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!!!!



An Analysis: Big Pharma and Social Media Usage

Posted in Social Media

A study conducted in November 2011 by Cegedim Strategic Data, a market research and promotional audit firm analyzed the world’s top 100 pharmaceutical companies expenditure on traditional promotional (marketing spends) and then compared that spending with their presence on Facebook and Twitter.

Not surprisingly, Pfizer, Novartis and Merck (the world’s largest big pharma companies) finished in the top three for traditional promotional spending. However, their use of social media i.e. Twitter and Facebook varied widely. For example, Pfizer—the top promotional spender—was first in its number of Twitter followers and third in the number of likes on Facebook. On the other hand, second ranked Novartis was fifth in the number of Twitter followers and in seventeenth position for likes on Facebook. Finally, third ranked Merck was fifteenth in the number of Twitter followers (third for the number of tweets) and in the tenth position for the number of likes on Facebook (but has more pages than any of its Facebook competitors).

Other notable companies included:

  • Johnson &Johnson, eleventh in promotional spending and number two on the number of Facebook likes
  • Roche, number fifteen on the promotional spending list was ranked number two for the number of Twitter followers
  • Proctor and Gamble which ranked a distant 54th in promotional spending was number four on the Twitter follower list

What does this all mean? A whole lot of nothing because nobody can determine what effects the use of social media has on the bottom line for most pharmaceutical companies. Unlike other industries, where social media can be used to sell products, it cannot be used for direct promotional purposes in the life sciences industry. While most people will tell you this is because of the lack of guidance by FDA on the use of social media, the bottom line is that social media will never be allowed for direct-to-consumer advertising in the pharmaceutical industry. That said, pharma and biotech will have to find other uses for social media including clinical trial recruitment and retention, adverse event reporting, employee recruitment and retention and education and outreach.

Until next time…

Good Luck and Good Tweeting (and Liking)


Pharmaceutical Direct-to-Consumer (DTC) Advertising Goes Mobile

Posted in BioBusiness

While big pharma continues to struggle with the use of social media to promote its products, direct-to-consumer advertising (DTC), the method of choice for American pharmaceutical advertising is alive, well and robust. Therefore, it should come as no surprise that big pharma is reallocating some its traditional DTC advertising dollars to deliver drug ads to mobile devices which are growing in popularity. 

According to a recent article posted on PharmaLive, drug companies are mainly using mobile devices —in addition to delivering ads—to “help educate patients and motivate them to seek, accept, and adhere to therapy.” In other words, to more effectively promote their products to improve sales and corporate profits. Regardless of the motive, medical communication agencies have recognized the trend and have responded by launching mobile divisions and initiatives at their firms. Some agencies are now generating close to 50% of their revenues from mobile initiatives and campaigns. Further, many pharmaceutical companies have finally realized that corporate websites can be more than simple placeholders on the Internet. To that end, the PharmaLive post notes that pharmaceutical brand websites are evolving into a robust resource structured to be easily searchable and maintained. Maybe a better understanding and use of social media is next up for drug makers.

Pfizer remains the leading spender and purveyor of DTC advertising despite a 15% overall decrease in 2010 as compared with 2009. PharmLive reports that the company allocated $903.8 million to brands such as Lipitor, Pristiq, Viagra, Chantix, and Lyrica. Of these brands, Pristiq saw the highest increase of DTC advertising in 2010, up 17% to $122.2 million compared to 2009.

As mobile media continues to grow, don’t be surprised if someone develops a TIVO-like fast forward app to skip all of the DTC ads on your iPhone or android devices.

Until next time..

Good Luck and Good Job Hunting!!!!!


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!!!!!!!!!


Social Media And Advertising

Posted in BioBusiness

Facebook has over 500 million users and Twitter has close to 175 million who write 95 million tweets daily. Conventionally wisdom suggests that using either of the platforms to advertise or brand a product or service would be a no brainer. However, my experience with paid ads on Facebook (I haven’t tried Twitter yet) suggests that the ROI on using social media to advertise may not be that substantial. There is no question that using social media tools like Facebook, Twitter, GroupOn  to build brand awareness or create a buzz about a product or service or to share coupons is extremely useful. But for straight up advertising and click through rates—not so much!!!

I will be the first to admit that I know little about marketing and advertising (although I did take an advertising class as a microbiology major @Cornell). However, the sheer number of users on Facebook and LinkedIn, suggested that I may be able to grow membership @ BioCrowd and promote readership @ BioJobBlog by advertising on these platforms. To that end,  I invested several hundred dollars into advertising campaigns on both platforms. Unfortunately neither campaign had any noticeable effects on enrollment at BioCrowd or readership at BioJobBlog. I attributed the lack of success of these campaigns to my woeful understanding of the arcane disciplines of marketing and advertising —I am a scientist, after all! 

Imagine my surprise (and delight) when I read an article in a local newspaper entitled “More and More Executives Using Social Media to Promote Business” which described several business owner’s experiences with advertising on social media that were identical to mine! Like me, they thought that advertising on Facebook and other social media platforms was so obvious that they couldn’t pass on the opportunity. Also, like me, they were extremely disappointed with the results. For example, a Princeton, NJ-based clothes retailer (which caters to college students) invested $500 on a Facebook ad. While the ad, that offered 20 percent discounts on clothing, received 1 million page views, not a single one translated into a sale! Others described similar experiences. I guess the old saying “misery loves company” may be apt here.

Although some still consider social media to be a passing fan, I strongly disagree. I think that social media is clearly here to stay and has become an essential way in which we communicate with one another. That said, because social media is only about six years old, it may be too soon to determine whether or not advertising on Facebook, Twitter, LinkedIn or other social media platforms can translate into a reasonable ROI. I guess only time (and money) will tell!

Until next time…

Good Luck and Good Job Hunting!!!!


Bringing Celebrities and Pharmaceutical Companies Together to Sell Prescription Drugs

Posted in BioBusiness

I read a fascinating article today posted on MedEdNews Insider Blog about the formation of a new agency called Rx Entertainment that helps to match celebrities with direct-to-consumer advertising campaigns created by pharmaceutical companies. Admittedly, I hadn’t thought much about the matching process, but in the past I have posted a few rants about direct-to-consumer advertising (DTC), Brooke Shields hawking Latisse for Allergan and the Robert Jarvik Lipitor brouhaha.

So, the post about an entertainment agency that helps to match celebrities with DTC prescription drug advertising campaigns piqued my interest. The blog post was actually an interview that was conducted by the blogger with the founder of Entertainment Rx (I love the name)! The interviewer asked the Rx Entertainment founder for examples of her agency’s matching maker prowess.  The list (see below) is very impressive:

  1. Claire Danes and Brooke Shields for Latisse
  2. Food Network’s Ellie Krieger for Centecor in the area of arthritis
  3. Gretchen Wilson for LapBand
  4. Jennifer Lopez for childhood vaccines
  5. Vanessa Williams and Virginia Madsen for Botox
  6. Sally Field for Boniva
  7. Jim Belushi, Bruce Jenner, Danica Patrick, and Patty Loveless for COPD
  8. Keri Russell on a campaign for Sanofi-Aventis  on the Sounds of Pertussis vaccine campaign
  9. Angelica Huston to help launch the well-known Merck Manual
  10. Elisabeth Hasselbeck and Marg Helgenberger for a fundraiser sponsored by P&G  where all the proceeds went to breast cancer research
  11. Robert DeNiro to help launch a nicotine patch. He was premiering one of his films in NY and a fundraiser for cancer research was tied to the event.
  12. Dara Torres worked with Centecor, and The National Psoriasis Foundation on a public service campaign to raise awareness for psoriasis
  13. Hector Elizondo on a campaign for CaringforAlz; campaign focused on the caregivers of Alzheimers patients (Hector’s mother suffered from the condition).  This was a national campaign supported by the Exelon brand team at Novartis.

According to the post, Rx Entertain manages the negotiation process between the celebs and pharmaceutical/biotechnology from beginning to end. There was no mention of the salaries paid to the celebrities for their participation in the DTC ads.  However the Rx Entertainment founder did offer several bits of cautionary advice:

The celebrity spokesperson ought to have a legitimate tie to the disease and that A-list celebrities may not always be the most appropriate spokespeople because of the baggage (scheduling issues, entourage and additional difficulties) they may bring to the campaign. 

That said who knew that B-list celebs had good shots at potential careers in the pharmaceutical and biotechnology industries? Talk about alternate career paths!

Until next time….

Good Luck and Good Job Hunting (ever consider acting????) !!!!!!!

Direct-to-Consumer Advertising: Have We Got a Deal for You!

Posted in Career Advice

Medicis Pharmaceutical, the maker of Dysport a drug approved by the US Food and Drug Administration (FDA) to smooth skin furrows between the eyebrows, recently introduced a marketing campaign that offers people who use Dysport drug discounts and a patient satisfaction rebate guarantee. The campaign, which runs through April 30, was intentionally designed to elevate Dysport’s image and cannibalize market share in the anti wrinkle market from Allergan the maker of Botox and the market leader.

The Dysport promotion, running on the product’s Web site and in a few glossy magazines like Us Weekly, offers a $75 rebate check on an initial Dysport treatment for wrinkles between the eyebrows, a procedure that can cost consumers $300 to $500. Satisfied customers can receive a $75 rebate on a follow-up Dysport treatment, while dissatisfied customers who want to switch can receive a $75 rebate on a Botox treatment.

While this is an unprecedented and novel campaign, it demonstrates the lengths that Medicis is willing to go through to garner market share from Botox which enjoyed a monopoly on injectable toxins in the US until the introduction of Dysport last year. Last year, worldwide sales of Botox were roughly $1.3 billion. Industry analysts estimate that Medicis may be able to capture a 20 to 25 percent share of the US market.  

While the marketing campaign may seem a bit odd and brash, Medicis isn’t the first pharmaceutical company to use rebates and drug discounts to inspire patient brand loyalty. For example, Sepracor offers a seven-day free trial of its popular sleeping pill Lunesta. Merck is running a print ad with a voucher for a free 30-day supply of its Januvia tablets for Type 2 diabetes. Another Merck ad carries a $20 coupon for the allergy and asthma drug Singulair. However, the use of product rebates and drug discounts is mostly used to market so-called vanity medicine drugs (like Latisse, Botox and Dysport) which have been approved by FDA for clinical use but are not covered by medical insurance. Patients who use these drugs are paying out of pocket and, in essence, are buying from physicians. Many worry that this practice may induce doctors and patients to make medical decisions based on money not safety or efficacy. 

In the case of Botox and Dysport neither product is entirely risk free. For those of you who may not know, both are purified forms of botulinum toxin — a toxin produced by Clostridium botulinum that interferes with nerve transmission and involuntary muscle contractions. The injections cause temporary cosmetic problems like droopy eyelids or uneven eyebrows. And these drugs now carry federally mandated “black box” warnings on their labels stating that botulinum toxins have been associated with rare but potentially life-threatening health problems.

Although promotional programs like the one being offered by Medicis may be inappropriate or seemingly reckless, it—like those of Sepracor and Merck—are permissible under current direct-to-consumer (DTC) advertising regulations. Isn’t it time to reevaluate regulations that allow powerful, potentially-dangerous prescription drugs to be treated as consumer goods where price, not medical need, safety or efficacy, promotes their acceptance and use?

Until next time…

Good Luck and Good Looking!!!!!!!!!!

Direct-to-Consumer (DTC) Advertising:Historical Timeline and Impact

Posted in Career Advice

I was chatting with a fellow medical writing colleague the other day and the topic of direct-to-consumer (DTC) advertising came up. I suggested that DTC advertising is largely ineffectual but my colleague suggested otherwise. To prove his point, he sent me a fascinating article entitled “Direct-to-Consumer Advertising: An Attitude Survey of Psychiatric Physicians (Bhanji et al. Primary Psychiatry. 2008; 15(11):67-71). The conclusion of the paper was somewhat surprising (to me anyway):

……pilot survey of psychiatrists revealed that DTC advertising has the potential to improve awareness of medical conditions and decrease the stigma of mental illness. Surveyed psychiatrists believed that DTC had little significant effect on their personal prescribing practices. However, >80% of respondents reported they had prescribed medications specifically requested by their patients. Most respondents failed to endorse that DTC had a positive effect on the doctor-patient relationship, or on improved patients’ medication compliance.

This suggests that people (at least those suffering from mental illness) listen to and likely learn about their illnesses from DTC ads. Further, it explains why drug makers continue to spend large sums of money on DTC advertising despite diminishing ROI on traditional print and television advertising revenues —it works!  While the effectiveness of DTC advertising was interesting, the real eye opener was the authors’ historical account of the evolution of DTC advertising in the US. 

Although currently a hot topic, DTC advertising in the US has been around for nearly 300 years. In 1708, Nicholas Boone placed the first advertisement for a patent medication

in a Boston newspaper. For the next 230 years, advertisements for patented medications claiming to treat everything from dandruff to infidelity could be found in magazines, newspapers, and traveling medicine shows. In 1938, Congress passed the Food, Drug, and Cosmetic Act, which gave the FDA authority over the labeling of pharmaceuticals and the Federal Trade Commission control over their advertising.

No new legislation was introduced until 1962 when the Kefauver-Harris amendments proposed the concept of consumer protectionism when dealing with pharmaceuticals.

Under these amendments, authority for drug promotional advertising review was reassigned to the FDA. The FDA established requirements similar to those in existence today, i.e., specifications of contraindications, effectiveness, side effect profiles, and a cost-benefit discussion. Virtually all of the advertisements were targeted to physicians.

In 1981, the pharmaceutical industry proposed shifting marketing to include the consumer. At issue was the requirement to include extensive clinical information on the product, making it problematic to use television media to reach potential customers. That same year the Commissioner of the FDA, Arthur Hayes, requested the pharmaceutical industry put a voluntary moratorium on DTC advertising to allow the FDA to study their request to reduce the required disclaimers.

In 1985, the FDA concluded that the existing regulations to safeguard the public interest were adequate. This ruling had the effect of postponing the growth of DTC for the next 12 years. However, 1997 marked the beginning of rapid growth in DTC advertising. This change in marketing was attributed to the new FDA guidelines on broadcast DTC marketing. For the first time, drug manufacturers could present the name of the product and the condition it was intended to treat, and not report all of the contraindications.

The financial implications of this change in policy were enormous. In 1985, $17 million was spent on DTC marketing. By 2000, that figure rose to $2.5 billion, and $4.2 billion in 2005. In 2008, the estimated DTC marketing budget will be in the sum of $8 billion. Real spending on DTC advertising increased by 330% from 1996–2005.

As of 2007, only the US and New Zealand permit DTC advertising of prescription medications. In countries outside the US, the pharmaceutical industry has applied pressure to relax regulations regarding DTC marketing with little success. Despite DTC advertising being banned in most non-US countries, there is growing international concern that drug companies are circumventing legislation through the use of internet advertising and “spam” E-mail. Pharmaceutical companies also provide “awareness campaigns” or infomercials with vague references to prescription treatments in order to improve their sales abroad.

As previously mentioned on BioJobBlog, DTC advertising is big business. And, eliminating DTC advertising would likely help to reduce the cost associated with new drug development. This is because most drug makers don’t tell you that marketing and advertising costs are factored into the $1.0 billion that is generally believed to be the price associated with bringing a new drug to market. Who knew?

Until next time…

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


Signs of an Economic Recovery? Spending on Direct-to-Consumer Advertising is on the Rise Again

Posted in BioBusiness

A post on the Pharmalot blog today reports that spending on direct-to-consumer pharmaceutical advertising came bounding back in the third quarter —rising 15 percent to $1.16 billion, according to DTC Perspectives (which cited data from TNS Media Intelligence).

The increased spending marks the first quarterly gain in nearly two years after slumping 6.4 percent earlier this year from January to June. According to the Pharmalot post, “Internet spending increased the most—more than tripling between January and September to $221 million (display ads only). And, more ads were placed in newspapers, which showed a 25 percent gain to $104 million during the same period.

During the first nine months of 2009 the leading advertisers by brand (each of which spent more than $125 million each) were:

  1. Lipitor (Pfizer)
  2. Abilify (Bristol-Myers Squibb/Otsuka America)
  3. Cymbalta (Eli Lilly) and
  4. Advair (GlaxoSmithKline)

Could this be a sign that the pharmaceutical industry thinks that the economy is improving? Alternatively, maybe pharma marketers think that people might become increasingly stressed by the economy and drugs like Abilify and Cymbalta (a variety of psychiatric indications) and Lipitor (high blood pressure, cardiovascular disease ands stroke) may be in greater demand. And finally, from a completely cynical perspective, maybe drug makers want to sell as many drugs as possible before healthcare reform and possible price controls kick in?

Hat tip to Ed!!!!

Until next time…

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


Social Media and the Pharmaceutical Industry: A Historical Perspective and Commentary

Posted in Social Media

In today’s edition of the incisive EyeonFDA blog, Mark Senak, provides a historical perspective on events leading to the US Food and Drug Administration public hearing on the use of social media and medical promotion that will be held on Thursday and Friday, November 12 and 13, 2009. As Mark points out, registration for the meeting was closed because of an overwhelming response and the number of people who wanted to offer testimony on the topic. Many social media enthusiasts view the public hearing as something of a “game changer” that may influence the future direction of social media in the life sciences industry. But, as Mark, astutely points out, only four pharmaceutical companies and one or two trade organizations will be participating at the hearing. 

The lack of industry participation at the meeting is curious given that 14 companies received warning letters several months ago about their misuse of ad associated with the results obtain by Google search. Further, pharmaceutical companies have consistently and publicly stated that their aversion to social media is contingent upon the lack of FDA’s regulatory guidance for its use. By not actively participating in the public hearings later this week, many pharma companies have chosen to remain silent and will likely allow FDA to craft social media policies that guide the promotional activities of drug makers on its own. This begs the question: why would drug makers allow a federal regulatory agency to unilaterally dictate policy, when the policy will likely affect their bottom lines, i.e. sales and profits? The industry’s refusal to actively participate in these hearings is another example of the cat and mouse game that drug makers like to play with FDA. Put simply, drug makers expect and want FDA to commit (in writing) to certain policies and guidelines and once established, company regulators and lawyers are instructed to find loopholes and work-arounds. I liken the drug industry’s refusal to actively participate in the upcoming public hearings to the now infamous rope-ad-dope strategy Mohammed Ali used to knock out George Foreman in the now infamous Rumble in the Jungle in 1974. This is how wikipedia defines the rope-a-dope: “The rope-a-dope is performed by a boxer assuming a protected stance, in Ali’s classic pose, lying against the ropes, and allowing his opponent to hit him, in the hope that the opponent will become tired and make mistakes which the boxer can exploit in a counterattack.” I hope that I am wrong about the drug industry’s strategy and motives.

Without active industry participation it isn’t clear how effective the FDA public hearing on social media will be. As Mark adroitly points out in today’s post, “The bulk of the other presentations are tertiary stakeholders perhaps sensing a vehicle for free self-promotion such as advertising and public relations firms and bloggers, but they aren’t the real stakeholders in this issue.  The real stakeholders are those who are referred to in the meeting notice – the medical products industry.” I would also add the American public to the stakeholder list who also has considerable “skin in the game.”

Pharma’s active participation at many of the social media conferences that I recently attended indicates that something must be in it for pharma; otherwise they wouldn’t attend. There is no question that social media isn’t a passing fad and is now an integral part of the Web 2.0 experience. That said, for the first time in many years, drug makers have a unique opportunity to actively voice their ideas and concerns and collaboratively work with FDA to craft meaningful social media regulatory guidance. As many of us “outside observers” know, the agency doesn’t have all the answers and we would like to think that drug makers would extend a helping hand to avoid confusion and misunderstandings about the use of social media to promote their products and services. While only 4 companies are scheduled to speak at the hearings, I suspect that there will be many life science company representatives in attendance. Nevertheless, despite what may happen at this week’s hearings, I hope that, going forward, drug makers and device manufacturers will begin to view FDA as a partner rather than an adversary!

Until next time…

Good Luck and Good Job Hunting!!!!