Merck Says FDA Should Approve the “One-Click Rule”

Merck submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

About 75% of Merck’s comments that specifically address FDA’s questions is devoted to an argument in favor of the “one-click rule” as it applies to space-limited digital product ads. For more background on the one-click rule, see "Pharma Prefers '1-Click Rule' for Presenting Fair Balance in Social Media & Other Internet-based Rx Ads."

When FDA issued those infamous 14 notice of violation letters last spring, the drug industry was stunned and immediately pulled back from branded search engine advertising (see "The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!"). Apparently, Merck revised its sponsored search ads to the help-seeking format “in March 2009 in response to DDMAC's enforcement letters on sponsored links.”

As a result, across several brands, Merck “observed an increase in click-thru rates with the unbranded, help-seeking format indicating that the format may have attracted more users seeking condition-specific information. However, the number of landing (product) site pages consumed after the click-thru consistently declined. For one brand, the number of page views by the searcher dropped by nearly 50%.”

Merck claims this "decrease in content consumption could indicate a lack of transparency between the advertisement and the linked to content” and “current unbranded, help-seeking sponsored links do not meet the needs of health information seekers using Internet search engines.”

I’m trying to understand Merck’s argument. This is the example “help-seeking” ad it presented in its comments to the FDA:


Merck did some market research to evaluate this and other ad formats, including this product-claim format that Google has made available to drug companies in beta tests (see "Is Google the New FDA?"):


Merck asked its study subjects “How do you feel about having to click on the link to gain access to the product safety information?”

For the Product Claim ad, 78% said they found it very or somewhat acceptable. For the Help-Seeking ad, however, only 34% said it was acceptable. Well, of course it’s not acceptable -- to get to the product information from the Help-Seeking ad, you first have to click through to the product web site. But this doesn’t mean that the Help-Seeking ad did not “meet the needs of health information seekers using Internet search engines.”

I think what Merck really means is that ITS needs are not being met by Help-Seeking ads!

Concluding its comments on the one-click rule for Product Claim ads, Merck says “the use of hyperlinks is an appropriate and effective way to disclose product use and safety information in limited space formats. FDA should adopt standards to be consistent with FTC guidelines and allow hyperlinks to fulfill the regulatory requirements for product use and safety information disclosures in digital media with space limitations, including but not limited to, banner advertising, mobile applications, text messaging and sponsored advertisements in search engines.”