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most recent public hearing on the subject of social media marketing of drugs and medical devices, the FDA released a draft Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical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.
Update 7/24/2014, 11/25/2014: See my further discussion of these guidance documents in a Google+ FDA Guidance Hangout on Air and in an article on US FDA Social Media Guidance published in the UK PMlive directory of digital agencies.
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The FDA draft guidance boils down to three key points: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.
Update 7/24/2014: See my further discussion of these guidance documents in a Google+ FDA Guidance Hangout on Air.