One word can sum up FDA’s philosophy in the new draft guidances for promoting Rx products in the online realm: balance.

The agency is applying the same regulatory approach to information on the Internet that it takes towards print and broadcast promotions: there must be equal disclosure of a product’s benefits and risks. But given the space constraints of these platforms, this traditional tack could deter companies from using them.

“The rules are exactly the same as in every other context,” said Jeffrey Wasserstein, of Hyman, Phelps & McNamara. “FDA is saying to some extent, ‘Our hands are tied. We require fair balance and disclosure of risks. Why wouldn’t we do it here?’”

Wasserstein, who specializes in pharmaceutical promotional and marketing issues and is co-founder of the FDA Law Blog, said he would have liked to see some flexibility or creative thinking on FDA’s part. However, he said, “in fairness to them, short of coming up with something out of their regulatory paradigm it’s difficult to see what they could have come up with.”

FDA released two social media draft guidances on June 17. One advises companies how they can promote their products on social media platforms that have character space limitations, primarily Twitter. The other addresses how they can voluntarily correct misinformation about their products on independent third-party sites.

The agency said it worked across FDA centers and offices to develop best practices that can be applied to existing Internet/social media platforms and those that have yet to be developed.

“Regardless of the platform chosen by product manufacturers and their representatives to put forth product information, truthful, accurate, non-misleading, and balanced communications about medical products best serve the public,” FDA said in response to questions about the guidances.

What To Include In a Tweet

The character space limitations draft guidance suggests a formula for sending a twitter message about a product. It says each individual tweet should include the product name, its indication (i.e., the benefit information), the most serious risks associated with the product and a hyperlink to a destination (such as a landing page) that is devoted exclusively to the communication of risk information about the product.

Solving For 140: FDA’s Twitter Formula

The draft guidance states that at a minimum the message should communicate the most serious risks associated with the product, which generally would include risks in a boxed warning, those that are fatal or life-threatening, and all contraindications.

Given this requirement and the 140-character limitation of Tweets, the agency acknowledges that Twitter will not be appropriate for some products, particularly those with complex indications or extensive serious risks Also see "FDA’s Twitter Formula Allows Tweets About Products Without Excessive Risks" - Pink Sheet, 18 June, 2014..

FDA includes sample tweets about a fictional drug for mild to moderate memory loss, NoFocus. The agency says both the brand and generic names should be included in the message. It also advises that at least one dosage form and the quantitative ingredient information be included on the landing page associated with each hyperlink in the communication.

Sample Tweet

Source: Tweet text from FDA's draft guidance

While some stakeholders had been hoping that FDA would allow risk information to be conveyed by clicking on a hyperlink, Wasserstein said he did not expect the agency to do so since it has never permitted this in any other context.

Most firms have been waiting for FDA guidance before using Twitter to promote their products. AstraZeneca PLC is one company that has dabbled in the space and its experience shows some of the problems that can arise. Last year it sponsored tweets on the Associated Press’ Twitter feed that directed readers to its YouTube channel for information about GERD.

While the tweets did not mention AstraZeneca’s GERD treatment Nexium (esomeprazole), the drug name appeared when the tweets were expanded. When the company discovered this it deleted the tweets Also see "AstraZeneca Pulls Twitter Ads, Showing Risks Of Expansive Social Media Platforms" - Pink Sheet, 30 August, 2013..

The character space limitations draft guidance also discusses how to promote an Rx drug on sponsored links, such as Google’s Sitelinks. FDA notes that the proper sponsored-link format includes the brand and generic names with a hyperlink to a landing page about the drug and additional hyperlinks to landing pages that convey risk information for the drug.

Several years ago, FDA provided direction on what information must be included in company-sponsored search results when it issued a cluster of letters to 14 firms objecting to their sponsored links. The agency said that if links contain the name of the drug and a therapeutic claim, they must also include risk information. In addition, FDA said the links should also mention a product’s generic name Also see "Internet Searching May Get ‘Riskier’ For Patients After FDA Citations" - Pink Sheet, 6 April, 2009..

Next Guidance To Address Use Of Links

The misinformation draft guidance also emphasizes that companies must have a balanced approach in correcting errors about their products on independent third-party sites. Firms that choose to correct information must correct all errors within a defined area of the forum, including exaggerated efficacy claims ([A#14140617008]).

FDA clarified that once a company informs the author or site administrator of the misinformation it does not have to continue to monitor the site and FDA will not hold it accountable for the third party’s actions.

Since firms do not have to correct errors on these sites it remains to be seen whether the guidance will influence whether they do so.

FDA took nearly five years to produce the guidances. The agency began the process with a two-day meeting in November 2009 to get input from stakeholders. In January FDA issued its first draft guidance directed exclusively to social media. That document addressed what interactive promotional material, such as that on Twitter and Facebook, requires FDA review Also see "FDA’s Social Media Guidance Gives Firms A Pass On User-Generated Content" - Pink Sheet, 20 January, 2014..

The agency is required under the 2012 FDA Safety and Innovation Act to issue guidances by this July. In its guidance agenda for 2014 FDA noted that it would be issuing three guidances this year, the two just released and a guidance on the use of links to third-party sites ([A#00140210006]).

Wasserstein said one aspect of social media that has yet to be addressed is communication about adverse events. For example, if someone tweets about an adverse event and a firm tweets back and gets no response, it is unclear whether the company would need to take further action.

Public comments on the two draft guidances are due by Sept. 16.

Social Media Marketing: FDA’s Old-Time Approach May Turn Industry Away

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