FDA guidance on twitter is irrelevant for global pharma

By Daniel Ghinn

In June this year, the US FDA issued draft guidance for healthcare companies on how to tweet and conduct search advertising for branded products. Or to be more precise: Guidance for Industry on‘Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices’. The key point of this guidance is to address the challenge of character space limitations on platforms such as Twitter, which is restricted to 140 characters per tweet, or online paid search on search engines such as Google and Yahoo, which, in the FDA’s words, “have limited character spaces as well as other platform-imposed considerations”.

The FDA is clear that this new draft guidance is literally just that – a draft which has been distributed for comment purposes only, reflecting the FDA’s recommendations but not legally enforceable rights or responsibilities. “You may,” says the FDA, “use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations”. In other words, pharma is free to continue to innovate, within regulatory requirements.

It may be no surprise, then, that in the FDA’s own recommendations, nothing significant has changed for the pharmaceutical industry, which has been asking the US regulator for guidance since well before the 2009 FDA public hearing on social media.

A breakthrough for pharma on Twitter?

The FDA oversees labelling of drugs and medical devices in the US under the Federal Food, Drug and Cosmetic Act (FD&C Act), including advertising and promotion of these products. Under the FD&C Act, representations about a company’s product must include required information about that product’s risk. US television or print advertising of prescription drugs, for example, carries extensive required information about risk that would simply not fit into a tweet or sponsored search link.

“The FDA does appear to make a concession in its guidance, allowing companies to present a more concise description of risk information to fit within a single tweet”

The FDA does appear to make a concession in its guidance, allowing companies to present a more concise description of risk information to fit within a single tweet or sponsored search advertisement, provided that the risk information is comparable in scope to the benefit information also included. A mechanism should also be provided, says the FDA, providing direct access to a more complete discussion of the risks associated with the product.

On the one hand, this seems like a breakthrough: the FDA is allowing pharma to post concise benefit and risk information relating to a branded product via Twitter or sponsored search links, together with a link to more detailed risk information.

FDA guidance irrelevant in global market

In practice, however, things are more complicated with regards to Twitter since, unlike search advertising, where specific branded adverts may be targeted at users in selected countries, most tweets are visible to people using the Internet anywhere in the world, regardless of their location.

For a global company promoting products available in multiple markets, under different regulatory conditions, the FDA guidance is therefore largely irrelevant. An FDA-compliant tweet promoting a branded prescription product may be non-compliant in many markets outside the US, where the promotion of prescription products is not allowed at all.

Aside from geo-location targeted Twitter advertising, or sending direct messages to individual patients, both of which would carry their own regulatory compliance challenges but would be hidden from non-target stakeholders, pharma’s only option for supporting brands using Twitter is to post public tweets that may be read by a worldwide audience. What is pharma to do, then, when it comes to talking about products on Twitter? Let’s examine the different approaches adopted by two companies.

Novartis: ‘US ONLY’ tagging

A novel approach taken by Novartis is to label its US-focused brand promotion ‘US ONLY’, indicating to readers outside the US that the content is not intended for them. The company’s Gilenya branded Twitter account, @GILENYAGoUSOnly, includes ‘USOnly’ in the Twitter profile name and the text ‘For US audiences only’ in the profile description. This contrasts with Gilenya’s branded Facebook page, which has been configured for US-only audiences and is therefore not visible to most people outside the US. Unlike Twitter, Facebook includes options for page owners to restrict access according to a user’s location.

Novartis also includes the words ‘US only’ in tweets sent from the Gilenya profile, to remind readers that the content is only intended for US residents. The channel is used to connect patients with richer content too, such as a webcast where patients can hear from a healthcare professional:‘Considering GILENYA? Dr Wynn will be answering your questions at our next webcast. Sign up here: …US only’, reads a tweet linking to a webcast registration form for US residents. This approach allows registrants to confirm their locations prior to further participation.

Novartis also uses a ‘US ONLY’ tag on tweets from its global corporate account, @Novartis, to differentiate those tweets not intended for an international audience: ‘US ONLY: When living w/ #Cushings disease, pts should keep their docs in the loop. Get tips on talking to docs…’ reads a recent tweet.

Boehringer Ingelheim: targeting healthcare professionals

Boehringer Ingelheim (BI) has been a long-time pharma innovator in social media and its current Twitter tactics include engaging congress participants with targeted tweets featuring the generic name of its products.

‘At #SSC2014 and interested in reversal of #anticoagulants and #dabigatran? Head to room 203 C-E for 11:20…’ reads a recent tweet advertising a meeting on the Control of Anticoagulation, using the #SSC2014 hashtag to target attendees of the International Society on Thrombosis and Haemostasis Scientific and Standardization Committee annual meeting in Milwaukee.

In another tweet, the company shares news of a new study: ‘New study of dabigatran in patients with #Afib undergoing ablation:…’ The tweet links to a press release announcing a Pradaxa study, along with a caveat about intended audience: ‘For media outside of the US, the UK & Canada only”.

In another Twitter initiative, BI continues to develop the digital role of Key Opinion Leaders, with a Twitter chat connecting patients with Dr Geoffrey Cloud, Stroke Physician at St George’s Hospital in London, who joined Twitter to take part in the live chat. ‘My first activity on Twitter: joining #ChatAFib on Monday to talk about the role of #Afib patient education’, he tweeted.

So, while the FDA draft guidance might not have brought about the simplification of pharma social media some had hoped for, the reality is that the challenges of today’s complex, digitally-connected world continue to inspire innovation among pharma’s pioneers. This story is far from over.

This story was originally published in pharmaphorum.


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Meet the Author

Daniel Ghinn

Daniel has been at the helm throughout the company’s life since 1998. His rich expertise in working with pharmaceutical businesses has enabled CREATION to build business solutions that fit our clients’ needs.

Daniel is married to Jo, has three children, a cat, a dog, 28 fish, and 160,000 bees.