PDUFA Application Fees Rise 14% for 2006

The US Food and Drug Administration (Rockville, MD) will raise most prescription drug user fees by 14% for fiscal year 2006, according to a Federal Register announcement this week. Applications requiring clinical data will cost $767,400; other drug applications will require a payment of half that amount. Fees for establishments and products will increase only 1% to $264,000 and $42,130, respectively (see Table).

The increases for 2006 were adjusted to account for inflation as well as workload. The Prescription Drug User Fee Act (PDUFA) of 1992 authorized these fees with the aim of speeding up FDA review times by providing the agency with more resources. According to statutory amendments in 1997 and 2002, fees are adjusted annually so that total revenues from each category approximate the levels established in the statute, after first being adjusted for inflation and workload. Through the 2006 fees, the agency expects to generate a total of $296,988,623, divided approximately evenly among the three categories of fees.

The application fees apply to new drug applications (NDAs), biologics license applications (BLAs), commercial investigational new drug application (INDs), efficacy supplements, and manufacturing supplements. The new rates take effect Oct. 1, 2005.

–Laura Bush