FDA Requests Updates for User-Fee Assessment

Rockville, MD (May 5)-To establish user fees for the 2009 fiscal year, the US Food and Drug Administration is asking pharmaceutical manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16, 2008.

Under the Prescription Drug User Fee Amendments Act of 2007 (PDUFA IV), FDA is authorized to collect three types of user fees: application, product, and establishment fees. FDA will use information from companies to issue invoices for these fees in August.

In a “Dear Colleague” letter, FDA stated companies should provide the following by June 16: contact for user-fee invoices and lists of products and establishments subject to user fees.

Attached to each letter was a product list for each company that must be updated. The letter included resources for finding a list of each company’s prescription drug products (i.e., Orange Book) as well as licensed biological products subject to oversight by the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research.