The US Food and Drug Administration (FDA) has released an updated question-and-answer document intended to assist sponsors and manufacturers of generic drug products approved via the 505(j) regulatory pathway with paying statutorily mandated user fees under the Generic Drug User Fee Act (GDUFA).
FDA is relatively unique among federal agencies in that the majority of its funding comes not from congressional appropriations, but rather from industry-paid user fees. These fees are levied on prescription drugs, medical devices, biologics, biosimilars, tobacco and, as of 2012, generic pharmaceuticals.
The new GDUFA fees were instituted under the Prescription Drug User Fee Act of 2012, which for the first time brought generic drug manufacturers and sponsors under the user fee program. As explained by legislators and regulators during the legislative process, the fees are intended to accomplish two principal tasks:
- Clear a backlog of abbreviated new drug applications (ANDAs) that has grown exponentially in recent years, preventing expeditious approvals of generic drugs.
- Give additional funding to FDA to allow it to conduct more inspections, particularly of overseas facilities where many of the US' generic drugs now originate from
Several factors have complicated the GDUFA user fee rollout, including slower-than-expected registration by generic manufacturers, difficulty knowing which overseas facilities need to register, language barriers between some manufacturers and FDA, and delays in calculating the exact user fees to be paid by industry.
To help prepare generic drug manufacturers, FDA released two draft guidance documents in August 2012. The first, Self-Identification of Generic Drug Facilities, Sites and Organizations, explains which facilities and sponsors need to identify themselves as relevant entities under GDUFA.
The second, however, was a Q&A document "intended to provide answers to common questions from generic drug industry participants and other interested parties involved in the development and/or testing of generic drug products," FDA explained in a Federal Register announcement.
Final, Revised Guidance
At the time of the draft guidance document's release, the user fees payable under GDUFA had not yet been calculated, and FDA said in a new Federal Register posting that it has received several new questions that merit response.
And respond it has, in the form of a revised Q&A guidance document entitled Generic Drug User Fee Amendments of 2012: Questions and Answers.
As explained by FDA, "Revision 1 clarifies some of the questions and answers in the first version and adds several new questions and answers. The questions and answers address four key categories: Fees; self-identification of facilities, sites, and organizations; review of generic drug submissions; and inspections and compliance."
For example, FDA notes in the document that under GDUFA, it has committed to inspecting foreign facilities as frequently as domestic ones by 2017-a major change relative to current precedent.
Elsewhere, FDA notes that failure to pay GDUFA fees will result in a delayed review of any submitted ANDA. And a wide range of questions pertain to the GDUFA goal date metrics and how various actions will or will not affect them. For example, unsolicited amendments to an ANDA would extend the original goal date, while goal dates will be entirely inapplicable to facilities FDA determines have failed to self-identify.
The extensive 99-question guidance can be found on FDA's website.
Generic Drug User Fee Amendments of 2012: Questions and Answers
Federal Register Document
August 2012 GDUFA Announcements