Patient testimonial videos on the brand.com homepage for Premarin, an estrogen tablet manufactured by Wyeth (now Pfizer), overstated the drug's efficacy and minimized risks, while a journal ad for Allergan's Acuvail made unsubstantiated superiority claims, overstated efficacy, broadened the drug's indication, and omitted risk information, according to a pair of untitled DDMAC letters.
Videos on the Premarin website (which have since been taken down) featured testimonials made by five women, including “Mary,” who made the following statements, deemed violative by DDMAC:
- “I said: ‘How would being on Premarin affect me?' She [Mary's physician] said: ‘You're not going to go through menopause. You won't have hot flashes. You won't have any type of discomfort. And it would actually circumvent being on menopause at all.' And I said: ‘Great.'”
- “After surgery, for those 4 or 5 days that I was without any type of hormone therapy, I had some sensations that I'm really grateful I'm not going to go through. After a few days when the hormone therapy started to get into my system, it was gone.”
The claims “seriously misrepresent what is known about the efficacy of Premarin,” since they imply that that the drug will “eliminate all hot flashes, discomfort, and other symptoms associated with menopause, and that Premarin will ‘circumvent being on menopause at all,'” according to the letter. Other testimonial statements, such as “My life after Premarin became absolutely different…I got up feeling like the day is better,” and “I started feeling very much alive again,” were also misleading, since FDA is not aware of substantial clinical evidence to back up Premarin's ability to improve a patient's “overall physical and emotional functioning,” the letter said.
With respect to risk minimization, DDMAC took issue with the “colorful, audio-visual testimonials” of the five women sharing their positive experiences with Premarin, as compared with Premarin's risk info, which was “relegated to the bottom portion of the webpage below the testimonials, in a read-only text format, where it is unlikely to draw the viewer's attention.” In other words, the website “fails to convey this important risk information with a prominence and readability reasonably comparable to the claims of effectiveness,” according to the letter.
In the case of Allergan's journal ad for Acuvail, an ophthalmic drop approved in July 2009 for pain and inflammation caused by cataract surgery, DDMAC said the concept for the ad, which featured a series of increasingly larger and more brilliant diamond-shaped stones (and headlined “A New Shape In NSAID Therapy”), “misleadingly suggests that Acuvail confers more therapeutic benefits” than other ocular ketorolac products. DDMAC also said the claim “optimal outcomes” went too far, since Acuvail has not been shown to optimize all clinically relevant outcomes of cataract surgery, the letter said.
The Acuvail ad also omitted risk information contained in the drugs PI, specifically “reports that ocularly applied nonsteroidal anti-inflammatory drugs [or NSAIDs] may cause increased bleeding of ocular tissues,” and that Acuvail should not be administered while wearing contact lenses, the letter said.