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Volume 1, Issue 4
Consumers still aren't happy, but industry calls FDA's addition to PDUFA 'an important new step.'
After a snowed FDA announced plans to add fees on top of fees--by asking industry to partially cover review costs for television ads, in addition to those it's already required to pay as part of the Prescription Drug User Fee Act (PDUFA)--consumers were less enthusiastic than industry hoped they would be.
Patient advocates still don't believe that the changes go far enough to address their concerns. They want the funds to come from government--not industry--in order to keep an uncompromised distance between the two. And Consumers Union stressed that while speedier reviews might catch offenders in earlier stages of their campaigns, they don't keep the offending ads off the airwaves during the review process.
Still, industry leaders seemed pleased with the change, implemented to help FDA keep up with the mountain of drug-advertising material it needs to check each year. Flashy DTC ads have been blamed for creating mass-market demand for expensive or risky drugs that might be appropriate only for a small segment of the population--and drug company reputations have suffered as a result. PhRMA, which has tried to address the criticism by issuing a voluntary marketing code for the industry, trumpeted the additional fees as "an important new step."
The agency is asking for an extra $6.2 million in user fees from companies that want to advertise their drugs on television. The funds will support the addition of 27 more staff members to help FDA sort through a volume of marketing material that roughly doubled between 2002 and 2005.
There are limits to what the fees can accomplish, noted Peter Pitts, a former associate commissioner for external relations at FDA. "Right now, any review of promotional material is strictly optional," he said. "All it does is allow FDA to review ads with greater with alacrity."
Moreover, the fees don't address a larger issue for industry: a single standard for how the agency rules on ads. Pitts noted that some of the ads that receive warning letters are initially OK-ed by the agency. "There's no bright line; there's no consistency," he said. "It's not hard science; it's social science. DDMAC is soft on social science."
Although word of the new fee has been making its way through the rumor mill over the past several months, its official introduction comes just weeks after the Government Accountability Office (GAO) chastised FDA for oversight efforts that are slow and clumsy. The critical GAO report found that FDA is sending out fewer warning letters to rule breakers and taking longer to do so--so long, in fact, that about half of the inappropriate ads are out of circulation by the time marketers receive a warning.
FDA is still struggling with how to put more teeth into its warnings. A 2002 policy change required its Office of Chief Counsel to approve all warning letters--hoping to put the fear of legal action into marketers' hearts--but the change just slowed down the review process.