- FDA Proposes Social Media Guidelines for Pharmaceutical and Medical Device Companies
- July 14, 2014
- Law Firm: Baker Sterchi Cowden Rice L.L.C. - Kansas City Office
On June 17, the FDA released a draft guidance proposing guidelines for how manufacturers, packers, and distributors should present prescriptions and medical devices on internet/social media platforms with character space limitations, and guidelines regarding how a company may correct misinformation created or disseminated by independent third parties on FDA-approved or cleared products.
Guidance for Industry: Internet/ Social Media Platforms with Character Space Limitations- Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
In its guidance, the FDA notes that promotional labeling for drugs and devices and advertisement for prescription drugs and restricted devices can misbrand the product if representations about the use of the product are made without disclosing certain information about the product’s risk. The draft guidance sets out provisions companies should consider to create a balanced presentation. Risk information should be comparable in content and prominence to benefit claims to achieve a balanced presentation. The FDA acknowledges the difficulty companies may face in presenting necessary information on products with complex indications or extensive serious risks, especially on Internet/social media platforms with character space limitations. Therefore, the FDA advises if an accurate and balanced presentation of risks and benefits of a product are not possible within the character limits, the company should reconsider using that platform.
The guidelines set out three sections for consideration in presenting risk and benefit information on Internet/social media platforms with character space limitations. The sections include: general factors that companies should consider in the communication of benefit information, factors that the FDA considers in disclosure of risk information, and additional recommendations for the inclusion of other product information.
General Factors: Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication. Benefit information should be accompanied by risk information. If a company finds that adequate benefit and risk information, and other required information, cannot be communicated within the character space limitations, the company should consider a different platform.
Factors Considered in Disclosure of Risk Information: Risk information should be presented together with benefit information in a posting. The FDA encourages, at a minimum, a company should include the most serious risks associated with the product. A concise disclosure of specific risk information should be presented together with benefit information. The FDA acknowledges that a company may face constraints because of character space limitations, therefore, they suggest a mechanism, such as a hyperlink, be provided to allow direct access to a more complete discussion of risk information. Risk information should be comparable to the benefit information, including formatting.
Additional Recommendations for the Inclusion of Other Product Information: The FDA recommends the established name accompany the trade or brand name of the product. Additionally, the name of at least one specific dosage form and the quantitative ingredient information should be provided. The FDA suggests that companies include the generic name of the product directly to the right of, or directly below, the brand name and at least display at least one dosage form and quantitative ingredient information on the land page associated with the hyperlink. The FDA notes that common abbreviations, punctuation marks, and other symbols may be used to address character space limitations.
It should be noted that the FDA states in the draft guidance that these suggested regulations do not address promotion via product websites, webpages on social media, and online web banners, as they do not impose the same character space constraints, such as twitter.
Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about Prescription Drugs and Medical Devices
The second draft guidance released by the FDA responds to stakeholder’s requests for guidance regarding a company’s voluntary correction of misinformation created or disseminated by independent third parties. The FDA acknowledges that it may benefit the public health for companies to correct misinformation about their products. The FDA notes that the draft guidelines do not apply to communication owned, controlled, created, or influenced, or affirmatively adopted or enforced, by, or on behalf of, the company. The draft guidance sets out suggestions for companies to correct misinformation in a truthful and non-misleading way.
Appropriate Corrective Information: The FDA suggests that a company’s corrective information should be relevant and responsive to the misinformation, limited and tailored to the misinformation, non-promotional in nature, tone, and presentation, accurate, consistent with FDA- required labeling, supported by sufficient evidence, and discloses the person providing the corrective information’s affiliation with the company. In the alternative, the FDA suggests a company can provide a reputable source from which to obtain the correct information.
Correcting a Clearly Defined Portion of a Forum: Because a firm may not be able to correct all misinformation about its product in a single forum, a company should identify the misinformation it is choosing to correct in the forum, define the portion of the forum it is correcting, and describe the location or the nature of the misinformation that was corrected and should provide a date the correct is made to be sure that parties do not assume the company responded to the whole forum.
Approaches to Correcting Misinformation: A company may choose to correct misinformation directly on the forum, provide the corrective information to the independent author, or request that the site administrator remove the misinformation or allow comments to be posted. The FDA acknowledges that they will not hold a company accountable for an independent third party’s subsequent actions or lack thereof.
The FDA does not expect a company to continue to monitor the third-party website or communication once they have undertaken to correct the misinformation. Additionally, as long as the correction of misinformation is truthful and non-misleading pursuant to the recommendations by the FDA in the draft guidance the FDA does not intend to object to the voluntary corrections even if they do not satisfy otherwise applicable regulatory requirements. The FDA does provide a warning that “if a firm chooses to provide information outside the scope of this draft guidance, the firm should ensure the information it provides complies with any applicable requirements related to labeling or advertising.” Lastly, the FDA does not expect companies to submit corrections; however they do recommend that companies keep records to assist in responding to questions that may come from the FDA.