FDA’s New Social Media Policy

The social media policy of FDA applies to all employees and contractors of the drug administration. The policy outlines expectations and guidelines to encourage healthy use of technologies that support FDA’s communication and exchange of credible information with the primary interest of protecting and promoting public health.

Definition and scope of the policy

FDA defines social media as any web or mobile-based platforms that allow interaction of many individuals on a virtual platform through audio, video, photos, blogs, wikis, and microblogs. However, FDA’s social media policy does not supersede any legal obligations. Topics covered under this policy include, but is not limited to, social media information specific to FDA employees and scrutiny of FDA products, regulations, policies, programs, and initiatives within its jurisdiction. This policy also allows FDA to examine opinions or job titles to ensure dissemination of unbiased and scientifically backed data on social media platforms.1

Laws governing use of social media by FDA

FDA is required to comply with federal laws and regulations such as compliance with ethics, Section 508 of the FDA’s Accessible Electronic and Information Technology Policy, copyright, data privacy and security, as well as management of records.1

Social media etiquette and rules for FDA employees and contractors

FDA understands and encourages personal views of its employees and contractors provided they follow all standard and ethical conduct guidelines and principles laid down by the organization. Employees or contractors are not permitted to use their official title, authority, or FDA email address to open social media accounts nor are they allowed to disclose any non-public data unless authorized by the office of the FDA.

The Office of External Affairs (OEA) Web and Digital media team and the Office of Information Management and Technology (OIMT) monitor FDA’s social media compliance and are involved in devising social media strategies for communication. Official communications from the FDA are always screened by OEA and OIMT before reaching any public domain.

FDA guidance documents

There are four guidance documents published by the FDA that addresses questions on appropriate social media use for different situations such as:2

  • Presentation of risk-benefit data for prescription drugs and medical devices on media platforms that have character space limitations
  • Correction of incorrect or misinformed third-party data on prescription drugs and medical devices
  • Response to unsolicited requests for information considered off-label for prescription drugs and medical devices
  • Post marketing submissions of interactive promotional media for prescription drugs and devices

Presentation of risk-benefit data for prescription drugs and medical devices on media platforms that have character space limitations:3 FDA provides recommendations on how firms should provide accurate information on the therapeutic benefits of the product while adequately informing the public of the associated risks if used without appropriate medical advice. The FDA recommends that a drug’s risks and benefits should be conveyed in a single message for concise reading. If not all risks can be mentioned along with the benefits, the most serious or life-threatening risk should be communicated in that message. FDA also provides additional recommendations such as inclusion of established name along with trade or brand name of the product, or inclusion of at least one specific dosage form along with the risk-benefit profile of the drug or medical device.

Correction of incorrect or misinformed third-party data on prescription drugs and medical devices:4 Any misinformation by an independent third party should be accompanied by appropriate corrective actions by the firms. Appropriate correction actions should be accurate, concise, factual, scientifically backed, neutral in tone, and non-promotional in content. The information is posted in the same forum as the misinformation or should reference the inaccurate information. The firm should also mention its affiliation with the third party. Although FDA does not expect any firm to intimate them about the corrective measures taken, it recommends that the firm ensures appropriate record keeping of these corrective measures in case of future queries that may arise from the FDA’s office.

Response to unsolicited requests for information considered off-label for prescription drugs and medical devices:5 Unsolicited requests could be non-public and public requests made by individuals or an entity that is independent of the firm. Non-public unsolicited requests can be in the form of an e-mail or call seeking off-label information of a drug or medical device. Public unsolicited requests include questions asked during a live interaction with the firm or question posted on the firm’s website.

Response to non-public unsolicited requests: FDA recommends that response to such communications should be specific and private. The response should be sent only to the individual who has made the request with truthful, scientific, and accurate information. FDA also suggests that medical and scientific experts of the firm should address such requests while maintaining records of the requestor and the response provided, including any follow-up queries from the requestor.

Response to public unsolicited requests: FDA recommends that the firm responds to requests that are pertaining to its own product and not that of a competitor’s product. For all off-label use of products, the firm should ask the individual to reach out to their medical affairs or scientific department by providing the official contact number and email address. Representatives who answer such unsolicited requests should disclose their official association with the firm. These representatives should avoid providing responses that may be perceived as having a promotional tone.

Post marketing submissions of interactive promotional media for prescription drugs and devices:6 FDA considers a firm responsible for promoting their products on sites that are owned and controlled by the firm or on behalf of the firm. In addition, FDA holds the firm accountable for any promotional content that is generated by an employee or by an agent who acts on behalf of the firm. FDA also holds firms responsible for promotion on third-party sites if the said firm has existing privileges such as editorial review and preview. However, FDA does not hold a firm responsible for third-party promotion of its products if the firm has no influence on the third-party site other than an occasional financial support or if the firm supplements the third party with promotional material without the intent to influence promotion of its products on the third party website.

Firms are required to fill Form FDA 2253 (Regulatory Submissions in Electronic and Non-Electronic Format for promotional labeling and advertising materials for human prescription Drugs) or Form FDA 2201 (Electronic submission requirement for post marketing safety reports for approved new animal drugs) detailing the number of sites that they are responsible for. The firm should also provide communication details of any third-party site that it has engaged on Form FDA 2253 or Form FDA 2201.

A monthly updated listing is to be provided to the FDA to show non-restricted sites on which the firms are actively participating, i.e., real-time or interactive sessions. Any site with restricted access should also be brought to the notice of the FDA in the monthly listing on FDA 2253 or Form FDA 2201. Screen shots of these restricted-access sites should be included in the monthly listings. FDA also lays emphasis on formatting and encourages the firm to make visually appealing communications.

Importance of FDA social media policy

The social media guidance documents from FDA will ensure that pharmaceutical companies and biotechnology sectors make informed decisions by increasing transparency and by allowing public better access to credible knowledge sharing platforms to understand various diseases and available treatment options.

 Sources

  1. USFDA. (2015). U.S. Food and Drug Administration Social Media Policy. https://www.fda.gov/media/94313/download Accessed on April 30, 2020.
  2. https://www.fda.gov/about-fda/website-policies/fda-social-media-policy Accessed on April 30, 2020.
  3. USFDA. (2014). U.S. Department of Health and Human Services. Guidance for the industry. Internet/Social Media Platforms with Character Space Limitations – presenting risk and benefit information for prescription drugs and medical devices. https://www.fda.gov/media/88551/download Accessed on April 30, 2020.
  4. USFDA. (2014). U.S. Department of Health and Human Services. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. https://www.fda.gov/media/88545/download Accessed on April 30, 2020.
  5. USFDA. (2011). U.S. Department of Health and Human Service. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices https://www.fda.gov/media/82660/download. Accessed on April 30, 2020.
  6. USFDA. (2014). U.S. Department of Health and Human Service. Fulfilling Regulatory Requirements for Post marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics https://www.fda.gov/media/87685/download. Accessed on April 30, 2020.

Leave a Reply

Your email address will not be published. Required fields are marked *