FDA says failure to submit DTC ads will rate higher user fees

WASHINGTON The Food and Drug Administration is asking companies to notify them if they plan on participating in the agency’ direct-to-consumer advertisement review program in fiscal 2008, or suffer higher user fees.

The information from the companies will be used to establish the fiscal 2008 user fee amount charges for each submission. The companies will pay two fees under the program: one for each advertisement submitted and one paid during the company’s first year of participation in the program to establish a reserve fund.

The fee levels will be set to generate revenues of $6.25 million in the first year and at least $11.25 million from both user fee programs combined. This money will be used to hire 27 staff member to review submissions in 2008.

The FDA is looking to receive the money within 120 days after the bill’s enactment, or otherwise the program will not start. Companies will not have to pay fees for advertisements required for FDA review before dissemination, such as those for accelerated approval drugs.