Under the recently approved Generic Drug User Fee Act (GDUFA), the FDA will soon begin collecting application fees for pending and newly submitted Abbreviated New Drug Applications (ANDAs). All ANDAs pending on October 1, 2012 that have not received tentative approval will be required to pay a backlog fee. The exact dollar amount of the fee has yet to be established. The FDA intends to collect a total of $50 million via the backlog fee; thus, this total will be divided amongst the remaining sponsors with pending applications on October 1. Any new ANDAs submitted on or after October 1, 2012, will also now be subject to a fee. Like the backlog fee, the cost to each sponsor has yet to be determined, but has been estimated to be $53,000. Both the backlog fee and new application fee will be announced no later than October 31, 2012.
The uncertainty in cost leaves sponsors with pending ANDAs with a decision to make. Based on the current number of pending ANDAs, the fee could be under $20,000. However, the FDA is allowing sponsors to avoid paying the fee by withdrawing their applications by September 28. It is anticipated that a significant number of sponsors will take advantage of this option. As the number of pending applications decreases, the cost to each sponsor increases. If you have a pending application, now would be a good time to take a very critical look at your package. Do you feel as confident about the acceptability of your application now that it will cost $25,000 or more as you did when it was free?
Posted by Marla Scarola, Senior Consultant. For more information, please contact Marla at firstname.lastname@example.org.