Pharmaceuticals Since the pharmaceutical industry has been running informative promos in the U.S., advertising spending has exploded. Just two years ago, TV commercials for the potency pills Viagra, Cialis and Levitra could be seen by the dozen during commercial breaks. Sporting leagues such as Nascar and the NFL were more than happy to let Pfizer & Co. sponsor them, and the clips sometimes even showed men with a lascivious blonde in their arms. But that was soon over. One advertising campaign after another was criticized by the U.S. regulatory authority, the Food and Drug Administration (FDA), either for neglecting its duty to inform or for untrue or exaggerated content. The head of the regulatory agency, FDA Commissioner Thomas Abrams, even let it be known that he was "generally concerned about the declining quality" of direct-to-consumer (DTC) advertising, especially in the category of "Erectile Dysfunction" (ED). The campaigns have been banned from the airwaves, and the NFL even canceled its $18 million sponsorship of Schering-Plough's drug Levitra earlier this year.
To prevent further bankruptcies, the pharmaceutical lobby pulled itself together. Since the beginning of the year, the Pharmeceutical Research and Manufacturers of America (PhRMA) has issued new guidelines for DTC advertising. Among other things, they state that prescription drugs must be clearly identified as such, that the content should describe the benefits of a drug as well as its risks, and that target groups that are "not age-appropriate" for a particular drug should not be advertised: in other words, children and teenagers should not see any Viagra commercials.
In addition, it was stipulated that any new DTC advertising campaign should first be submitted to the FDA for review. No longer allowed are so-called "reminder ads" in which a drug's brand was touted without providing sufficient information about what they are good for and what risks they may have. "The rules are a step in the right direction," comments John Mack, publisher of Pharma Marketing News. However, he believes it will be impossible for the FDA to sign off on all new DTC campaigns because it simply cannot do so in terms of staff. "This is more of a PR move than a realistic goal. It's widely expected that only a few companies will comply."
The guidelines are a measure of voluntary self-regulation. They were also introduced because various politicians threatened to introduce legally binding rules for DTC. "The rules are a preemptive strike against possible measures that legislators might come up with in an election year," Mack says. Congressional elections are in November.
In one area, the new guidelines have already gained a foothold: in advertising for potency pills. In the Levitra commercials of the pharmaceutical company GlaxoSmithKline (GSK), two men discuss impotence and how it is related to other diseases such as diabetes or high blood pressure. The Internet campaign Mensfacts.com, sponsored by the three groups Bayer, GSK and Schering-Plough, has the same goal.
The discussion about DTC in the USA is as old as the practice itself. Especially since 1997, when the FDA issued new guidelines for prescription drugs, advertising spending on DTC has exploded. Since the pharmaceutical industry has been allowed to run radio and TV ads, DTC spending has increased from $700 million in 1997 to a record $5 billion in 2006. The total was slightly lower last year after Merck had to withdraw the DTC-advertised arthritis drug Vioxx from the market in late 2004 because of its potentially fatal side effects.
Physician associations, in particular, point out that people seeking help who go to the doctor often pressure their doctor to prescribe certain drugs they've seen in DTC ads. "I'm skeptical that the industry can satisfactorily self-regulate," also says Matt Hollon, a professor and internist at the University of Washington in Seattle. "DTC ultimately remains a haphazard way to promote health."
"We won't see how good the industry is in its self-regulatory efforts until next year at the earliest," says Michael Santoro, a business professor at Rutgers University and co-editor of the book "Ethics and the Pharmaceutical Industry." "It depends on how serious they are about being able to transform themselves from just a lobby into a professional industry."
"Becoming cautious "Interview with Michael Guarini,
Executive Group Director of Ogilvyhealthworld.com.WW: What impact are the new rules having on pharmaceutical advertising?Michael Guarini: We are seeing an acceleration of a trend that was there before, and that is that more alternative forms are being done, such as more relationship marketing. Also, "help seeking" spots with doctors are popular, so we see lots of men and women in white coats talking about diseases in the spots. What doesn't work anymore are the "reminder ads," which are these 15-second clips that say ask your doctor about this or that medication. WW: Have any other practices been addressed?Michael Guarini: There have been protests before about those clips where entertainment stars were shown talking about a drug. There was discussion about whether or not they were really taking that pill. That's where companies have become more cautious and are using fewer celebrities in DTC ads.WW: How does the FDA's new review process affect you?Michael Guarini: Everything now has to be submitted to the FDA before publication. That means a lot more work for them and that everything takes a little longer.Gerti Schön
Swissmedic wants a partial advertising banIf Swissmedic, the Agency for Therapeutic Products, has its way,
information or advertising for prescription drugs should no longer be found on the Internet. The reason: pharmaceutical companies were increasingly mixing information with advertising. However, the regulation does not affect information approved by the authorities, such as that which is publicly available on the Internet via the Medicines Compendium. According to the NZZ am Sonntag, doctors and pharmacists will only be able to access certain information with a password from 2007. However, the regulation is considered rather absurd and not well thought out enough, because the Internet does not stop at Swiss borders. The pharmaceutical industry is also anything but enthusiastic and is considering legal action against Swissmedic.
The happy medium that allows consumers to be protected from inadmissible advertising while at the same time providing patients with comprehensive information options has not yet been found.
Kathrin Fischer