Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Direct patient engagement through social media speeds recruitment to cancer research study

Direct patient engagement through social media speeds recruitment to cancer research study | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A crowd-sourcing strategy aimed at accelerating research into metastatic breast cancer has registered more than 2,000 patients from all 50 states in its first seven months, report researchers from Dana-Farber Cancer Institute and the Broad Institute of MIT and Harvard at the American Society of Clinical Oncology Annual Meeting.

Via Julie O'Donnell, Lionel Reichardt / le Pharmageek
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Did FDA Avoid the "Social Media Guidance Cliff"?

Did FDA Avoid the "Social Media Guidance Cliff"? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Section 1121 of the Prescription Drug User Fee Act (PDUFA) states: "Not later than 2 years after the date of enactment [signed into law on 9-July-2012], FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA" (see here). 

I call this the "Social Media Guidance Cliff."

Pharma Guy's insight:


Well, today is exactly two years after PDUFA V was signed into law. While FDA has issued a few social media guidance documents, it still has one more to go: Use of Links


FDA's "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014," which was published in January 2014, promised that it would publish that guidance sometime in 2014 (see here).


Section 1121 was not specific as to how many social media guidances FDA should issue before toddy's deadline. So I guess FDA is off the hook as far as complying with section 1121 is concerned.

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Rich Meyer: Drug companies should build their own online communities

Rich Meyer: Drug companies should build their own online communities | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Can we establish an online community in drug marketing ?

The answer to that is YES.  I did when I worked at Eli Lilly and was in charge of marketing for Sarafem back in 2002.  We allowed people to post their experiences around PMDD but the posts would not go live until they were reviewed by my MLR team. Because of the importance of woman sharing their experiences my MLR team was able to approve the posts within 48 hours and we had a disclaimer that we could edit the post to eliminate not approved FDA claims.


In the first week alone we had almost 300 posts and 99% of them were positive with women sharing their experiences around PMDD and how it affected their lifestyles.  Not only were women sharing their experiences, but in a follow up survey, we found that close to 70% had asked their doctor about Sarafem. This was key because a lot of physicians did not believe that PMDD was a “medical condition” but once we shared the posts from women they quickly became believers.

Pharma Guy's insight:


I appreciate Rich's comments, but he cites old experiences with an online pharma discussion forum. This highlights the fact that the drug industry used to sponsor several of these patient discussion groups in the past -- see, for example, Question Everything --

 but no longer do so. Why not?


Today, there are many more online options available to consumers/patients for discussing their medical conditions and seeking advice from peers. Why would they choose to do this on a pharma site? 


My view is that pharma's reputation has eroded rapidly in the past 10 years (read, for example, the articles in the Pharma Marketing Ethics & Corporate Reputation Compendium). That means, all other things being equal, consumers will opt not to trust pharma and especially not trust whatever is said on a pharma-sponsored site even if it is supposedly from a legitimate patient. Remember, nobody knows you're a dog on the Internet and nobody knows when pharma creates artificial patients to tell positive stories about their products; see, for example, Fictional Patient Story Wins Gold, Whereas Authentic Patient Story Wins Bronze at Lions Health 2014

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ARIAD Pharmaceuticals' Public Twitter Policy

ARIAD Pharmaceuticals' Public Twitter Policy | Pharmaguy's Insights Into Drug Industry News | Scoop.it

ARIAD, like many biopharmaceutical companies, is in the process of engaging in conversations via new social media channels like Twitter.

About @ARIADPharm:
  • Welcomes your mentions/replies and we’ll do our best to respond to most questions. We will not respond to personal attacks, foul language, disparaging comments or topics that do not relate directly to the company. We may not be able to respond to your questions immediately and some responses may be limited in nature.
  • May not be able to address some questions/comments, including questions directly related to financial matters, ongoing legal matters, regulatory issues or certain other elements of our business.
  • Hopes that your contributions will add value to the overall dialogue and we appreciate you providing links or other resources to support any claims.
Disclaimers:
  • Any personal medical issues should be addressed with your physician rather than the Twitter account, which is not moderated by clinicians.
  • Twitter accounts that ARIAD follows or is followed by do not indicate an endorsement of the account owner or their products and services.
  • ARIAD may provide links or references to other sites as part of its Tweets. However, ARIAD claims no responsibility for the content of such other sites and shall not be liable for any damages or injury arising from that content. Any links to other sites are provided as merely a convenience to the users of this platform.
Pharma Guy's insight:

Back in June, 2014, I praised Aruad: "It's refreshing to see a social media policy published by a pharma company. I recently praised Boehringer Ingelheim's video social media policy (see Gefällt Mir! Boehringer Ingelheim Invites Two-Way Communication Via Social Media). Most large pharma companies (e.g., Pfizer) do not do this although they boast of having policies that the public cannot access (read Pfizer, Show Us Your Social Media "Playbook")."

 

But since the company raised the price of its leukemia treatment 4 or more times in a year to meet investor expectations (read Wall Street is Fueling Drug Price Hikes, Not "Benefit to Patients" as Claimed by Ariad & Other #pharma Companies; http://sco.lt/8FBHg9), I have to reconsider how I rate the social media savviness of pharma companies and bring into it their general attitude towards patients as well. 

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MedHawk's curator insight, June 25, 2014 1:30 PM

Social media is changing the nature and atmosphere of health care interface between customers and pharmaceutical companies. The transformation of information gathering and the emergence of the engaged patient has demonstrated the increased importance of social media in the broader healthcare context. ARIAD, like many biopharmaceutical companies, is currently in the process of establishing conversations via Twitter.

 

It is apparent that a growing percentage of today’s patients are increasingly using digital tools as part of their overall health maintenance. In a recent survey, 51% of patients say they’d feel more valued as a patient via digital health communications, and another survey indicates that 41% of people said social media would affect their choice of healthcare provider.

 

These communications are important for pharmaceutical companies to have more understanding and awareness of what is important to the patients and those whose lives are affected by cancer. For ARIAD, social media allows customers to ask questions anonymously without feeling embarrassed to ask. This is a key technique to establish consumer trust for the company.

 

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FDA's Social Media Guidances Provide Little That's New, Says Coalition for Healthcare Communication

Indeed, at the Drug Information Association Annual Meeting held last week in San Diego, Abrams noted that he expected minimal use of space-limited media because of the agency’s requirements on risk information. Cooke wrote that OPDP’s call for risk information that includes the most serious risks associated with the product, as well as all boxed warnings, makes it “difficult to imagine a product that has fatal or life-threatening risk, contraindications or boxed warnings that could be contained within the space-limited context of a Tweet, which has a 140-character limitation.” For example, he cited one product’s boxed warning, which alone contains 692 characters.


This approach “would limit the availability of space-limited communications to the small subset of prescription products whose risk and benefit information” meet the agency’s requirements, Cooke said, adding that the framework set forth by the draft guidance “seems more amenable to the participation of products with limited risks and short benefit statements.” He told the Coalition that the agency “could have suggested some approved abbreviations to help companies meet the requirements in a limited space – such as using ‘risks incl death’ instead of ‘risks include’ and listing all possible inclusions –but it chose not to.”


In an e-mail to Bloomberg BNA June 17, James N. Czaban, chairman of the FDA Practice Group at Wiley Rein LLP, said that the risk/benefit guidance “is actually very limited in scope” because it does not address many other types of online activity. He also told BNA that “The idea that FDA would allow a black box warning to be condensed for use in the format of Google Sitelinks or even Twitter is quite surprising given existing promotional limitations on black box products, and the length and seriousness of such warnings for many drugs,” Czaban told BNA. “Will any company risk such an approach from a liability perspective, even if it could meet the space limitations?”


Czaban said that “the bottom line is that FDA’s guidance leaves many questions unanswered, and its examples are of limited utility.”

Pharma Guy's insight:


Here's how I believe pharma can create a compliant tweet INCLUDES a 692-character boxed warning: A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance

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Thinking Outside the Tweet

Thinking Outside the Tweet | Pharmaguy's Insights Into Drug Industry News | Scoop.it

I couldn't sleep last night. For some reason I became obsessed with trying to figure out a way that pharma companies can create Rx branded tweets that satisfy FDA's recent "Industry Guidance for Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices."

Pharma Guy's insight:

"The draft guidance does not mention Tweets accompanied by images, which is perhaps a way to present ISI along with benefit information in the tweet itself," I said. "I have created a mock-up using Lipitor as an example."

Here's a screen shot of how this tweet would look on Twitter (would it pass muster with FDA? Tell me your opinion on Pharma Marketing Blog).

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FDA Guidance Says Companies Have Broad Leeway to Correct Misinformation

FDA Guidance Says Companies Have Broad Leeway to Correct Misinformation | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The US Food and Drug Administration (FDA) has released a new draft guidance document on social media focused on how companies can correct blatant misinformation contained on the Internet and social media channels, long a source of frustration for FDA-regulated companies.


The agency is now out with its third social media draft guidance, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.


As FDA explains in the guidance, the Internet has made is considerably easier for outside third parties—from other companies to consumers—to disseminate information about drugs, including factually incorrect or misleading information.


And that information sometimes finds its way onto websites where the sponsor of a drug product has the opportunity to correct misinformation about the product. The question companies have had until now is, ”How can we do so without falling afoul of FDA regulations on product promotion?”


The fear of some companies was that by responding with anything other than full and complete prescribing information, the companies might be cited for misleading promotion. And in many forums, companies are constrained in the space they have to respond to someone.


The good news for companies: FDA says it "does not intend to object" if a company "voluntarily corrects misinformation [posted by a third party unaffiliated with the company] in a truthful and non-misleading manner"—a manner described in FDA's latest draft guidance.

Pharma Guy's insight:


In Example 11 of the guidance document, FDA says:


“A firm finds a webpage about its product that was written by an independent third party on an Internet-based, interactive, collaboratively edited encyclopedia. The firm may choose to contact the author of the webpage and provide corrective information to the author.”

 

Obviously, FDA is referring to Wikipedia when it talks about “an independent third party on an Internet-based, interactive, collaboratively edited encyclopedia.” Although pharma companies may be able to contact the author of “misinformation” by leaving a message on the author’s talk page, that message may be ignored.

 

There’s a better way, which I wrote about in Pharma Marketing News.

 

In that article (find it here http://bit.ly/pmn130302p ), I wrote about the “right way” to correct Wikipedia articles:

 

Recall that back in June, 2012, Dr. Bertalan Meskó (@Berci), in an open letter to pharma, urged the pharmaceutical industry to employ Wikipedia editors and thus "funnel [their] vast resources" to help.

 

"Based on the pretty negative past encounters between pharma employees and Wikipedia editors (pharma employees trying to edit entries about their own products in a quite non-neutral way), we advise you to employ a Wikipedia editor if you want to make sure only evidence-based information is included in entries about your own products,” said Berci in 2012 (see http://bit.ly/pmn11602).

 

“Appointing someone from within your company as a 'spokesperson' in Wikipedia who would perform all edits on behalf of the company is an excellent way to update those entries," said Berci.

 

You would think that the pharmaceutical industry would have jumped at the chance to establish a liaison with Wikipedia to help edit articles about their products. At least one pharma company, in fact, did seem to endorse the idea, at least in principle.

 

Boehringer Ingelheim (BI) responded to Berci via Twitter: "We look for patient safety issues & react. Its important to stick to Wikipedia policies too, so all transparent." But when asked by Berci if BI had posted anything online about this, BI responded "No at this point in time we have not....yet." He remains optimistic.

 

In a PMN survey, 57% of respondents agreed that pharma companies should appoint an official Wikipedia editor (see chart above and survey summary here: http://bit.ly/pgdaily012914-2A). 

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Joel Finkle's curator insight, June 19, 2014 1:03 PM

More on FDA and social media use

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Celebrities + Social Media: Balancing Benefits and Risks

Celebrities + Social Media: Balancing Benefits and Risks | Pharmaguy's Insights Into Drug Industry News | Scoop.it

This article focuses on the risks and benefits of using celebrities and social media to promote pharma brands and proposes that it may be time for the pharma industry to disclose the details of payments made to celebrities as they now are required to do for physician payments.


Topics (partial list):

  • Paula Deen & Victoza: Brilliant or Dumb?
  • Mickelson's Enbrel Shill Audition
  • The Kardashian Kerfuffle
  • Fast Acting FDA!
  • Corrective Social Media Messages
  • The ROI of Social Media
  • It's Time For Celebrity Payment "Sunshine"
  • Chart: The Pharma Social Media Hype Cycle
  • Chart: Pharma Paid Celebrity Best Practices Survey Results


Download the full pdf version of this article here.

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Pharma Guy's curator insight, September 10, 2015 7:34 AM

Practically every other day you hear that a celebrity has teamed up with a pharmaceutical company to promote an Rx drug or raise awareness about a medical condition treated by a drug of the sponsoring company. The Kim Kardashian Instagram Kerfuffle is just an extreme case where a social media branded endorsement by a celebrity was cited as violative by the FDA. Did it hurt or benefit the brand?


The other good vs bad issue of  celebrity endorsements is the PR they are able to generate, This PR, of course, van help the brand, but it can also hurt the reputation of the drug industry as pharma "buys" the opinion of more and more celebrities. Inevitably, consumers will want to know how much these celebrities are being paid. That information is kept by pharma as a closely guarded secret just as it used to keep secret the payments made to physicians. Will there be a political backlash where lawmakers suggest a Celebrity Sunshine Law? 


I believe in transparency, so I hope the industry discloses payments to celebrities without the necessity of further regulations/laws. But I'm also a pessimist when it comes from lawmakers who receive a lot of financial support from celebrities, which is another area that needs transparency!

Celebrities News's curator insight, April 19, 2017 2:31 AM
Celebrities News's curator insight, April 19, 2017 2:31 AM
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Forget ROI! - Pharma must measure return on engagement

Forget ROI! - Pharma must measure return on engagement | Pharmaguy's Insights Into Drug Industry News | Scoop.it

One of the biggest challenges currently facing pharma is the increasing difficulty of not only reaching, but also influencing HCPs through traditional and non-traditional sales and marketing efforts. As we've known for some while, sales forces are getting ever increasingly smaller. In fact a recent study showed that just 27 per cent of sales visits result in the rep actually getting to see a HCP – on the flip side the survey showed only 23 per cent of the HCPs would rate the sales force performance as excellent.


At a time of increased competition, these findings are worrying. Costs are skyrocketing, engagement is decreasing, and the demand for RoI is higher than ever. With responsibility of every penny spent needing to be attributed, the vicious circle of unease continues to swell.


The bottom line is that the way RoI is measured is flawed. HCPs are not loyal to one brand; they could defect to another brand tomorrow. So measuring the investment in a 'campaign' is not the biggest measure anymore. We now need to treat HCPs as consumers. And in consumer marketing capturing brand loyalty has been practiced for decades.


I believe that it is time to drop our over reliance on just chasing those unattainable and arguably, misleading, RoI metrics. It is now the time to look at incorporating relationship and engagement metrics that build loyalty towards a brand.


Pharma Guy's insight:


"Treat HCPs as consumers," "build loyalty" ... if only pharma could offer physicians a "frequent prescriber rewards" program! But wait, the industry used to do just that -- and may still be doing so -- by offering high prescribers "consultant" gigs. In the old days, pharma gave away free trips to medical conferences and free dinners at nice restaurants. Now, with the Sunshine law in effect, it's not so easy to reward physicians that way any more.


The author, Ash Rishi, suggests that pharma adopt consumer practices to "use the power of emotion, to engage, to attract and then to retain customers"; e.g., HCPs. It seems to me that pharma mastered that practice years ago when it started hiring attractive, young sales reps. See, for example, this.


Regarding "each marketing tactic needs to put the patient at the heart of their branding strategies," emotions and loyalty programs are also used by pharma marketers. Just consider the emotional appeal of DTC ads and drug coupon loyalty programs (e.g., read Lipitor For You! Actually, For Card Carrying Members Only!).


Thanks to Rishi I now have another term to include in the Pharma Marketing Glossary: MOT. Rishi doesn't explain what this is, but here is what I learned: It stands for "Moment of Truth," which is a concept coined by Proctor & Gamble.


There are many variations of this term:

  • First Moment of Truth (FMOT) - the actual term first coined by P&G: "This is considered to be the decision point to buy a specific brand or product." (here)
  • Second Moment of Truth - also coined by P&G
  • Third Moment of Truth
  • Zero Moment of Truth (ZMOT) - coined by Google
  • BSMOT - coined by PharmaGuy: Can you guess the meaning?


The term "First Moment of Truth" (commonly called FMOT) was coined by Procter & Gamble in 2005 to define the first interaction between a shopper and a product on a store's shelf. This moment was considered one of the most important marketing opportunities for a brand, as P&G asserted -- and others believed -- that shoppers make up their mind about a product in the first few seconds after they encounter that product for the first time.


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What Happens To Your Social Media Presence When You Die? [INFOGRAPHIC]

What Happens To Your Social Media Presence When You Die? [INFOGRAPHIC] | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Do you realise, that everyone you know, someday, will die?

And I hate to be the one to break it to you, but at some point – hopefully in the distant, distant future – you’re going to leave this mortal coil, too.*

So here’s the big question: what happens to our social media profiles when we cease to exist?


Consider this: in the first eight years of its existence, 30 million Facebook users died.


30 million.


But that’s just the start. If the social network stops growing, the number of people who will have died “on Facebook” will surpass the living by 2065.


Add Twitter, LinkedIn, Pinterest, Google and every other social platform into the mix and we could be looking at billions of virtual tombs.

You think your social media profile is dead now? Just wait until you’ve actually died.


This visual from WebpageFX looks at what happens to your online presence when you die.

Pharma Guy's insight:


Depressing, but important to know. There should be an app to handle all this when you die.

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rhalper's comment, July 4, 2014 12:12 PM
I think there might be. Alternatively, you need to give all your passwords to your survivors. It's ghoulish when I get posts from dead people!
Pharma Guy's comment, July 4, 2014 12:49 PM
What do they say?
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Social media fails, says Rich Meyer, interpreting Gallup data

Social media fails, says Rich Meyer, interpreting Gallup data | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Most consumers aren’t visiting social media sites to engage with brands — they are there to interact with people they know. According to Gallup research, the vast majority of consumers (94%) who use Facebook, Twitter, and other social networking channels do so to connect with family and friends. They are far less interested in learning about companies and/or their products, which implies that many companies have social media strategies in place that may be largely misdirected.


What does this mean for pharma marketers? 
  1. Social media alone is not going to deliver on the promise of patients asking for an Rx.  It is PART of an integrated marketing initiative to reach health searching consumers online.
  2. Pharma, which is heavily ROI driven, needs to think of social media, not as a conversion platform, but rather a way to help patients get the information they need to make health care decisions.
  3. DTC marketers should experiment with social media but have clear and concise objectives before allocating resources.
Pharma Guy's insight:

50 Ways (for pharma) to Use Social Media - does not include directly influencing consumers to "buy" your drug

Sung to the tune “50 Ways to Leave Your Lover” by Paul Simon

"The problem is all inside your head", FDA said to me
The answer is easy if you take it logically
I'd like to help you in your struggle to be AER free
There must be fifty ways to use social media

FDA said it's really not my habit to intrude
Furthermore, I hope my meaning won't be lost or misconstrued
But I'll repeat myself, at the risk of being crude
There must be fifty ways to use social media
Fifty ways to use social media

You just Tweet the right way, GSK
Make a new Blog, Janssen-Cilag
You don't need to be coy, Daiichi Sankyo
Just get yourself free
Hop on the bus, Novartis
You don't need to discuss much
Just drop the key(word), Lilly
And get yourself free

Ooo slip out the back door, Bayer
Make a new plan, Allergan
You don't need to be wiser, Pfizer
Just listen to me
Hop on the grid, Orchid
You don't need to discuss much
Just drop the search ad, Gilead
And get yourself free

FDA said it grieves me so to see you in such pain
I wish there was something I could do to make you smile again
I said I appreciate that and would you please explain
About the fifty ways

FDA said why don't we both just sleep on it tonight
And I believe in the morning you'll begin to see the light
And then FDA sent me a warning letter 
Boy, that didn’t make me feel any better!
Still, there must be fifty ways to use social media
Fifty ways to use social media
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The Hawaiian Shirt is Back from Italy and Ready for the Next Pharmaguy Social Media Pioneer Award Recipient!

The Hawaiian Shirt is Back from Italy and Ready for the Next Pharmaguy Social Media Pioneer Award Recipient! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

I just received the coveted Hawaiian shirt from Davide Bottalico and the Roche Italy Digital Academy Team, recipients of the Fourth Annual Pharmaguy Social Media Pioneer Award (see "Davide Bottalico and the Roche Digital Academy Team Receive the 4th Annual Pharmaguy Social Media Pioneer Award!").

I was a little afraid that Davide would get pizza on the shirt when I spotted an image on his Facebook page of him wearing it. But I see that it is in mint condition -- freshly dry-cleaned and wrapped in plastic! Thanks Davide for taking such good care of this revered  symbol of "standing out from the crowd."

The Award gives kudos and recognition to the pioneers within the pharma industry who have lead the way through the darkness that is pharmaceutical social media – even if the end result did not meet their expectations, failed miserably in terms of ROI, or was just a pilot campaign to test the waters. Campaigns come and go, but pioneers move on to new positions and continue to spread their influence far and wide. 

Learn more about ALL the past recipients of this Award here. I hope to give shirt to the next recipient(s) of the Award sometime in October, 2014.

Pharma Guy's insight:


Although I know a lot of pharma people who are social media pioneers (e.g, see my TOP 100 Pharma Twitter Pioneers list), I need help to discover the people who often work behind the curtain -- moderating discussions, writing blogs, managing the Twitter accounts, etc. -- and who are more or less invisible. With your help, I hope to peel back the curtain and tell the stories of these people.

Please, if you know someone who I should consider to receive this award -- or if you yourself feel you quality -- let mw know. Use this form.

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The FDA Social Media Guidances May Not Change Anything: Senak Explains

The FDA Social Media Guidances May Not Change Anything: Senak Explains | Pharmaguy's Insights Into Drug Industry News | Scoop.it
After a five-year wait, the FDA this week released guidelines for how drug and device makers should deal with social media. One provides a blueprint for correcting misinformation on websites run by others, while the second guidance discusses the use of Twitter. We spoke with Mark Senak, a senior vice president and partner at the FleishmanHillard public relations firm that works closely with drug makers and who also writes the Eye On FDA blog, about what the guidances may – or may not - change.


Pharmalot: And what about the other guidance, which refers to using Twitter?


Senak: Using Twitter for specific product communications prior to the guidance was problematic because there were so many unknowns. But now it’s problematic because of what we know.


Pharmalot: What do you mean?


Senak: In general, the manufacturer must present risk information in the same venue as any discussion of a product. In characters placed in a limited venue, people didn’t know how to cram all of that into 140 characters, particularly after the banishment of a one-click rule in 2009, [my emphasis] when you couldn’t use a link to take you elsewhere to read the info.


So people avoided Twitter, because it wasn’t known how to satisfy requirements. Looking at the guidance and the example of how to develop a Tweet, it’s still so constricted that I think product-specific communication by Twitter is still problematic. Again, I think it’s a situation where not much has changed.

Pharma Guy's insight:


I take issue with Senak's statement that the "one-click rule" was "banished" by the FDA in 2009. He's referring to the famous 14 letters FDA sent to major drug companies on April 2, 2009 (read "Ramifications of FDA Regulatory Actions").


Here's what I wrote in November 2007 - nearly one and one-half years prior to when Senak says FDA "banished" the one-click rule (read: The "One-Click Rule": Rant or No Rant?):


The "one-click rule" is no rule at all and is merely a platitude online pharmaceutical marketers spout to trick us into believing that they obey "rules." Since I spend a lot of time documenting how pharma marketers violate this "rule" repeatedly, I thought I would write a comment to the authors of a document that advised pharma about the "rule." Here it is. You decide if it is a "rant" or not.


In the paper, the authors make frequent reference to the so-called "one-click rule" regarding access to fair balance information on the Internet.

If you search Google on "one-click rule FDA" you won't find any references to this rule that the FDA has made, but you will find my post "Girl from Google." (posted in November 2005).

That's because, in that post, I discuss how the so-called "one-click rule" was used to justify Google Adwords (aka, "BAdwords") that violate FDA guidelines -- these ads mention the brand name and indication, but do NOT include any fair balance as is required by FDA. (NOTE: THE FDA'S 14 LETTERS PRECISELY TARGETED THESE KINDS OF ADS IN APRIL, 2009, MORE THAN 2 YEARS AFTER I POINTED OUT THAT THESE ADS VIOLATED FDA REGULATIONS!).

One person from a pharmaceutical company, perhaps playing the devil's advocate, contended that these "BAdword" ads may pass muster with the FDA because the package insert or brief summary is "one or two clicks away." His argument was that without specific guidance from the FDA, no one knows what is correct in this case.


It is a shame that the FDA does not have any guidance for the industry as far as Internet advertising is concerned. This means that marketers can use lack of guidance as a defense for sneaking in ads that push the envelope. What are the chances that the FDA would ever notice (BUT THEY DID!). These ads are fleeting, here today, gone tomorrow!


ONE YEAR AFTER I MADE THIS POST AND AFTER I ISSUED A CALL FOR A PUBLIC HEARING AT THE FDA TO DISCUSS THIS ISSUE (READ "Developing Guidelines for Pharma's Use of the Internet & Social Media: A Call for a Public Hearing at FDA), THE FDA DID HAVE THAT HEARING AND THE REST IS HISTORY.

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FDA Finally Proposes Social Media Guidelines

FDA Finally Proposes Social Media Guidelines | Pharmaguy's Insights Into Drug Industry News | Scoop.it
After several years of anticipation, the FDA has finally proposed a pair of guidelines for how drug and device makers should cope with some of the challenges and pitfalls posed by social media.


One of the so-called draft guidances offers instructions on how companies should attempt to correct product information on websites that are run by others, such as chat rooms. The otheraddresses how products – including risk and benefit information – can be discussed in venues such as Twitter, as well as paid search links on Google and Yahoo, all of which have limited space. This will involve using links to product web sites, for instances, that can be clicked.


“These are intended to have a beneficial impact on public health,” Tom Abrams, who heads the FDA Office of Prescription Drug Promotion, tells us. “But these were not developed in a vacuum. They were developed with careful consideration and with input from industry and many other stakeholders. There was a lot of important consideration given to the issues.”


For third-party websites, suchas Wikipedia, the draft guidance suggests that companies should feel free to correct misinformation, but that any correction must include balanced information and the source of the revision or update must be noted, Abrams explains. This means a company or company employee or contractor should be credited with any additions.


“The information should not be promotional and should be factually correct. This is not an opportunity for a company to tout its drugs,” he says. “The information [being added or revised] should be consistent with the FDA-approved [product] labeling and for it to be effective, you want it posted right by the misinformation.”


The guidance also says that companies should contact writers, such as bloggers, to make changes when they learn of misinformation. Abrams notes companies will not be held responsible for those who do not make changes. If none of this is possible, he says companies should contact web site operators and suggest they delete the misinformation or open the site to comments so that corrections can be made.

Pharma Guy's insight:


Well, well, well. I can't believe it! And I thought FDA would miss the July 2014 deadline imposed by Congress. For more on that, read: Will FDA Avoid the "Social Media Guidance Cliff"?

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