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 Moreover, the lack of specificity in that framework has led to inaccurate and outdated information swirling around the Internet concerning health care and wellness issues.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 "

Back in April, Leigh Fazzina, chair-elect of PRSA’s Health Academy, wrote in PRSAY of the dire need for long-promised and oft-delayed social-media guidelines from the U.S. Food and Drug Administration. We’re still waiting.

A recent article in The Washington Post summed up the frustration that many in the healthcare and pharmaceutical sectors feel over their company’s use of social media. Headlined “Drug companies lose protections on Facebook, some decide to close pages,” the article told of one of the greatest challenges PR professionals in this sector face: knowing when and where it is appropriate — or legal — to communicate online with consumers.

After promising to release guidelines late last year, the FDA has yet to commit to an updated deadline. Understandably, this is leaving many frustrated. Unsure of what their companies’ next steps should be in the vastly growing and powerful social media space, they either go it alone or pull back, waiting for guidance.

I can hear legal calling now: no communication or comment is the better way to go.

It’s time for the FDA to act and to properly advise those it regulates. This is the same government regulator whose commissioner dubbed it “America’s Innovation Agency” in a recent Wall Street Journal op-ed.

Continue reading " Dear FDA: Your Social Media Guidance Is Requested (Part II) "

Eight in 10 Internet users have looked online for health information, and many e-patients say the Internet has had a significant impact on the way they care for themselves or for others. Nearly one in four Internet users living with a chronic condition say they have gone online to find people who share similar health concerns.

It is no surprise that health care companies with practical information about treatments are eager to be where the patients already are — active in social media and social networking. However, the Food and Drug Administration’s repeated delays in issuing guidance on the use of social media leaves many stakeholders in the lurch.

The FDA plays an essential role as a protector of public health. It is charged with monitoring drug company promotional messages for fair balance and truthfulness, and it is committed to helping patients make informed health care choices. This is why the agency brought together patient organizations, corporations, educators and government representatives to discuss ways to improve printed patient medication information.

However, we need to use all available communications channels to help educate patients — including social media. It goes without reason that having access to information when patients need it and in the format they want would enhance their decision-making process. Millions of Americans are dependent on prescription drugs, yet research by the Mayo Clinic has shown that most patients can’t recall or do not understand the medication instructions they receive from health care providers.

Without a doubt, there will be problems and mishaps whenever the FDA’s guidelines are implemented. In the world of social media, you never know for certain what will happen. It is impossible to guess how social media will be used by patients or how it will evolve.

Continue reading " Dear FDA: Your Social Media Guidance is Requested "