Published May 9, 2011 in Washington Drug Letter
The FDA and generic-drug makers hope to reduce the backlog of ANDAs within five years and by that time have applications for generics reviewed within 10 months, according to the latest in negotiations for generic-drug user fees.
Also, the two sides agreed to a user-fee budget of $250 million to $300 million, say minutes from the April 14 talks to establish such a program.
The Generic Pharmaceutical Association, active pharmaceutical ingredient (API) trade groups and the FDA have discussed the details of a generic-drug user fee in a series of closed-door meetings since late February.
Talks are confidential, with the only public disclosure being minutes released by the FDA. But it wasn’t until the most recent meeting where the parties established a common framework of goals.
“Industry and FDA agreed that the parties are in alignment on key goals necessary to implement a workable user-fee program,” the minutes state.
Goals include a 10-month review time for ANDAs after five years, when the FDA hopes to have a backlog of applications cleared. Commissioner Margaret Hamburg told Congress earlier this year more than 350 pending ANDAs are for first-to-market drugs (WDL, March 21).
The FDA is also committed to providing risk-adjusted surveillance inspections every two years.
“There was mutual recognition that the parties still need to find solutions and make additional changes to accommodate all the factors above,” the minutes state.
The FDA also outlined its goals on bioequivalence inspections and postmarketing activities, responding to citizen petitions and working on risk evaluation and mitigation strategies. Details weren’t provided in the minutes.
In previous meetings, the FDA stated its need to boost staff to meet the increased number of inspections (WDL, April 25).
Talks are moving along with the goal of a June deadline around the corner. Legislation on the fees is expected to be included with the Prescription Drug User Fee Act reauthorization presented to Congress early next year.
On Tuesday, the FDA is planning a public meeting at its White Oak campus on the ongoing talks to update the public on the process and hear feedback.
The last negotiations meeting took place April 28, but minutes haven’t been posted on the FDA’s website. The agency was scheduled to address inspectional resource needs. — David Pittman