Fee Talks Reach Starting Line As Report Shows Growing FDA Workload" - Pink Sheet, 14 Mar, 2016.).
GDUFA Finance Still To Come
Even as industry and FDA work to accelerate the pace of negotiation, financial issues – likely the most important part of the process – have yet to significantly advance.
The minutes indicate "a number of financial issues," were considered during the meeting.
Both sides will look to set and potentially adjust the rates for manufacturing facilities as well as application sponsors in the upcoming user fee cycle.
There have been a number of questions raised about the fees charged to generic drug manufacturers and ANDA sponsors.
Some in industry complained that fees were too high for small businesses. Talks have included discussion of whether to implement a fee waiver or discount for them, which could affect the amounts others would pay (Also see "Generic User Fee 'Relief' For Small Firms Would Mean Bigger Bills For Large One" - Pink Sheet, 25 Jan, 2016.).
Firms also were concerned about the large amount of GDUFA revenue that FDA did not spend during the first two years of the program and suggested fees should adjust because of it.
FDA argued that the carryover balance was high in part because it took some time to hire the additional staff necessary for its growing generic drug program (Also see "FDA's GDUFA War Chest Grows, And Industry May Look For Lower Fees" - Pink Sheet, 8 Jun, 2015.).
Divide And Conquer
FDA and industry appeared to make a change during a Feb. 17 meeting to help make more headway towards a new agreement.
Minutes state that negotiators split into two groups to deal with several ANDA review process issues.
Generic drug program workload and submission rates also were discussed during the Feb. 3 meeting.
One group handled review timelines for GDUFA II submissions, complex generics, regulatory science, controlled correspondence, transparency and communication.
The second group discussed facility evaluation, inspection parity and drug master file issues, according to the minutes.
Industry has been concerned for several years that GDUFA has not sparked more improvement in the time needed to approve ANDAs.
The median time to approval was projected to be about 36 months in fiscal years 2016 and 2017, a decrease from the 42-month median registered in FY 2015.
After languishing during the first two years of GDUFA, FDA's ANDA approval output has dramatically increased (Also see "FDA's Generic Drug Workload, Productivity Beating Budget Estimates" - Pink Sheet, 22 Feb, 2016.).
FDA and industry also have considered establishing a priority review pathway for some ANDAs (Also see "GDUFA II: Priority Reviews Considered For Some ANDAs" - Pink Sheet, 6 Nov, 2015.).
Congress is interested in the idea to prevent or stop dramatic drug price spikes (Also see "Could Drug Price Spikes Spur ANDA Priority Reviews?" - Pink Sheet, 28 Jan, 2016.).