In today’s digital age where misinformation can spread rapidly and widely via internet-based channels, the U.S. Food and Drug Administration (FDA) has taken a significant step toward ensuring that accurate information about medical devices and prescription drugs is available to the public.
On July 8, 2024, the FDA issued non-binding guidance for industry titled, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” providing a framework for companies to voluntarily respond to and correct misinformation about their approved or cleared products that has been created or shared on the internet by independent third parties not acting on their behalf. The guidance also sets forth a new enforcement policy, by which the FDA will not enforce certain requirements against ‘tailored responsive communications,’ if those communications are made in accordance with the guidance’s new criteria.
Understanding the FDA’s Guidance
The FDA’s guidance (or “new guidance”) is presently in draft form and open to comment and suggestions for the 60 day period following its release. It replaces the agency’s previous draft guidance issued in 2014 titled, “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” which was never finalized by the FDA.
Over the past 10 years, the explosive growth of internet-based communication has presented considerable challenges for industry, particularly with respect to information being shared by unauthorized individuals. Therefore, even in its current non-binding form, the new guidance still offers valuable insight into the FDA’s thinking, which companies can leverage to inform internet-based communications being made in response to such misinformation.
Specifically, the new guidance provides the following key takeaways for industry:
- Scope of covered communications and misinformation
The new guidance covers voluntary, “internet-based” communications by a company addressing misinformation about its approved/cleared products that was created or shared on the internet by an independent third party. The following FDA definitions are noteworthy:- “Internet-based” information includes information shared on social media, podcasts, email, group messaging, and discussion forums.
- “Misinformation” is defined as “implicit or explicit false, inaccurate, or misleading representations of fact about or related to the company’s approved/cleared medical product.”
- “Independent third party” is a “person or entity that, in communicating about a company’s approved/cleared medical product, is not acting on behalf of that company.”
- Criteria for identifying misinformation
In the new guidance, the FDA outlines several criteria for identifying misinformation:- Factual Inaccuracy – the information is demonstrably false based on scientific evidence.
- Misleading Context – the information, while factually accurate, is presented in a way that misleads or creates a false impression.
- Potential Harm – the misinformation has the potential to cause harm to public health or safety.
- Responding to Misinformation
In order to fall within the protections of the enforcement policy, the new guidance advises that tailored responsive communications be:- Timely – Companies should respond promptly to correct misinformation;
- Truthful and Evidence-Based – Responses must be based on accurate and credible scientific evidence;
- Clear – Responses should clearly identify the specific misinformation being addressed, as well as at least one specific internet-based, independent third party communication in which the misinformation appears; and
- Supported – Responses should include certain required disclosures.
- Channels for Correction
The FDA encourages the use of the same channels where the misinformation was discovered, such as social media platforms, by responding directly to posts or comments. Additionally, industry can leverage the following:- Company Websites – by providing corrections and accurate information on official websites; and
- Press Releases – by issuing statements to reach a broader audience.
- Documentation and Reporting
Companies are advised to document their efforts to correct misinformation, such as by keeping records of the misinformation identified, the corrective actions taken, and the outcomes. The FDA reserves the right to review these records to ensure compliance with the new guidance. - Legal and Regulatory Considerations
While the new guidance provides a framework for approaching responses to misinformation, it also emphasizes the importance of adhering to existing laws and regulations regarding advertising and promotion of medical devices and prescription drugs. In other words, corrective actions should not inadvertently violate applicable laws and regulations.
Implications for Industry
The FDA’s new guidance is issued as a proactive measure to help combat the pervasive issue of misinformation in the healthcare sector. By providing a clear framework for companies to follow, the FDA aims to enhance the public’s trust by ensuring access to accurate and reliable information, as well as promote safety by reducing the risk of harm caused by misinformation. By encouraging companies to take an active role in monitoring and correcting misinformation, the FDA has made clear that companies can and should play a vital role in ensuring that accurate information prevails, ultimately protecting consumers and enhancing the credibility of the healthcare industry.
If you would like to discuss the FDA’s new guidance in greater detail, please contact Michèle Linde at mlinde@outsidegc.com.
Michèle Linde is a partner with OGC and brings more than 30 years of in-house and private legal practice experience in the life sciences industry, including work with branded and generic pharmaceuticals, medical devices, academia, cosmetics and the champagne industry. Prior to joining Outside GC, Michèle served as EVP, Global Corporate Governance, Chief Legal Officer & Corporate Secretary at Virpax Pharmaceuticals. She can be reached at mlinde@outsidegc.com or 302-256-4724.