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 Moreover, the lack of specificity in that framework has led to inaccurate and outdated information swirling around the Internet concerning health care and wellness issues.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)
Here is an overview of PRSA and WOMMA’s joint comments and recommendations to the FDA:
- PRSA and WOMMA members need the FDA’s guidance on how they can properly and appropriately communicate with, and market to, consumers in online and social-media forums.
- The proposed Guidelines ignore the public’s desire to access information concerning health care and health issues in an expedient and efficient manner online and via social media.
- The delay in providing proper guidance has led to a gap in open and transparent communication and has been detrimental to the online patient communities who rely on these communications for information and support.
- By providing communicators and marketers in the health care and pharmaceutical industries with proper social-media guidance, the FDA will help enhance the quality of information available to consumers, while ensuring businesses can continue to innovate, both in their online marketing communications strategies and product development.
- The realities of the digital age and how consumers employ the Web to find health-care and health-issues information must be met by a robust set of Guidelines from the FDA. That guidance might cover: platform-specific issues; digital disclosure by companies in online platforms and across social media; conflicts-of-interest; and direct versus indirect communications.
In addition to these recommendations, we further suggest that the FDA provide for some form of responsible, self-regulated infrastructure in which companies can proactively and reactively communicate with consumers online, via social media and other digital forums. This would provide a means for health care and pharmaceutical companies to answer consumers’ questions in the digital forums where they now live and work. That level of responsiveness will aid in society’s informed decision making.
We’re grateful for the opportunity to reinforce the principles of ethical and responsible public relations practice in health care, and we look forward to continuing the discussion with the FDA. We hope that discussion includes more specifics so that health care and pharmaceutical PR professionals have the regulatory guidance they need to benefit the public.
Gerard F. Corbett, APR, Fellow PRSA, is chair and CEO of the Public Relations Society of America.
