FDA Issues Draft Guidance for Drug and Device Information on Social Media

by Akerman LLP - Health Law Rx

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character limited service such as Twitter as well as how to respond to incorrect or misleading information posted on the Internet by independent third parties. The FDA's guidance effectively forecloses the use of Twitter with drugs and devices having substantial risk factors.

Tweets Must Include Risk Information

When using Twitter and other character limited services, the Agency emphasized that, despite the small space, companies must include risks along with benefits in each individual message or tweet. Thus, an appropriate tweet should consist of three pieces: 1) the benefits, 2) the most significant risks, and 3) a direct hyperlink to a complete discussion of the risks. Additionally, messages dealing with prescription drugs must list both the brand and generic drug names. For a service limited to 140 characters, including this information can be a challenge.

The FDA recommends that a tweet or other size-limited message include "all risk concepts from a boxed warning, all risks that are known to be fatal, and all contraindications." If a drug has a boxed warning along with any fatal risks or contraindications, it will be difficult to comply with the Agency's guidance in a 140 character tweet. If a drug has no boxed warnings, fatal risks, or contraindications, the company must include the most serious remaining risk. As shown by the FDA's model, even a tweet about a drug that has no boxed warning, fatal risks, or contraindications still has very little room for much mention of its benefits:

NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk [134/140]

Thus, for drugs with more serious risks (or even long brand or generic names), Twitter is unlikely to be a viable platform.

Hyperlinks Must Lead Directly to Risk Information

At least one hyperlink in the tweet must link directly to the complete risk information. It is not sufficient for the link to point back towards a page with promotional material such as a drug's home page. Further, for drugs, a dosage form and amount must be listed along with the drug's brand and generic names at the beginning of the web page. The FDA will not object to the use of URL shortening services (e.g., https://goo.gl/ or https://bitly.com), though the Agency prefers that the text of the hyperlink indicate that it will lead to risk information.

Guidelines Also Apply to Sponsored Links

The FDA's guidance also applies to sponsored links on Google and other search engines. Any sponsored link promotion must include the same three components (benefits, risk, link), along with the generic name for drugs which must be placed directly to the right of or below the brand name. Given the character limitations, this placement could be problematic for drugs with a longer generic name. The short name chosen by the FDA in its model is illustrative (underlined text indicates hyperlinks):

Headhurtz (ouchafol) [20/25 character limit]




For severe headache from traumatic brain injury


Boxed Warning



Potential for brain swelling

Potentially fatal drug reaction



Risk Information


Life-threatening drop in heart rate

Important safety information


Risks Only Required if Benefits are Discussed

The FDA's social media guidance only applies to those messages that discuss benefit information. It does not apply to "reminder promotions," which the FDA describes as "labeling or advertising that calls attention to the name of a drug or device but does not include indications, dosage recommendations, or other information."

Companies Not Responsible for Independent Third Party Content

The FDA also issued guidance detailing how a company should respond to inaccurate information posted online by independent third parties, such as in a blog or forum post. Importantly, the Agency stressed that a company has no obligation to respond to content generated by entities over which it has no control. This applies even if the information is posted on a forum supplied by the company, provided that the company does not substantively screen or edit posts (other than for profanity or the like).

Voluntary Correction of Misinformation

If a company does choose to respond to misinformation, the correction need not satisfy "otherwise applicable regulatory requirements regarding labeling or advertising," provided that the correction satisfy the requirements listed in the guidance document. The response should:

  • Be relevant and responsive to the misinformation;
  • Be limited and tailored to the misinformation;
  • Be non-promotional in nature, tone, and presentation;
  • Be accurate;
  • Be consistent with the FDA-required labeling for the product;
  • Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
  • Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author);
  • and Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

While most of these requirements are self-explanatory, the Agency provides additional guidance on a few of them.

Label Information Must Be Included with Correction

Regardless of whether all label information is relevant to the misinformation, the FDA requires that the label information be included in a "readily accessible format" along with the correction. This can either be in a link directly to the label information or in a PDF document containing the label information. Links to web pages containing any promotional content or tone will not satisfy this requirement.

Company Should Clearly Define the Scope of the Corrected Material (and Correct ALL Misinformation Therein)

If a company chooses to correct misinformation, it should clearly define what material it is correcting. For instance, if a company is only responding to a single post, it should make that clear. Once the company has defined the scope, it must correct all misinformation within that scope, both positive and negative. Thus, if a post contains information incorrectly identifying the side effects of a drug while at the same time exaggerating its effectiveness, the company must correct both errors.

Additionally, the correction must be limited to addressing the misinformation. If a post contains an error regarding a contraindication, the company cannot both correct that error and also, for example, compare the product to a competitor's product.

Continual Monitoring Not Required, But Records Should Be Kept  

If a company corrects an error, or attempts to correct an error (by e-mailing a blog author, for example), it is under no obligation to continue to monitor the forum or site to ensure that the original author has implemented the correction, or that anyone else has not posted additional misinformation. However, to ensure that the company can respond to any FDA inquiry, appropriate records of any corrections (including the original misinformation) should be retained. This is particularly important in light of the ephemeral nature of information on the Internet.

Guidance Shows Care Must Be Taken When Using Social Media

As these guidance documents show, companies wishing to use social media platforms must be careful not to engage in the sort of informal back and forth which may be used by others on these platforms. Tweets should be carefully vetted to make sure the benefit and risk information is balanced and that the required links are present. Additionally, employees attempting to correct mistakes should always make sure to link back to the label, clearly define the material they are correcting, and correct all misinformation within that material.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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