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Five Regulatory Myths About FDA Regulation of Pharma in the Digital Health Arena #esante #hcsmeufr #digitalhealth

From www.mobihealthnews.com

Digital tools offer an opportunity to revolutionize bio/pharma care, so why isn’t more being done faster?

 

Bio/pharma is desperate to offer new value to patients, providers and payers, and digital can unlock both clinical and economic outcomes.

 

That’s why we are heartbroken when these companies barely dip their toe in the digital waters. They want to move faster, but fear of regulatory consequences is creating significant friction and even paralysis.

 

No doubt there are valid issues to manage and unknowns to navigate. At the same time, at least some regulatory fears are rooted in myths rather than facts. By busting these myths, bio/pharma can more confidently enter the digital health market.

 

TOP 5 MYTHS

 

  1. FDA wants to tightly regulate bio/pharma software.
  2. Companion digital health developers always create regulatory risk for bio/pharma.
  3. Any clinical trial software will be regulated as a medical device.
  4. Any bio/pharma software must be approved via a supplemental NDA.
  5. Bio/pharma companies must report adverse events in any databases they touch.
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Pharmaceutical Landscape on Social Media

From unmetric.com

Many pharmaceutical companies have been cautious about their social media presence. However, that’s no surprise given the advertising restrictions and potential minefields of discussing prescription medicine in an uncontrolled environment. This report looks at how 16 companies have embraced social media and the trends that have emerged in the industry over the last five years.

 

Due to the restrictions imposed upon the industry by the FDA, we found that pharmaceutical companies have split their social media presence into four independent silos (see image).

 

On Facebook, pharmaceutical companies saw growth from both Corporate pages and Career pages. The high growth of the Careers pages is perhaps an indicator of the low number of total Fans these pages have. As for the Corporate pages, the high growth rate suggests that this silo was a very important channel for pharma brands in 2016.

 

On Twitter, pharmaceutical companies struggled to increase Follower growth throughout 2016. The Branded portals’ handles were the biggest drivers of Follower growth mostly due to the comparatively low number of Followers. Just like on Facebook, the OTC Brand handles didn’t register any significant growth. This could be due to companies refocusing their efforts in other silos.

 

Further Reading:

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Tumblr Not High on Pharma's Most Popular Social Media Platforms List for 2017 & 2018

From www.marketwired.com

A new study of pharmaceutical marketing teams found that the most popular social media forum groups plan to use in the next one to two years is Facebook (73%), according to data published by business intelligence firm Cutting Edge Information.


Data found in the study, Pharmaceutical Marketing: Reevaluate Digital Trends and Metrics for Social Media and Mobile Success, which was published less than a month ago, revealed that YouTube (64%) and LinkedIn (55%) are also common for surveyed life science marketing teams, with Twitter (45%) at a more distant fourth.


Not as popular, but still commonly used social networking sites include Instagram and Tumblr, with 18% and 9% of pharmaceutical marketing teams utilizing them, respectively. Additional data from the study show that no surveyed pharmaceutical and medical device companies report using Pinterest, Vine, Flickr and Reddit.


"New technology offers many opportunities in the pharmaceutical industry," said Natalie DeMasi, research team leader at Cutting Edge Information. "As a result, social media and mobile platforms are becoming more and more a part of teams' digital strategies."

 

But some consultants say Tumblr deserves more respect from pharma. Read “Pharma Tumbles for Tumblr. ‘It's Not Your Grandfather's Social Media!’"

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Pharma Marketers Should Re-evaluate the Use of Social Media in Light of Growing Consumer Mistrust

From worldofdtcmarketing.com

As pharma gets ready to explore social media, perhaps they should first ask patients/consumers if they want to engage pharma companies via social media as new research indicates that social media has a very low confidence among US adults.

 

The biggest threat to online health seekers is “trust in information”. There are a lot of sites out there that will automatically cookie users and use those cookies to serve up ads which makes a lot of people uncomfortable.

 

Can pharma leverage social media to enable patient conversations? The answer is yes, but legal people need to stay away from coffee to allow someone at pharma to talk with patients and the FDA has to better understand what patients want from pharma companies via social media.

 

In the course of my research I have learned that nothing is more private than a patients’ health. Using social media to engage pharma companies is a very huge step and pharma has to make sure that the step is worth it by adding value in the patient’s eyes, not marketers.

 

Social media is NOT the answer for pharma at a time when all social media marketing is tanking with stories of false metrics and extremely low organic reach. Social media is part of DTC marketing, but it’s only a very small part of the pie.

 

Further Reading:

  • “Patients Prefer Easy-to-Find Health Info Over Trusted Health Info”; http://sco.lt/7lCFSj
  • “Millennials Trust Pharma Social Media, Mobile Apps & Advertising a Hell of a Lot More Than Their Geezer Parents!”; http://sco.lt/5vrNwH
JEAN PASCAL POISSONNET's curator insight, January 16, 2017 12:27 PM
This sounds like a warning to Pharma industry as to the use of social media. What this article says is that health is not to be merchandised. Patients expect reliable information and long term commitment from Pharma industry to accompany them, not marketing coups. This can be done no doubt through the use of social media if used as true and trustworthy set of dialogue tools. 

The Fault, Dear Pharma, is Not in SM ROI, But in Yourselves, That You Lack Commitment

From worldofdtcmarketing.com

[Richard Meyer, says] False information is a problem with social media so much that Facebook is trying to stop false news stories at the sources. But what about all the bad information when it comes to healthcare? In most cases, it’s consumers who are left to sort out what is true and what is false, but we all suffer when it leads to a patient not getting help on a small problem that can lead to a huge medical issue.

 

Only 7% of social network users have provided a review of pharma products according to Wave research and while that is a low number it’s still significant given the number of people who use social media.

 

However, we need to look beyond the numbers for how people use social media for health. Rodale found that the top uses for social media and health information were information about a medical condition (55%) followed by reviews and ranks of doctors (38%). In other words, consumers are not necessarily going to use social media to comment about a specific drug or treatment. However, there is considerable risk if pharma continues to ignore the conversation.

 

While it does seem that some pharma companies are indeed starting to embrace social media the biggest stumbling block seems to be that damn ROI bug which dictates everything that pharma marketers do (see chart).

 

Social media is becoming a more important part of the conversation and decision making around health care treatments, but I do not believe that a lot of patients believe what they read on social media when it comes to treatment reviews. However, that being said pharma still needs to decide whether they want to be part of the conversation or continue to remain on the same legal and regulatory side lines.

 

Further Reading:

Pharma Guy's curator insight, January 2, 2017 8:37 AM

Is it really proving ROI that prevents pharma marketers from using social media? I don’t think so. First, how often do pharma marketers actually measure the ROI of their regular, non-social media campaigns? Probably never (listen to this podcast, for example, “You Want Marketing ROI? You're Not Ready to Measure ROI!”; http://bit.ly/PMNT029) . Second, when the ROI of social media campaigns have been measured, most often it is positive (listen to this podcast audio snippet, for example, “A Successful, Integrated Mobile App Ad Campaign”; http://bit.ly/2aueB45).

 

A more likely reason is lack of resources; i.e., money and personnel (FTEs), or commitment. For example, it would take a huge amount of resources to track down and correction misinformation about drugs on social media. The same is true for social media (read, for example, “Janssen to Shut Down Psoriasis 360 FaceBook Page Due to Lack of Commitment”; http://bit.ly/GPBCrk).

abandoneddotterel's comment, January 3, 2017 6:20 AM
Thats magnificent...

Flowchart: How Pharma Can Handle Every Type of Comment on Social Media

From pharmamkting.blogspot.com

Pharma Guy's curator insight, December 14, 2016 7:16 AM

Philippe Kirby (@PhilippeKirby), Pharma Customer Engagement Ecosystem designer & developer @ Merck & MSD, asked "Is this a joke?" I respect Philippe opinion and have interviewed him about the "near future" of digital pharma back in 2013 (listen here), so I should respond to his question & hopefully stimulate some further discussion.

Should #Pharma Spend More Time Engaging Docs via Social Channels?

From www.wearecouch.com

Recent research indicates most pharma marketing is still shooting towards the old goal posts, in that they’re not actively maximising the digital opportunity. The same research highlighted that doctors today estimate they spend around 84 hours a year dealing with pharma through non-personal channels. This works out to around 64% of their pharma interaction time, with 26,000 of the most popular prescribers on the receiving end of 2,800 pieces of communications every year from the pharma industry. 

Time pressured physicians have cut down on the number of face-to-face meetings with pharma sales reps. Research data from sales and marketing firm ZS Associates indicates that far fewer physicians have time to meet with sales reps, resulting in many now seeing less than 30% of those who try to arrange meetings with them.

Clearly, medical communications must develop a fresh approach, with more emphasis placed on multichannel marketing efforts, delivering carefully crafted messages that build and maintain physicians’ trust. Despite the fact that the survey analyses indicate that around 75% of physicians don’t entirely trust pharma marketing information, an (almost) equally large percentage (around 65%) indicate a willingness to interact with pharma through social channels.

Pharma Guy's curator insight, December 6, 2016 6:20 AM

Related articles:

  • “Infographic: Only 10% of Docs Prefer Info Direct from #Pharma to Make Treatment Decisions”; http://sco.lt/8JgzoX
  • “Is #Pharma ‘Pecking’ Docs to Death Across Multiple Channels?”; http://sco.lt/733MUT

By 2018, Social Media and App Marketing Will Be Preferred Pharma-to-Physician Communications Channels

From www.fiercepharma.com

Pharma companies’ marketing communications to their target audience of healthcare providers are increasingly digital. That's not terribly surprising, considering the uptake in digital channels among physicians for professional use.

What is changing, however, is the way pharma reaches doctors, according to an annual report from from healthcare and pharma solutions provider Indegene. In 2016 in the U.S., brand promotional emails, healthcare provider portals and key opinion leader webinars are the top three ways pharma companies reach out. However, by 2018, KOL webinars, social media and mobile apps will top the list, with social media and mobile apps growing the fastest, by 50% and 27%, respectively.

The social media investment is already underway, which will power the expected usage jump, Urvi Mehta, strategic relationships manager at Indegene, told FiercePharma.

“Social media is a very powerful channel that can help in understanding the end consumers. It’s easy to make marketing decisions like segmentation, course of patient education, and influence adherence through listening and analysis of the social behavior,” she said.

While KOL webinar growth will be smaller at 8.8%, that channel was identified as the best return-on-investment generator by the more than 100 global pharma and life science companies that responded to the survey.

ROI, in fact, is an ongoing concern. Even among the rise in projected spending, seven out of 10 pharma companies noted that demonstrating ROI is the biggest barrier when implementing new communication strategies.

U.S. pharma companies are second globally in digital spending, with 31% of companies spending more than 20% of their budgets on digital. By 2018, Indegene expects that to increase to 40% of companies. China leads with 33% of its pharma companies spending more than 20% on digital, and that figure is expected to rise to 50% by 2018.
Pharma Guy's curator insight, November 28, 2016 1:05 PM

Related articles:

  • “How Pharma Can Fully Digitize Interactions with Healthcare Professionals”; http://sco.lt/7KtvM1
  • “To Reach Docs, #Pharma Marketers Must Begin Mobile Strategy Well Before Drug Launch, Says Expert”; http://sco.lt/6KHoTR
  • “The Value of Medical Content Channels According to HCPs vs Pharma Professionals”; http://bit.ly/1SzAhZ7
passedtree's comment, November 29, 2016 1:03 AM
Really good

How is Pharma using social media?

From www.slideshare.net

Over the past decade, the rise of social media has caused a huge shift in the way businesses interact with customers. Pharma, often thought of as a guarded industry when it comes to social, is upping its game and using social to reach a wide audience including patients and healthcare professionals.

Pharma Guy's curator insight, November 20, 2016 7:19 AM

Also read "Pharma on Instagram"; http://sco.lt/4nv5LV and  “Pharma Use of Social Media: Not Very Engaging & Not Mostly for Patients”; http://sco.lt/8Gv973

#FDA to Study Space-Limited Communications. Will It Help #Pharma Market Drugs on Twitter & Facebook?

From www.raps.org

The US Food and Drug Administration (FDA) is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited.

"The objective of this research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about the drug are made within character-space-limited communications used in prescription drug promotion," FDA says (here).

To test this theory, FDA says it plans to conduct four studies, two involving Twitter and two using Google sponsored links, to determine how well participants understand and retain risk information depending on whether the information is contained within the communication or merely linked to.

Under current regulations for prescription drug promotion, drugmakers are required to include a balance of information regarding a drug's benefits and risks. However, on many social media platforms the amount of space for text is limited. For instance, Twitter allows just 140 characters per "tweet," making it difficult or impossible for drugmakers to promote their products on the platform.

"The rise of Internet communications that have character space limitations, such as sponsored link promotion and microblog messaging, has led to questions about how to use these communications for prescription drug promotion while complying with the fair balance requirements," FDA says.

While FDA has yet to provide final guidance on pharmaceutical advertising on character-space-limited platforms, the agency's approach in its draft guidance would require risk information in the body of a communication.

"Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communications. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product," the draft guidance states.

However, many in industry have argued that risk information can be presented effectively by including a link to a page that discusses the benefits and risks of a product more fully, and that including risk information in the communication itself is unnecessary (for more on that, read: "Overcoming Space Limitations in Social Media"; http://sco.lt/9LmYmv).

Pharma Guy's curator insight, November 8, 2016 12:21 PM

Related article: “Survey Results: FDA's Regulation of Drug & Device Promotion via the Internet & Social Media”; http://sco.lt/6KIVNJ

How #Pharma Uses Social Media - For Advertising, Not So Much. Duh! #infographic

From pharma.remmont.com

New communications technology has the potential to both disrupt and enhance the pharmaceutical industry, but research shows that pharma often needs to up its game when it comes to the adoption of new technologies.

 

Mobile devices have transformed how we access and consume content, and are poised to make similarly huge changes to the way consider our health (read “The mHealth App Market is at the Saturation Point”; http://sco.lt/5thWGv). mHealth revenue is projected to reach 26 billion by 2017, and the number of health apps has doubled in just the past two years. Social is also likely to have a major impact in the way that pharma communicates in the coming years. 52% of physician’s surveyed by Deloitte in this research expressed interest in communicating with pharma companies via social media.

 

However, pharma currently lags behind other verticals for using social media. Pharma spending on digital advertising is far below that of other industries, and it still conducts most of it’s communications with physicians via traditional channels. There is big potential for new communications technology to make the pharmaceutical industry more efficient and more engaged with it’s customers. This infographic from Deloitte shows the potential for new digital technology to allow pharma to market itself more effectively.

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Pharma Use of Social Media: Not Very Engaging & Not Mostly for Patients

From www.fiercepharma.com

The good news is that pharma is solidly onboard with social media use. The not-as-good news is that most companies still have work to do in understanding their social media audiences, according to the latest Social Check-up by Ogilvy Healthworld, part of Ogilvy CommonHealth.

The group partnered with Pulsar for its third annual review of pharma social media use, with researchers expanding this year from 13 companies to include the 20 largest pharma companies by revenue. They evaluated each one’s corporate social media presence, including the number, type and content theme of posts across Facebook, Twitter, YouTube and Instagram.

Boehringer Ingelheim and Novo Nordisk ranked at the top with the highest social media engagement numbers, while Allergan, Teva, Takeda, Gilead and Astellas all ranked pretty closely together among those with the lowest engagement.

However, simply putting out the most content didn’t always equate with better engagement. Eli Lilly, for example, posted the most content by pure number of posts during the 6-month period study, but the Indianapolis drugmaker only ranked slightly above average in engagement.

In general, the average pharma company’s use of social media tracks closely with general business posting rates, the researchers said. Every week, the pharma companies averaged 7 Facebook posts, 26 Tweets, one YouTube video and four Instagram posts.

As far as what those posts contained, Ogilvy CommonHealth found that 29% were about disease awareness, followed by 25% company news, 19% around meetings and events, 13% corporate social responsibility, 8% product and research updates, 2% pharma industry news with the remaining 3% other topics.

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Social Media Failed to Do the Job, So Biogen Turned to DTC to Promote Tecfidera

From www.mmm-online.com

Biogen CEO George Scangos told investors the company's direct-to-consumer advertising campaign for its multiple-sclerosis drug Tecfidera was designed to address “low awareness” for the drug.

“We were surprised, actually, at the beginning by the low awareness among patients of Tecfidera,” Scangos said during Biogen's first-quarter earnings call Thursday, “and we had data suggesting that when patients did learn about Tecfidera and went to their physician to discuss it, they often had it prescribed.”

He added that the ad “did succeed” in raising awareness about Tecfidera even though the drug's sales missed analysts' estimates for the quarter. Tecfidera brought in sales of $744 million for the first quarter of 2016, missing analysts estimates of $750 million, however sales are still up 12% from the $648 million the drug brought in during the first quarter of 2015. However, compared to last quarter, Tecfidera sales are down 5%.

Scangos would not say whether that heightened awareness from the DTC campaign translated into more sales. He said the drugmaker plans to give investors an update on the campaign during its next quarterly earnings call.

Low awareness of Tecfidera is surprising given the warm reception it received from neurologists even before the drug had become available, according to a poll conducted by WorldOne Interactive.

 

[It's also surprising given the hype about how social media mentions predicted great sales. For more on that, read "Using Social Media as an Early Predictor of a New Drug's Market Share"; http://bit.ly/Mantelconvo]

Pharma Guy's curator insight, April 22, 2016 11:56 AM

There was a lot of hype about how social media mentions predicted great sales of Tecfidera. For more on that, read "Using Social Media as an Early Predictor of a New Drug's Market Share"; http://bit.ly/Mantelconvo

Louis Shih's curator insight, April 23, 2016 5:21 AM

興趣的文章(1)

Docs Paid by #Pharma Promote Drugs Online without Disclosure of COI

From www.statnews.com

Physicians across the United States routinely offer medical advice on social media — but often fail to mention that they have accepted tens and sometimes hundreds of thousands of dollars from the companies that make the prescription drugs they tout.


A STAT examination of hundreds of social media accounts shows that health care professionals virtually never note their conflicts of interest, some of them significant, when promoting drugs or medical devices on sites such as Facebook, Instagram, and Twitter. The practice cuts across all specialties.


Among the cases of note:


  • Women’s health specialists who serve as consultants for the company that developed Addyi, the female libido drug, use Twitter to promote that medication and related treatments.
  • A child psychiatrist featured on YouTube steers viewers to the website for Saphris, an antipsychotic drug made by Allergan, which has paid her to promote it.
  • An internist posts on Facebook about the positive effects of a cholesterol drug manufactured by a company that paid him nearly $60,000.


There is no evidence any of these doctors meant to deceive or mislead patients. And they were not legally obligated to disclose payments from drug companies in their social media posts.


But the growing use of social media by medical professionals raises serious ethical questions — and makes it impossible for patients or other doctors to know whether a physician’s enthusiasm or disdain for any particular drug may have been influenced by payments from the pharmaceutical industry.


Some doctors say disclosure is impractical in the limited space that social media offers when they have financial ties with multiple drug makers. “It’s become very unwieldy and problematic and it’s ridiculous for a tweet,” said Dr. James Simon, a physician who frequently uses Twitter to promote drugs made by companies that have paid him as a consultant and promoter.


But Reuben Guttman, an attorney in Washington who specializes in food and drug law, said the system leaves patients vulnerable to misinformation.


“Doctors who accept these dollars and then turn around and promote on social media corrupt the market for honest medical information,” Guttman said. “And drug companies that pay these doctors are similarly poisoning the market for honest information.”

Pharma Guy's curator insight, February 29, 2016 6:36 AM

AMA guidelines -- Professionalism in the Use of Social Med (http://bit.ly/AMA-SMpolicy) -- do NOT address this issue at all. It's telling that the ads do not mention product names and comply with FDA regulations even though those regulations do not apply to physicians. It's as if pharma medical-legal depth have written these ads for their physician partners.

Which #Pharma Companies are BIG in Social Media Engagement? Hint: Doesn't Correlate with Sales!

From www.slideshare.net

Ogilvy CommonHealth Worldwide evaluated  how  14 major pharma companies  were  performing  across  six  key  categories:  


  1. Social presence: How  many  social  networks  was  the  company  on?   
  2. Activity: Was  the  content  kept  fresh  with  regular  updates?
  3. Engagement: Were  the  companies    engaging  their  users  and  generating interest?    
  4. Social network: How  simple  and  intuitive  was  the   connection  between  social  networks?    
  5. Virality: Was  the  content  spread  around   the  social  sphere?
  6. Sommunity Size: How  big  was  the  community?
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Digital, social, mobile : les chiffres 2015

From wearesocial.fr

2014 fut une année charnière dans la croissance du digital et notre rapport “Digital, Social and Mobile 2015” tend à montrer que les chiffres seront encore plus incroyables. Incluant des chiffr
Isabelle Boucher-Doigneau - Cultureuse's curator insight, January 22, 2015 3:28 AM

Incontournable et très bien fait !