FDA Establishes User Fee Rates for DTC Voluntary Review Program

Companies participating in the FDA’s voluntary direct-to-consumer (DTC) advertisement review program will pay $41,390 for each ad submitted in fiscal 2008. 

The fees are part of a new voluntary DTC prescription drug television ad review program authorized by P.L. 110-85, the FDA Amendments Act. The user fees are set to generate revenues of $6.25 million in fiscal 2008.

In an earlier Federal Register notice, the FDA asked companies to indicate if they were planning on participating in the review program, and if so, how many DTC television ads they would submit during fiscal 2008. The FDA based its fees on information received from that notice.

If a company submits more advertisements than it told the FDA it planned to submit, it will have to pay an additional fee of 50 percent on top of the established individual fee for each submission. Participants who do not pay the fees on time will have to pay a total fee of $62,085.

In addition to the review fees, companies also must pay a one-time fee their first year of participating in the program to establish its operating reserves. Companies that responded to the FDA by Nov. 26 will have an operating reserve fee equal to the total fee amount the company assesses in review fees for fiscal 2008.

Companies that did not notify the FDA by Nov. 26 of their intent to participate will pay an operating fee 50 percent higher than what they would have owed if they had notified the FDA and paid on time.

Companies who join in fiscal 2009 through fiscal 2012 will have to pay an operating reserve fee that is either the total amount of advisory reviews for all of the company’s proposed DTC ads for that year or the total amount of review fees that would have been assessed in fiscal 2008, whichever is higher.