Last week, the FDA published on its website a warning letter to AMARC Enterprises, Inc., a marketer of a dietary supplement known as Poly-MVA. (Here is the company’s description of the supplement.) While the letter is not addressed to a high-profile company or product, given that the FDA’s action will likely have broader significance beyond just AMARC and its Poly-MVA supplement, all currently or potentially FDA-regulated entities, including consumer genomics companies, should take note.
The AMARC letter, issued by a regional compliance office and dating to this past December, is unremarkable in most respects. The majority of the letter focuses on website copy, printed information packets, customer testimonials and other materials that appear, at least to the FDA, to represent claims made by AMARC that the Poly-MVA supplement is “intended for use in the cure, mitigation, treatment, or prevention of disease,” thus making it a drug subject to FDA regulatory approval.
What has captured the attention of several FDA watchers, however, is the “claim” that the FDA highlights about three quarters of the way through its letter:
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.”
According to the FDA, “liking” a Facebook post or providing a link to third party material through a Facebook page is evidence that ARMARC was itself making the claims in the third party content on behalf of its own products.
This apparent guidance from the FDA is noteworthy for what it means for regulated and potentially regulated companies (more on that below) and, perhaps more so, for the manner in which it was delivered: buried deep within in an otherwise unremarkable letter to an otherwise unremarkable supplement marketer.
The FDA and Social Media. For several years now, many stakeholders in the drug and device industries have lamented the lack of clear guidance from the FDA regarding the appropriate use of social media. As in many other areas where traditional FDA regulatory paradigms have been shaken up by scientific and technological advances, the agency has been relatively quick to recognize the need for guidance, but far slower to provide needed clarity.
In 2009, the FDA held a “Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” Then, in 2011, the FDA issued a draft guidance document on the much more limited topic of “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (pdf) in which the agency acknowledged the existence of emerging social media tools and technologies, but limited its guidance to one highly specific consumer/patient-company interaction that may or may not occur through social media. Rather than formal and final guidance or rulemaking, most of the FDA’s activity surrounding the appropriate use of social media has occurred by way of private conversations or public, company-specific warning letters and similar communications, such as in the AMARC example discussed above.
The faint light at the end of the tunnel is a provision buried deep within last summer’s FDA Safety and Innovation Act (FDASIA) (pdf). The primary purpose of the FDASIA was to reauthorize a number of important FDA user fee programs, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), and authorize other fees and programs designed to speed and improve drug and device reviews and approvals. But the FDASIA also contained several other items of interest.
One we have covered previously at the Genomics Law Report was the requirement that the FDA collaborate with other federal agencies to deliver, within 18 months of the FDASIA’s passage, a strategic framework for information-technology regulation, including mHealth technologies. (Sec. 618) Another item, of more relevance to this discussion, was the requirement that the FDA, within two years of the FDASIA’s passage, “issue guidance that describes [FDA] policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by [the FDA].” (Sec. 1121)
Unfortunately, the FDASIA-imposed deadline, assuming it is timely met by the FDA, is still more than a year away, meaning that clear, comprehensive and formal social media guidance from the FDA likely remains over the horizon.
Implications for Consumer Genomics. If all of this sounds familiar to regular readers of the Genomics Law Report, well, it should. Here’s a one-sentence synopsis of the FDA’s history with social media:
Disruptive technological and scientific advancements fail to fit neatly into preexisting regulatory categories, leading to case-by-case oversight and as-yet-unfulfilled promises for greater transparency and clarity.
That’s not really a surprise. Science and technology have historically advanced far more rapidly than legislators or regulators can hope to keep pace, and the explosion of social media and genomic sequencing technologies have left the FDA scrambling.
But the AMARC letter and the FDA’s continued approach of case-by-case regulatory authority as opposed to clear and comprehensive industry guidance is yet another reminder to the personal genomics industry that an absence of formal regulatory guidance does not equate to an absence of regulatory risk.
We’ve written at length at the Genomics Law Report (see, e.g., here, here, here and here) about the importance of intended use in guiding the likely regulatory response to consumer genomics products and services. With AMARC, the FDA indicated its willingness to look far beyond explicit product labeling and messaging (e.g., what’s on the product package or on the official company website), in this particular case to Facebook “likes” and links.
In the absence of formal guidance, how far the FDA’s gaze will ultimately stretch in seeking evidence of intended use remains to be seen. For instance, does a retweet on Twitter, as with a Facebook “like”, imply endorsement? What about a company choosing to follow, “friend” or connect with a third party who makes claims about the company’s product? As usual, the problem with case-by-case oversight is that it frequently produces more questions than answers.
So while we await further clarification from Washington, D.C., consumer genomics companies and management would do well to remember that, in addition to their actual and potential customers, regulators may be monitoring their Facebook, LinkedIn, Twitter and other social media accounts and that even seemingly innocuous activities – a “like” here, a retweet or #followfriday there – might one day be used against them.