Pharmacy Times, Volume 0, 0

Pharmaceutical manufacturers that advertise prescription drugs directly to the public may soon have to pay the government for the cost of reviewing their ads, under a new user-fee proposal being floated by the FDA.

Under the current system, prescription drugmakers planning to broadcast direct-to-consumer (DTC) advertisements have the option of submitting their planned television ads to the FDA for advisory review before public dissemination. This approach enhances the accuracy of DTC ads and reduces the chance that manufacturers may be asked to make costly changes in their ads if the FDA challenges the claims.

The problem is that “FDA’s DTC advisory review workload has been steadily increasing, while staffing for this activity has remained relatively level,” FDA Assistant Commissioner for Planning Theresa M. Mullin explained to Congress.

To finance staff expansion, Mullen said that the agency plans to impose special new user fees totaling $6.25 million annually on manufacturers seeking prebroadcast advisory reviews of DTC prescription-drug TV ads.