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出自识林

2013-08-02 FDA,Lachman CONSULTANTS

FDA Announces Fiscal Year 2014 Generic Drug Fees
Today the U.S. Food and Drug Administration (FDA) published the fiscal year 2014 generic drug user fees as required under the Generic Drug User Fee Amendments of 2012 (GDUFA) in the Federal Register. FDA is aware that industry is adjusting to the new requirements and fees, and FDA minimized the increase in fees as much as possible.

As specified in the statute, the fiscal year 2014 fees include an increase over the 2013 fees. In the first year of the program (2013), the total revenue included a one-time fee for applications pending as of October 1, 2012. With this one-time fee removed from the calculation, the remaining fees make up the total revenue, which resulted in the increase. Additional factors, including the number of facilities that self-identify under GDUFA, are also used in calculating the facility fee.

Comments by Bob Pollock
This rise in fees will likely cause many small generic firms to get very nervous, as the cost of doing business with the Office of Generic Drugs (OGD) is getting steeper and the pace of approvals is not yet picking up speed. In addition, with median approval times staying at about 33-34 months, many small manufacturers with no approved products may be waiting three fee cycles prior to seeing their product approved. We also hear discontent from many application holders, indicating that communications with OGD are not yet improving. It is also still very difficult to obtain meetings with OGD. Many firms were hoping for immediate signs of approval, which is a bit unrealistic, given the backlog OGD has accumulated over the years, but here we are almost a year into GDUFA and changes still are not very evident. The generic industry knows that there are no metrics associated with OGD performance goals for the first two years of GDUFA; however, the questions is, will the industry remain patient until the goals kick-in in for cohort year three application submission. Still worries abound regarding applications that were in the original backlog and those ANDAs submitted in years 1 and 2 of GDUFA, especially if OGD will concentrate its efforts to meet the year three goal metrics. With the potential of fees rising even more next year and no potential for changes to the GDUFA program until its first 5 year cycle is over in 2017, the industry will keep a close eye on performance and will likely keep the pressure on the Agency and Congress if things do not improve soon.

2014财年收费标准（2013.10.1-2014.9.30）

2014财年FDA场地注册中国企业名单（145家）
（API 92家，FDF 19家，分析检测 20家，临床BE或生物多样性研究 1家，体外BE或生化检测 2家，分装 11家）