I finally realized that U.S. sports channels just aren’t going to bend to my will and start showing more rugby. The result of this is that I’ve been watching a lot of American football lately instead. One thing I’ve always noticed when watching football is how many commercial breaks there are during the game. During televised rugby matches, you generally get ads only at halftime or if there happens to be a long injury break. Of course, some ads have become highlights in themselves during the Super Bowl. Some could even be good for you! Maybe…
I’m speaking of course about the many ads for pharmaceutical products that claim to be effective in the treatment of a wide variety of ailments, conditions, and diseases. Recently, when I saw one such ad during a game, I commented that this type and extent of pharmaceutical advertising is not something you would normally see in other countries. So, I looked it up. It turns out that the U.S. and my home country, New Zealand, are the only two industrialized nations that allow “direct-to-consumer advertising” (DTCA) for prescription-only medication.
Here in the U.S., the regulation of DTCA for prescription drugs is overseen by the Office of Prescription Drug Promotion within the Food and Drug Administration (FDA), while the advertising of over-the-counter medicine and other health-related products is within the jurisdiction of the Federal Trade Commission (FTC). For prescription drugs, the relevant law is the Federal Food, Drug, and Cosmetic Act (FD&C Act) (contained in Title 21 of the U.S. Code), and related regulations. Prescription drug advertising must be accurate and not misleading, and the regulations contain detailed requirements for these ads. For example, under section 502(n) of the statute, statements relating to side effects and contraindications “shall be presented in a clear, conspicuous, and neutral manner,” and the regulations similarly require a “true statement of information in brief summary relating to side effects, contraindications, and effectiveness,” depending on the type of ad. The law allows the FDA to “prereview” television ads and the agency monitors drug promotion in other ways as well. It also provides guidance to companies on what is acceptable, and receives and investigates complaints from consumers. It can take enforcement action where ads are found to be false or misleading.
The FDA’s website provides information to the public about what is, and what isn’t, acceptable in relation to prescription drug advertising. It covers the three types of ads: product-claim ads, reminder ads, and help-seeking ads. I also found an interesting journal article on the U.S. National Library of Medicine (NLM) website that describes the regulatory system and its history, as well as the enforcement of the laws, and the arguments in favor and against DTCA of prescription medicine. The article notes the huge increase in spending on such advertising in the last thirty years—from $12 million in 1980, to a peak of $5 billion in 2006 and 2007. Most of this budget is spent on television advertising: now, “[t]he average American television viewer watches as many as nine drug ads a day, totaling 16 hours per year, which far exceeds the amount of time the average individual spends with a primary care physician.”
In New Zealand, the Ministry of Health is responsible for the policy and legislation relating to pharmaceuticals, including DTCA. One part of the Ministry, MedSafe, is responsible for providing guidance and monitoring compliance with the law. There is also a strong element of self-regulation in the context of the marketing of medicines (and for advertising practices in general) in New Zealand, with the non-governmental Advertising Standards Authority taking responsibility for receiving and ruling on complaints related to advertising.
The relevant legal instruments are the Medicines Act 1981 and the Medicines Regulations 1984. The law includes prohibitions against medical advertisements targeted to the public that falsely state or imply that a product will prevent, alleviate, or cure particular conditions or diseases—including arthritis, baldness, infertility, and mental disorders. In addition, advertising of any medicine cannot imply or claim that the product “is a panacea or infallible;” is recommended by a practitioner; or has beneficially impacted the health of a particular person or class of persons. Under the regulations, ads for prescription medicines must include “a statement that the medicine has risks and benefits” and “a statement about how to find further information on the risks and benefits of the medicine.”
The system for regulating medicines and other “therapeutic products” in New Zealand, including rules related to advertising, will likely be affected by major changes proposed in the Therapeutic Products and Medicines Bill. This bill seeks to establish a joint regulatory body with Australia with consistent rules to be developed and applied in the two countries. The passage of the bill would implement an agreement signed in 2003 which aims to “safeguard public health and safety in Australia and New Zealand by establishing and maintaining a joint scheme consistent with international best practice for the regulation of the quality, safety, and efficacy or performance of therapeutic products, and of their manufacture, supply, import, export and promotion.” Interestingly, Australia, like other countries, currently prohibits DTCA of prescription medicines. There have also been various discussions regarding the existing laws in New Zealand, and the government has sought the views of the public on whether they should be changed.
So, why do so few developed countries permit DTCA of prescription medicines? What are the concerns about DTCA? Whether or not to maintain prohibitions on such advertising has been discussed in many countries, with the general conclusion that the potential harms outweigh the potential benefits. The World Health Organization (WHO) highlighted some of the discussions in the U.S. and elsewhere in a 2009 news bulletin, and there are various studies and reports available on the WHO website that examine the issues and policy considerations related to DTCA. One WHO presentation states that the main concerns about DTCA are that it: “increases prescription costs”; contains misleading statements that lead to irrational use of prescription medicine and undue risks; often breaches regulations; creates strains on physician-patient relationships; “promotes medicalisation of normal life”; and that there is “no evidence of health benefits.”
Similarly, the aforementioned article lists the arguments against allowing DTCA of prescription medicine as being that it: “misinforms patients”; “overemphasizes drug benefits”; “promotes new drugs before safety profiles are fully known”; “manufactures disease and encourages drug over-utilization”; “leads to inappropriate prescribing”; “strains relationships with health care providers”; “wastes appointment time”; “is not rigorously regulated“; and “increases costs.”
There are of course constitutional considerations related to the protection of freedom of speech. The same article discusses this point and provides information about relevant U.S. Supreme Court decisions on the regulation of commercial speech. In addition, the author sets out various arguments made in favor of DTCA, including that it: “informs, educates, and empowers patients”; “encourages patients to contact a clinician”; “promotes patient dialogue with health care providers”; “strengthens a patient’s relationship with a clinician”; “encourages patient compliance”; “reduces underdiagnosis and undertreatment of conditions”; “removes the stigma associated with certain diseases”; and “encourages product competition and lower prices.”
What do you think about these ads and their impact? Will you stay and watch them during the Super Bowl, or will that be the time you go and get some more chili and chicken wings?
This is our third Super Bowl-related post. Last year we wrote about sports blackout rules; and in 2011, we wrote about legal aspects of the halftime entertainment. You can also read the Super Bowl editions of other Library of Congress blogs:
- Super (Advertising) Bowl! (Inside Adams, 2010)
- Are You Ready for Some Football? (In the Muse, 2010)
- Pic of the Week: Super Bowl I (Inside Adams, 2011)
- Armchair Quarterback (Inside Adams, 2011)
- Sheet Music of the Week: Super Bowl Edition (In the Muse, 2011)
Update: Inside Adams has also published a Super Bowl-related post for 2013. Check out Turf Wars on the Football Field for information on the arguments over natural vs. artificial turf.