FDA drew a line in the digital sand last Friday when it sent warning letters to 14 pharmaceutical and biotech firms citing them for negligent online advertising tactics.  While the letters varied in terms of product specification, the main point was that pharma has been negligent in the way it presents search engine ads delivered by Google, Yahoo, and Microsoft.

“The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Aromasin, Caduet, Chantix, Detrol LA, Lyrica, and Celebrex, but fail to communicate any risk information associated with the use of these drugs,” stated one of the letters—this one sent to Pfizer.

The main point of contention is that when you search for a term—for example, “cholesterol”—a conventional search engine text ad would have a headline that reads “Learn More About X Brand” followed by a subhead that says “Click here to see how X Brand can help with your cholesterol,” followed by a URL.

FDA stated its opinion that using a condition in conjunction with a brand name in a search ad triggers the “fair balance” provisions that apply to print and television ads. According to insiders, FDA has been vague as to whether those rules apply to search ads, and most ad agencies have been operating under the assumption that there was a “one-click rule”: that if the fair balance warnings are within one click of the search ad, then that satisfies the fair balance requirements FDA could impose.

Pharma can no longer display a condition and a brand together in the body copy of the ad. Here are two examples of what is now expected:

A) Branded: “Try Pharma X: Click here to see how Pharma X can help you.”
www.pharma-x.com

B) Unbranded: “Want to learn more about cholesterol? Click here to learn more about it.”
www.cholesterolinfo4U.com

Google told Pharma Exec that since they were directed to pharma companies, Google couldn’t comment on the specific letters.

“We provide an advertising platform to our customers, and we will help them advertise in a way that complies with all regulations,” said Mary Ann Belliveau, healthcare advertising director at Google. “Obviously, these warning letters will change the format of the sponsored links people see next to organic search results. We expect that our pharma clients will continue to find creative ways to inform consumers and advertise in a compliant way.”

New Advertising for New Media
While the pharma companies in question were quiet about what they will do in response to the letters, many experts in the marketing and online industry were shocked by FDA’s reaction to the new media.

“It’s seems like a regulatory overreaction by FDA,” said John Kamp, executive director of the Coalition for Healthcare Communication. “Warning letters are serious to pharma companies, and the fact that there are 14 companies in the zone here suggests that a whole lot of people in the industry were confused about what the rules were.”

For years, pharma marketers have argued that there are no guidelines for marketing on the Internet, and this lack of information has left drug companies in the lurch when it comes to social media practices. There is fear that this type of “knee-jerk reaction” might cause pharma companies to avoid search engine marketing altogether.

Arnold Friede, a lawyer at McDermott Will & Emery, said that there must be an understanding that a search engine ad is not necessarily an advertisement, but a link to the actual ad (where risk/benefit information resides).

The whole purpose of a sponsored link is to persuade the information seeker to click on the link. The landing page is part and parcel of the entire "advertisement,” Friede said. “Indeed, if sponsored links go away because of FDA's position here, then the information seeker will be relegated to wading through a list of Web sites, most of which are not even regulated by FDA and which contain all manner of information the validity of which is largely unknown.”

Attention to Detail
However, there are some experts that think any attention from FDA to Internet advertising is good attention. Ignite Health head Fabio Gratton told Pharm Exec that these letters send a message that FDA is keenly aware of the importance of the online channel, that they are concerned about the public’s safety, and that—despite the agency not having issued specific guidelines for this channel—the old rules still apply.

“This doesn’t mean that there won’t be an increased demand for more explicit guidance. And perhaps the FDA will even respond,” Gratton said. “Until then, I believe these letters demonstrate that there is a keen awareness that the Internet is a critical and influential medium for health consumers—and that is a great step in the right direction.”

In response to criticism of the warning letters, FDA wrote: “We are concerned from a public health perspective whenever promotion undermines the safe use of a drug by minimizing the risks associated with the product or by failing to appropriately communicate its approved uses.”