The new PhRMA Principles for self-regulation of consumer drug advertising may mark the beginning of a new era in consumer marketing for drugs. In this new era, television viewers will better understand drug ads and will less often be annoyed by pitches for erectile dysfunction and other adult drugs.

These two aspects of the Principles adopted by PhRMA and 23+ of its drug company members also may spur FDA to create consumer advertising rules customized for consumers, rather than just fiddle with the rules designed for medical professional promotion.

In the PhRMA Principles, the single most important change is the channeling of ED and other adult product ads to programs seen predominantly by adults. These ads have caused the most political and parental angst. Moving them out of family time should mollify many of DTC’s most vocal critics.

This change is specified in Principle 13: “In terms of content and placement, DTC and print advertisements should be targeted to avoid audiences that are not age appropriate for the messages involved.” Later in the Q & A, this Principle is given further elaboration: “Advertisements containing content that may be inappropriate for children should be targeted to programs or publications that are reasonably expected to draw an audience of 80 % of adults (18 years or older).”

PhRMA leaders at the August 3 press conference announcing the Principles made it clear that this means the end of ED ads on most televised sports and other family programs. For example, Karen Katen, President of Pfizer Human Health Pfizer and one of the principal authors of the Principles, said: “Pfizer will not be advertising Viagra on the Super Bowl.” Billy Tauzin, new PhRMA head, added: “America’s parents will experience a different type of family television.”

PhRMA Principle 13 is arguably the toughest adult advertising guideline in the business, including those from the Beer Institute, the Wine Institute and the Distilled Spirits Council of the United States. Jean Pool, chief operating officer of the mega media buying agency Universal McCann tells me that although the “80% over 18 principle” is stringent, drug companies will still be able to place ads in many television shows, including golf, morning news and most adult cable shows. Furthermore, most newspaper sections and many magazines still will be able to carry these ads. But don’t expect to see ED ads on the Super Bowl and in People Magazine.

Policymakers in Congress and at the FDA should be pleased about this change for at least two reasons. First, the results are already apparent on family hour TV and will soon be so in many print publications. Just this week I viewed an entire baseball game without an ED ad. In fact, the only one I saw recently appeared on CNBC, the morning business program undoubtedly avoided by nearly everyone under 35 years old.

Second, and more important, channeling ED ads to adult programming effectively resolves this problem, something that would have been nearly impossible for the FDA and the Congress. Running ads for adult products during family programming is largely a matter of morals and taste. FDA has no jurisdiction there. Congress has been largely unsuccessful whenever it’s tried to legislate on moral issues. For example, Congress traditionally has tried to address television “indecency” through FCC regulation but most often gets overturned by the Supreme Court under the strict standards of the First Amendment. Last year, Congress decried the infamous Janet Jackson “wardrobe malfunction” on the Super Bowl, but was able to accomplish little more than an after the fact fine through the FCC.

Ultimately, after much wrangling and press attention, the actions of Congress and the FCC did little more than fill content of the broadcast news and entertainment shows, and did little to satisfy citizen concerns about taste and morals. By contrast, here PhRMA companies promised to do it, are beginning to do so immediately, and by January 1st of next year will have done it.

The second major move by PhRMA and its companies was the voluntary elimination of television “reminder ads.” Principle 10 states: “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.”

Officially, reminder ads are not ads for drugs because although the drug is named, its use is not. So, drug companies can avoid the full requirements of a full product ad by not naming its use. Apparently, reminder ads are a hold over from the exception to the full product ad rules that long ago enabled drug companies to pass out pens, subscription pads and other utilitarian items to doctors with only the name or logo of an often prescribed drug. The FDA reasoned that since they were mere “reminders” and not full product ads, the usual advertising rules need not apply.

Fast forwarding to the present, the use of reminder ads in television consumer advertising often led to more confusion than consumer information. With the exception of the few products whose names were common knowledge, such as Viagra, or where the names clearly gave away their use, such as Nicorette, most consumers were left confused by reminder ads. Indeed, many consumers likely blamed their confusion on the drug company advertiser. PhRMA rightfully recognized that it was time to abandon television ads with waving cornfields or dancing couples that left consumers more confused than enlightened.

Again, the PhRMA Principles put a quick end to a questionable practice.

The PhRMA recognition of the problem with reminder ads highlights the second major point here. It’s time for FDA to reform its consumer ad policies that are both extremely cautious and impossibly subjective. Wayne Pines addressed many problems with FDA consumer marketing policy in a recent edition of the FDLI Update. There he said: “The time has come for FDA to recognize--and incorporate into its regulatory approach—the view that DTC advertising is not just a derivative form of physician advertising. Simply put, what a physician needs to know (in deciding whether to prescribe a drug and how to advise a patient when a product is prescribed) is different from what a consumer needs to learn from a DTC advertisement.” “A New Approach to Risk Disclosure in DTC Advertising”, FDLI Update, November /December 2004

Pines in that article focused on the disadvantages of requiring the same “ brief summary” and risk information to consumers as to doctors, a problem apparent to any reader of the fine print in a magazine or newspaper drug ad. Even more importantly, the FDA should eliminate the immense subjectivity of FDA advertising policy. For as Pines said, “There is no way that any company or advertising agency can anticipate all the issues that a collective DDMAC review will identify. ….The time has come to rethink FDA’s basic approach to consumer advertising.” Ibid.

FDA should develop a full set of advertising principles that take into account the needs of consumers, including their ability to understand and appropriately respond to risk disclosures. While FDA deserves credit for encouraging more consumer friendly disclosures recently, it’s time to take further steps on these and give companies the tools to defend the product liability and failure to warn law suits that stem from allegedly inadequate disclosures. FDA, the companies, and consumers all stand to gain by better policies that foster better communication. FDA must lead the way.

Meanwhile, FDA must adhere explicitly to the First Amendment mandates required of all government agencies when developing commercial speech limits. Though rigorous, the Supreme Court’s rules are quite straightforward. In short, ad restrictions must work, must be as limited as possible, and must be avoided if non-speech restrictions would suffice. These mandates require good evidence, public transparency, critical reasoning, tough but objective standards, and common sense. These are among the FDA’s traditional core competencies. Here is a perfect place to put them into use.

Doing so will enable FDA to regain its position as the pre-eminent regulator of drug marketing, and to begin to sweep away the encroachments on its jurisdiction by the HHS-IG, state legislators, and plaintiff’s attorneys. American citizens don’t need multiple sets of drug marketing regulations that make sense, work and can be vigorously enforced.

Summing up, the PhRMA Principles immediately made two significant improvements in DTC advertising that were uniquely within the power of the industry to accomplish. It’s now time for the FDA to continue the progress. The result will be that consumers will learn more about their drug options and enable them to make decisions that lead to longer, less painful and more productive lives.

John Kamp is the executive director of the Coalition for Healthcare Communication, a group comprised of trade associations and companies that provide professional communication services to drug companies.

This article is reproduced here with permission from the FDA Advertising and Promotion Manual September, 2005

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