Some drug companies and their trade group, the Pharmaceutical Research and Manufacturers of America, find the petition's timing troubling. PhRMA came up with a DTC code of conduct that went into effect Jan. 1; the FDA held hearings in November regarding a revamp of the guidelines, and is still working through the process.
"There is a relationship between pharmaceutical companies, PhRMA and the FDA-however strong or however tenuous it may be-and you have to wonder what this [petition] does right now," said an executive at one of the top five drug makers.
"We're scratching our heads over this one," said PhRMA spokesman Ken Johnson.
The petition comes nine years after the FDA began allowing DTC advertising-and just five months after the FDA convened public hearings to take input on revamping the marketing guidelines. It's seen as a push by agencies upset about the review process at the FDA, which some say is time-consuming and lacks clarity.
In a Washington press conference, coalition Executive Director John Kamp and Peter J. Pitts, senior VP-global health affairs, Manning, Selvage & Lee, a coalition member, said the idea of the petition was to get objective rules for DTC advertising that lead to more predictable interpretations of creative. They said current rules are too "elastic" with the result that while the Federal Trade Commission's view of individual ads can be pretty well predicted, the FDA's view of drug advertisements can't.
deciphering the language
"Bold new leadership is required at the FDA," said Mr. Kamp. "We can have drug companies create better advertisements without the fear of getting a warning letter."
The coalition represents trade associations that specialize in medical advertising and marketing, including the American Association of Advertising Agencies, Healthcare Marketing and Communications Council and the Public Relations Society of America. It does receive some financial aid from the drug industry.
The FDA released a terse statement that said: "FDA is currently reviewing all the comments and research data submitted to the docket for the DTC Part 15 Hearing that was conducted on Nov 1-2. The FDA needs to complete its review and evaluation of the data and comments before it can determine what the next steps may be for its DTC policy."
"The FDA knew this was coming," Mr. Kamp said of the petition, "but nobody endorsed it. We're not surprised."
Consumer groups are wondering what some of the language in the petition means, including one part that suggests the warnings that appear with ads should be pared down to only include the most severe issues. Right now, the coalition believes that ads "over-warn and under-inform," and "create more confusion than communication." However, Bill Vaughan, senior policy analyst at Washington-based Consumers Union, said that "some of us would like to read to the end to be aware of the consequences."
The coalition said current FDA requirements were derived from rules aimed at communicating with doctors, and do not fit DTC advertising,with the result being long statements serving no one's needs.
Dr. Peter Lurie, deputy director of research for Public Citizen, said that while he agrees that more consumer-oriented regulations are needed for DTC, he worries that the kind of regulation the industry will seek will be different from the kind that consumer groups would like. "In practical terms what I'm worried about is they will be downplaying safety and outsourcing warnings" to Web pages, he said.
He said Public Citizen would expect to be involved in any move to create new DTC rules. "It would open a battle that can go either way."
Agencies defended the petition. "This FDA recognizes the proven power of prescription-medicine advertising to promote awareness of treatable medical conditions and treatment options," said Harry Sweeney, chairman of Dorland Global Health Communications. "But new rules can enhance this power and accelerate its benefits to both advertisers and the public health."
"Great advertising requires clear, consistent messages," said Ron Pantello, CEO of Havas' Euro RSCG Life Worldwide.
Mr. Kamp said the lack of clear standards leaves the FDA going over ads frame by frame because there is confusion on what is and isn't allowed. Clear objective standards, he said, could also avoid "plaintiffs lawyers and state attorneys general creating their own ideas" on drug advertising. "It's now up to the FDA."