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5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations

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The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media. The first was entitled, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about prescription Drugs and Medical Devices. The second was entitled, Internet/Social Media Limitations – Presenting Risk And Benefit Information for Prescription Drugs and Medical Devices, which is the focus of this post.

While not as clear or concise as their other previous guidance releases, there are 5 key things digital marketers need to be aware of, some of which potentially muddying the waters more then originally planned.

1. Brands may present product claims within character–limited setting, but must include several elements to be considered compliant.

If and when a brand or product chooses to put claim information inside of a tweet, the claim must contain several elements, including:

  • The product and generic name
  • Appropriate balance for the claim being made
  • A direct link to a page containing more complete discussion of the associated risks of the product

The example used by the FDA is for a fictitious product, NoFocus, with the structure of the tweet illuminating the requirements.

NoFocus (rememberzineHCL) for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk

When presenting balance to a claim, the brand or product does not need to present the full risk statement, but instead is required to communicate, “the most serious risks associated with the product.” Read More…

5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation

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Yesterday the FDA released not one, but two documents providing draft guidance on the utilization of particular aspects of social media, entitled Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about prescription Drugs and Medical Devices, which is the focus of this post. The other, Internet/Social Media Limitations – Presenting Risk And Benefit Information for Prescription Drugs and Medical Devicescan be read about in another posting.

In keeping with the tradition of most of these releases, these guidelines are drafts and may change over time, but in reading them there are 5 key things digital marketers need to be aware of.

1. Brands may host open conversations on corporate-owned sites, without being responsible for the content.

This is surprising news, but the FDA’s own example for what its guidance entails opens the door for such communications. Beginning on line 141 the FDA writes,

“Example 4: A firm hosts a discussion forum about its drug’s or device’s FDA-approved use on its corporate website and does not participate in the discussion, but it does monitor the forum for profanity and obscenity. The forum includes an overarching clear and conspicuous statement that the firm did not create the content of the forum. The firm is not responsible for the information that is posted by independent third parties and can, if it so chooses, correct misinformation according to this guidance.”

For years, brands have struggled with the possibility of hosting discussions, particularly as they relate to educating patients and interested parties about how to use or stay compliant with a particular product. This statement by the FDA indicates that that activity is now approved for consideration. One caveat, the guidance does not release the brand/corporation from monitoring for possible adverse event notifications, only stating that the brand/corporation is free from responsibility for the content being posted by independent third-parties. Read More…

For Pharma, All Of This Has Happened Before

SO SAY WE ALL

As someone who grew up with the internet and made it my career I can tell you, the era we’re in right now looks and smells oddly familiar. How? Well ‘back in my day’ the Internet was just a thing. Conceptual. New. No one understood it but everyone was talking about it. Consumers played with it. Brands tried to use it. The media talked about it endlessly. Like with most new things, objectives for success were often poorly defined, but money, gobs and gobs of money were thrown at it.

Strategies evolved that more or less correlated to success. People got smarter. The tools got cheaper and easier to use while the barriers to working the on net got smaller and easier to manage.

Inside of pharma, regulators and brand managers alike struggled to define how to use the internet properly. Adoption happened slowly. Things seemed risky. Hands were wrung, and decisions delayed until others took the lead.

More case studies were needed.

Soon everyone was an internet ‘expert’ and the scrum began. Every agency, freelancer, and Johnny-come-lately tried to get digital work. Innovation was sought at the expense of meaningful results. Things had to be new. They had to be shiny. And they had to have lots and lots of Flash.

Prices fell. The talent pool swelled. Expertise was defined by what you’d just launched. The noise level rose. Soon it became hard to tell what was great from what was working. Flashy was the new good.

Now, reread the previous paragraphs and replace the word ‘internet’ with the words ‘social media’ or ‘mobile’.  All of this has happened before.

Then, terrible things happened. The economy tanked. 9/11 occurred. The dot–conomy imploded. All those people dreaming of their internet riches and piles of stock options e-lost all their virtual iDollars and ended up in thepoorhouse.com.

The party was over.

Read More…

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.