SILVER
SPRING, Md., July 8, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration is
advancing its mission of ensuring the public has access to
accurate, up-to-date science-based information to inform decisions
about FDA-regulated medical products to maintain and improve their
health. The agency is providing updated recommendations to empower
industry seeking to voluntarily address misinformation about or
related to their approved/cleared medical products.
"Regulated industry plays a critical role in ensuring
consumers have accurate information about medical products. We've
updated our draft guidance to help further ensure industry has
clarity and additional flexibility to promptly and proactively
issue responsive communications to address misinformation they are
seeing," said FDA Commissioner Robert M.
Califf, M.D. "The growing spread of rumors about science and
medicine continues to put patients and consumers at risk. 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."
In today's health care system, health care providers and
consumers often turn to the internet to obtain health and
medical-related information. However, not all information found
online about medical products is reliable. There are many false
statements and conclusions shared online and the structure and
popularity of social media platforms have meant that false,
inaccurate and/or misleading information about medical products can
spread rapidly to a broad audience. Basing medical decisions on
inaccurate information can have adverse consequences as it can lead
patients and health care providers to choose treatments that are
not safe and effective, or to forgo treatments that are. The FDA
believes it is critically important to promptly address
misinformation about medical products. The revised draft guidance
issued today supports the efforts of medical product companies that
share this interest in helping the public get factual, accurate and
scientifically sound information about medical products.
Specifically, the revised draft guidance, Addressing
Misinformation About Medical Devices and Prescription Drugs
Questions and Answers, sets out a policy that supports
companies that issue certain kinds of internet-based communications
("tailored responsive communications") to address internet-based
misinformation about or related to their approved/cleared medical
products when that misinformation is created or disseminated by an
independent third party. For example, a company might choose to use
this type of communication when a celebrity, healthcare provider or
influencer, not acting on behalf of the company, posts false,
inaccurate and/or misleading representations of fact about the
company's approved/cleared medical product on social media.
Additionally, this revised draft guidance provides companies with
many examples that illustrate the types of misinformation found
online that a company might choose to address with a tailored
responsive communication, along with some considerations relevant
to the current digital information environment.
The revised draft guidance also describes existing avenues
("general medical product communications") that companies might
also choose to use to address misinformation about their medical
products wherever that misinformation may appear. This draft
guidance revises and replaces the draft guidance for industry,
Internet/Social Media Platforms: Correcting Independent
Third-Party Misinformation About Prescription Drugs and Medical
Devices, issued in June
2014. The revised draft guidance is open for public comment
for 60 days.
In addition to providing these updated draft recommendations,
the FDA has taken and will continue to take steps to communicate
accurate, up-to-date, science-based information to the public. Some
examples of such efforts include:
- Providing timely, digestible, factual information to news media
and other organizations;
- Creating resources on the FDA's website and social media to
address common questions about the products the agency
regulates;
- Participating in speaking engagements to draw attention to the
dangers of misinformation and to provide factual information about
FDA-regulated medical products and public health issues;
- Providing interested parties with toolkits of resources;
and
- Posting memos and other regulatory documents that outline the
agency's decision-making, consistent with applicable law(s).
The FDA will continue to proactively offer resources about
medical products to provide factual and scientifically sound
information to the public. The agency remains committed to helping
address misinformation and continues to support other interested
parties that choose to engage on this critical issue.
Additional Resources:
- Addressing Misinformation About Medical Devices and
Prescription Drugs Questions and Answers Guidance for Industry
- FDA's Rumor Control Page
Media Contact: Carly
(Kempler) Pflaum, 240-672-8872
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration