FDA and Social Media: Much Ado About Nothing

Posted in Social Media, Uncategorized

Since the inception of blogs, Facebook, Twitter, YouTube and other social media platforms, many life sciences companies, mainly big pharma, have been anxiously awaiting regulatory guidance from the US Food and Drug Administration on how to use them. Interestingly, FDA did issue some guidance in 2012 on it use last year but many drugmakers felt that it was insufficient and not detailed enough.  Despite the lack of clearly defined regulatory guidance, many companies took the social media plunge anyway. And according to a recent survey of regulatory actions and letters conducted by Mark Senak author of the fabulous EyeonFDA Blog the agency has done very little to thwart the social media strategies implemented by drug companies. In fact, there has been no obvious increase in the number of warning letters or violation letters regarding the use of digital or social media as compared with traditional media violations.

Senak drew this conclusion after analyzing 173 warning and notice of violation letters (advertising and media related) that were issued by the agency from 2008 to 2012.  Of the 173 regulatory letters that were issued, 675 violations were cited and only 43% involved digital media.  And, for the most part, most of the cited violation had little to do with the digital or social media vehicle used but more to do with the message being delivered. For the full report click here.

What does this all mean? While it is difficult to draw any firm conclusion, I believe that the bottom line is that the importance and significant of the long awaited FDA guidance on the use of social media has been overstated. Put simply, if you follow the existing rules guiding advertising and print media, companies ought to be able to craft a regulatory-compliant social media communication strategy without the fear of running afoul of the agency.  Those who violate the existing rules will likely be caught and have to clean up their acts.

The bottom line. Many drug companies have been able to mount very effective social media campaigns without getting into trouble with FDA.  The key to success is following the rules and implementing a digital/social media campaign that has passed internal regulatory muster to insure that everything is in order and regulatory compliant. Companies that have made the investment into digital/social media will be successful whereas others that jump into the game without taking the time to understand the rules of engagement will fail.

Until next time…

Good Luck and Good Job Hunting!!!!



Pharma and Social Media: Lilly Launches A YouTube Channel

Posted in Social Media

Mark Senak, author of the outstanding EyeonFDA blog, tweeted today, that Eli Lilly & Co had launched a YouTube Channel. According to a post on the company’s blog Lilly Pad, its new channel dubbed the “Lilly Health Channel” will “videos on health and wellness, employee and community outreach efforts, health innovation, Lilly programs and other non-product-branded initiatives.”

While the announcement of a launch of another pharma-sponsored YouTube channel is no longer new or novel, Eli Lilly has been trying to transform itself into a modern, social media and crowdsourcing-focused pharmaceutical company. For example, Lilly is one of only a handful of big pharma companies that sponsors its own corporate blog. Moreover, the company is a leader in using so-called crowdsourcing to discover and develop potential new drugs. It has spun off at least two ventures that utilize a crowdsourcing approach to new drug discovery. Finally, unlike most other big pharma CEOs, its chief executive John Lechleiter has been outspoken about the lack of innovation and available workforce talent in the US life sciences industry. 

Is Lilly truly the pharmaceutical company of the future? That remains to be seen! 

Until next time… 

Good Luck and Good Viewing!!!!


A Death Knell For Social Media and Pharma?

Posted in Social Media

For the past few years, I along with many others have advocated the use of social media platforms (mainly Facebook, Twitter and YouTube) by life sciences companies. Despite a very positive beginning by companies like Novo Nordisk, Johnson and Johnson and others, the implementation of social media in the life sciences industry has been stymied by a lack of regulatory guidance by the US Food and Drug Administration (FDA) and legal and commercialization concerns. While many believe that FDA guidance on the topic will be the panacea that they were waiting for, I personally don’t believe that it will make one bit of difference. That said, Steve Woodruff, the author of the IMPACTIVITI Blog, provides one of the best analyses that I have encountered that explains why social media and pharma don’t work well.

In a post entitled “Time to Give Up on Pharma and Social Media,” Steve cogently provides four compelling reasons why it will be difficult for pharma to ever embrace social media for commercial purposes. They include 1) the lack of regulatory guidance; 2) pharma does not communicate or interact in real time; 3) personnel turnover, short term thinking, lack of innovation and too much focus on quarterly profits; and 4) pharma’s addiction to centralized, one-way controlled communications. His bottom line:

Public, interactive, real-time social media platforms and commercial pharma communications simply don’t mesh well 

While I agree with Steve that social media may not be ideal for commercial purposes in the prescription life sciences industry, it may be perfectly well suited for pharmacovigilance and adverse event reporting, clinical trial recruitment and management, education, community outreach and employee recruitment and retention. These are not new ideas. But, because they cost money to implement and don’t contribute the most company’s revenue-driven bottom lines, life sciences companies have not actively explored or embraced them for these purposes. 

Whether big pharma and biotech companies like it or not, social media is here to stay. And, if these companies fail to act soon, they eventually will begin to lose their competitive edges and perhaps more importantly, market share. 

Until next time.. 

Good Luck and Good Job Hunting!!!!!!!!



FDA Delays Social Media Guidance Yet Again!

Posted in Social Media

The Pharmalot Blog today reported that FDA, for the second time in four months, has postponed plans to issue its widely anticipated guidance on social media. Guidance was initially expected last December. When FDA announced it wasn’t going to be able to make its original deadline, the guidance was rescheduled for release in the first quarter of 2011, which was presumably was to occur this month. At this point it is anyone’s guess as to when the long awaited guidance document(s) will be issued by the agency.

According to the Pharmalot post the guidance will address:

“responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; online communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet and correcting misinformation…”

The agency further added:

“We are developing multiple draft guidances to address these topics to benefit industry and the public by ensuring that these draft guidances are meaningful and well thought out when they are issued.”

While many companies still contend that FDA’s guidance will be necessary for them to engage in social media, most have realized that if they wait for the agency’s guidance the social media craze may pass them by; possibly jeopardizing substantial financial opportunities afforded by social media in other industries. The notion that FDA’s guidance on social media will help pharma unravel the so-called social media conundrum is misguided and, in my humble opinion, wishful thinking. 

Companies who are familiar with working with FDA understand that guidance documents may offer some help to better understand certain regulations. But, it is generally up to a company with questions to directly solicit input from the agency rather than rely on an interpretation of a specific guidance recommendation (s). The goal of social media is to promote conversations and provide greater transparency surrounding both business and social interactions. Ironically, it appears the many of the companies that are most anxiously awaiting FDA’s social media guidance are the very ones that want to continue to develop products without involving the agency unless absolutely necessary. Go figure…..

Until next time…

Good Luck and Good Tweeting*

*Although FDA has yet to issue social media for the life sciences industry it has a YouTube Channel, Facebook Page  and at least two twitter accounts (@FDA_Drug_Info and @FDArecalls)!


Social Media: Is the Demise of Online Video Viewing Drawing Near?

Posted in Social Media

According to a blurb in  today’s NY Times, a recent Nielsen survey found that over the past year online video gained fewer viewers. More specifically, survey results showed that the number of people who watched online videos increased only 3.1 percent from Jan. 31, 2010 to Jan. 31, 2011. While the number of viewers showed only a slight increase, the amount of time individuals spent viewing video increased almost 45 percent to 4 hours 39 minutes during the same period.

The increase in online video viewing time was attributed to the growing popularity of websites like Netflix and Hulu that offer viewers access to long-form video streaming. This shift may signal the beginning of the end of the popularity of short-form videos offered by sites like YouTube. To that end, in recent months, YouTube (owned by Google) has signaled its intent to focus more on long-form video content.

Although there may be a shift taking place in online video viewing behavior, I think that rumors about the death of online video viewing have been greatly exaggerated. In my opinion, video is here to stay but it may no longer represent a “stand alone” web destination. In the future, video and other rich media assets will likely be bundled with text and other written content as part of the online viewed experience. A good example of this is being pioneered by companies like Atavist—a publisher of long-form journalism and fiction.

Interestingly, the popularity of short form videos is just beginning to take off in the life sciences and related industries. As usual, it appears that lay consumers are way ahead of the scientific community when it comes to cultural trends….go figure!

Until next time…

Good Luck and Good Viewing!!!!!!!


Why Is Video Not Catching On in the Life Sciences Industry?

Posted in BioBusiness

While video may be losing some of its “newness" and cache in social media circles, it continues to grow and has become a mainstay of networking platforms like Facebook, Twitter, and of course YouTube!  Despite its popularity in most industries, the life sciences industry continues to eschew its use. The reasons for this are not clear but it is counter intuitive given the billions of dollars the pharmaceutical and biotechnology companies annually invest in direct-to-consumer advertising

Several big pharma companies, most notably Johnson & Johnson, have attempted to increase the use of video to connect with its stakeholders but its efforts haven’t yield much of an ROI. I suspect that most industry insiders will tell you that the main reason why video is not routinely used is the lack of regulatory guidelines guiding its use on social media platforms. While this is a facile explanation, the existing regulatory guidelines for direct-to-consumer television advertising certainly apply to video!

In a post today on the EyeonFDA blog, Mark Senak offers a variety of ways in which life sciences companies can leverage video to their advantage to promote good will among shareholders and stakeholders alike. His ideas make sense and are very much within the regulatory guidelines for direct-to-consumer advertising. Whether or not direct-to-consumer advertising is a good thing is a topic for another post!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!


FDA Update: Product Recalls, Social Media and Biosimilar Guidelines

Posted in BioBusiness

Whether you like President Obama or not, the changes he made in the leadership at the US Food and Drug Administration (FDA) is beginning to yield results. After just two years, the agency is well on its way to modernization and overcoming its descent into the dark ages during the failed Bush Administration.

Mark Senak, the intrepid author of the EyeonFDA blog has been assiduously following and blogging about many of the new things going on at the agency. First, in a post a last week, Mark noted that FDA has updated its website and created a product recall page that collects recall information on all of the products that it regulates and deposited it in an easy to find product recall page. With product recalls in the food and life sciences industry increasing in frequency, this page will help to alert consumers about tainted products before learning of them on the nightly news. 

Second, Mark points out that FDA has finally entered the 21st century and is now fully engaged in social media.

“FDA begins to join the 21st Century launching a Facebook page that has been long anticipated on this blog. FDA has not completed the Social Media Quadrant – (1) a blog, (2) several twitter feeds (3) a YouTube channel, and (4) a Facebook page.  And as added good measure, the agency opened a Flickr page.  The agency is now fully engaged in activities that many in the industry it regulates think is forbidden them…. And the beat goes on.”

Finally, earlier this week FDA announced that it would hold long-awaited public hearings to get input on proposed biosimilar regulatory guidance. As Mark duly notes, this process is likely to be contentious and protracted.    

"The FDA has set November 2-3 for a meeting to get input on a wide span of questions regarding the development of a regulatory pathway for biosimilars.  The scope of the questions is demonstrative of the number of outstanding issues the agency faces and will likely result in a protracted process. "

Central to the debate (and ultimate success of biosimilars) is the question of interchangeability and substitution of name brand products with biosimilar molecules. According to Mark, the agency will focus on the following questions

"What factors should the agency consider in determining whether a proposed interchangeable biological product can be "expected to produce the same clinical result as the reference product in any given patient?"

"What factors should the agency consider in evaluating the potential risk related to alternating or switching between use of the proposed interchangeable biological product and the reference product or among interchangeable biological products?"

What has become patently obvious to many of us who have been following the debate over the last decade is that unless biosimilars are interchangeable or substitutable for brand name biologics, the commercial success of the biosimilar industry may be in serious jeopardy. Put simply, there is no question that safe and effective biosimilars can be manufactured; the real question is whether or not physicians will prescribe biosimilar products if they are required to be branded by regulatory agencies. This is because physicians are reluctant to switch patients to new biologic products if a patient is doing well on a currently prescribed regimen. Since most physicians pay little attention to drug pricing, it is highly unlikely that they will switch a patient to product simply because there may be a 20 percent reduction in drug price. And, unless biosimilar products are deemed interchangeable with their branded counterparts, pharmacists (based on insurance formularies) will not be able to offer patients a generic equivalent of a name brand biologics. 

With the cost of biologic treatments skyrocketing, it will be interesting to see what the agency will do with this question.

Until next time…

Good Luck and Good Job Hunting!!!!!!


Words of Wisdom from the Executive Suite

Posted in Career Advice

For the past few years, CEOs have been taking a lot of heat; and in many cases rightfully so. However, from time to time some of these “captains of industry” say things that may be useful to ambitious young executives, employees and would-be entrepreneurs. 

The folks over at BestCollegesOnline sent me a link to a post entitled “The 30 Best CEO Interviews You Should Watch on YouTube.” While I haven’t seen any of the videos (I don’t have the luxury of time to do so), viewing some of them may be worth it!

Check them out and let me know if find a good one.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!


YouTube and Pharma: An Update

Posted in BioBusiness

There is no question that video is taking the Internet by storm and is quickly replacing the written word as a means of communication. Despite the obvious business opportunities offered by videos, most big pharma companies have failed to jump on the video bandwagon. As always, there are exceptions to the status quo and a handful of life sciences companies most notably Johnson & Johnson, have been experimenting with video over the past few years.

According to Mark Senak, the unofficial life sciences company video archivist and author of the always insightful EyeonFDA blog, there are presently about 15 companies that have channels on YouTube; the largest video sharing website on the Internet. Previously, Mark was able to find 10 or so active companies on the YouTube website. Despite this modest increase, Mark notes that most pharma YouTube channels are not regularly maintained and suffer from lack of original content. 

There is no question that video is expensive to make if it is done commercially. However, Ken Grant at Analtech, a small chromatography company in Delaware, who has successfully used video to drive and improve business outcomes, contends that a low cost Flip video camera or equivalent is sufficient to get the job done! 

I suspect that big pharma may be waiting for FDA to weigh in on the use of social media for promotional purposes before it allocates any resources for video production. However, as I have stated many times before, social media can be used in many other ways (besides for promotional purposes) to meet business objectives and maintain corporate brand integrity. Until pharma marketers and brand managers recognize this, social media and pharma will be a moot point.

Until next time…

Good Luck and Good Job Hunting!!!!!!!


Educating Pharma About Social Media

Posted in Social Media

We scientists tend to be a serious bunch who often hard on difficult projects with lofty goals and expectations. However, like most other people, many of us have well developed senses of humor and enjoy a good laugh from time to time.

While working on my recent post on pharma and social media, I came across a post on Wendy Blackburn’s blog, epharma Rx, that showcased a clever and well-crafted video created by her agency InTouchSolutions to help pharma companies overcome fears about social media.  I think BioJobBlog readers will enjoy it because it uses scientific principles (presumably understood by life sciences companies employees) to poke fun and educate pharma executives about social media 

Hat tip to Wendy and the InTouchSolutions Team

Until next time…

Good Luck and Good Viewing!!!!!!!