The FDA’s draft industry guidance for off-label responses to consumers’ health care queries is a start but could benefit from specifics to appropriately advise health care communicators.
Last week, PRSA and the Word of Mouth Marketing Association (WOMMA) filed joint comments with the U.S. Food and Drug Administration concerning its proposed social media guidelines. Our central points can be summed up as follows: self-regulation works, and professional communicators and marketers are responsible and ethical practitioners.
The comments are a continuation of PRSA’s recent regulatory affairs work with the Federal Trade Commission and the Senate Subcommittee on Contracting Oversight.
The feedback we provided the FDA reflects the core values of PRSA’s Code of Ethics. We made clear our belief that public relations professionals are keen to protect consumers’ rights through open and honest communications, while advocating for the brands they represent. Those goals do not have to be mutually exclusive. In fact, each can enhance the quality of information provided to the public through proactive and transparent communications practices.
Our comments are the culmination of a long-standing advocacy campaign by PRSA to obtain adequate social media guidelines from the FDA. Through a variety of commentary pieces, we have expressed our perspective that the regulatory framework that currently governs health care and pharmaceutical brands’ online communications with consumers is inadequate. Moreover, the lack of specificity in that framework has led to inaccurate and outdated information swirling around the Internet concerning health care and wellness issues.
It is crucial that the FDA presents viable guidance for how companies can utilize social media to accommodate consumers’ fact-finding needs concerning health care and wellness issues. While a start, the proposed Guidelines lack specificity and relevance that communicators and marketers require to successfully perform their jobs within FDA guidelines. (Related: Dear FDA: Your Social Media Guidance is Requested)
Continue reading " Reviewing the FDA’s Proposed Social Media Guidelines "

