The FDA, Social Media & Consumer Genomics: A Lot Not to “Like”

pharma-social-mediaLast 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.


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Filed under FDA LDT Regulation, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation

Patenting and Personal Genomics: 23andMe Receives its First Patent, and Plenty of Questions

Earlier this week 23andMe, the Silicon Valley-based personal genomics company, was awarded its first patent: US Patent Number 8,187,811, entitled “Polymorphisms associated with Parkinson’s disease”.

23andMe co-founder Anne Wojcicki announced the issuance of the patent via a post on the company’s blog late Monday evening, attempting to strike a tenuous balance between her company’s oft-championed philosophical devotion to providing individuals with “unfettered access to their genomes” and its desire to commercialize the genomic information so many of those very same individuals have shared, free of charge, with 23andMe. With its new patent, 23andMe also injected itself into the middle of what Wojcicki herself described as the “hot debate” surrounding the patentability of “inventions related to genetics.” Wojcicki’s announcement appeared to catch more than a few of the company’s customers by surprise, sparking concern about the company’s intentions on 23andMe’s blog, Twitter and elsewhere, along with rapid and pointed commentaries from Stuart Hogarth and Madeleine Ball, among others.

Of the various questions asked of and about 23andMe and its new patent, these may be the three most common: Where did this patent come from, and why didn’t I hear about it before? What does 23andMe’s patent cover? How is 23andMe going to use its patent? Let’s take each question in turn.


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Filed under Biobanking, Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomics & Society, Industry News, Informed Consent, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP

The Next Social Media Revolution Will Occur In…Personalized Medicine?

Social media – including Facebook, Twitter and other social networking platforms – are widely credited with fundamentally altering the nature of political discourse and, in some instances, credited as catalysts of political revolution. But social media’s ability to affect change need not be limited to politics, as recent developments in the arena of personalized medicine and consumer genomics continue to demonstrate.

Social Media as a Research Tool. Last month, PatientsLikeMe, an online patient community, made headlines with a study published in Nature Biotechnology in which the company analyzed self-reported data from nearly 600 patients to demonstrate that the use of lithium had no effect on the progression of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease).

The study’s findings are valuable for ALS patients, who frequently experiment with unproven treatments in an attempt to slow progression of the degenerative disease for which there is not yet an effective therapy. But the long-term impact of the study’s methodological approach, which suggests “that data reported by patients over the internet may be useful for accelerating clinical discovery and evaluating the effectiveness of drugs already in use,” should be felt far beyond the ALS community.


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Filed under Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Industry News

Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest

Protecting Your Brand Name on the Internet

Bench to Market (article)Twenty-four hundred years ago, in the scroll age, the marketing guru Socrates observed, “Regard your good name as the richest jewel you can possibly be possessed of.” In the intervening years, only the technology of communication has changed; the wisdom of protecting your brand name and the goodwill it carries is still valid. For many of today’s businesses that are built on innovative products or services, such as those provided by many of the readers of The Genomics Law Report, the Internet and its social media are the most important methods of communicating with potential customers and collaborators.

Brand protection on the Internet begins with selecting and registering a “domain name.” Domain names are akin to virtual street addresses on the Internet, where the registry or “top level domain” is the name of the street and the string to the left of the “.” in the domain name is the ‘second level domain name.” Thus, “genomicslawreport.com” is the unique address for our site, consisting of the second level domain “genomicslawreport” registered on the popular “com” street. Anyone in the world can find us and no one else publishing there. We have grown jaded about this technological marvel, but a consequence of the domain name system is that every business should want to be sure that it preemptively registers domain names that support its brand and take reasonable and prudent measures to assure that others do not unfairly profit from the goodwill residing in that brand by registering domain names that impersonate, mimic or denigrate the brand or that sell counterfeit products under the brand name.


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Filed under Badges, Bench to Market

Weekly Twitter Roundup: Personalized Medicine Edition

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In addition, this past week I attended the Partners Healthcare conference on Personalized Medicine, and provided live updates from a number of the sessions. So, this version of the weekly Twitter roundup comes in two sections: the regular roundup followed by my Tweets from the conference.

Part I: A recap of the standard @genomicslawyer Tweets:

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Filed under General Interest, Industry News

Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest, Industry News

Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest, Industry News

Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest, Industry News

Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest, Industry News