Regulatory Open Forum

For those of you who are responsible for advertising and promotion review, the social media continue to present a challenge.  Many companies are confused about the rules.  The FDA has not yet issued any guidance, despite many promises to do so.  However, Facebook has recently announced that they have changed their policies with respect to certain types of postings.  Drug and devise companies' ability to disable commenting on some of their pages has been curtailed.   Facebook has decided to require that the commenting function be available on new disease awareness pages and pages that focus on certain diseases or patient communities. (Facebook will  reportedly allow comment blocking on branded drug pages.) This will surely lead to a reassessment of social media strategies by companies. Although these social media platforms provide valuable patient and Health Care Professional interfaces, monitoring of comments can be a regulatory burden on companies who choose to stay in the space.  Some companies, such as J&J, have already decided that the burden outweighs the benefits and are shutting down some of their sites.  Those of you with responsibilities in this area will want to review your own strategies.

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Charlene Gallagher
Gallagher Consulting
Berwyn PA
United States
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What type of regulatory burden is J&J evaluating?  Are they using their Facebook/LinkedIn/Twitter to make labeling claims?

And it seems odd to me that companies would want to disable commenting.  If you are going to get involved in social media, you need to foster a conversation, not control a one-way funnel of information.  Otherwise, your effectiveness in the social medial realm will suffer.  It's a situation of you are in social media and embrace the feedback, or you get out.

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Ryan Kasun
Regulatory & Quality Engineer
Regulatory & Quality Solutions, LLC
www.raqasolutions.com
Murrysville PA
United States
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Original Message:
Sent: 08-17-2011 10:21
From: Charlene Gallagher
Subject: Facebook changes policies

For those of you who are responsible for advertising and promotion review, the social media continue to present a challenge.  Many companies are confused about the rules.  The FDA has not yet issued any guidance, despite many promises to do so.  However, Facebook has recently announced that they have changed their policies with respect to certain types of postings.  Drug and devise companies' ability to disable commenting on some of their pages has been curtailed.   Facebook has decided to require that the commenting function be available on new disease awareness pages and pages that focus on certain diseases or patient communities. (Facebook will  reportedly allow comment blocking on branded drug pages.) This will surely lead to a reassessment of social media strategies by companies. Although these social media platforms provide valuable patient and Health Care Professional interfaces, monitoring of comments can be a regulatory burden on companies who choose to stay in the space.  Some companies, such as J&J, have already decided that the burden outweighs the benefits and are shutting down some of their sites.  Those of you with responsibilities in this area will want to review your own strategies.

-------------------------------------------
Charlene Gallagher
Gallagher Consulting
Berwyn PA
United States
-------------------------------------------

In the RAPS weekly update, they posted the following: http://www.raps.org/newsroom/latest-news.aspx#feature218aug11

The way I read it, the problem is if lay-people post their own claims, it's up to the Manufacturer to set people straight, lest the layman's comments be taken as documented statements.

For example, if someone went to one of these Facebook pages, and said "hey did you know Bayers Aspirin will cure Athletes Foot" (I totally made that up) then it's up to Bayer to say "no it doesn't".  Otherwise, someone can say "I was on Bayers Facebook page, and it said it cures Athletes Foot".  This becomes a labeling issue, making claims against the intended use.
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Heather Hogan
Quality, Regulatory Affairs & Compliance Analyst
Data Innovations
South Burlington VT
United States
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Original Message:
Sent: 08-17-2011 11:34
From: Ryan Kasun
Subject: Facebook changes policies

What type of regulatory burden is J&J evaluating?  Are they using their Facebook/LinkedIn/Twitter to make labeling claims?

And it seems odd to me that companies would want to disable commenting.  If you are going to get involved in social media, you need to foster a conversation, not control a one-way funnel of information.  Otherwise, your effectiveness in the social medial realm will suffer.  It's a situation of you are in social media and embrace the feedback, or you get out.

-------------------------------------------
Ryan Kasun
Regulatory & Quality Engineer
Regulatory & Quality Solutions, LLC
www.raqasolutions.com
Murrysville PA
United States
-------------------------------------------






Original Message:
Sent: 08-17-2011 10:21
From: Charlene Gallagher
Subject: Facebook changes policies

For those of you who are responsible for advertising and promotion review, the social media continue to present a challenge.  Many companies are confused about the rules.  The FDA has not yet issued any guidance, despite many promises to do so.  However, Facebook has recently announced that they have changed their policies with respect to certain types of postings.  Drug and devise companies' ability to disable commenting on some of their pages has been curtailed.   Facebook has decided to require that the commenting function be available on new disease awareness pages and pages that focus on certain diseases or patient communities. (Facebook will  reportedly allow comment blocking on branded drug pages.) This will surely lead to a reassessment of social media strategies by companies. Although these social media platforms provide valuable patient and Health Care Professional interfaces, monitoring of comments can be a regulatory burden on companies who choose to stay in the space.  Some companies, such as J&J, have already decided that the burden outweighs the benefits and are shutting down some of their sites.  Those of you with responsibilities in this area will want to review your own strategies.

-------------------------------------------
Charlene Gallagher
Gallagher Consulting
Berwyn PA
United States
-------------------------------------------

I understand the anecdotal example of "I was on Bayer's FB page and it said that asprin cures athlete's foot"; however, I know the same types of conversation occurs face-to-face, on Yahoo! Answers (or other Q&A forums), etc.

Again, I say that social media is about a conversation that occurs over the internet.  If the FDA expects manufacturers to correct each and every lay-based statement with a "no its not", then they set a dangerous precedent with any lay claims for products.  What will Bayer do about people using Aspirin to dry up zits?  Everyone knows it's a common use of the product and, in fact, I'm quite positive that the "home remedy" has been published in many forms, paper or electronic.

Of course, I would love to propose a common sense solution that does not require so much over-head, but I am at a loss for ideas right now.  It certainly is difficult to rely on common sense in an overly litigious environment, but there must be a common ground.

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Ryan Kasun
Regulatory & Quality Engineer
Regulatory & Quality Solutions, LLC
www.raqasolutions.com
Murrysville PA
United States
-------------------------------------------






Original Message:
Sent: 08-18-2011 15:58
From: Heather Hogan
Subject: Facebook changes policies


In the RAPS weekly update, they posted the following: http://www.raps.org/newsroom/latest-news.aspx#feature218aug11

The way I read it, the problem is if lay-people post their own claims, it's up to the Manufacturer to set people straight, lest the layman's comments be taken as documented statements.

For example, if someone went to one of these Facebook pages, and said "hey did you know Bayers Aspirin will cure Athletes Foot" (I totally made that up) then it's up to Bayer to say "no it doesn't".  Otherwise, someone can say "I was on Bayers Facebook page, and it said it cures Athletes Foot".  This becomes a labeling issue, making claims against the intended use.
-------------------------------------------
Heather Hogan
Quality, Regulatory Affairs & Compliance Analyst
Data Innovations
South Burlington VT
United States
-------------------------------------------

Companies are only required to monitor social media where they have direct or indirect monies involved, e.g. a disease awareness Facebook (FB) page, a company twitter stream or a sponsored health advocacy forum. Many companies have already found ways to do this by clearing outlining moderation policies on FB pages, even going so far in some cases as to have their moderation policies as the landing page. This gives them the right to moderate (read "delete") posts that contain off-label discussions or offer medical advice. They also include policy language regarding how they treat and how to report an adverse event. And, lastly, they set up monitoring via social media monitoring software or the simpler, human monitoring method.

The secondary question is, wouldn't you want to know, even in non-company sponsored forums, if patients were reporting adverse events? I was just at a conference where Kimberly-Clark reported that they heard first via blog posts that their feeding tubes were failing early. Then, they were able to mobilize and take action to fix the problem, communicate to their users, and most importantly help the patients.

If you would like more detail about the FB comments, I wrote a blog about it today that may be a helpful resource: http://ow.ly/67K1b

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Maureen Shaffer
Vice President, Life Sciences
Prolifiq Software
Beaverton OR
United States
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Original Message:
Sent: 08-19-2011 09:47
From: Ryan Kasun
Subject: Facebook changes policies

I understand the anecdotal example of "I was on Bayer's FB page and it said that asprin cures athlete's foot"; however, I know the same types of conversation occurs face-to-face, on Yahoo! Answers (or other Q&A forums), etc.

Again, I say that social media is about a conversation that occurs over the internet.  If the FDA expects manufacturers to correct each and every lay-based statement with a "no its not", then they set a dangerous precedent with any lay claims for products.  What will Bayer do about people using Aspirin to dry up zits?  Everyone knows it's a common use of the product and, in fact, I'm quite positive that the "home remedy" has been published in many forms, paper or electronic.

Of course, I would love to propose a common sense solution that does not require so much over-head, but I am at a loss for ideas right now.  It certainly is difficult to rely on common sense in an overly litigious environment, but there must be a common ground.

-------------------------------------------
Ryan Kasun
Regulatory & Quality Engineer
Regulatory & Quality Solutions, LLC
www.raqasolutions.com
Murrysville PA
United States
-------------------------------------------






Original Message:
Sent: 08-18-2011 15:58
From: Heather Hogan
Subject: Facebook changes policies


In the RAPS weekly update, they posted the following: http://www.raps.org/newsroom/latest-news.aspx#feature218aug11

The way I read it, the problem is if lay-people post their own claims, it's up to the Manufacturer to set people straight, lest the layman's comments be taken as documented statements.

For example, if someone went to one of these Facebook pages, and said "hey did you know Bayers Aspirin will cure Athletes Foot" (I totally made that up) then it's up to Bayer to say "no it doesn't".  Otherwise, someone can say "I was on Bayers Facebook page, and it said it cures Athletes Foot".  This becomes a labeling issue, making claims against the intended use.
-------------------------------------------
Heather Hogan
Quality, Regulatory Affairs & Compliance Analyst
Data Innovations
South Burlington VT
United States
-------------------------------------------