In the September 13, 2004 edition of the
P.I.L.S Compliance Column we took an in-depth look at the practice known as direct-to-consumer (DTC) advertising. This form of advertising remains controversial and has gain notoriety recently partly due to the
VIOXX recall. Proponents say it enhances consumer knowledge and improves public health by fostering a dialogue between patients and their healthcare providers whereas critics argue that the system is designed by the pharmaceutical industry to boost drug sales by misleading patients into believing that they need a drug that may be unsuitable for them. DTC advertising has been shown to escalate drug profits but in turn cause soaring health insurance premiums and the cost of Medicare and Medicaid.
Good for business
The Pharmaceutical Research and Manufacturers of America (PhRMA) are strong proponents of DTC advertising saying that “Study after study has shown that advertisements for medicines help improve awareness of diseases and their treatments, leading to better health and even saving lives.” Certainly PhRMA members must believe that DTC advertising is good for business when they were willing to spend over $4 billion on print and TV ads in 2004 alone.
Guiding principles
In a major policy speech before the American Legislative Exchange Council’s 32nd Annual Meeting on August 2, 2005, PhRMA President and CEO Billy Tauzin announced the pharmaceutical industry’s “Guiding Principles” on DTC advertising. The voluntary code has already received support from 23 leading U.S. pharmaceutical research companies and will go into effect on January 2006. The full text of the 15 Guiding Principles is given below.
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Guiding Principles
1. These Principles are premised on the recognition that DTC advertising of prescription medicines can benefit the public health by increasing awareness about diseases, educating patients about treatment options, motivating patients to contact their physicians and engage in a dialogue about health concerns, increasing the likelihood that patients will receive appropriate care for conditions that are frequently under-diagnosed and under-treated, and encouraging compliance with prescription drug treatment regimens.
2. In accordance with FDA regulations, all DTC information should be accurate and not misleading, should make claims only when supported by substantial evidence, should reflect balance between risks and benefits, and should be consistent with FDA approved labeling.
3. DTC television and print advertising which is designed to market a prescription drug should also be designed to responsibly educate the consumer about that medicine and, where appropriate, the condition for which it may be prescribed.
4. DTC television and print advertising of prescription drugs should clearly indicate that the medicine is a prescription drug to distinguish such advertising from other advertising for non-prescription products.
5. DTC television and print advertising should foster responsible communications between patients and health care professionals to help patients achieve better health and a more complete appreciation of both the health benefits and the known risks associated with the medicine being advertised.
6. In order to foster responsible communication between patients and health care professionals, 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 health care professionals’ knowledge of the condition being treated. Companies should continue to educate health care professionals as additional valid information about a new medicine is obtained from all reliable sources.
7. Working with the FDA, companies should continue to responsibly alter or discontinue a DTC advertising campaign should new and reliable information indicate a serious previously unknown safety risk.
8. Companies should submit all new DTC television advertisements to the FDA before releasing these advertisements for broadcast.
9. DTC television and print advertising should include information about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition.
10. DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.
11. DTC television and print advertising should be designed to achieve a balanced presentation of both the benefits and the risks associated with the advertised prescription medicine. Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals.
12. All DTC advertising should respect the seriousness of the health conditions and the medicine being advertised.
13. In terms of content and placement, DTC television and print advertisements should be targeted to avoid audiences that are not age appropriate for the messages involved.
14. Companies are encouraged to promote health and disease awareness as part of their DTC advertising.
15. Companies are encouraged to include information in all DTC advertising, where feasible, about help for the uninsured and underinsured.
Source: PhRMA Guiding Principles |
Despite being a good public relations move, there is little to indicate that these voluntary guidelines will result in any reduction in the amount of money spent on DTC advertising. Arguably compliance with the guidelines could add to the cost of running a DTC advertising campaign.
No specific time is indicated under Principle 6 whereby pharmaceutical companies must wait before advertising a new product. The idea behind Principle 6 is to ensure that health care professionals will have a reasonable opportunity to learn about new medications so that they can provide patients with up-to-date information and guide patients towards the most appropriate treatment option. Takeda Pharmaceuticals has already announced that they will delay TV ads for a new insomnia treatment Rozerem in order to comply with Principle 6. "The last thing we want to do is drive patients into physicians' offices asking them about a new product that physicians aren't necessarily going to have all of the recent information on," said Takeda spokesperson Matt Kuhn.
Many DTC advertising critics had called for a specific time restriction to be included but PhRMA President and CEO Billy Tauzin said that didn’t make sense as it could delay information reaching the public on lifesaving drugs.
In reality, the inclusion of Principle 8 is little more than good public relations, since by law all DTC television advertisements must already be submitted to the FDA. Principle 2’s call that information should “be accurate and not misleading” is also currently required by law.
One might expect that in order to comply with Principle 12, pharmaceutical advertising might become dull and dreary, however PhRMA stress that used appropriately humor remains an effective tool for attracting public attention, reducing stigma and communicating important educational messages.
Principle 13 is clearly directed towards the advertising of products for conditions such as erectile dysfunction. Eli Lilly and Pfizer have both agreed to limit the promotion of Cialis and Viagra respectively to appropriate audiences (with 80 percent of the audience being age 18 or older). The onus will lie with individual companies will to examine audience composition data and determine whether a particular program or publication is reasonably likely to attract an audience that is age appropriate for a particular advertisement. With this approach PhRMA members have resolved a difficult issue largely beyond the reach of Congress and the FDA because of the First Amendment limits on government actions. However, while this is presented as a guideline to restrict inappropriate advertising, surely it makes good business sense for pharmaceutical companies to be directing their advertising to targeted audiences.
Placebo reform
Of course, not everyone is happy with the industry’s attempt to self-police DTC advertising and some believe that full governmental regulation is the correct approach. Sidney Wolfe, director of consumer-rights organization Public Citizen, said, "It's a frantic, desperate attempt to make their image improve and fend off legislation".
Rob Schneider, director of Consumers Union’s prescription drug reform effort, is also unhappy with the PhRMA plan saying “It appears the pharmaceutical industry has produced a placebo rather than supporting real reform of drug advertising”.
Two-year refrain
Last month, Senate Majority leader Bill First (R, Tenn.) had asked pharmaceutical companies to voluntarily refrain from DTC advertising for two years from product launch. Frist said this week he would monitor whether voluntary guidelines "go far enough in stemming the tide of often unbalanced and misleading DTC advertising". Bristol-Myers Sqibb launched a “Direct-To-Consumer Communications Code” in June of this year. In their code the company plans to refrain from any DTC advertising for new drugs for a one year period, focusing effort “on educating medical professionals about the new prescription medication and seek their input regarding their experience prescribing the medication.”
Accountability
In addition to releasing the 15 Guiding Principles, PhRMA have also announced plans to establish an office of accountability that will be responsible for receiving comments from the general public and from health care professionals regarding DTC advertising. Starting in January 2007, the PhRMA office of accountability will select an independent panel to review comments received, track overall industry trends as they relate to the Principles, and to make recommendations in accordance with the Principles.
Love it or loath it, DTC advertising is here to stay and therefore any steps to ensure that the practice is performed in an ethical way has to be a good thing.
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