While the ambiguous regulatory environment has generally stymied online communications for the healthcare industry, unbranded disease education websites have provided an opportunity to maximize reach, engagement and innovation of online initiatives without contravening existing FDA regulations.
As evidenced by recent warning letters issued to pharmaceutical companies about unbranded websites, in the eyes of DDMAC, the distinction between branded and unbranded is increasingly blurred. Unbranded activities and any unbranded site that has “perceptual similarity” to a branded site, even in subtle presentation elements, may now be subject to the same regulations for transparency and safety information.
This week’s Check-Up provides you with a guide to the key issues surfaced in warning letters from the FDA, based on the recent Pharmalot Webcast by Arnold Friede, “Unbranded Websites: Understanding the Jurisdiction and Working Within the Guidelines of DDMAC.”
These recent warnings serve as an important caution and precedent for the healthcare industry at large as it attempts to tread carefully in regulatory limbo. To help navigate that, here are five things to think about when building unbranded sites.
The Context
The FDA distinguished between disease awareness communications and promotional speech in its draft guidelines provided in the FDA/DDMAC’s June 2004 Draft “Guidance for Industry, “Help-Seeking” and Other Disease Awareness Communications By or on Behalf of Drug and Device Firms.” In these guidelines, however, the FDA’s definition of disease awareness communications includes communications that “discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device.”
“Perceptual Similarity”
According to the draft guidelines, perceptual similarity pertains to the likeness between unbranded page and branded page in regards to themes, story lines and presentation elements (including colors, logos, tag lines, graphics, distinctive visual elements, common narrator or background music and motifs). Close physical or temporal proximity can also have a “repetitive effect,” causing the two pieces to be “remembered as one entity.” To avoid perceptual similarity, sites should be distinct in terms of thematic, graphic, visual and other presentation elements.
“Bookending”
Bookending occurs when “reminder” advertising or product claim promotions are featured on the disease awareness information site. Close proximity of this advertising to the disease education information could also constitute perceptual similarity and may cue the audience to link the disease education site and the drug.
Implicit Link between Brand and Disease Site
Depending on overall meaning and context, companies that launch a product site for a first-in-class drug should be cautious as the FDA might deem this promotional (due to the obvious association).
Brand Presence on Unbranded Site
Including the brand name or logo on the disease awareness piece may be enough for FDA to deem it promotional, depending on overall meaning and context. These warnings about branding do not mean transparency should be compromised. The other breaches described above most likely carried more weight in the warning notice, rather than the branding alone. As always, honesty is the best policy, and disclosure is imperative.
What Does It Mean?
While the current parameters seems to rest on subtle inferences and elusive linkages, pharmaceutical companies should not be deterred from pursuing disease awareness education initiatives, which often provide crucial information and support for patients. Arnold Friede advised that we must be “altruistic” when approaching unbranded online initiatives – but we should also take practical measures. We can be proactive, establish our own internal protocol and train employees to practice self-regulation.
Image credit: Mr.T in DC
