FDA Sends Warning Letter to Website to Cease & Desist: It Doesn't

FDA Sends Warning Letter to Website to Cease & Desist: It Doesn't

@skypen posted this tweet recently: "Interesting warning letter for flu med for false claims via web, twitter & facebook http://t.co/FWI0y4Ch," which I found in the ePharma Pioneer Club Forum.

What I found interesting about this letter is that it addressed an issue more serious than the typical "false claims" letter that Rx pharma companies sometimes receive. This letter pointed out that a product ("Triple Flu Defense") was being "promoted for conditions that cause the product to be a drug" subject to FDA regulation. "Triple Flu Defense," however, never submitted a new drug application to the FDA for marketing approval. Hence the letter.

FDA pointed out that several unsubstantiated efficacy claims were made, such as:

• “Relieves Flu Symptoms” 
• “Eases Flu Vaccine Side Effects” 
• “…[T]his product is of inestimable value in the prevention and mitigation of influenza.” “Triple Flu Defense can also be used to alleviate side effects from the flu vaccine.”

In addition, said FDA, the website "includes claims in the form of testimonials that establish the intended use of your product as a drug. Examples of these testimonials include the following:

• “It really works. My husband didn’t take the formula and got sick and I didn’t. It has no side effects.” 
• “I have been around people with the flu and haven’t gotten sick since taking Triple Flu Defense.” 
• “I had been sick for a week with the flu and thought I was never going to feel better. I took two doses of Triple Flu Defense and felt a lot better. It works great.” 
• “I'm one of the few people I know who didn't get the flu this past year because of Triple Flu Defense!”  
• “I took Triple Flu Defense during the season. I didn’t get sick all winter.”

Pretty amazing claims!

When I accessed the Triple Flu Defense Web site (here), I expected to see that it had been taken down in response to the FDA's waring. After all, the FDA sent the letter via UPS overnight on December 14, 2011 and demanded action within 15 days. But it's almost a month later and all the claims are still there (see screen shot; click to enlarge and read the claims).

In contrast, when Rx Web sites are cited for violations by the FDA, the offending pages are gone by the time you learn about the letter!

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

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.”