FDAnews Marketing and Sales Bulletin

Congress has appropriated funds for the FDA’s voluntary review of direct-to-consumer (DTC) advertisements in H.R. 2764 rather than having the agency collect user fees to fund the program.

H.R. 2764, the omnibus appropriations bill, funds the agency’s DTC review program at approximately $6.25 million, a source said. The amount matches the FDA’s estimated cost for the program and provides an increase of $4 million above 2007 levels.

The bill, recently signed into law, funds the FDA at $1.73 billion for fiscal 2008.

The FDA recently established user fees for companies participating in the voluntary ad review program at $41,390 for each ad submitted this year.

The agency said if the program did not receive sufficient funding — at least $11.25 million from review fees and operating reserve fees — by Jan. 25, the review program would not start and all companies would be refunded their fees.

The FDA’s Division of Drug Marketing, Advertising and Communications is “evaluating the recently passed appropriations law and its effect on the user fee program and will provide information about the status of the program as soon as we are able,” FDA spokeswoman Karen Mahoney said.

More information on H.R. 2764 can been at thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.02764:.