PhRMA punts on moratorium but bans TV reminder ads
The guidelines, which cover TV and print ads but not sponsorships, say: "companies should spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign. In determining what constitutes an appropriate time, companies should take into account the relative importance of informing patients of the availability of a new medicine, the complexity of the risk-benefit profile of that new medicine and healthcare professionals' knowledge of the condition being raised."
The office of Senate Majority Leader Bill Frist, whose recent criticism of DTC was repeatedly cited by his former colleague, PhRMA chief Billy Tauzin, issued a release welcoming the guidelines but panning their exclusion of a moratorium on ads for new products. Frist said in the statement: "While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure." Individual signatory companies will be releasing their interpretations of the guidelines in the coming weeks.
Defending the board's decision to leave the waiting period on advertising new products wide open, Tauzin said the Sherman Anti-Trust Act forbids the group from coordinating any specific time-out on members' advertising and that the First Amendment prohibits the government from doing so. "When you're in a free-speech area, a voluntary approach is the best approach," said Tauzin. Futhermore, members said flexibility was needed to deal with products of differing risks, benefits and urgency. "Lets say someone found a cure for cancer," said PhRMA chair Bill Weldon. "Should that take a year to get out?"
The Principles stipulate that companies "should submit all new DTC television advertisements to the FDA before releasing these advertisements for broadcast." Current law mandates that companies submit all new TV ads to the FDA, but signatories will be required to submit ads earlier than required and to furnish the agency with the ad's air date. In addition, previously-submitted ads that have been significantly changed must be resubmitted.
The guidelines bar TV reminder ads, stating that any TV ad "that identifies a product by name should clearly state the health conditions for which the medicine is being approved and the major risks associated with the medicine being approved." "No more are you going to see reminder ads on television," said Tauzin. "They're gone." Tauzin said the vote to can reminder ads was a close one, but that the board decided the ads "don't serve the purpose of education."
While not specifically referring to ED, the guidelines state: "In terms of content and placement, television and print advertisements should be targeted to avoid audiences that are not age appropriate for the audiences involved." Tauzin said that the board had agreed informally to set the watershed at programs and publications with an 80 percent adult viewership. Pfizer's Karen Katen said her company, which will release its interpretation of the guidelines in the next two weeks, will set the bar higher still when advertising sensitive products.
Other clauses encouraged more disease-awareness advertising, better balance of risk-benefit information and a more sober tone in ads. "That's not to say that humor is not appropriate," said Tauzin, "but it should be a more serious tone."
Tauzin said 23 member companies have already signed on to the principles, including Novartis, AstraZeneca, GlaxoSmithKline and Sepracor.
PhRMA will empanel an independent compliance review committe