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FDA States Keywords Do Not Have To Be Reported on Form 2253s

Sept. 3, 2013 – An FDA official’s statement during a recent enforcement Webinar that online keywords do not have to be submitted to the agency on FDA Form 2253s confirms – in the absence of explicit guidance from the FDA regarding Internet issues – what most in industry already had inferred from enforcement actions taken by the agency over the years, according to Dale Cooke, Vice President/Group Director, Digitas Health.

At an enforcement update Webinar held July 29, Office of Prescription Drug Promotion Regulatory Counsel Julie Chronis was asked whether firms were required to submit keywords used for Internet promotion on 2253s, to which she replied, “Keywords do not have to be submitted on 2253s.”

Although this may seem like a minor comment, Chronis’ response validates industry’s assumptions, Cooke said. “We’ve long told clients that they do not have to submit their keywords on a 2253, and the [Chronis comment] confirmed that advice. But there are definitely considerations about ensuring compliance that go beyond the 2253 submission.”

Marketers reasoned that FDA’s silence on the issue of keywords – for example, the absence of any mention of keywords in 14 letters issued in March 2009 to address alleged search engine marketing violations – demonstrated “that sponsors were not required to submit the keywords,” Cooke told the Coalition. “That was also consistent with offline practices because the function of keywords is analogous to a media buy for an offline print ad. The keywords selected determine where the ad can show up, but they aren’t themselves part of the ad.”

However, industry could not be certain that this was the FDA’s official stance. “The silence by the FDA could have merely been an oversight or a matter of FDA not having a settled position,” Cooke noted. “Actually hearing the FDA articulate this position – even in an informal, non-binding setting such as a Webinar – provides confirmation that our reasoning was correct.”

Bill Evans, Chief Digital Officer, Team Chemistry at WPP, and Managing Editor, Dose of Digital, views Chronis’ statement as “basically a signal that FDA can’t or doesn’t feel the need to preapprove keywords. It’s a herculean task, given that a typical brand may have 400-700 keywords. FDA has been fairly consistent in its guidance and warnings on keywords, so a pre-review is both cumbersome and unnecessary. For marketers, this eases up schedules, but increases the responsibility to keep a brand’s message and metadata on track.”

Indeed, legal experts have suggested that the FDA still may cite companies for the use of sponsored links, search terms and metatags. This includes keywords “that broaden indications or inherently promote off-label uses,” said Wayne Pines of APCO Worldwide. “For example, if my drug for asthma pops up first in a search for foot fungus, the FDA clearly would object to that,” he said.

“The rules of the road are fairly clear and, when followed, simple to abide by,” Evans stated. “Make no claims about a product that can’t be supported with balance: something that’s almost impossible to do in a metadata/keyword environment. Make any kind of claim about a brand without a balance statement and you will get a Warning Letter. Nothing about this has changed,” he asserted.

Cooke disclosed that Digitas Health has established best practices for metadata and keywords. “We advise clients to ensure that all of their message targeting is on label, [which] means both limiting the keywords targeted to the approved indication as well as developing a list of negative keywords for the most commonly searched off-label indications,” he explained. “We advise clients to take steps proactively to prevent their messages from appearing in response to off-label searches by using a robust negative keyword strategy.”

Behind the Digitas Health strategy is a process that is based on an understanding of relevant FDA considerations and of Google search behavior by the targeted users, be they healthcare providers, patients or caretakers, Cooke continued. For example, “we tell all of our clients that they need to take not just their text ads but also their keywords through the medical-legal-regulatory promotional review process.”

He also provided some basic rules that will help companies avoid FDA enforcement action in this area:

  • Stay on label;
  • Use reminder advertising when appropriate;
  • Make sure you mention the generic name with any mention of the brand (even in a URL);
  • Submit any promotional messaging under 2253; and
  • Do not communicate indication and product name in any message without corresponding risk information to provide balance.

Evans reiterated that claims can only be made in a balanced setting. “Do otherwise at your peril,” he said. “Since people mainly search online with very specific types of phrases, this should be an easy one to comply with. I always scratch my head when I read about Warning Letters being issued for this type of thing, as it seems like a … mistake that is easily avoided and with no clear benefit for coloring outside the lines.”

Pines noted that the FDA official’s response regarding online keywords is a clarification and not a change of FDA policy. He also suggested that now that this question has been raised with the agency, “the real issue is whether the agency’s position is going to change when it puts out its social media guidance. This is the type of question that the FDA should be looking at, and I wouldn’t be surprised if they address it.”