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FDA’s Latest “Guidance” About Mobile Apps Is Much Ado About Nothing

If you spend any amount of time in this business, you no doubt woke up this morning with your Twitter feed loaded with “What the FDA’s Latest Letter Teaches Us About Mobile” tweets. I did.

Let me boil it down for you. Nothing. It teaches us nothing. No, I take that back. If you happen to be the one person left in the universe that doesn’t understand that in order to market any kind of diagnostic device in the United States, it first must be submitted and gain approval from the FDA, then good news! Today has a teachable moment just for you.

In case you missed it, the FDA issued an “It Has Come To Our Attention” letter to Biosense Technologies Private Limited concerning it’s uChek Urine Analyzer. Apparently, BTPL went to market with a smart phone version of a urine stick analysis tool without running it by the FDA first. Or, as noted in their letter, it may just be that FDA can’t find the paperwork.

“We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance number for the uChek Urine analyzer. We request that you provide us with the FDA clearance number for the uChek Urine analyzer. If you do not believe that you are required to obtain FDA clearance for the uChek Urine analyzer, please provide us with the basis for that determination.”

2 things here. First, the reason BTPL got a letter was for (maybe) acting in violation of the rules and guidelines that have existed before smart phone devices began being regulated. The only reason people are posting anything about this is the fact that the words “mobile phone” appear in the letter. Second, you will probably get an email or tweet today that suggests that you need to contact X,Y, or Z person as this “new guidance” should require some great consultation to rethink your mobile strategy. Let me save you some time and suggest that their council will be much ado about nothing as well.

Calm Down. The FDA is Not Trying to Regulate Facebook

Over the past few days, several articles have popped up with the alarming headline that the FDA is now issuing warning letters due to brands use of Facebook’s ‘Like’ function. You can read one of the takes on it here, in Scott Gotleib’s Forbes article “FDA Wants to Regulate Drug Firms on the Internet and It’s Targeting Facebook ‘Likes’.

The problem with this article, and with so many of the others I’ve read, is that the ‘Like’ function wasn’t the reason that the FDA issued the letter. Mr. Gotleib actually describes the issue, but ignores it.

He writes, “In its latest Warning Letter, FDA cited a multitude of serious violations against the marketer of a drug product called Poly-MVA. The company had sold its product through the use of testimonials that were not substantiated by good science, according to FDA. One seemingly blatant abuse, still found on the company’s website when Gaffney checked, was a testimonial from a “Mr. Doug Wray,” whose improper endorsement suggests that by taking Poly-MVA, he was cured of his multiple myeloma. In the Warning Letter, FDA also made a novel mention of the company’s Facebook “Like” of one of these exaggerated testimonials. Until now, it was never clear whether FDA would treat a “Like” (or a re-tweet for that matter) as an endorsement of the underlying content. That question seems to have been answered.”

The problem, from FDA’s perspective, was not the ‘Like’ button. It was the exaggerated claims and unsubstantiated testimonials. The FDA will ALWAYS flag those. Yes, Facebook was the medium some of these claims were issued, but Poly-MVA would have gotten that warning letter if they had pushed these claims in print, radio or whatever.

In pharma, the use of social media is a hot button issue, which brands are mostly terrified of using. I would hope that as industry observers cover issues like this one, they would more accurately describe situation and circumstances, rather than publishing mis-leading headlines that are alarmist and inaccurate.

The FDA isn’t sanctioning Facebook, it’s sanctioning false claims. So all you social media nay-sayers and alarmists out there, please calm down.

Things To Do On Facebook When You’re Dead

Recently, a former colleague of mine posted on Facebook that a notification showed up on his page suggesting he become friends with someone who had passed away a short time ago.

As poignant as a moment as that was, given how we as consumers rely more on web based services than ever before, it prompted a series of questions in my mind, namely:

  • Who gets access to your profiles when you die?
  • What happens to your URLs, user names, etc?
  • What happens to your content? Who gets the rights to your iTunes content, for instance? How do you transfer ownership?
  • Will digital wakes or funerals via something like a Google+ hangout ever become part of our culture?

In the world we live in today, more seniors than ever have jumped online. According to Pew, as of February 2012, one third (34%) of internet users age 65 and older use social networking sites such as Facebook, and 18% do so on a typical day.

The seniors of today represent just the tip of the digital iceberg. The issues surrounding the transfer of your online life once your offline life has come to an end are only going to become more pronounced as the Boomer generation gets older.

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10 Sneaky Marketing Tactics You Need to Avoid

Every once and a while, I get approached to write an article for a non-healthcare publication. I like to do these because they help ensure that I don’t get too narrowly focused on healthcare and pharma and lose track of everything else out there in digital marketing. When iMedia Connection asked me to write an article about deceptive digital marketing tactics, I knew it was right up my alley.

The article was just published today as an “In Focus” article, which they do twice a week. That means you can see my mugshot right on the homepage of iMedia Connection if you head over there right now. If you missed it, here’s what you missed…not too exciting, I know.

Jonathan Richman iMedia Connection Article

The article is entitled: “10 Sneaky Marketing Tactics You Need to Avoid.” Suffice it to say, if you work for a pharma or healthcare company and you’re doing any of these, you need to stop immediately. I think the industry is already lacking enough in the trust department that you don’t need anything else to cast you in a negative light. The 10 sneaky tactics include: AstroTurfing,lucky guesses, anonymous cleanup, image manipulation, trapping visitors, an inability to cancel, stealing credentials, bundling, pulling the switch and, crafty SEO. Clickthrough to the full article to see what all these mean and to ensure you’re not doing any of them: “10 Sneaky Marketing Tactics You Need to Avoid.”