According to a short piece in the Wall Street Journal, the FDA “is looking at whether coupons and rebates that are part of some prescription-drug advertisements might cause consumers to think a drug is safer or more effective than it really is.”

The agency said it is concerned that consumers viewing advertisements that contain a coupon, a free-trial offer or other price promotion might place more emphasis on the benefits rather than the risks of a drug. “Coupons and price promotions may imply superior drug efficacy,” the FDA said. [WSJ]

In a Federal Register notice (Docket No. 2006N-0029), FDA cited studies that show that people tend to rate owned objects more favorably than those they do not own, even when those objects have been assigned to them at random. This has been termed the “mere ownership” or “mere possession” effect. Other studies have shown that consumers rate a product more favorably when they are simply given a gift certificate or a coupon for that product or service.

For complex products such as prescription drugs where supervision of a physician is required to evaluate both appropriateness and performance, coupons and free trial offers may send signals that foster consumer misperceptions about the advertised prescription drug product, says the FDA. Thus, prescription drugs promoted with coupons or free trial offers may be seen as more widely indicated, more appropriate and/or less risky than they really are. Inclusion of a mechanism that affects consumers’ perception of the product’s risks is especially problematic in reminder ads because this type of ad contains no accompanying risk information. Furthermore, coupons and price promotions may imply superior drug efficacy.

What the FDA proposes is to do a study to examine the impact coupons have on consumers’ perceptions of risks and benefits and the overall impression of the product in DTC full-product and reminder advertisements. Participants will be asked to read different versions of a single print advertisement for a new drug. Versions differ according to whether or not there is a free offer and the type of offer. After reading the advertisement, they will be asked questions about their evaluation of the information presented in the advertisement.

Sleep Aid Drugs Test Case
Here’s the kicker: the study will be limited to one disease condition — insomnia! It strikes me as no coincidence that insomnia was chosen. According to a story in today’s New York Times, Record Sales of Sleeping Pills Are Causing Worries.

As noted in a previous post, insomnia drugs are replacing ED drugs as the “bad boys” of DTC advertising (see “Insomnia – the Next DTC Frontier“). As such, these ads will be getting increasing scrutiny. Already, we are seeing amnesia side effect stories that will become the subject of talk-show jokes. An example: an Air Force linguist in Qatar claimed to have been raped by another linguist, but she couldn’t be sure. “[The victim] testified that she was not sure whether the incident was a dream because she had taken Ambien…” [NYT] One of the side effects of Ambien and other sleep aid drugs is amnesia and sleepwalking, or in this case, sleepraping.

[Another victim of Ambien sleepwalking raided a refrigerator in a seemingly unwholesome manner and later claimed not to remember. Ambien was also investigated as a factor in the Staten Island Ferry crash in 2003, but I’m thinking alcohol was more of a factor in that case.]

I haven’t seen any Ambien or Lunesta DTC print ads offering coupons, but if the ED drug ad war is any indication, we are likely to see these ads. FDA, therefore, seems to be taking a pre-emptive strike and trying to gather data to back up future warning letters addressing these ads.

It is interesting to note that until recently Sepracor was running Lunesta reminder ads on TV. While not technically violating PhRMA DTC guidelines (see “PhRMA Finalizes DTC Principles“), Sepracor definitely pushed the envelope. One can expect that Sepracor is or will run reminder print ads since these ads are NOT covered by PhRMA Guidelines. And my guess is that some of these ads are likely to include coupons. Hence FDA’s concerns.