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Direct-to-Consumer (DTC) Advertising in the Age of the Internet and Social Media

August 26, 2015 | Elaina Howard, PhD, Clinical Research Scientist II | Regulatory Affairs

More and more consumers are turning to online platforms to get information about all types of products, and as such, pharmaceutical companies have turned to online advertising of their products.

Because the internet and social media are becoming increasingly popular outlets for direct-to-consumer (DTC) advertising of prescription drugs, the FDA has established regulatory guidelines for this type of advertising by pharmaceutical and biotechnology companies.

In 2009, the FDA convened a public hearing to solicit comments on its proposed regulation of online DTC advertising, as well as the use of social media in the advertising of pharmaceutical products.

Since that time, FDA has issues four draft guidance documents covering their current thinking on the following topics:

Presenting

Each of these guidances are summarized briefly below.

Presenting2

This guidance references platforms such as Twitter (limit of 140 characters) and sponsored links for search engines, which also have character space limitations.

Despite these space limitations, the same regulations for product promotional advertising apply.

Both benefit and risk information should be presented in a balanced fashion, as well as a way (eg, hyperlink) for consumers to access a more complete risk assessment.

When creating DTC ads using these platforms, the following should be taken into consideration:

  • Benefit information should be accurate, non-misleading, and reveal material facts within each individual communication.
  • Benefit information must be accompanied by risk information within the same individual communication; if this cannot be done, another platform should be considered in which a fair balance of benefit and risk information can be presented.
  • For risk information, the most serious risks should be presented, at a minimum.
  • In terms of product information, the proprietary and established names for a drug must both be presented, and any landing page associated with a hyperlink must communicate these names and at least one dosage form and quantitative ingredient.

In order to accomplish all of this using a platform with character space limitations, the use of commonly recognized symbols, dashes, and abbreviations can be helpful!

An example of how to present benefit:risk information within character limitations is below:

Presenting3

correcting

As discussed in this guidance, examples of third-party misinformation may appear on many online platforms.

For instance, what would you do if someone provided misinformation about your product in a blog post or via comments, independent chat rooms, social media posts, or even interactive, crowdsourced reference pages such as Wikipedia?

incorrect
Whether or not a company provides a correction for the misinformation is voluntary; however, should a company decide to do so, the communication should:·

  • Be relevant, tailored, and responsive to the misinformation·
  • Be non-promotional, accurate, and consistent with the FDA-required labeling for the product
  • Be supported by sufficient evidence and be posted in conjunction with the misinformation in the same area or forum
  • Disclose that the person providing the corrective information is affiliated with the company responsible for the product

requiring

This guidance outlines the situations in which online interactive promotional material, such as blogs, microblogs, social networking sites, and live podcasts, should be submitted to the FDA.

Interactive, real-time sites must be submitted to the FDA at the time of the initial display, and monthly update reports are required. These reports do not need to include screenshots of the site’s material, unless the site is restricted or password protected.

Online sites that do not display real-time information, such as static web pages, are subject to regulations similar to those for print ads and are not covered in this guidance.

responding

Although products are often prescribed for off-label use by healthcare professionals, pharmaceutical companies need to be careful how and when they provide information about off-label use of their products. This guidance addresses responding to unsolicited requests for off-label information, including those that occur via social media.

This guidance differentiates between unsolicited (requests from individuals not affiliated with the company) and solicited requests (invitation from a representative of the pharmaceutical company) and only details how to respond to unsolicited requests.

In terms of unsolicited requests, the guidance differentiates between public and nonpublic requests:

publicrequests2

Warning letters: DTC advertising using social media

If the FDA finds that DTC advertising materials are not compliant with these regulatory guidances, they will issue a warning letter detailing the violations.

These warning letters, and the promotional material or a screenshot of the material the letter references, are posted here.

These letters are useful in determining the types of violations that are eliciting letters from the FDA and are especially useful when considering the use of DTC advertising in newer platforms, such as social media.

Stay tuned for our upcoming post evaluating the Kim Kardashian drug promotion debacle and the ensuing warning letter from the FDA…

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Category: Regulatory Affairs
Keywords: DTC Ads, Internet, Social Media

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