Five
years after its most recent public hearing on the subject of social
media marketing of drugs and medical devices, the FDA released a draft Guidance
for Industry Internet/Social Media Platforms with Character Space
Limitations— Presenting Risk and Benefit Information for Prescription
Drugs and Medical Devices. Publication was prompted by a statutory
deadline in the FDASIA, and there is a 90-day comment period now open.
It's a little disappointing that it literally took an act of Congress to
get the agency to focus and act on this issue, and that despite the
focus all we're getting here is nonbinding sub-regulatory guidance.
One key issue regarding FDA regulation of short-form internet
marketing has long been fair balance -- communicating risks as well as
benefits.
The FDA draft guidance boils down to three key points:
1. Benefit information should be accurate and non-misleading and
reveal material facts within each individual character-space-limited
communication (e.g., each individual message or tweet).
2. Benefit information should be accompanied by risk information within each individual character-space-limited communication.
3.
If a firm concludes that adequate benefit and risk information, as well
as other required information, cannot all be communicated within the
same character-space-limited communication, then the firm should
reconsider using that platform for the intended promotional message.
More specifically, risk and benefit information should be balanced:
1. Risk information should be presented together with benefit
information within each individual character-space-limited communication
(e.g., each individual message or tweet).
2. The content of risk
information presented within each individual character-space-limited
communication should, at a minimum, include the most serious risks
associated with the product.
3. A mechanism, such as a hyperlink, should also be provided within
each individual character-space-limited communication to allow direct
access to a more complete discussion of risk information about the
product.
4. The prominence of risk information should be
comparable to the benefit information within each individual
character-space-limited communication, taking into consideration any
formatting capabilities available on the specific Internet/social media
platform.
In the end, then, the "one-click rule" bandied about within the
industry in the years leading up to the most recent FDA public hearing
on the subject has become memorialized in the agency's draft guidance.
The FDA detailed sample tweets and short-form Google ads, and gave
annotated examples of satisfactory character-limited ads, including, for
example:
NoFocus (rememberine HCl) for mild to moderate memory loss-May cause
seizures in 502 patients with a seizure disorder www.nofocus.com/risk
This tweet includes brand and established names, just a dash to
separate benefits from risks, and a link to the safety information page
of the product website.
This represents a great leap forward. No doubt there will be much to
delve into and consider in order to prepare comments for submission to
the agency, and there are issues to be considered in the related draft correction of misinformation guidance released simultaneously by the FDA.
David Harlow
The Harlow Group LLC
Health Care Law and Consulting