At a Glance
- FDA has issued new guidance to assist manufacturers in responding to misinformation on prescription drugs and medical devices posted by influential sources online, including those promoting unapproved indications.
- The guidance provides recommendations for tailored responsive communications, which are those that firms might use to address internet-based misinformation. In the context of tailored responsive communications, the guidance also outlines FDA’s enforcement policy.
- The guidance also provides recommendations for general medical product communications, which are existing avenues of communication under FDA authorities that firms may use to address misinformation (e.g., sales aids, TV and radio advertisements, and help-seeking or institutional communications).
On July 9, 2024, the Food and Drug Administrations (FDA) replaced a 10-year-old draft industry guidance on misinformation and social media information on prescription drugs and medical devices. The new guidance assists manufacturers in responding to instances of misinformation posted by influential sources online, including those promoting unapproved indications.
“Misinformation in the health information environment is a longstanding and increasingly widespread public health concern,” FDA states. Citing to various sources, the guidance reports: “In the modern American health care system, many individuals want to take an active role in their health care decision-making, and they often seek out relevant information to inform their choices. The internet is now the leading source used by consumers to obtain health information, and healthcare providers also frequently seek the latest medical information on the internet.”
Combatting misinformation has been a top priority of FDA Commissioner Robert Califf: “The growing spread of rumors about science and medicine continues to put patients and consumers at risk,” FDA Commissioner Califf said in a July 8, 2024, statement. “We remain steadfast in our commitment to address this public health concern and continue to support and encourage all parties in the public health ecosystem to take an active role.”
Not surprisingly, the new guidance says medical product communications addressing misinformation are expected to comply with all relevant FDA regulations. Communications should be truthful and accurate, scientifically sound, and directly relevant and responsive to the identified misinformation. All communications should include disclosure that it is posted by or on behalf of the firm and a link to FDA-approved labeling.
The guidance provides recommendations for two types of communications:
- Tailored responsive communications — those that firms might use to address internet-based misinformation
- General medical product communications — existing avenues of communication under FDA authorities that firms may use to address misinformation (e.g., sales aids, TV and radio advertisements, and help-seeking or institutional communications).
In the context of the tailored responsive communications, the guidance also outlines FDA’s enforcement policy.
It should be noted that like all regulatory communications, this guidance includes important definitions, details and caveats. For example, ‘firm” is defined as “the persons or entities legally responsible for the labeling of approved/cleared medical products, which includes applicants, sponsors, manufacturers, packers, distributors, and any persons communicating on behalf of these entities.” Please refer to the full text or legal counsel for help.
The guidance focuses on communications a firm might choose to share in response to posts by a celebrity, influencer or health care provider that include false or misleading information (also defined) about the firm’s medical product — for example attributing adverse events to the product without evidence or incorrectly describing the approved use.
Tailored responsive communications “should clearly identify both the specific misinformation that the firm is addressing and a specific internet-based, independent third-party communication in which that misinformation appears.” When addressing misinformation that is widespread, firms should clearly identify at least one online communication that includes the false information. If responding to content with multiple false or misleading statements, a firm should specifically address each one.
The new guidance helpfully includes 18 examples of the types of communications that firms may wish to respond to, sometimes adding how and whether FDA would find the communications falls within its exercise of enforcement discretion:
Example 4: An HCP [health care provider], who is an independent third party, posts on her own social media account a statement that Drug Class A (a class of drugs approved to lower low-density lipoprotein (LDL) cholesterol, as an adjunct to diet, in certain patients) has been shown to cause Alzheimer’s disease and therefore should not be used by patients to lower LDL. There is no evidence that drugs in Drug Class A cause Alzheimer’s disease. The HCP’s statement is false, inaccurate, and/or misleading.
And spooky (and ironically or purposefully numbered) example 13:
Example 13: An individual, who is an independent third party, posts on his social media account that his dad is taking a new prescription drug, Drug X, in the form of an injection to treat his lung cancer. The individual states that Drug X is a terrible choice for his dad because it is made using tissue from cadavers. While the individual’s statement that Drug X is a terrible choice is a value statement, that statement rests on a basis that falls within the definition of misinformation because the statement that Drug X is made using tissue from cadavers is false. Therefore, a firm’s response to this statement could fall within the enforcement policy outlined in this guidance if the recommendations of the guidance are followed.
Through this guidance, FDA recognizes the internet can be a scary place for evidence-based information on prescription drugs and medical devices. That said, the agency knows its own constraints, namely that FDA does not have the authority to and/or is prohibited from regulating personal and/or private sector communication. Accordingly, FDA encourages industry and private sector coalitions to help combat misinformation online.
