FDA Issues Draft Guidance for Drug and Device Information on Social Media

by Akerman LLP
Contact

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices.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]  
www.headhurtz.com  
For severe headache from traumatic brain injury  
Boxed Warning Warning
Potential for brain swelling Potentially fatal drug reaction
Warning 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.

© Akerman LLP | Attorney Advertising

Written by:

Akerman LLP
Contact
more
less

Akerman LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.