In November, the FDA will host a 2-day public meeting on direct-to-consumer (DTC) promotion of regulated products, including prescription drugs. According to the September 13, 2005 Federal Register notice, the FDA is interested in hearing opinions on a number of topics relating to DTC. This hearing promises to be a prelude to new FDA rules governing DTC.

From the look of the questions the FDA is seeking comments on, I’d say any new FDA rules are likely to be very similar to the voluntary guidelines announced by PhRMA in August (see “PhRMA Finalizes DTC Principles“). If so, this would be a case of the hen leading the fox and would represent a victory for the pharmaceutical industry, which was criticized for not going far enough to reign in DTC advertising.

Or, you may look at it another way: it’s always unwise to propose meaningful voluntary guidelines because it’s likely to end up as mandatory government regulations. This may be why PhRMA was reluctant to go further with its guidelines and especially why the guidelines did not include a DTC moratorium period following a drug’s launch.

Whatever! The important thing is to see what exactly is on the table that might lead to further regulations. The following are excerpts from the FDA’s notice — with commentary, of course, to put things in [my] perspective and give you some more background information.

Likely to Lead to New DTC Regulations
According to the notice “FDA is particularly interested in hearing the views and comments from the public as to whether, and if so how, the agency’s current regulations and the agency’s interpretation of those regulations and actions under them should be modified to better address consumer-directed promotion of regulated products. FDA is holding this hearing because it believes the agency, the industry, and other members of the public now have enough experience with DTC promotion to understand what regulatory issues may need to be addressed in new FDA activities.”

These “new activities” may focus on the following issues:

DTC Education
The pharmaceutical industry contends that DTC is educational. Hank McKinnell, CEO of Pfizer, for example, prefers to call pharma ads to consumers “DTC Education” (see “A Call to Action: A Mea Non Culpa by Big Pharma“). Johnson & Johnson Chief Executive William Weldon said in an address to PhRMA: “Our communication with patients should really be thought of as Direct to Consumer Education” (see “DTC Straight Talk“).

FDA is not so sure about the educational merit of DTC…

Disease Awareness Education
FDA wants to know if DTC needs additional educational content about the disease or condition. “FDA is … specifically interested in whether paying greater attention to the educational component of an advertisement (i.e., devoting more attention to defining the disease and its manifestations) would help consumers better understand the role drug and device therapy may play in treating that disease.”

[HEN vs. FOX: PhRMA (the “FOX” in this case) has already addressed this in its guidelines: “Companies are encouraged to promote health and disease awareness as part of their DTC advertising.”

Individual drug companies have gone further. Pfizer, for example, pledges in 2006 to “invest a meaningful amount — on par with what it spends on a branded advertisement campaign” to create non-branded ads such as disease-awareness ads and compliance ads.]

Reminder Ads
FDA asks: “What is the potential role of reminder ads in all types of consumer promotion, such as broadcast, print, and the Internet?”

[HEN vs. FOX: PhRMA essentially pre-empted this concern in its principle 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.”

For more on this, see “Reminder Ads – Pharma’s Dodo?

However, FDA didn’t limit its concern just to television advertising and wants to include the Internet as well. I am not sure how much reminder ads are being run on the Internet, but the whole issue of DTC on the Internet needs closer inspection, IMHO.]

Risk Communication
The FDA has done some research on patient and physician views of DTC (see, for example, “Results from FDA Physician Survey on DTC Advertising” and the 2004 final report on these surveys) and “is interested in hearing why consumers and healthcare providers may believe that risk information is not being communicated as clearly as benefit information, even though that information is present.”

[HEN vs. FOX: Nobody seems to have a good idea why risk information is not communicated well to consumers. Pfizer, for example, says it is studying how to do this better.

For more on this, see “Can Drug Ads Communicate Risk?

Meanwhile PhRMA principle 11 states: “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.”]

The FDA asks: “How could the content and format of risk information in promotional pieces be better communicated to consumers? Because consumers sometimes lack advanced medical knowledge, how can FDA help ensure that those consumers who are not medical experts understand a product’s risks?”

The agency is concerned about the context as well as the content regarding communication of risk in DTC: “ad[s] may continue to present positive scenes of individuals enjoying the benefits of the advertised product during the presentation of risk information, which is usually presented separately from the benefit information. Do such common advertising techniques create barriers to consumers’ understanding of risk information?”

[There are alternatives to the “common advertising techniques” often used to gloss over risk information. News ads by J&J which, for example, put drug risk on a more-equal footing with drug benefits. See “DTC Straight Talk“.]

Coupons, Free Trials, and Money-Back Guarantees
FDA raises a concern about using certain promotional techniques for drugs and devices that have been “imported” from other industries (e.g., packaged goods).

“Some companies offer consumers coupons, free samples, free trials, and money-back guarantees for prescription drugs in both full-product as well as reminder advertisements (which do not inform the consumer about the benefits or risks associated with the product). Are these approaches appropriate ways to influence consumers?”

[This issue was not addressed in any of the voluntary DTC industry guidelines that I have seen. I expect that the industry will defend these tactics as valid and even claim that they are helpful in lowering the costs of drugs.]

Celebrity Spokepersons and Actors Portraying Docs
FDA: “Another standard marketing technique uses real people, or actors portrayed as real people, to provide positive reports (testimonials) about an advertised product. Applied to medical products, this technique portrays patients who describe how a drug or device helped them manage their medical condition. In rarer instances, healthcare providers, or actors portraying them, vouch for the use of the product. Such approaches plainly do not reflect a data-oriented approach to promotion and may not be recognized by consumers as anecdotes. FDA is interested in whether and how techniques mislead consumers about the risk-benefit tradeoffs of prescription or restricted medical products.”

[Again, the industry’s voluntary guidelines do not address this issue. The DTC straight talk ads of J&J, however, use real physicians, which seems more honest. I haven’t noticed a “Not a Real Doctor” notice on DTC ads that use actors portraying doctors. You know, like the “Professional driver on closed track” notices in car commercials.]

Comparative Ads
FDA: “Promotion that compares one product to another or to several others is becoming more common in DTC promotion. Given that this information is often scientific or numerical in nature, how can companies convey this information in a way that is informative to consumers without advanced education, and how well are companies currently doing this?”

Package Insert
FDA: “For promotional labeling, is the current package insert the best way to meet the requirement to bear adequate directions for use in consumer-directed materials? Are there ways to modify the content, format, and language of the package insert that would make this information more easily understood by consumers?”

For more on why package inserts aretrulyl inadequate, see “Future of Drug Print Ads“.

DTC and New Communications Technologies
The FDA has never developed specific regulations for drug promotions via the Internet despite holding public meetings on the topic. At the upcoming November meeting, it appears that they will once again consider if new communications technologies require special treatment.

FDA: “As new communication technologies emerge, they create opportunities for novel approaches to DTC promotion. What issues should the agency consider with regard to the effect of these technologies on DTC promotion?”

“FDA research has shown great increases in the number of people who now use the Internet to search for information about prescription drugs. Drug companies produce video news releases, audio news releases, and print “advertorials,” which are disseminated to TV and radio stations. At times, TV and radio stations do not make it clear to consumers that such promotional pieces are generated by regulated industry. The agency is interested in hearing the public’s views on these promotional techniques and the issues they raise.”

Once again, FDA seems to be firmly planted in the past. There are new communication tools such as blogs, RSS, etc. that the industry will surely experiment with to generate “buzz” which will not be labeled as paid promotion. For more on this, see “Buzz is NOT regulated by FDA“.

I should reveal that I am involved in helping the pharma industry get up to speed on using novel communication tools such as blogs. For example, I will be the Chairperson and speaker at the first conference devoted to pharmaceutical blogging (see PharmaBlogging Conference information on Pharma Marketing Network).