Much brouhaha over the FDA’s Warning Letter to AMARC Enterprises.
The attention is due, in part, to pharma’s thirst for FDA guidance on the use of social media. Alas, while this particular FDA letter isn’t entirely ersatz, it isn’t entirely relevant to moving the agenda forward either. (Note: When asked about this letter, OPDP chief Tom Abrams passed the query along to CFSAN -- as dietary supplements are regulted as foods.) Nevertheless, there are some important lessons.
Here’s how the FDA letter begins:
This letter concerns your firm’s marketing of the products, Poly-MVA and Poly-MVA for Pets. The U.S. Food and Drug Administration (FDA) reviewed your websites, www.polymva.com and www.polymva.net, as well as literature included in the information packet which accompanied the sale and shipment of your product, “Poly MVA” on November 15 and has determined that “Poly MVA” is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The claims in the literature and on your websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act.
Translation: You are promoting a dietary supplement as a drug.
No news there. The letter continues:
In addition, we reviewed your websites at www.polymva4pets.com and www.polymvaforpets.com where you promote and sell your “Poly-MVA for Pets” veterinary product. We have determined that Poly-MVA for Pets is intended for use in the cure, mitigation, treatment, or prevention of disease in animals, or to affect the structure or function of the body of animals, which makes it a drug under section 201(g)(1) of the Act. [21 U.S.C. § 321(g)(1)]. Further, as discussed below, this product is an unapproved new animal drug as defined by the Act and your marketing of it therefore violates the law.
Translation: You are marketing a dietary supplement as an animal drug.
Okay – so this is your garden-variety structure/function violation. But here’s where it get’s interesting.
The FDA isn’t just dinging AMARC on a blasé structure/function claim. The agency is calling them out because those claims are about curing cancer!
The point to be taken here is that the agency cannot (obviously) go after every dietary supplement company making inappropriate structure/function claims. The FDA needs to prioritize, to deliver the biggest bang for the regulatory buck. And false cancer claims are right up there at the top of the list.
It’s also important to note that, of the many promotional infractions, the issue of social media is at the bottom (literally) of the letter. This is not a letter about social media infractions, it’s a letter about promotional infractions of which social media is one dimension.
But what the FDA does write about social media is instructive:
We also note claims made on your Facebook account accessible at: https://www.facebook.com/poly.mva, which includes a link to your website at www.polymva.com. The following are examples of the claims:
In a March 10, 2011 post which was “liked” by “Poly Mva”:
- “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”
In a May 5, 2010 post you provide a link to the blog post titled, “Children with Cancer Often Use Alternative Approaches” which can be found on your website at www.polymva.com/blog-news/218/children-with-cancer-often-use-alternative-approaches. At the end of the post is the following statement and a link to the website, www.facr.org:
- “For information on how palladium lipoic complexes can nutritionally support the body during cancer and cancer therapy, visit the Foundation for Advancement in Cancer Research’s website.”
Folks – it’s not the platform that is non-compliant, it is the content. Why does everyone get weak-in-the-knees whenever the FDA mentions a contextual violation on social media? When the agency sends out warning letters on sales materials, do we jump up and down and say, “Jumpin' Jehosaphat, we can’t create sales materials!” (Or TV commercials. Or convention booth displays.)
Here’s what the FDA said about the AMARC website:
Examples of claims in the form of testimonials, on your websites, www.polymva.com and www.polymva.net, on the webpage titled, “Customer Experiences” include:
- “I want everyone to know that I am now 3 years clear of lung cancer!! When I was told I had a mass in my lung, the first thing I did when I returned home was to call AMARC Enterprises – the PolyMVA people. PolyMVA helped save my life. I began a regimen of PolyMVA…After 3 months, the Stage 2 cancer was down to Stage 1. And here I am, 3 years later…the PET Scan is as clear as a bell. Thank you again and again for the support that PolyMVA gave my body in my fight against cancer!”
- “...I said “No” Chemotherapy!...I became quite ill and was diagnosed with stage 3 ovarian cancer…I had surgery to remove a very large tumor and was scheduled to begin an aggressive chemotherapy regimen as the cancer had spread. Even with chemotherapy I was aware that the prognosis was not encouraging…One of the supplements that my naturopath highly recommended was Poly MVA…In my opinion anyone in my situation involving cancer could be greatly improved by using Poly MVA…”
It’s useful to look back at the FDA’s “most recent” missive on social media, the December 27, 2011 Draft Guidance, “Responding to Unsolicited Requests
For Off‐Label Information About Prescription Drugs and Medical Devices.”
Statements that promote a drug or medical device for uses other than those approved or cleared by FDA may be used as evidence of a new intended use.
Translation: It’s the content, not the platform.
Unsolicited requests are those initiated by persons or entities that are completely
independent of the relevant firm. (This may include many health care professionals, health care organizations, members of the academic community, and formulary committees, as well as consumers such as patients and caregivers). Requests that are prompted in any way by a manufacturer or its representatives are not unsolicited requests.
Translation: “Liking” an off-label post or sharing it under the guise of a “customer testimonial” (whether solicited or not) is off-label promotion.
The value of the AMARC letter isn’t to divine FDA intent across social media. The value is to remember that violative is violative across platforms.
In other words, if you wouldn’t say it off-line, don’t say it online.
Take a breath.