Do your social marketing assets contain non-compliant content?
In an industry with low barriers to entry in terms of clinical, tourism, travel and healthcare marketing competency and where marketers can become “certified” by writing a check and sitting in a seminar room for a couple of days plus the price of an airline ticket and hotel room, there are a lot of incompetent, but “certified” medical tourism actors, owners and marketers out there – many of whom display and post non-compliant marketing and advertising content at risk of shutdown from Google and other consumer protection regulators.
In the USA, the U.S. Food and Drug Administration (FDA) reviews websites and social media accounts to determine if the content violates compliance regulations set forth in U.S. code.
Based on its review, FDA may determine that the content and advertising claims on websites and social media posts intended to promoted treatments, medications, and therapies for various conditions can be deemed as drugs or other treatments under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The intended use of a product or service may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution, 21 C.F.R. § 201.128. When they discover these websites and posts, directly from the provider of on the digital assets of a facilitator or other marketing agent, they usually send a letter to the provider advising that they believe the content that advertises products or services without FDA-approved applications to be in violation of the Act.
In my career as a consultant, I have reviewed hundreds of advertisements and websites and social media posts that violate the above provisions of the Federal Food, Drug and Cosmetic Act advertising and promoting unproven, investigational or experimental treatments for stem cells, prolotherapy, PRP, cancer treatments, off-label uses for medications, herbal preparations and even surgeries.
Many new facilitators who lack any clinical training whatsoever tend to post articles and other digital content that are simply filler content. They do this out of ignorance because they don’t have a clue what else to post, they don’t know medicine or dentistry or rehab, they don’t have customers so they cannot “know” their customers needs, desires and ways that their customers consume content, and they believe that they are marketing to the entire world. They also believe (out of ignorance) that the SEO gods will reward them with high positioning on search engine return pages (SERP) for having content on the site.
These advertisers haven’t been supplied official content from the provider(s) of services they represent. So, in order to find content about stuff they really know little about, they head on over to the Mayo Clinic website, the National Institutes of Health or even copy and paste text from other facilitators’ and providers websites. Since all have graduated high school and were taught the rules of plagiarism, they cite their source and call it good. Nope not even close!
Nobody comes to a medical tourism facilitator’s website looking for an explanation of “What is Diabetes” or “What is an Anterior Hip Replacement”. So the filler content they hoist onto their website is aimed at no one in particular and generally is deemed irrelevant upon landing on the page. Potential medical travel patients receive this information from their physician or dentist. Therefore, there is no need for a facilitator or a hospital advertiser to explain these conditions and the variety of treatments that might “cure”, “mitigate”, “treat” or “prevent” the condition. And while the facilitator views this content as “filler” being used for SEO and SERP value, they could easily run afoul of the FDA compliance laws by how they present the content. When presented in correlation to a procedure, a medication, or a therapeutic intervention of some sort, words matter.
As facilitators and even some providers promote many of their products and services for specific conditions such as, but not limited to infections, hair loss, arthritis, Parkinson’s disease, Multiple Sclerosis,substance abuse addictions, diabetes, obesity, hypertension, cancer, insomnia, heart disease, post-traumatic stress disorder (PTSD), dementia, and other serious conditions and aesthetic treatments that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. If “vulnerable” consumers are interested in the cures or treatments offered on a website over-promise, that’s a problem. The problem, in a nutshell is that the words in the content assert or establish the intended use of the products, procedures and treatments or medications. That’s what “opens the door” to the FDA scrutiny.
When I point this potential risk of violation out, some marketers react badly. They become defensive and respond with, “Yes but I am not marketing services in the USA, so the FDA regulations don’t apply.” Oh really? Show me a reasoned opinion letter from a duly-licensed attorney that formally expresses advice based on their special knowledge as an expert that says that. These letters are drafted at a client’s request, and can run, on average $5000 – $8000 per letter – often much, much more than that. If someone gets defensive with me after asking my help to review their website, I wrap up the consultation and move on. Trying to fight with a person with that position is like trying to teach a pig to sing. It shouldn’t be attempted, and it upsets the pig. I don’t want that client. Not at any price.I’ll give them the names of others who may rubber stamp their materials out of ignorance or greed.
The letter has weight in a defense against a warning or violation letter from a compliance regulator because it shows the intention to obtain qualified advice. The attorney stakes their reputation and places their professional liability insurance on the line in giving this formal opinion. This is because the standard for liability for negligent opinions in The Restatement Second, Torts § 299A sets a liability standard for legal advice as the absence of application of “the skill and knowledge normally possessed by members of that profession or trade in good standing.” Usually, the website owner or advertiser can produce no such documentation. So no lawyer will issue a reasoned opinion letter without charge, and they won’t draft the letter without researching where the advertisement or post will be viewed (193 countries) and what the reader could or should interpret the advertisement’s promises and claims. So the matter of FDA regulatory applicability isn’t as simple as the ignorant marketer may assume.
Advertising claims and even anecdotal patient testimonials can all be reviewed by the FDA reviewers. Cleverly using the word “may” as in …may help prevent or …may help cure a condition or the adjectives such as “leading” “acceptable” or use of percentages and statistics can also be problematic. Treatments, procedures and even telehealth and telemedicine software and remote health monitoring tools can also be considered as “new drugs” pr “new treatments” under section 201(p) of the Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug or treatment may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for the drug. FDA approves a new drug or procedure/treatment on the basis of scientific data and information demonstrating that the drug is safe and effective.
In the case of herbal remedies and even application of heat and cold or massage can be interpreted as prescription medications or treatments because, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)] for some of the claims made for them, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer it.
Furthermore, these procedures, treatments and interventions could be “misbranded” under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these products and services fail to bear adequate directions for use for all of their claims. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for a prescription drug to be used by a layperson. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson (21 C.F.R. §§ 201.100(c)(2) and 201.115). Accordingly, because there are no FDA-approved applications for these products, the labeling of these products fails to bear adequate directions for their intended use and, therefore the products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
WHY DO I KNOW THESE THINGS?
That’s easy. I am frequently called upon to be an expert witness on medical tourism matters. So that person who called me yesterday but didn’t engage me or that I didn’t accept as a client could easily face me in compliance violation hearings at a later date. They may also bump into me again if they attempt to raise capital through outside investors conducting due diligence as I do a fair amount of due diligence consultation for venture cap funds and private equity investors.
THINGS TO KNOW BEFORE YOU POST OR HIRE AN AGENCY OR FACILITATOR TO MARKET AND ADVERTISE YOUR GOODS AND SERVICES
It is the responsibility of the practitioner or facility being marketed or advertised to ensure that all products, advertisements, statements of claims, anecdotal testimonials, and other words are in compliance with all requirements of the Act and federal regulations if the ads appear in the USA or are aimed at patients who are U.S. citizens protected under the consumer protection and health and safety regulations. So a provider in India or Turkey or Colombia or Mexico or some other country cannot simply abdicate responsibility by stating that the facilitator or marketer was an independent contractor or consultant and thus solely responsible for what it publishes. It also cannot hide behind disclaimers of liability.
Very few consultants working in health tourism business development have the specialized training (in their own country and outside their home country) to recommend or review ad copy, social posts, and other collateral and website content. One cannot simply apply the basic consumer protection standards and regulations to domestic and international health services and consider the matter closed.
Even with all my training and decades of experience, while I may spot a cause for concern, I won’t recommend how to fix it with prescriptive advice. If you ask me to opine on your content, posts, memes, statements, testimonials, and other collateral, I am going to recommend due diligence with a qualified attorney who will supply a reasoned opinion letter. I would also recommend that the client seek a second letter of “no issues or concerns” letter from the FDA’s compliance team. If the client has already received a Warning Letter from the FDA, responses are usually due within 15 days and must be substantive in that they must contain details of whatever corrective action has been taken and a go forward plan that details how the violation will be prevented in the future.
About Maria Todd
To learn more or inquire about marketing compliance in health tourism, contact Maria Todd today via email or by phone. Follow her blogs to find articles with fresh, original content here and on LinkedIn’s Pulse to find a ton of insights and information on advertising and compliance issues for today’s healthcare providers and facilities.
You can also find her internationally-published books on health tourism and information for medical tourism facilitators at your favorite retail or online bookseller.
Invite Maria Todd to deliver the keynote address or present a hands-on training workshop or Master Class at your next event. But don’t wait because her calendar fills up months in advance. You can also request private coaching or training at your location to meet your exact executive leadership coaching and staff training needs.