PDUFA Passed with Refined DTC Component - Pharmaceutical Executive

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PDUFA Passed with Refined DTC Component


PharmExec Direct Marketing Edition

Last Thursday, the House and Senate approved the newest version of the Prescription Drug User Fee Act (PDUFA) as part of a total FDA overhaul. However, the big talk was what wasn't included in the legislation: A provision that would have given FDA the right to pull consumer ads as it saw fit was excluded from PDUFA, and some say that it was the ad agency lobbyists, not pharma, that pulled the plug.

"When we proposed to Reps. Waxman and Kennedy that they delete all provisions relating to ad restrictions, we did not do so without having a credible counteroffer," said Jim Davidson, executive director of the Advertising Coalition. "We asked that they adopt a system similar to the one used by the Federal Trade Commission that would provide FDA with the authority to cite an advertiser for an ad that it feels is false or misleading."

The new provision allows FDA to seek advisory review of prescription drug television advertising and levy large fines against false advertising. Advertisers will have the opportunity to request a hearing to determine if the ad is in fact false or misleading, and a judge will decide if FDA can fine the advertiser. According to Davidson, FDA has never had that authority previously.

"PDUFA is something that industry generally wanted," said Linda Bentley, member at Mintz Levin law firm in Boston. "I think that while some companies might not be happy about the size of the user fees, the fact that the money will be used to augment FDA's staff and to provide some sort of reporting requirement in respect to how long it takes for them to evaluate various types of submissions—that's something that industry supports."

This is the second hit in the last few months experienced by opponents of DTC. Back in May, a provision calling for a three-year moratorium on ads for new drugs failed to get approval, and a two-year version didn't fare much better.

According to Davidson, DTC is far from a dead issue. "I think there are several factors that will continue to push people to support restrictions and/or bans on prescription drug advertising," Davidson says. "Hopefully, we will not have this in the near term, but there is the possibility that there might be another drug that has the problems associated with it that Vioxx had. That would start this all over again."

Another item that could incite renewed grumblings about DTC is the rising cost of Medicare Part D. Some DTC critics claim that it is inconsistent for the government to permit broad promotion of pharmaceutical products for which the feds will be paying the bill. The earliest projection by the administration was that Medicare Part D would cost $398 billion over 10 years. The latest estimate from the Office of Management and Budget was $1.2 trillion over 10 years. "If the cost of that program continues to escalate at that rate, there will be calls for more limits on advertising," Davidson said.

Advocates of consumer advertising claim there is no evidence that restrictions on DTC ads would do anything to improve drug safety. They argue that an ad ban would keep consumers from hearing about risk information.

"PhRMA members lobbying for advertising might not have been the most effective strategy," Davidson said. "I think that it's a lot more effective when you have media and advertising groups making the argument that these restrictions would constitute restrictions on First Amendment rights."

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