The Coalition for Healthcare Communication says it's too soon to talk about user fees to fund ad reviews through the FDA's DDMAC. An agreement reportedly reached between industry and the FDA would provide $6.25 million in user fees in fiscal year 2008 to fund review of TV spots before they air.
“New money for DDMAC reviews puts the cart before the horse,” according to Coalition for Healthcare Communication executive director John Kamp.
He said the coalition's citizen petition last March “outlined major concerns about the FDA's DTC review process that first must be addressed. For example, the process should be much more consistent and predictable. Once there is agreement that the DTC review process better meets the needs of patients and professionals, then everyone can better assess how best to fully fund it.”
At the time the petition was submitted, Kamp said the FDA's current ad rules require complicated information that many consumers cannot understand or use on a practical basis.