On June 18, the U.S. Food and Drug Administration
("FDA" or the "Agency") issued draft guidance
documents addressing the presentation of risk and benefit
information for prescription drugs and devices on internet/social
media platforms permitting limited character usage, such as Twitter, and
regarding how a firm may correct misinformation disseminated by an
independent third party concerning a product approved or
cleared by FDA. The highly anticipated draft guidance documents
come in response to stakeholder requests for specific
guidelines.
Guidance for Industry: Internet/Social Media
Platforms with Character Space Limitations—Presenting Risk
and Benefit Information for Prescription Drugs and Medical
Devices
FDA initiates its discussion of character-limited product promotion
by reinforcing regulatory requirements and concepts broadly
applicable to product promotion and by maintaining the standard
that benefit information should be balanced by the presentation of
content- and prominence-comparable risk information. The Agency,
however, acknowledges the challenge firms may have in achieving the
appropriate balance while also presenting necessary product
information. Therefore, at the outset of any such campaign, FDA
advises the promoting company to undertake the fundamental
evaluation of whether the platform is appropriate for promotion of
the particular product. For example, products with complex
indications or extensive serious risks may not be amenable to
promotion via character-limited platforms.
FDA outlines three components for inclusion in promotion via
internet/social media platforms with character space limitations,
namely: general factors, risk information disclosure factors, and
other product information recommendations.
General Factors. In each communication, benefit
information must be accurate, be non-misleading, and reveal
material facts, and it should be accompanied by risk information.
If adequate benefit and risk information as well as other required
information cannot all be communicated within the character limits,
FDA encourages the firm to reconsider the platform's use.
Risk Information Disclosure Factors. In each
communication, risk information should be presented in conjunction
with benefit information, at a minimum disclose the most serious
risks for the product, and be presented with comparable prominence
to benefit information. Additionally, direct access to a more
complete discussion of risk information should be provided to the
audience, e.g., a hyperlink routing the audience to a
nonpromotional landing page dedicated solely to risk
information.
Other Product Information Recommendations. Two
additional requirements to be met within the character limitations
include the presentation of the promoted product's established
name and inclusion of at least one specific dosage form and
quantitative ingredient information. FDA indicates that a firm
should include the established name directly after the brand name
but accepts the use of commonly recognized linguistic symbols in
place of words and the use of scientific abbreviations for chemical
ingredients to reduce character usage. FDA suggests the latter
requirement will be satisfied by inclusion of at least one dosage
form and quantitative ingredient information (in conjunction with
the brand and established names) on the hyperlinked risk
information landing page.
The draft guidance document makes effective use of examples in
detailing particular promotion through Twitter and Sitelink
extensions of hypothetical drugs. If the prescribed guidelines are
followed, the Agency asserts it does not intend to object to
promotion via these and similarly character-constrained
platforms.
FDA explicitly provides that the draft guidance document is not
intended to address product promotion through websites, webpages on
social media platforms, online web banners, or responsive web
design, maintaining these platforms do not impose the same
character constraints as those contemplated by the draft guidance
document.
Guidance for Industry: Internet/Social Media
Platforms: Correcting Independent Third-Party Misinformation About
Prescription Drugs and Medical Devices
FDA initiates its discussion of dissemination of misinformation by
summarizing the problem facing stakeholders. It states that while
"the Internet has facilitated the transmission of information,
allowing patients and other interested parties the opportunity to
share experiences as well as to communicate with others about drugs
and devices," such information "might not always be
accurate and may be dangerous or harmful to the public
health." FDA makes a point to differentiate
"communications that are owned, controlled, created, or
influenced, or affirmatively adopted or endorsed, by, or on behalf
of, the firm," to which the guidance does not apply. To
facilitate the correction of misinformation by third parties, the
draft guidance specifies three parameters for how a firm may
voluntarily correct the misinformation "in a truthful and
non-misleading manner."
Appropriate Corrective Action. The firm should
provide information that is relevant, tailored to the
misinformation, nonpromotional, accurate, consistent with the
product's labeling, and discloses the affiliation of the
provider to the firm.
Extent of Misinformation Corrected. Although a
firm is not expected to correct all misinformation in a particular
forum, the firm should clearly identify the misinformation and the
portion of the forum it is correcting, to ensure that readers do
not assume the firm has necessarily responded to the entire
forum.
Approaches to Corrective Action. The firm may
choose among several approaches to making the correction, including
correcting information directly on the forum, providing corrective
information to the author of the misinformation, or requesting the
author to remove the misinformation or allow comments to be
posted.
Ultimately, the draft guidance provides a safe harbor of sorts for
firms correcting misinformation. First, FDA does not expect the
firm seeking to correct misinformation to continue to monitor the
forum that contained misinformation. Second, as long as the
correction is made in accordance with the guidance, "FDA does
not intend to object if these voluntary corrections do not satisfy
otherwise applicable regulatory requirements, if any."
Finally, FDA does not expect firms to report corrections, but they
should "keep records to assist in responding to questions that
may come from the Agency."
FDA is accepting comments on both draft guidance documents.
Comments are due by September 16.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.