Recently, FDA released two draft guidance documents on the promotion of prescription drugs and medical devices on the Internet and social media platforms. The long-awaited guidance provides recommendations for firms that choose to correct misinformation disseminated by independent third parties and to promote their products on space-constrained platforms, such as Twitter or sponsored ads. Comments on the guidance documents are due by September 15, 2014.
The first guidance document – Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices – describes how FDA believes manufacturers, packers, and distributors of prescription drugs and medical devices should respond to misinformation (either positive or negative) about their products disseminated by independent third parties, either on the firm’s website(s) or social media accounts or those of a third party. The guidance applies only to third-party communications for which the firm is not responsible, which may include firm-hosted discussions – in which the firm does not participate – about its products, as long as those discussions include a clear and conspicuous statement that the firm did not create or control the user-generated content.
A firm is not required to correct misinformation created or disseminated by an independent third party who is not under the firm’s control or influence, but, if it chooses to do so, FDA recommends that the firm provide appropriate corrective information that:
- Is relevant and responsive to the misinformation;
- Is limited and tailored to the misinformation;
- Is non-promotional in nature, tone, and presentation;
- Is accurate;
- Is consistent with the product’s FDA-required labeling;
- Is supported by sufficient evidence (including substantial evidence, when appropriate);
- Either is posted in conjunction with the misinformation in the same area or forum, or references the misinformation and is intended to be posted in conjunction with it; and
- Discloses that the person providing the corrective information is affiliated with the firm.
Additionally, the firm should provide the FDA-required labeling (or a link thereto). The firm is not required to correct all misinformation on a given blog or forum but, if it chooses to correct any misinformation, should clearly identify the misinformation it is correcting. The firm should also address all misinformation in a given comment or portion of a website. Finally, while FDA does not expect the firm to submit corrections to the Agency for review, the firm should maintain records of the misinformation (content, date/location of appearance) and subsequent correction.
Presenting Information with Character Space Limitations
The second guidance document – Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices – describes how firms that choose to present benefit and risk information on platforms with space constraints, such as via online microblog messaging or online paid searches, should do so. In general, promotional information must include both the benefit and risk information in the same space-constrained communication, and FDA recommends that firms evaluate whether a space-constrained platform is the best promotional tool for a particular product.
If a firm decides to promote its product on a space-constrained platform, having concluded that adequate benefit and risk information and any required information can be communicated within the space constraints, FDA recommends that the benefit information be accurate and non-misleading and reveal material facts within each individual communication. Because the accompanying risk information should be comparable in scope to the benefit information, the firm should consider whether the risk information qualifies any representations made about the product and is presented with comparable prominence and readability. Additionally, the content of the risk information should, at a minimum, include the most serious risks (e.g., fatal or life-threatening risks and contraindications) and a direct hyperlink to a more complete discussion of risk information.
Finally, FDA also recommends that firms consider FDCA requirements that, in advertising, the trade or brand name accompany the established name and that the advertisement prominently display the name of at least one specific dosage form in conjunction with the quantitative ingredient information.