By Michael J. Sacopulos, JD
It’s so easy to “like” something on Facebook that it almost becomes second nature. All you have to do is click that omnipresent thumbs-up image, and voila! As such, it has become a common practice for cosmetic surgery centers to “like” products they post and “like” comments their patients share.
But liker beware: The federal Food and Drug Administration (FDA) may not like all this liking. Since 2011, the FDA has issued a dozen Warning Letters citing violations on commercial Facebook pages. These letters collectively demonstrate a clear trend that social media space is subject to the same scrutiny as labeling under the Federal Food, Drug and Cosmetic Act (FDCA).
IS LIKING AKIN TO ENDORSEMENT?
Earlier this year, the FDA warned AMARC Enterprises (AMARC) that numerous cancer treatment claims made on the company website, including the company’s Facebook page, violated the FDCA. It cited the following consumer Facebook post, which was “liked” by the site administrator:
“PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation…Thank you AMARC.”
As evidenced here, clicking “like” can be viewed as a public endorsement. PolyMVA has not been approved by the FDA as a drug, so the claims are illegal under the FDCA. This mistake could easily happen again and again as new cosmetic products come to market or are used off-label, and it doesn’t matter if the “like” is posted on a physician’s personal Facebook page or his practice’s Facebook page.
For more on Facebook and social media etiquette, check out these articles from the PSP archives:
The FDA can look into how a company is promoting its product as part of any investigation. This means if your practice ever comes under scrutiny, head’s up: Your profile is fair game.
AS YOU LIKE IT
The FDA believes that a company’s website constitutes product labeling, not advertising. This said, there is no formal guidance on how to promote FDA-regulated products on the Internet. In 2011, the FDA did issue draft guidance for social media use. In this document, it states that individuals are generally responsible and accountable for any website or social media content that “they maintain and over which they have full control.”
Far short of the comprehensive recommendations the industry had hoped for, this Guidance left many questions unanswered. Unless and until the FDA provides clear directives, doctors should approve posts before they go live and carefully review their advertising and promotional materials—including the information and materials available on the Internet and through social media. It is also prudent to ensure that there is a robust policy in place for product promotion, including specific guidelines for Facebook pages and other company-controlled websites. It is standard practice for busy surgeons to outsource their social media, and it’s now even more important that your contractor is aware of the rules.
Like it or not, this is the way it is going to be for the near future.
|Michael J. Sacopulos, JD, is the CEO of Medical Risk Institute (MRI) and serves as general counsel for Medical Justice Services. Additionally, he is the legal analyst for several national publications, including Plastic Surgery Practice. He may be reached via [email protected].|