September 2006 - Pharmaceutical Technology

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September 2006

Pharmaceutical Technology


Regulations

FDA Boosts User Fees 17–19% for FY 2007


PDUFA user fees charged in four categories for each of the years 2000–2007.
In an Aug. 2 Federal Register announcement (1), the US Food and Drug Administration (Rockville, MD, http://www.fda.gov/) announced its Prescription Drug User Fee Amendments of 2002 (PDUFA III) fees for fiscal year 2007 (Oct. 1, 2006–Sept. 30, 2007). The new fee schedule for drug and biological products will be:
  • $896,200 for an application requiring clinical data, up 17% from $767,400 for FY 2006;
  • $448,100 for an application not requiring clinical data or a supplement requiring clinical data, up 17% from $383,700;
  • $313,100 for establishment fees, up 19% from $264,000;
  • $49,750 for product fees, up 18% from $42,130.

The agency will begin issuing invoices for establishment and product fees under the new schedule this month.


Indexed user fees for the years 2000–2007. The fees charged for each year are shown as percentages of the 2000 fees.
The 2007 schedule represents the biggest fee increases since 2003, when fees rose by an average of 60%. Fees have increased by an average of 175% since 2000. Fees for applications requiring clinical data, for applications not requiring clinical data, and for supplements requiring clinical data have increased by nearly 214% since 2000. All fees have increased to varying degrees each year, with two exceptions. In 2002, establishment fees declined by 4% and product fees declined by 1% (2–8).

References

1. US Food and Drug Administration, "Establishment of Prescription Drug User Fee Rates for Fiscal Year 2007," Federal Register 71 (148), 43780–43784 (Aug. 2, 2006). DOCID:fr02au06-96.

2. FDA, "Establishment of Prescription Drug User Fee Rates for Fiscal Year 2006," Federal Register 70 (146), 44106–44109 (Aug. 1, 2005). DOCID: fr01au05-49.

3. FDA, "Establishment of Prescription Drug User Fee Rates for Fiscal Year 2005," Federal Register 69 (147), 46165–46168 (Aug. 2, 2004). DOCID: fr02au04-55.

4. FDA, "Establishment of Prescription Drug User Fee Rates for Fiscal Year 2004," Federal Register 68 (148), 45249–45252 (Aug. 1, 2003). DOCID: fr01au03-75.

5. FDA , "Establishment of Prescription Drug User Fee Rates for Fiscal Year 2003," Federal Register 67 (149), 50448–50451 (Aug. 2, 2002). DOCID: fr02au02-75.

6. FDA, "Establishment of Prescription Drug User Fee Rates for Fiscal Year 2002," Federal Register 66 (11), 2222–2226 (Jan. 16, 2001). DOCID: fr16ja02-78.

7. FDA, "Establishment of Prescription Drug User Fee Rates for Fiscal Year 2001," Federal Register 65 (243), 79107–79111 (Dec. 18, 2000). DOCID: fr18de00-100.

8. FDA, "Establishment of Prescription Drug User Fee Rates for Fiscal Year 2000," Federal Register 64 (248), 72669–72673 (Dec. 28, 1999). DOCID: fr28de99-104.

–Douglas McCormick and Erik Greb


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