FDA Announces Fee Rates for 2008

Rockville, MD (Oct. 9)-The US Food and Drug Administration posted its rates for user fees for fiscal year 2008, effective Oct. 1, 2007 through Sept. 30, 2008.

Under the Prescription Drug and User Fee Amendments of 2007 (PDUFA IV), revenues generated from application fees, establishment fees, and product fees “provide one-third of the PDUFA fee revenue collected each year,” according to the FDA notice. The total fee revenue amount for fiscal year 2008 is $459,412,000, including adjustments for inflation and workload charges and an additional $25 million in user fees for drug safety.

The reported application fee for applications requiring clinical data is $1,178,000 for fiscal year 2008, while those applications not requiring clinical data and supplements will have a fee of $589,000. The 2008 establishment fee is $392,700. FDA estimates that 35 establishment fee waivers will be made for fiscal year 2008, with 10 waivers coming from a new orphan drug exemption in the FDA Amendments Act, which reauthorized PDUFA.

In addition, according to the FDA notice, the product fee for fiscal year 2008 will be $65,030. The agency estimates 2355 products will be billed for product fees in the upcoming fiscal year. Seventy products will receive waivers or reductions, including 30 exempted based on the new orphan drug exemption, according to FDA. Product fees are assessed on products for each person who is named as an applicant in a human drug application who has had an application or supplement pending after Sept. 1, 1992.

The FDA’s notice on prescription drug user fee rates is available here.

For a related story, see Bush Signs Bill Reauthorizing PDUFA, posted on Oct 5, 2007.