INDUSTRY INCLINED TO SUPPORT NEW USER FEES TO SPEED DTC AD REVIEWS
The pharmaceutical industry is likely to move past any concerns it has with new user fees if they will help speed the FDA's reviews of DTC advertising, several sources say.
The additional funds are necessary because review times have increased as the agency receives a greater volume of proposed ads and more complex ads, Thomas Abrams, the director of the FDA's Division of Drug Marketing and Communications, said. There is "more work than we can get to," he told attendees during a Sept. 18 DTC conference presented by the Food and Drug Law Institute. As a result, the average time for the agency to review ads for new drugs is 45 to 50 days and the time to review broadcast DTC ads is 80 days.
The FDA is negotiating with industry to get new user fees as part of the Prescription Drug User Fee Act (PDUFA) reauthorization process, Abrams said. The agency's user-fee proposal, which it originally proposed last November, should be submitted to Congress in a few months, he added. PDUFA is due to expire on Oct. 1, 2007.
Industry officials are coming closer to supporting these fees and, in the end, will likely support them, an industry source said. Given longer review times for DTC ads, there is "growing willingness" within industry to pay to speed them up. Industry officials are assuming these funds will be smaller than the product-review fees they already pay and feel that the additional costs are outweighed by the benefit of a more predictable, streamlined review. "Pragmatically, let's get on with it," the source added.
Others agree. John Kamp, executive director of the Coalition for Healthcare Communication, said that while companies do not want to be "paying the fee of the person that hangs" them, the need for more timely reviews will overwhelm this concern. Industry's position on this topic is the key issue in PDUFA negotiations, he added.