Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads "artificially enhance consumers' perceptions of the product's quality" while also resulting in an "unbalanced or misleading impression of the product's safety." To test whether or not this is true, the FDA will soon start yet another study focused on Rx print ads: "Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions" (see Federal Register Notice archived here).

[I recently posted about another planned FDA study to determine if disease awareness information in branded ads confuses consumers. See FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"]

The history of this study is long and mysterious. I first blogged about it 2006; read "FDA, Coupons, and Sleep Aid DTC Ads." Shortly after that the Federal Register notice regarding the study was "yanked" (see "FDA Backs Down on Coupon Study"). Also, the Advertising Age and Wall Street Journal articles cited in those posts can no longer be found in the archives.

In September, 2011, however, the proposed study re-emerged in the Federal Register (here). Whatever happened between 2006 and 2011 is anybody's guess, but I assume that the Bush era FDA leaders axed the proposed study when they learned of it. By September, 2011, these people were on the way out and the door was open again to propose the study anew.

Anyhoo, I want to focus here on comments that PhRMA made in response to the proposal. Alexander Gaffney (@AlecGaffney), Health wonk and writer of news for @RAPSorg, summarized the general attitude of PhRMA (see "US Regulators Move Ahead With Planned Study on DTC Marketing"):

In its statement to FDA, PhRMA wrote it was “concerned that the study, as currently envisioned, will not yield information that is relevant to FDA’s regulatory responsibilities to ensure that DTC advertising is truthful, accurate and balanced.”

“Although the study may provide interesting information about the effect of promotional offers on consumer attitudes toward a brand,” explained PhRMA, “it likely will provide little information on whether promotional offers create or contribute to false or misleading advertising, particularly under real-world circumstances or whether additional regulatory requirements are warranted.”

PhRMA: The Physician is the Decider
I dug a little deeper into PhRMA comments (here) and was surprised to learn that PhRMA's position is that "it is the physician, not the patient (my emphasis), who ultimately must decide whether the benefits of the advertised drug outweigh its risks for any particular patient." Thus, says PhRMA, "the risks of 'misperceptions' ... should be even lower [PhRMA's emphasis] for prescription drugs than for experience goods [i.e., a product or service where product characteristics, such as quality or price are difficult to observe in advance, but these characteristics can be ascertained upon consumption] because any potential misperception, of necessity, will be quickly corrected prior to use through consultation with the patient's treating physician."

This is a very paternalistic POV in this day and age of social media and patient empowerment. Actually, it is the old "learned intermediary" defense that the drug industry often raises (in the past, less so these days) to shield itself from blame when things go wrong.

FDA must respond to comments submitted, but I couldn't find a direct response to PhRMA's comments cited above. I did find, however, the following comments and FDA's response that addressed the issue of the patient-physician relationship generally:

(Comment 22) Two comments mentioned that the study does not assess how consumer perceptions of product risks and benefits are translated into a discussion with their health care provider. One comment stated that because these products can only be purchased after a discussion with a health care provider, the study be redesigned so that consumer perceptions are measured after a discussion with a health care provider.

(Response) We concur that this study does not address behaviors, such as how ad perceptions are translated into a discussion with a health care provider. As noted previously, one purpose of DTC advertising is to motivate consumers to engage in a discussion with their health care provider about health concerns. Another purpose, supported by research findings (Refs. 20 and 21), is to increase awareness of available treatments. DTC advertising does not exist solely in the confines of a doctor's office; rather, DTC advertising targets consumers outside of a doctor's office, with the goal of prompting consumers to ask their physicians about the product. In deciding whether or not to discuss a particular product with their health care provider, consumers presumably are engaging in some sort of judgment about the product being promoted. Therefore, clear communication of risks and benefits is needed for consumers before a consultation with a physician, and it is valid to measure these impressions.