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." [See "Reminder Ads - Pharma's Dodo?"]
NOTE: In the blog post mentioned above I had links to the PhRMA DTC Guiding Principles, but these links no longer work. You can find the principles by clicking here.The FDA supported PhRMA's stance against reminder ads:
"Reminder ads" may disclose the name of the product and certain specific descriptive information such as dosage form (i.e., tablet, capsule, or syrup) or price information, but they are not allowed to give the product’s indication (use) or to make any claims or representations about the product. Reminder ads specifically are not allowed for products with serious warnings (called "black box" warnings) in their approved labeling. The regulations specifically exempt "reminder" ads from the risk disclosure requirements because historically they were designed generally to remind health care professionals of a product's availability. These ads can be confusing and frustrating to consumers – and potentially misleading – but, increasingly, we find them to be testing the limits of what might be considered a product claim. Because we believe they serve no useful purpose in the DTC arena, and have the potential to cause harm, we welcome the recent announcement from the Pharmaceutical Research and Manufacturers Association (PhRMA) that essentially supports the elimination of this type of advertisement directed at a consumer audience. [See "Statemnet Before Senate Special Committee on Aging".]According to an August 2, 2005, Sepracor press release:
"Sepracor is committed to responsibly communicating with patients and consumers through patient awareness programs, such as that for our insomnia drug, LUNESTA(TM) brand eszopiclone. Our philosophy of increasing disease awareness, improving patient education, and encouraging candid dialogue with physicians, is mirrored in the new Guiding Principles," said Timothy J. Barberich, Chairman and Chief Executive Officer of Sepracor. "We believe that this approach to patient awareness is crucial in establishing trust with patients and physicians alike and serves as an important mechanism to help patients make more informed decisions about their health." [see "Sepracor Adopts 'Guiding Principles' for Consumer Advertising".]The press release doesn't say Sepracor will adopt only some of the principles, so I assume it promised to adopt principle #10 as well. I was surpised, therefore, to see a Lunesta reminder ad last Friday evening on TV -- I believe it was on the History channel.
I looked into reporting this to PhRMA's "Office of Accountability," which accepts comments form the public. Unfortunately, PhRMA doesn't accept e-mail comments from the public, only written letters:
"If you would like to submit a comment to the PhRMA Office of Accountability about a particular DTC advertisement, please follow these steps:
- The Office can only accept comments made in writing and mailed to the PhRMA Office of Accountability, 950 F Street, NW, Washington, DC 20004 or faxed to 202-775-0258.
- The comment should provide information sufficient to identify the company and/or DTC advertisement at issue.
- The comment should relate in some way to an aspect of DTC advertising covered by the Principles.
- Please be sure to include a return address so the Office of Accountability can acknowledge receipt of your comment.
I don't know about you, but the last time I wrote a letter was... I can't remember! PhRMA certainly isn't making it easy to report these violations. Besides, I could just as easily do what PhRMA promises to do -- send my complaint to Sepracor directly. The person to contact is probably the person listed at the bottom of the press release: Jonae R. Barnes, Vice President, Investor Relations, 508-481-6700. I hope he doesn't answer calls from investors only.
It's interesting that just the other day -- before I saw the Lunesta reminder ad -- a BusinessWeek reporter called me to discuss the topic of "Disease Mongering". She read my recent blog on the subject (see "Disease Awareness or Disease Mongering?").
One question she asked was: "Did you think pharmaceutical companies were only playing lip service to PhRMA's guidelines and sneaking in ads that violated them?"
Being, as always, fair to the industry, I responded that it seemed that the industry was actually abiding by the principles. I did mention that Sepracor had been running Lunesta reminder ads on TV right up to the January 1, 2006 effective date of the guidelines, which I thought was a calculated compliance with the letter of the guidelines but a violation of the spirit (see "Insomnia - the Next DTC Frontier").
Besides, I honestly bought the argument that the air time for these ads were purchased well before the guidelines were announced and one might forgive a few that were aired after the announcement on that basis. However, it is now several months into 2006 and that argument no longer has merit.
So, why is Sepracor running these reminder ads? Well, for one thing, there is a lot of competition in the "sleep aid" market and pharma marketers may be pressured to push the envelope (see "Insomnia - the Next DTC Frontier"). It's especially easy to run reminder ads under the radar as it were on cable TV. Sepracor could plausibly deny any knowledge of such ads being run -- end of story.