
Digital marketing – can we talk?
pharmafile | April 22, 2010 | Feature | Medical Communications | digital pharma, social media
The internet and online developments such as YouTube, Twitter, Wikipedia and Facebook have already revolutionised how we communicate, and with whom.
But because of the highly sensitive nature of medical problems and medicines, communications between pharma and patients remain highly problematic, even in the de-regulated US. The demand for online health information is huge, and the US pharma industry has been pressing for clarification on rules for communicating online. The issue came to a head in March 2009 when the FDA took action to clamp down on a industry marketing practice which it thought could be endangering patients’ safety.
The US regulator sent letters to 14 major pharmaceutical companies warning them that their ‘search advertisments’, the short text ads that run beside Google results, were lacking in balanced information.
The companies were told they had to start including risk information about each drug or else be rewritten or removed. (Pharma search ads do not run in Europe, of course, because of the ban on direct to consumer advertising.)
Companies have now changed their search adverts to comply, but industry executives claim the solution is worse than the problem: their ads are more confusing and misleading than they ever would have been before.
The FDA held a special two-day event in November last year in which pharma companies and healthcare communications agencies were invited to share their views, and make suggestions for guidelines. Then in February this year a number of major US pharma companies, among them Pfizer, Novartis, Bayer. Lilly and Johnson & Johnson, filed detailed submissions on the subject, in response to five key questions from the FDA. (To see the submissions in full visit www.regulations.gov and search for ‘FDA and social media tools’.)
Give us clear regulations, not guidelines
AstraZeneca’s comment on the need for greater clarity represented a widely expressed point: “Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making. In our absence, consumers will turn to information sources that are not regulated and not always well informed.”
Once initial guidance has been developed AstraZeneca also suggests the FDA considers regularly reviewing this to ensure it remains up-to-date.
Among the most interesting submissions was that from Pfizer. Authored by its senior legal executive Geoffrey Levitt, it goes into some detail about what it believes would represent best practice. This even extends to illustrating its points with mock-ups of branded YouTube channels, branded patient forums and branded mobile applications.
Above all, Levitt’s key recommendation is that the FDA should go beyond mere ‘guidelines’ and create legally enforceable regulations.
“To assure that these requirements are legally enforceable and respect First Amendment values [freedom of speech] the agency should ultimately establish these new rules through notice-and-comment rulemaking, even if the agency initially proceeds through guidance.”
The FDA questions
Below are the five questions posed by the FDA, simplified here in the name of clarity and brevity.
1. If pharma prompts a conversation, is it responsible for what is said?
This addresses the thorny question of how accountable pharma companies should be for communications made on their behalf by third parties, or online conversations sparked off by these communications.
The FDA seems to be hinting that pharma companies cannot wash their hands of comments and conversations on websites or chat rooms that they have set up. It points out that while companies might not be able to directly control what site users say, it can moderate – effectively block or edit – the comments, and also control how long these comments remain available on the web.
It adds that materials staying on the internet for a longer period can eventually reach a “much broader audience than originally engaged”. It also points out that it is possible for companies to prompt others to communicate about their products – which might include people adding comments to open forums, or specialist bloggers. It says companies can also create online communities for patients or healthcare professionals, which raises questions about who must take ultimate responsibility for such information.
The FDA says it wants to clarify when an online conversation is “subject to substantive influence by companies that market products related to the communication or discussion’’.
The FDA does not provide a case to illustrate this particular point, but one hypothetical example would be a US pharma company ‘sponsoring’ a health blogger’s website. The question of just how independent this blogger is from the company – and conversely how responsible the company is for his or her remarks – is clearly a difficult one to answer without guidelines or principles. The FDA has asked how should companies disclose their involvement or influence over discussions or material, particularly discussions or material on third-party sites
2. How can pharma provide the full information on a drug when web talk is so abbreviated?
The FDA’s next difficult question is about how pharma companies can disclose all the prescribing and safety data it is obliged to under US law when it is communicating via the web. It mentions in particular microblogs – such as Twitter, and mobile technology, which lend themselves to very short, sharp messages, which make consumers unlikely to visit pages dedicated to lengthy safety information.
Novartis says a tool could be developed to shorten the URLs for product safety information but still promote public awareness. It says in its submission: “A new short URL, essentially a bit.ly for the FDA, that points to drug information on an FDA controlled website could be set up. Our recommendation is that the URL include a mention of “safe” or “safety.” This website could then contain prescribing information and important safety information wholly controlled and approved by the FDA, removing the need for multiple, additional reviews by an FDA committee of language used on the internet. One review, many uses.”
Novartis says the FDA could establish a set of search terms that are in the interest of public health and the FDA’s compliance agenda. It says: “These terms can be assigned a hashtag (“#”). Widely recognised by social media users, hashtags communicate and make it easier for people to find information.
“As an example, a manufacturer putting out a disease or product awareness message could then include in the message tags such as #[disease state], #usonly and #blackbox to alert patients and physicians to important aspects of the communication. It also assures the FDA that appropriate patient education steps are being carried out.”
3. What rules should govern pharma corrections to misleading or incorrect information on the web?
The FDA says there is a lack of clarity among pharma companies about how to respond to what they see as “misconceptions or misinformation about their products” on web sites beyond their control, such as blogs, social networking sites or Wikipedia-type sites. Some companies want to correct these mistakes, while others say they that if they correct such errors they could be viewed as being responsible for all the information on the target website rather than just the information they submit. US pharma companies generally said they should not be obliged to monitor and correct information about their products on third party web sites, but neither should they be penalised for seeking to correct misinformation. But clearly the FDA will have to set out rules for a more uniform approach to the problem across the industry.
4. Links to other sites
The ease with which internet users can move between sites via links means they can also move from approved/accurate information to potentially non-approved and inaccurate information very quickly. The FDA points out that pharma companies have, for instance, links to patient support group websites, “Some of these may contain information about unapproved disease conditions or unapproved uses of approved products”.
Furthermore, it points out that some companies are using unbranded URL links (i.e. where the product name is not mentioned) that take users directly to branded information. The FDA asks if parameters be established for links to and from web sites. Novartis says that merely linking to a third-party site should not make the manufacturer responsible for it. It says a number of its product sites provide links for patients to other resources (e.g. the American Heart Association and the Susan G. Komen Foundation). It says a standard disclaimer pop-up should suffice.
5. Adverse event reporting and the internet
As in the off-line world, pharma is expected to promptly review all adverse event information received or otherwise obtained from the internet and social media tools. The question is, just how far does this responsibility stretch? As the number of comment boards and networking sites continues to proliferate, monitoring all of them for any mention of adverse events would be a Herculean task.
The FDA’s current position is that companies should review any internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any sites that they do not sponsor; however, if they become aware of an adverse experience on an internet site that they do not sponsor, they should review the adverse experience and determine if it should be reported to FDA.
Implications for Europe
Regulation of pharma communications with patients is, of course, very different in Europe to the US.
It is widely expected that once published the FDA’s guidance will become de-facto rules outside of the US as well, which would provide some guidance for European marketers in the absence of similar European laws or guidance.
These and other issues were recently debated at the Berlin social media conference – or ‘unconference organised by Healthcare Social Media in Europe (#hcsmeu on Twitter) For more information visit: www.hcsmeucamp.com.
This article also appears in The Digital Pharma Guide 2010.
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