One of the challenges for pharmaceutical companies communicating online is knowing how to apply regulative compliance legislation in the ever-changing landscape of Internet advertising.

In the United States, one of only two countries in the world where direct-to-consumer (DTC) advertising of prescription medicines is allowed (I believe the only other country operating a DTC model is New Zealand), the Internet continues to provide new opportunities for engaging consumers directly. Yet regulators are not known for taking a proactive approach to new communications technology, so guidelines about applying regulation are sometimes responsive rather than proactive.

Such was the case when the Division of Drug Marketing, Advertising and Communications (DDMAC) of the US Food and Drug Administration (FDA) wrote to fourteen pharmaceutical companies in the United States at the end of March about their use of sponsored links on Internet search engines.

Major pharmaceutical companies worldwide have been using sponsored links on Internet search engines for some years, interpreting and applying local regulations whilst attempting to maximise return on advertising budgets. In non-DTC markets, regulation rules out any form of advertising of prescription brands but paid search has been used in corporate communications campaigns.

It is possible that in the US, the FDA’s failure to respond earlier to offending advertisements gave pharmaceutical companies a sense that the kind of advertising appearing on Internet search engines was acceptable. Some of the offending adverts date back to September 2008, yet all the warning letters were dated 26 March 2009.

Unprecedented action

It is certainly unusual for the FDA to issue fourteen letters of a similar nature in just one day. Perhaps this was an attempt not to single out an individual pharmaceutical company; or perhaps the FDA simply took some time to decide its position on Internet search advertising. What is helpful about the warnings, at least, is that the letters now make clear the FDA’s stance on this issue.

Outside the US, whilst regulation varies between territories, the FDA action provides insights into the minds of regulators and clues about how other national and international regulation might be interpreted when it comes to Internet search advertising.

Creation Interactive has carried out analysis of the FDA warnings, the affected pharmaceutical companies and their brands based on information supplied by the US Center for Drug Evaluation and Research (CDER) Freedom of Electronic Information Office. The key findings provide useful guidance for pharmaceutical companies planning Internet advertising (we have not published the full extent of our analysis here, however if you represent one of the affected pharmaceutical companies we would be pleased to supply you with a copy; please simply request a copy from Daniel Ghinn).

Internet paid search adverts are similar in format across the major search engines. The format for Google’s AdWords is a headline of up to 25 characters, followed by two lines of up to 35 characters each, followed by a display URL (web address) of up to 35 characters. So for example one of the adverts affected by the FDA warnings appeared as follows:

prescription drug internet search advertising

Note that this is not a copy of an actual Google AdWords advert but an example of how an advert might appear based on the evidence in the FDA warning letter.

FDA warnings

The FDA letters covered five specific warnings about advertising that violates regulations. Here is a summary:

Omission of risk information

Every one of the FDA’s fourteen letters to pharmaceutical companies warns about omission of risk information. The FDA pointed out that by omitting risks associated with drugs promoted in the adverts, the adverts suggest that the named brands are safer than has been demonstrated.

The FDA was clear to point out that whilst the adverts were linked to the products’ websites (which included risk information), this was insufficient to mitigate what it said was the misleading omission of risk information from the advertising.

Minimization of risk information

One of the fourteen letters goes beyond the omission of risk information to warn about minimization of risk information. Specifically, the advert text claimed that the drug has “Low Incidence of Side Effects. The FDA pointed out that the use of this claim, coupled with total omission of risk information, severely minimizes the risks of [the advertised drug]“.

Inadequate communication of indication

All but one of the fourteen letters warns of inadequate communication of indication. The primary issue here appears to be that by failing to adequately describe the indication, the indication for the drug is broadened. For example, the FDA pointed out to one pharmaceutical company that their advert for a drug “misleadingly broadens the indication of [the advertised drug] by implying that any patient with cancer who requires treatment for breakthrough pain is a candidate for [the drug’s] therapy, when this is not the case.

Overstatement of efficacy

One of the fourteen letters adds a warning about overstatement of efficacy by failing to state that there is a limited time over which the drug can be used. The FDA warned “By omitting this information, the link suggests that the drug can be used indefinitely, when this is not the case.

Failure to use established brand names

All fourteen of the FDA’s letters warned of failure to use the full established names of the drug being promoted.

FDA requested action

The FDA letters request that the pharmaceutical companies immediately cease the advertising and respond with details of all promotional materials in use for the affected drugs.

The FDA also encourages the pharmaceutical companies to review their promotional materials for other prescription drugs promoted in the United States and to discontinue or revise any materials with the same or similar violations.

What does this mean for Internet search advertising?

These FDA warnings are challenging. Some of the ads, for example, do not mention brand names in ad text or headlines, only in the URL itself. Yet the FDA specifically warns about these ads, that “the  sponsored links for [these drugs] fail to present the full established name of the drugs being promoted, despite the requirement to do so.

There are several possible arguments against the FDA warnings, and it remains to be seen whether any of the affected pharmaceutical companies will contest the warnings. However what is clear from the letters is that the FDA views Internet search advertising as a complete advertisement, not – as many might suggest – simply a link to information.

One of the challenges with Internet search advertising is the limited length of text available for your advertisement. In fact it may not be possible to publish an Internet search advertisement that adequately meets the FDA requirements.

Whilst the FDA warnings bring some clarity to its position, there are still questions left unanswered about the way that Internet search advertising is targeted. for example, if a pharmaceutical company placed an Internet search advertisement that did not mention their drug name at all, but was targeted at Internet user searches for the drug name, would the FDA consider this a violation of regulations? It might be difficult to prove such advertising was taking place.

Another interesting possibility is whether the FDA would consider that ‘natural’ or ‘organic’ search results might be seen as advertising. On the one hand, website owners are not in control of what appears in natural search results because by their nature the result or position cannot be ‘bought’. However it is possible to influence the way a website is described in natural search results, and its relative position on the page. Advanced search engine optimisation strategies are employed by pharmaceutical companies to achieve these results.

The international impact of the FDA warnings should also be considered by pharmaceutical companies outside of the United States. Whilst regulation and regulators differ around the world, it remains to be seen whether the FDA action will shape regulator action internationally.

Recommendations for pharmaceutical marketers

You might ask why so many pharmaceutical companies received an FDA warning all in one day. How and why are Internet advertisements approved that would never be published in a magazine or shown on television? Could it be that Medical, Legal and Regulatory Affairs departments are not communicating with marketers and communicators? Or is it a lack of awareness of the medium, or of the current FDA regulations? Or simply that ‘everybody else is doing it so why don’t we’? For most of the companies affected, it is possible that several of these factors were combined.

The FDA warnings will certainly provide some food for thought for pharmaceutical brand managers and communicators around the world. Yet there is much that can still be achieved by pharmaceutical companies within the boundaries of regulation.

If you are a senior leader or have responsibility for regulatory affairs for a pharmaceutical company, what should you do? My advice would be to educate your medical, legal, brand and communications teams. Workshop together, constructively. Don’t avoid the issue, but tackle it head on. Take proactive action. Analyse your current digital marketing. Research Internet user behaviour, and engage regulators in an informed discussion.

If you are affected by the topics discussed in this article and would like advice about how to take action, why not talk with one of Creation Interactive’s experts in digital engagement strategy? If you are responsible for marketing or communications in prescription-only or over-the-counter medicines, our experience could help you develop a successfuldigital advertising strategy. Contact us to find out how we could help.

Thanks to Eye on FDA for inspiring this piece by first alerting us to the FDA action, and thank you so much to pharmaceutical colleagues for your constructive input to my drafts. You know who you are!