FDA Q&A Document on Addressing Misinformation About Devices and Drugs: Overview

Table of content

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, had published a guidance document dedicated to addressing misinformation about medical devices and prescription drugs allowed to be marketed and used in the country. Structured as a questions-and-answers document, the guidance highlights the key points related to the applicable regulatory requirements and also provides additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance. 

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.

Introduction

First of all, the authority acknowledges that in the age of digital communication, misinformation about medical devices and prescription drugs has become a pressing issue, prompting the need for guidance from regulatory authorities. In response to the said issues, the FDA has developed a draft guidance document to assist companies in addressing misinformation about their approved or cleared medical products. 

This guidance aims to support firms that choose to address misinformation voluntarily and outlines specific communication strategies that can be employed. The document, once finalized, will represent the FDA’s current thinking on the subject, although as it was mentioned before, it does not establish legally binding obligations for the FDA or the public.

Understanding Misinformation

For the purpose of this guidance, “misinformation” refers to implicit or explicit false, inaccurate, or misleading representations of fact about a firm’s approved or cleared medical product. Such misinformation can have significant negative impacts on individual and public health by influencing medical decisions that may lead to unsafe or ineffective treatments or the avoidance of beneficial ones. 

The rapid spread of misinformation, particularly through internet-based communications, poses a severe challenge, especially when disseminated by influential individuals or platforms with large followings. Thus, addressing this misinformation is crucial, especially concerning medical products related to serious or life-threatening conditions.

Purpose and Scope

The guidance seeks to advance the FDA’s mission to ensure the public receives accurate, up-to-date, and science-based information about medical products. It revises and replaces the 2014 draft guidance titled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices”. 

The updated guidance incorporates feedback from various stakeholders, reflecting the agency’s commitment to addressing this critical issue.

The guidance outlines two main approaches for addressing misinformation:

1. Tailored Responsive Communications: Internet-based communications that specifically address misinformation created or disseminated by independent third parties.
2. General Medical Product Communications: Traditional communication methods, such as advertisements and promotional materials, that may also address misinformation.

The guidance emphasizes that companies can choose alternative approaches as long as they satisfy applicable legal requirements. However, it does not apply to communications addressing misinformation about emergency use authorizations under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Tailored Responsive Communications

According to the guidance, tailored responsive communications refer to voluntary, internet-based messages created by firms to identify and address misinformation about their approved or cleared medical products. This approach focuses on misinformation disseminated by independent third parties and provides a framework for companies to respond effectively.

The FDA further outlines an enforcement policy for tailored responsive communications, detailing the agency’s approach to monitoring and regulating these communications:

1. Non-Enforcement of Promotional Requirements: If a firm adheres to the recommendations in the guidance, the FDA does not intend to enforce requirements related to promotional labeling and advertising for these communications.
2. No Evidence of New Intended Use: When tailored responsive communications address misinformation suggesting unapproved uses of a product, the FDA will not use these communications as evidence of a new intended use, provided the firm’s communication aligns with the guidance.

The guidance also provides several recommendations for firms engaging in tailored responsive communications:

• Identify Misinformation: Clearly identify and address specific instances of misinformation that could harm public health or mislead healthcare providers and patients.
• Be Accurate and Transparent: Ensure that responses are accurate, balanced, and provide clear context to correct the misinformation.
• Maintain Professionalism: Use a professional tone and avoid unnecessary confrontation or escalation when addressing misinformation.
• Document Communications: Keep detailed records of all communications related to misinformation to support transparency and accountability.

General Medical Product Communications

General medical product communications encompass a wide range of traditional communication channels, such as sales aids, television and radio advertisements, and institutional communications. These methods are not specifically tailored to internet-based misinformation but can include content that addresses misinformation as part of broader messaging strategies.

Unlike tailored responsive communications, general medical product communications are subject to standard FDA regulatory requirements. Companies must comply with all applicable regulations unless a specific enforcement policy provides an exception.

Firms can incorporate misinformation correction into their general communication strategies through the following methods:

• Educational Campaigns: Launch educational initiatives to inform the public and healthcare professionals about the accurate use and benefits of the product.
• Targeted Advertisements: Utilize targeted advertising to reach audiences exposed to misinformation and provide factual information to counter false claims.
• Public Relations Efforts: Engage in public relations activities to reinforce positive messaging and counteract misinformation effectively.

Illustrative Examples and Scenarios

In order to assist the parties involved with understanding the concepts described therein, the guidance also includes hypothetical scenarios as examples to illustrate the application of its recommendations and strategies. These examples are intended for illustrative purposes only and should not be interpreted as legally binding templates.

Scenario 1: Social Media Misinformation

A popular social media influencer shares inaccurate information about a prescription drug, claiming it has dangerous side effects not supported by scientific evidence. The pharmaceutical company decides to respond with a tailored responsive communication on the same platform, providing accurate information about the drug’s safety profile and linking to reputable sources.

Scenario 2: Misleading Advertisements

An independent third-party website publishes misleading advertisements suggesting that a medical device can be used for unapproved purposes. The device manufacturer uses general medical product communications to clarify the approved uses of the device and emphasize its safety and effectiveness.

Scenario 3: Viral Misinformation Campaign

A viral misinformation campaign spreads false claims about a vaccine’s efficacy and safety. The vaccine manufacturer launches a comprehensive educational campaign, including traditional media advertisements and digital outreach, to counteract the misinformation and provide accurate information to the public.

As the guidance evolves, the FDA remains open to feedback and engagement from industry stakeholders. Working collaboratively, the agency and companies can continue to refine strategies for addressing misinformation and ensuring that patients and healthcare providers have access to reliable information.

Conclusion

In summary, the present FDA guidance outlines the most important types of communication approaches to be followed by the entities responsible for medical devices and other healthcare products when addressing misinformation related to their products spreading all around the market. The document provides specific recommendations to be taken into consideration to ensure the correct information is communicated properly to the affected parties, mitigating the risks associated with potential misinformation.

Source

https://www.fda.gov/media/179827/download

How Can RegDesk Help?

RegDesk is an AI-powered Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Global expansion has never been this simple.