ORPHAN-DRUG FUNDING PROGRAM TO SEE CHANGES

The FDA's funding program for clinical trials investigating orphan drugs will undergo some changes in fiscal 2006, including alterations to the way funding limitations are established, according to a notice released by the agency.

In past years, the FDA's Office of Orphan Products Development (OPD) based its grant limitations on direct costs incurred by applicants. However, beginning in fiscal 2006, the dollar limitation will be based on an applicant's total costs, which include both direct and indirect costs for the funded study.

As a result of the change, the FDA is raising the maximum grant to $200,000 annually for smaller trials and $350,000 for larger trials. Previously, the dollar limitations were set at $150,000 for smaller trials and $300,000 for larger trials. Smaller grants can be awarded for Phase I, II or III trials, while the larger grants are reserved for studies continuing in Phase II or III. The grants continue for up to three years, depending on the nature of the study.

In addition to the dollar limitation change, the FDA has reduced the number of receipt dates for orphan-drug grant applications from two to one. In previous years, OPD accepted applications twice per year - once in April and again in October. In fiscal 2006, the only application receipt date is April 19, 2005. Interested parties must file a letter of intent to submit a grant application by March 18, 2005.

To view a copy of the FDA's notice, published in the Federal Register, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/oc04165-n000001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/oc04165-n000001.pdf).