Pharmaceutical brand teams are generally dissatisfied with their outsourced digital marketing, according to a study by Cutting Edge Information (see press release).
In surveys and interviews, executives acknowledged the challenges that their industry presents to external communication agencies, not the least being the lack of clear regulatory guidelines for pharmaceutical digital marketing. Despite that, pharmaceutical brand teams' opinions of agency performance are generally negative. Across all activity categories, only 21 percent of responses were "good" while 35 percent were "poor." No respondent ranked their experience with outsourced digital marketing as "very good." This is based on 34 responses.
It seems that familiarity breeds contempt -- the poor rating of digital agencies comes at a time when pharma marketers have increased the proportion of marketing dollars spent on digital.
Data from the summary report claims that "traditional digital marketing" (Web sites, web display ads/banners, email, search) represented 26.6% of the overall pharma marketing budget in 2011 compared to 23.7% in 2010; a 12% increase. These absolute percentages are similar to what PwC/IAB reported for all industries (see, for example, this chart). But my analysis suggests only 11% of pharma's total DTC marketing budget is devoted to "traditional digital marketing" (see "Ad Dollars Follow Eyeballs to Web").
Social and Mobile marketing are not "traditional digital marketing" according to Cutting Edge's definition. While the share of marketing dollars spent on traditional digital marketing has increased 12% from 2009 to 2011, the share for Social and Mobile digital "channels"/technologies (which is it?) have increased by 99% and 288%, respectively, according to Cutting Edge data (see chart below created from Cutting Edge data).
The report cites this caveat about the data: "this data does not suggest that actual spending by pharmaceutical companies on print media declined 26% between 2009 and 2011 but that print media is taking on a less significant role as a percentage of the total marketing mix." The same is true for the increase in share of social media and mobile: these "channels" are taking on a MORE significant role, especially since there are data suggesting that the OVERALL pharma DTC (direct-to-consumer) marketing budget decreased from 2009 to 2011 (see this chart).
My goal in attending conferences like CBI's iPharmaCONNECT, which is currently in progress in Philadelphia, is to come away with at least one new topic worthy of discussion. Thanks to yesterday's session on "What Makes a Health App Effective?" presented by Jim Dayton (@JimDayton), Snr Dir Emerging Media at Intouch Solutions, I have a topic I think worthy: Are we getting too much religion (preaching to the faithful) versus science (useful data) at these conferences?
Dayton was reviewing the story and "success" of GoMeals, the iPhone/iPad/Android app developed by Sanofi Aventis that is intended to help people with diabetes count their calories whether at home or eating out at restaurants. I have reviewed this program in a previous post (read "The iPad as a Pharma Marketing Platform").
One piece of data that Dayton presented was the fact that the GoMeals app has been downloaded about 415,000 times since it was launched in November 2009. Of course, it is widely known that nearly 85% of the people who download apps use them maybe once or twice and then never use them again. I did that with GoMeals. I stopped using it when my favorite local restaurants were not included in the database.
Also, like me, maybe many people downloaded the GoMeals app to multiple devices (eg, iPhones and iPads).
Thus, the number of downloads of an app is NOT a useful KPI (Key Performance Indicator), IMHO.
Dayton did mention that GoMeals enjoyed an abandon rate slightly less than the 80-85% average I mentioned above. But he couldn't (or wouldn't) give the audience any hard data regarding that or practically anything else that might be considered a true KPI.
Dayton, of course, is limited in what he can reveal about his client's product. It's obvious, however, that Sanofi considers GoMeals a success because it has continued to update the program and supports it with a web site and a twitter account. All of this requires a certain commitment of resources. But is this commitment justified by relevant data or just because the faithful believe in the program? Do you justify money spent by science or by religion?
Sanofi obviously collects useful data from GoMeals users. For example, the application includes a survey that asks questions such as:
Do you or anyone in your household who uses GoMeals have diabetes?
How often do you use GoMeals?
Answers to these critical questions would provide some true KPIs. Unfortunately, we don't know what the answers are unless Sanofi chooses to reveal them.
That lead me to ask an unusual question during the panel session yesterday; namely, why doesn't Sanofi reveal these data? The only answer I got was that GoMeals was considered an important part of the marketing plan and therefore that information was proprietary.
I understand that there is a lot of competition among pharma companies in the Type 2 diabetes arena and a lot of this has to do with diets, meals, and menus rather than the benefits of the drugs being marketed (see "Three Companies Compete for Diabetes Market Share Using Recipes Rather Than Product Efficacy"). If competing on helping diabetics with meal planning is the most important part of your marketing plan, then sure, you got to keep this stuff secret.
But how important are mobile apps in pharma's integrated marketing approach? It's got to be a very small part of the pie in terms of resources. If Sanofi revealed what percent of the GoMeals users actually had diabetes, would that be giving too much away?
Why should pharma companies reveal more hard data that can prove (or disprove) the effectiveness of social media and mobile apps? If the SM and mobile evangelists want to convince us that pharma should be doing more in this area, they need to give us some hard data in support of that. If they hide these data and just report "soft," meaningless numbers, I think they are preaching, not teaching.
Often, when proponents of pharma eMarketing get together at industry conferences, or cry into their beers at receptions afterward, they lament the fact that the drug industry isn't doing as much as other industries in the "e" arena. Sometimes, they cite eMarketing campaigns of companies like Procter & Gamble (P&G) and ask, Why aren't drug companies doing that?
The responses to that question generally fall into the category of "It's Regulations, Stupid!" That is, FDA regulations are hampering what pharma marketers can do online. The packaged goods industry -- of which P&G is a member -- is not regulated like the drug industry is regulated. True that!
So, let's look at another industry that IS regulated: the insurance industry. Where do insurance marketers spend their dollars and how does that compare with pharma? It just so happens that I came across some data that might shed some light on that (see the chart below; click on the chart to enlarge).
The data come from Kantar Media. The Internet data does NOT include search advertising. The insurance data is for the first three quarters of 2011 (total spend = $3.56 Bn) whereas the data for pharma is for 2010 (total spend = $4.3 Bn). To compare apples to apples, in 2010 the insurance industry media spend pie looks like this: TV, 54%; Print, 6%; Internet, 21%.
No matter how you look at it, the insurance industry favors Internet over print whereas the opposite is true for pharma. Why?
Here's what I have learned from personal experience. In my family -- and probably in your family too -- health decisions and purchases are generally the domain of my wife, whereas insurance decisions and purchases are my responsibility. It's no secret that pharma marketers target mostly women. My wife reads magazines like Prevention, etc. that feature a lot of drug ads. I don't read these magazines. While I have seen print ads for insurance companies, they haven't made much of an impression on me, whereas TV ads have.
So, from my personal experience, it's logical that both industries allocate a big portion of their media spend on TV advertising, but only the drug industry spends a lot on print advertising.
What's surprising, however, is the insurance industry's 28% of total media spend on the Internet (versus 5% for the pharma industry).
Coincidentally, yesterday I received an e-mail message from Geico about their "Family Pricing Program" for my son Greg. (We are Geico customers, having both our car and home insurance with them.) The message said:
"If Gregory is getting ready to graduate, preparing for a new job, or looking to establish a little independence, our Family Pricing program allows you the freedom of moving Gregory to his own policy while he continues to receive the same great rates you're currently receiving."
That spooked me a bit because Greg just started his first full-time job after graduating and I mentioned to my wife that soon it will be time for Greg to get his own insurance policy! I tweeted:
"Got email from Geico about transferring my son 2 his own car insur plan now that he has a job. How'd they know I was just thinking that?"
Of course, they didn't know what I was thinking, but it was nice to know that they anticipated what I may be thinking! Geico knows a lot about me and my family. They know our ages, our sex, our driver's license numbers, our driving records, what kinds of cars we own, etc. I had to give them that information to get insurance. No big deal.
So, it would be easy for Geico to anticipate that Greg recently graduated and that he may have a new job. Further, they know from experience that parents want to get their kids off their insurance plans ASAP.
After I posted that tweet, I received this response from "Shay" tweeting from the @GEICO_Service Twitter account:
"We would be more than happy to give him a quote! He can go to geico.com or give us a call at 1-800-861-8380. -Shay"
That was a pleasant note that makes this whole experience even more personal than if I just got an e-mail message.
When I complained that Greg was likely to push back on the idea of paying his own insurance, Shay reassured me that "We will do everything we can!" and added: "Thank you so much for being part of the GEICO family!"
I don't think I can leverage this new found "family" relationship to get an even better deal from Geico, but the experience made me an even better fan of Geico -- I was already impressed with their online services. Hopefully, if we ever need to make a claim, I will be equally impressed.
Can the pharmaceutical industry do something similar? I'm not sure. The first hurdle for pharma is breaking away from print. As I said, pharma marketers may depend upon print to reach their core audience -- women. But they may be ignoring social media's ability to reach that core -- listen, for example, to this podcast: "How to Score With Women (as a Marketer) via Social Media."
Keep in mind, however, that social media marketing is virtually "free" compared to print advertising, which is something the packaged goods industry is learning (see "The Coming Pharma Digital Depression"). Given that, even if pharma moves big time into social media marketing, I'm not sure the spend pie would look much different. The insurance industry probably spends a lot more on internet display advertising and e-mail direct marketing than does the pharma industry. These activities are much more expensive than paying Shay to reach out to me via Twitter!
I just love following Fabio Gratton on Twitter. Yesterday he posted this tweet:
"Has anyone download this Pfizer app? (only available in Israel). Terrific idea! http://t.co/JAMzbIa4 #mhealth"
When Fabio says something is terrific, I have to see it.
The app he was talking about is Pfizer’s ‘public restroom’ iPhone app, which targets consumers in Israel. BTW, there are in fact no public toilets in Israel!
So, how do you find a public toilet where there is none?
"We launched a GPS app that locates the nearest toilet – restaurants included!”, said Tali Rosin, public affairs and policy manager with Pfizer Israel. According to a reviewer (here), "users can add toilets not already in the app’s database, and can also grade toilets they visit for criteria such as cleanliness, availability of toilet tissue, or whether they needed to ask for a key."
Now THAT's a mobile app that George Costanza would rate among his TOP 25! Actually, Pfizer's app was among Apple App Store’s coveted “Top 25” most-downloaded apps and was downloaded over 15,000 times in about 3 months after it was launched in September 2011.
You could refer to this app as the Mobile George Costanza Public Toilet Finder:
The app is designed to raise awareness about Overactive Bladder (OAB). People with OAB would find this app useful because the condition is characterized by frequent urges to urinate. I bet it's also useful for tourists.
NOTE: It's only useful if the database includes good coverage of a city with lots of ratings from other users. Otherwise, it's a simple matter to walk into any restaurant and ask to use the toilet. You don't need an app for that! I suspect there are a lot of "George Costanzas" out there who may not have OAB, but like to know where the best toilets are located, just in case.
The app also includes an RSS function that automatically sends news feeds to the app. I am not sure what kind of news -- maybe tweets from Pfizer. Interestingly, it also facilitates calls from within the app to Pfizer's hotline.
Pfizer claims that the app has a positive ROI and has lead to an increase in product sales (I suppose for Toviaz, its OAB drug; see here).
Mass Media DTC Trumps Mobile Marketing So why don't we see such "innovative" smartphone pharma apps here in the U.S.?
Simple. We have direct-to-consumer (DTC) BRAND advertising via mass media and the Internet here in the U.S. That EASILY trumps NON-BRANDED disease awareness social media and mobile apps in terms of awareness. That is one reason why pharma's spending on social media and mobile marketing is so minuscule.
Another reason why the availability of DTC marketing in the U.S. leads to minuscule eMarketing is that brand managers spend so much on mass media DTC there is very little left in the budget for "e" of any sort and a big chunk of that goes to building web sites and buying search engine ads to drive traffic to those web sites, IMHO.
P&G Discovers It's "Free" to Advertise on Facebook!
That's the gist of an article written by Jim Edwards over at Business Insider - Advertising (read the article here).
Of course, advertising on Facebook is not really free, but it's pretty darn close when compared to TV. According to the article, "P&G said it would lay off 1,600 staffers, including marketers, as part of a cost-cutting exercise."
Interestingly, P&G CEO Robert McDonald had some interesting comments about the cost-effectiveness of digital advertising, including:
"I believe that over time, we will see the increase in the cost of advertising moderate. There are just so many different media available today and we're quickly moving more and more of our businesses into digital. And in that space, there are lots of different avenues available. In the digital space, with things like Facebook and Google and others, we find that the return on investment of the advertising, when properly designed, when the big idea is there, can be much more efficient."
If a packaged goods company like P&G is "moderating" its cost of advertising by shifting to digital and laying off marketers, then the pharmaceutical industry can't be far behind. A "recession" in pharma digital marketing is even more likely considering the well-known "patent cliff" that's currently in progress; ie, blockbuster drugs with a combined $170 billion in annual sales will go off-patent by 2015. That means even less mass media advertising and more digital advertising.
But "more digital advertising" does not mean that much more money will be spent in the digital arena. That's because of social media, where it's virtually free to advertise!
Today, I will present a webinar on this topic as part of a BrightTalk "Digital Marketing & Pharma Summit" series of webcasts. The title of my presentation is "The Coming Pharma Patent Cliff and 'Recession' in Digital Spending."
According to BrightTalk's Quoc-Thai Dang, "At this summit, we'll be exploring the realities of how Pharma is spending it's budgets on digital. Experts will critically evaluate the impact of social media and mobile marketing, and if this has had an impact on their business."
My webinar will be at 10:00 AM this morning (January 31, 2012). You can go here to attend live or listen afterward or use the widget below.
I admit that my ideas are only half-baked and invite your comments.
"A reporter in Times Square gathered over 200 random people and allowed them to try Thera Max™ Cold and Flu right on the spot. The results provided would give a non-biased, random and unscripted evaluation of the product and the results it provided. The overall consensus was, 'It really works.'"
According to the press release (read it here) this was the result of "A Social Media Strategy in Times Square [that] Boasts Great Results for TheraMax Cold and Flu."
What's the social media component? Videos from the TheraMax "No Cold Here -- Times Square, NYC" promotion have been uploaded to the Thera Max Facebook and YouTube pages.
Luckily, this social media "strategy" hasn't garnered very many views on YouTube (see video here). There have been only 148 views so far and half of them were by me!
I say "luckily" for a couple of reasons:
The claims of efficacy made in the video for this "homeopathic remedy of ingredients pre-approved by the FDA" are shameful. "Awesome", "no nasal congestion here." etc. No wonder Rx drug marketers have social media envy!
The "random people" trip all over themselves trying to promote the product as if they were auditioning for a TV ad spot! Wait! They ARE auditioning! "On February 1, 2012, one Grand Prize Winner will be selected at random to receive a TheraMax customized iPad2," says the press release!
I don't have the stomach to see what's happening on the Facebook page!
The following montage of frames from the video demonstrate the depths to which some people will stoop for a chance to star on YouTube and win a lousy iPad2!
It's time to revisit a survey I ran a couple of years ago that attempted to predict future healthcare market scenarios that would impact the drug industry. The survey asks respondents how likely it is for certain events or conditions to unfold in the next 5 to 8 years (ie, 2012 to 2019).
You can take the survey here. But before you do that, let's review the first-round of results (ie, responses collected from 2 December 2009 through 8 January 2010). Events since then may have made some of the following scenarios more or less likely. You tell me.
The scenarios -- with my updated comments included in brackets [] -- that are included in the survey are as follows (see the chart afterward for the first-round results):
New follow-on biologics legislation in the U.S. will increase competition from generic equivalents and eventually decrease brand profits. [I think the legislation is still bogged down and when finalized may not have much impact within the time frame specified.]
Broadcast (ie, TV) Direct-to-Consumer (DTC) drug promotion will be banned or sharply curtailed by law in the U.S. [This may have been a big issue back in the day, but it doesn't seem to be center stage right now.]
The European Union will finally allow Direct-to-Consumer (DTC) advertising to its citizens. [The European Commission, the executive arm of the EU, recently ruled that pharma companies would not be allowed to disseminate information about drugs and their indications beyond a narrow set of circumstances. For the details, see, "In Rejecting Proposal, EU Dashes Drugmakers’ Hopes of Having a Voice"]
Internet-based drug promotion (including search engine marketing) will overtake TV-based DTC in the U.S. in terms of dollars spent. [There's still time for this to happen. I'm guessing that right now only about 5% (maybe 10% if you include search advertising) of pharma's DTC advertising budget is spent on Internet advertising whereas TV accounts for over 50% of the budget. See "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"]
Due to decreasing effectiveness of traditional physician detailing and rise of non-personal detailing, the role of traditional sales representative will become obsolete. [I'm surprised that over 50% of respondents think this is likely to happen before 2020 (see chart below). Perhaps a sign is the recent closing of Pharmaceutical Representative Magazine (see here). Also read this article: "Consequences of eDetailing Technology".]
New healthcare reform legislation will dramatically increase the sales of drugs in the U.S.
Extensive outcomes data available to payers and comparative effectiveness research will force the industry much further down the path of pay-for-performance (ie, adopt a more flexible approach to pricing). [For background in this, read the article "A Case for Supporting Comparative Effectiveness Research".]
Patients will become even more influential and empowered in making healthcare decisions as they are forced to pay a larger share of costs and/or have access to health information from a variety of sources. [For more background on this, read the article "The Empowered Patient: What It Means for Pharma Marketers".]
More efficient targeting of drugs and marketing to specific patient populations will greatly increase effectiveness and decrease side effects of drugs. [See, for example, "New Big Pharma Economies of Scale: Less Patients Needed to Reach Blockbuster Sales". At least one targeted therapy (I can't recall which), however, recently failed and that may cast a shadow on progress in this area.]
Social media marketing will become a significant part (>10%) of the pharmaceutical marketing mix. [Hmmm... A lot of people seem to believe this is likely (see chart), but FDA's delay in issuing guidance may have dampened the outlook for pharma use of social media.]
The next BIG opportunity for targeted marketing to patients and physicians is mobile apps on "smart phones." [To prepare for this, I recommend you read the article "Everything You Need to Know About Mobile Platforms". Take the survey and you will get a discount code that allows you to get this at no charge.]
Pharmaceutical and biotech companies will continue to increase their outsourcing of clinical trials and related drug development. Outsourcing will account for more than 50% of R&D spending by 2019.
The following chart summarizes first-round (prior to January 2010) survey results. Please take the survey now and help me get a more current view of what may be dow the road.
I just read an interesting MM&M piece about how measures to curb the deficit might impact the pharmaceutical industry (see "Pharma Marketing Outlook 2012: Detailing D.C."). One small comment caught my attention: "A first draft of what is likely to be one of several not-crystal-clear guidances on social media and Internet communications has been circulating at FDA for most of the year, held up over legal worries." [my emphasis]
Oddly, no details were offered regarding the nature of the "legal worries." As the author of the MM&M piece probably knows, I wrote about this back in July when I suggested that a "Citizen Petition Filed by Pharma Likely to Delay Indefinitely the Issuance of FDA Social Media Guidance" (here). The petition asks for "comprehensive, clear and binding regulations" as opposed to "guidelines," which are non-binding (ie, can easily be changed by the FDA).
Before granting a petition, FDA staffers evaluate it, "a process that may take several weeks to more than a year, depending on the issue's complexity," according to the FDA.
Why is this such a big deal? I have pointed out that if the petitioners -- Allergan, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis -- are not satisfied with how the FDA responds to the petition, they are likely to "take the matter to court" ( further hamstringing the FDA efforts to issue social media guidance. The number one pharma company and one of the petitioners is already on record opposing any social media guidance on first amendment grounds (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").
In particular, the petitioners are looking for more guidance in four key areas: scientific exchange, sharing information with formulary committees and payers, providing independent third-party clinical practice guidelines, and responding to unsolicited requests for information. It seems that the FDA changed its social media agenda -- thus further delaying issuance of guidance -- to satisfy these specific needs (see "FDA Drops Social Media from Its 2011 Guidance Agenda").
Another, related, "legal worry" that could be holding up FDA's issuance of social media guidance is a "friends of the court" brief to the court hearing the appeal of the Caronia off-label promotion case. This petition was filed by some of the same pharmaceutical companies mentioned above (see "Pharma Turns Up the Heat on Off-Label 'Free Speech' Chilled by FDA - Implications for Social Media Marketing"). The companies -- who call themselves the Medical Information Working Group (MIWG) -- contend that FDA's regulations "lack coherence and clarity." MIWG is talking about regulations regarding off-label information disseminated by regulated companies such as themselves.
This push for an end to FDA's off-label marketing ban is the latest industry action that puts the FDA in a very weakened position viz-a-viz issuing any marketing guidance (and certainly NOT social media guidance) for the foreseeable future. The industry hopes the court case in question -- the Caronia off-label promotion case -- will end up in the Supreme Court. In the meantime, FDA is probably thinking "let's wait and see what happens before we issue any new guidance that 'lacks coherence and clarity'."
Pfizer's @pfizer_news Twitter account just posted this tweet:
"Toviaz top-line primary endpoint results positive in overactive bladder study of nocturnal urinary urgency http://t.co/OU60l6oZ" (see here).
The link is to a press release that reports the results of a study that purports to show that Toviaz (a reformulation of off-patent Detrol) is "statistically significantly superior to placebo" in treating OAB (Over Active Bladder). The "statistically significantly superior" results were "based on patient self-reporting," which is a very subjective measure of efficacy to say the least.
OAB is one of those "medical conditions" that has been refurbished by the drug industry so that more people -- especially women -- can believe they have a problem requiring treatment by a pill rather than by some other, less invasive, means. I wrote about this before -- see "Overactive Bladder: 'Pharmacia instrumental in creating new disease' says Former VP." Pharmacia was purchased by Pfizer after that post was made.
An anonymous commenter to that post said:
"In the case of OAB, Pharmacia (and later Pfizer and others) provided an acceptable name for the condition, increased awareness, and provided access to effective treatment for a large group of patients (women especially) suffering a hugely difficult condition. Your wife, your choice - diapers or Detrol?"
I thought the last sentence was worth immortalizing in the title of this post because it is said that OAB is one of those conditions that "women especially" suffer from.
The Pfizer press release claims that "approximately 33 million Americans are estimated to suffer from overactive bladder symptoms." It doesn't say how many of these Americans are women, but the Toviaz Web site features a woman posing as a patient ("Not an actual patient") as in this banner:
Yesterday, I asked "Do Women Take More Drugs Than Men Because They Need To or Because They Are Targeted by DTC Advertising?" (see here). Toviaz ads (eg, the Toviaz.com Web site) demonstrate how women are targeted by direct-to-consumer (DTC) advertisers. As I mentioned in yesterday's post, I plan to discuss this in an upcoming Pharma Marketing Talk LIVE podcast discussion tomorrow (see "How to Score With Women (as a Marketer) via Social Media").
One other thing I have to say about the @pfizer_news tweet is that it is an example of a branded tweet that may not comply with FDA regulations because it mentions a brand name drug plus its indication but does not include any "fair balance" (ie, major side effect information) as required by law.
Most pharma social media initiatives such as company blogs and twitter accounts (including @pfizer_news) are managed by corporate communications people who are increasingly taking on the role of brand marketers. These people tend to think of themselves as outside of FDA's purview. Consequently, Pfizer may claim that the Toviaz-branded tweet is notice of a press release, not advertising, and that the press release contains the necessary fair balance (albeit one click away).
In the post about OAB mentioned above, I included slides from a Pharmacia VP that demonstrate the importance of PR and the media in "creating a new disease." One slide said "Drive potential patients to physician offices by using DTC and PR with symptom recognition." Another slide (see below) shows that the Media are an important component in creating consumer demand:
"FDA’s regulations censor manufacturers," says the Medical Information Working Group (MIWG), an "informal" group of pharmaceutical companies that includes Allergan, Amgen, Boehringer Ingelheim USA, Eli Lilly & Co., GlaxoSmithKline, Johnson & Johnson, Novartis Pharmaceuticals, Novo Nordisk, Pfizer, Purdue Pharma, and sanofi-aventis U.S.
In a "friends of the court" brief to the court hearing the appeal of the Caronia off-label promotion case (see here), the MIWG contends that a manufacturer that "speaks about the lawful off-label uses of its products subjects itself to potential enforcement action unless FDA and DOJ determine, in their sole discretion, that they will not treat the speech as evidence of an 'intended use' for the product. This creates a chill on manufacturers’ speech, which has serious potential consequences for physicians, patients, and the public health."
Because of FDA's regulations that "lack coherence and clarity," MIWG claims physicians will have difficulty obtaining "objective, balanced, and accurate information on important unapproved uses of approved products." Furthermore, MIWG contends that pharma companies are "uniquely positioned to provide physicians with such information."
That's rich, considering that the drug industry often has difficulty providing "objective, balanced, and accurate information" on APPROVED uses of drugs as evident from all the FDA warning letters, which address this difficulty (for a list of the most recent letters, see here).
Should the heat the drug industry is bringing against FDA's off-label authority succeed, I envision off-label "woolly mammoths" (aka, sales reps) breaking free of the chilly ice and running amok among physicians offering "objective, balanced, and accurate information" - all without any oversight!
Much has been written about this legal issue, which you can find here, here, and here. Aside from the "objective, balanced, and accurate" claim, what caught my attention in the language of the brief was the overlap in the arguments presented with arguments pharma (eg, Pfizer) has made about how FDA should (or should not) regulate the promotion of Rx drugs via the Internet and social media.
On page 10 of the brief, for example, the argument is made that so-called "safe harbors" (eg, FDA guidelines for distribution of off-label reprints; see "FDA's Good Reprint Practices Guidance") are "not the product of formal rulemaking" and are "in most instances explicitly 'non-binding'." This was the argument Pfizer made against FDA issuing social media guidelines (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"). As part of that argument, Pfizer said that "for FDA to regulate in this sensitive area [social media] through guidance instead of rulemaking inherently raises First Amendment concerns because of the nature of the process used to develop guidance, and the nature of the Agency pronouncements that result." (NOTE: Both documents are written by some of the same lawyers.)
Another parallel appears on page 11 of the brief, which delves into "unsolicited requests." The brief noted that FDA allows pharma company representatives (eg, paid physician speakers) to provide off-label information in response to an "unsolicited request" (eg, a question from the audience; perhaps from a physician "planted" in the audience for that specific purpose?).
Recall that the FDA's 2011 guidance "agenda" called for the agency to issue guidance regarding "unsolicited requests" from any source, including the Internet. That particular guidance, says FDA, was part of its promised social media guidance (see "FDA Drops Social Media from Its 2011 Guidance Agenda"). Before FDA can do THAT, it has to contend with the legal issues raised by MIWG in its brief.
This push for an end to FDA's off-label marketing ban is the latest industry action that puts the FDA in a very weakened position viz-a-viz issuing any marketing guidance (and certainly NOT social media guidance) for the foreseeable future. The industry hopes the court case in question -- the Caronia off-label promotion case -- will end up in the Supreme Court. In the meantime, FDA is probably thinking "let's wait and see what happens before we issue any new guidance that 'lacks coherence and clarity'."
Today is the day that Facebook will no longer allow pharmaceutical companies to disable comments made to their Facebook pages.
"Today is the day that many pharma and healthcare companies that like their Facebook Pages hoped would never come. Remain calm," said Jonathan Richman on his Dose of Digital Blog.
As Jonathan noticed, so far it doesn’t appear that Facebook has actually turned on comments on any pharma pages.
Facebook may be tardy in carrying out its threat, but that's NOT the "free ride" I am talking about.
No matter when the new policy is implemented, pharma Facebook pages such as this one for Lunesta (see screen shot below) can STILL have comments disabled (listen to this podcast interview of Jonathan Richman for the details).
The difference between the Lunesta Facebook page and the standard www.lunesta.com Web page is:
The Facebook page is FREE! The pharmaceutical company that markets Lunesta (Sunovion; formerly Sepracor) pays Facebook NOTHING to create and maintain this page, whereas it pays to create and maintain the drug.com site.
This is the best deal in town! Call it CUGC: "Corporate User Generated Content."
I hope the pharmaceutical industry doesn't cry too hard if and when Facebook implements its comment policy change. After all, there's a loophole you can drive a truck through.
By now everyone is aware that the FDA has missed its SECOND deadline for issuing some form of guidance to the drug industry for the promotion of Rx products via the Internet and specifically via social media (see, for example, "No News is No News – DDMAC Fails to Produce Guidance").
Of course, further delay in issuing such guidance is very frustrating for the dozens of stakeholders who the FDA invited in November 2009 to make presentations at a public hearing.
To highlight that frustration, on April 1, 2011 (April Fools Day), I created a bogus PhRMA Statement, which included these memorable lines:
"Due to FDA’s limited resources and an increasing workload, FDA should seek out help developing social media guidance. PhRMA intends to continue to serve as a constructive partner in that regard. So why not give us a call or tweet us? We’ll be happy to draft some guidelines tout de suite."
and
“FDA says it wants the draft guidances ‘well thought out’ when they are issued. I mean, how difficult can it be? PhRMA Intern will be returning after the Spring semester is over and we can assign her to the project."
and
“FDA’s failure to act in this matter is a slap in the face of the pharmaceutical industry, which urgently requires social media guidance. ‘Let's Build Something Together’ is a famous tag line from Lowe’s Home Improvement. That sums up our position with regard to building FDA social media guidance as well."
The joke was successful as far as April Fools go and PhRMA had to act fast to contain the media's confusion. Christian Clymer (@CCatPhRMA), Social Media Lead for PhRMA, tweeted this in response to my post:
"Have you been fooled? See @pharmaguy April Fool's joke and PhRMA's real statement here... http://bit.ly/gEqjyz"
The link in his post leads to another note on PhRMA's blog:
April Facts v. April Fool's
by Kate Connors on 4/1/2011
Perhaps you’ve seen John Mack’s April Fool’s post that says he’s gotten a copy of PhRMA’s “statement” on the Food and Drug Administration’s delayed social media guidelines.
Mack’s post, which presents a fictitious statement, has made the rounds this morning, underscoring the immediacy of social media.
Go ahead and read PhRMA's ACTUAL statement. I think if PhRMA allowed itself to speak frankly, the real PhRMA Statement would have closely resembled my April Fools version. Now that April Fool's is over, I have removed the fake statement from this blog. See you NEXT April 1!
FDA's DDMAC is playing Scrooge to the drug industry's Tiny Tim this Christmas season and -- to mix metaphors -- won't be laying the golden goose egg everyone was expecting in 2010. The egg of which I am speaking, of course, is guidance for drug promotion via the Internet and social media.
According to a post over at EyeOnFDA, DDMAC issued this statement:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:
Responding to unsolicited requests
Fulfilling regulatory requirements when using tools associated with space limitations
Fulfilling post-marketing submission requirements
On-line communications for which manufacturers, packers, or distributors are accountable
Use of links on the Internet
Correcting misinformation
Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.
I am not sure where this statement was made or to whom exactly, but I'll take it at face value.
This delay does not bode well for all of us expecting action from the FDA. With the new, Republican-controlled Congress coming into session next year, "Lame Duck" (or Cooked Goose) FDA officials are likely to be summoned before Senate and House committees to testify and to be grilled by Republicans. FDA may have to defend a lot of its recent regulatory actions. Obviously, Republicans favor less regulation and not more regulation. This may set the atmosphere within the FDA to be less vigilant regarding the regulation of drug advertising in general and Internet advertising in particular.
Also, political battles are likely to rage during the next Congress regarding recent online privacy initiatives by the FTC and the White House. The FDA may be caught up in these battles and be forced to be more cautious about issuing Internet guidelines. The announced delay may even be the first sign of caution. I note that the Center for Digital Democracy, for example, said FDA was incapable of policing privacy issues related to online health marketing (see "New Media Privacy Issues & Online Health Marketing").
About 2.30 minutes into this 8-minute Marketplace Morning Report is a short piece about pharma's use of social media for promoting drugs. I am quoted in the piece. Essentially, it's the same quote/sound bite that TIME used about pharma being "marginalized" if they do not figure out how to participate in social media discussions (see "Pharma is "Cleverly Navigating" the Social Media Space Says TIME Magazine").
My segment is preceded by an ad for Novo Nordisk, "since 1923 innovative developer of diabetes treatments and delivery devices." It's interesting that Novo Nordisk is a sponsor of this MarketPlace segment because its Race with Insulin campaign was also featured in the TIME magazine story, which called its twitter social media campaign "provocative."
Both stories are ambivalent regarding pharma's use of social media and may even be said to be supportive of pharma's cause to push the FDA into releasing guidelines. Both stories also say that FDA will release these guidelines before the end of the year.
It could be a coincidence that Novo Nordisk is linked to both these stories, but I'm beginning to feel that I am been played like fiddle by a Novo Nordisk engineered PR campaign! What do you think. Listen to the embedded Marketplace segment below (or find it here after it is archived as a podcast dated 12/20/2010).
"Surprisingly, it's the pharmaceutical industry that's been at the forefront of moving the FDA to issue social-media rules," reports TIME Magazine reporter Steven Gray in a story published online today (see "Drug Companies Take Their Pitch to Social Media — Carefully").
Steven interviewed me for this story and quotes me in this passage: "The companies realize their traditional websites and advertising strategies are no longer sufficient tools to promote products in a competitive marketplace in which doctors, pharmacists and consumers aggressively trade information about medicine on blogs. The companies are also aware that 'if they can't fully participate in the social-media conversation, they get marginalized,' says John Mack, publisher of Pharma Marketing Blog, which attracts about 25,000 industry readers a month."
I thank Steven for this 10 minutes of fame.
Steven's article focuses exclusively on Novo Nordisk's Race with Insulin Twitter campaign (@racewithinsulin), which is described as "one of the most provocative examples of how pharmaceutical companies are cleverly navigating the emerging, largely unregulated social-media space." "Provocative," yes. "Cleverly navigating," not so much. I only need to point out the story about how sanofi aventis not so cleverly launched a Facebook page to debunk that (see "Where's Your Social Media Crisis Management Plan?").
The article is actually a very good PR piece for Novo Nordisk and Race with Insulin. Although I mentioned to Steven my blog post heard about Kimball's infamous branded Tweet heard round the world (see "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!"), this wasn't mentioned in the article. That particular tweet was not particularly clever, although I agree that it was provocative.
You've no doubt heard from many industry people that the media is out to get them and write negative stories about the drug industry. In fact, that's the kind of story I was expecting Steven to write. He, for example, wanted me to OK his use of the word "provocative" to describe the Race with Insulin social media campaign. The TIME piece, however, is not provocative and does not attack the drug industry for its efforts, which is fine with me. Just remember this the next time an industry executive complains about the media!
Like the Wizard of Oz performing his "magic" behind the curtain, there may be many pharma "wizards" happily managing social media projects behind the scenes and out of public view. All it takes is a new age "Dorothy" to pull back the curtain. That "Dorothy" is Jess Seilheimer (@Jaeselle), who alerted me about the possibilities in a comment to yesterday's post about Shwen Gwee (see "Happy Pharma Social Media Halloween!"). Shwen leads Digital Strategy and Social Media within the Marketing department at Vertex Pharmaceuticals.
There's a bit of a brouhaha coursing through Twitterdom and the pharma blogosphere about Shwen. Some critics (eg, Rich Meyer, @richmeyer) say that Shwen "has not really done anything of substance yet and works for a company that does not even have any approved drugs yet." I pointed out that "Shwen may actually be working on ... a [social media] project within Vertex but not talking about it."
Today, the WSJ published an article touting a drug under development at Vertex that may CURE Hepatitis C! (see "New Hepatitis C Drugs May Be Blockbusters"). Surely, Shwen is hard at work "behind the curtain" developing a social media marketing strategy that will launch in concert with the new drug. In fact, as Jess points out, there may be "plenty of initiatives that pre-launch brands focus on in this phase, some of which may not be public knowledge."
Here is what Jess had to say about that and other ways that pharmaceutical companies may be using social media "behind the curtain:"
I'm of the belief that no one should try to validate who "does what" in social media when you're only qualifying it to an approved brand or initiatives in the public domain.
Exhibit A) There are plenty of ways to utilize social media engagement and digital channel in the pre-launch market awareness phase. Initiatives that pre-launch brands focus on in this phase, some of which may not be public knowledge.
- crowd sourcing HCPs input re: R&D initiatives
- utilizing PatientsLikeMe to identify, recruit and communicate with appropriate patients for phase III trial enrollment
- private HCP advisory board networks built through Ozmosis or Within3 social platforms
- 3rd party social sentiment/listening analysis through Buzz Metrics, et al (something that takes months to garner learnings then analyzed/utilized internally to inform target engagement strategies for launch)
- Unbranded disease awareness campaigns development- creating a need for new market entry (again something that may take months to create---tactics which may be teased out on a phased approach
Exhibit B) There are also corporate level initiatives that utilize building policy around a company's POV on how they approach using these channels to optimize their communications.
- these initiatives happen behind the scenes for months
- corporate initiatives are sometimes not publicly published/available for analysis like Roche or AZ
- corporate level investment in internal staff onboarding, education and applicability of using social media as a means to communicate internally with each other.
My point: Having a public brand/corporate supported "patient community" does not equate to "I have done social media', and we should use caution when trying to qualify someone;s knowldeg or within the area. Lastly, let's please consider using appropriate terminology when referring to utilizing social engagement channels for our business/brand objective-- it's not "doing social media".
Al things to take into consideration when proclaiming "people haven't done anything in social media".
I leave tonight to attend and speak at the 2nd annual DigiPharm Europe 2010 conference in London. I am looking forward to meeting a few people I learned about after I launched The Pharmaguy Social Media Pioneer Award nomination process. These include Alex Butler, Digital Strategy and Social Media Manager at Janssen-Cilag; Kai Gait, Digital Commerce Marketing Manager at GlaxoSmithKline; Gary Monk, Product Manager - Concerta XL, Janssen Cilag;
I am not a real road warrior and may not have all my tools with me to allow me to blog a lot while I am attending the conference. But I will try an update this blog at least once or twice during the week and for sure send out tweets from the conference. Follow me on Twitter: @Pharmaguy.
I, and others, have often criticized pharms's forays into social media as being "inauthentic" because no real dialogue is allowed (see, for example, "Pharma "Social Networks": Close But No Cigar Award"). Without the dialogue, social media campaigns are not likely to reach full potential by "going viral," which is the point recently made by my Twitter friend @jonmrich during an #hcsmeu discussion last Friday. "Here's a hint for pharma," said Jon, "Nothing will go viral if you don't allow 'Likes' or comments. Guaranteed."
There are, however, a few pharma social media sites that DO allow comments and Johnson & Johnson (JNJ) leads the pack in that regard.
Today, I discovered (hat tip to @andrewspong) that Janssen-Cilag, Ltd, part of the Johnson & Johnson family of companies, is probably the first European pharmaceutical company to produce a non-branded disease awareness YouTube video that allows comments and "Likes." The video is entitled "ADHD: A day in the life by Janssen-Cilag Ltd." You can view the video here or see embedded version at end of this post. But just in case it is pulled in the future, here's a screen shot:
According to the channel notes "This new short film, produced by Janssen‐Cilag Ltd , tackles some of the issues surrounding Attention Deficit Hyperactivity Disorder (ADHD) from the perspective of a child with the condition. For more information visit www.livingwithadhd.co.uk.
"The film was made after talking to groups of doctors, patients, parents and teachers, who told us that too often people think 'ADHD' is just an excuse for 'badly behaved kids'. The film should help people understand what it's like to actually have ADHD.
"If you know anybody affected by ADHD, please do share this film with them. Together, let's make sure all families get the help and support they need."
The "Commenting Policy" states "All submissions will be reviewed and may not be posted if deemed inappropriate. Comments which are off-topic, offensive, or promotional, will not be posted. Please note that we will not post comments about any specific products or treatments, whether they are sold by Janssen-Cilag Ltd or not."
@garymonk, who apparently is the person responsible for this YouTube site, says that Janssen-Cilag has published the "vast majority" of comments. I believe it because there is "a couple of spats boiling away" according to @andrewspong, another Twitter friend of mine.
The site also allows visitors to vote whether or not they "Like" the video. As of today only 51 votes have be cast (43 like the video, 8 do not like it).
Will this video go viral? So far the video has been viewed 58, 624 times since it was uploaded on June 9, 2010.
It's interesting to note that the Johnson & Johnson (JNJ) YouTube video, "Brad's Story: A 12-year old with ADHD," is at the top of the list of related videos. It also allows comments and "Likes." The JNJ ADHD video was uploaded to YouTube back on June 22, 2009 and has been viewed 62,983 times (150 "Likes" vs 12 dislikes). So, by that measure, the Janssen-Cilag video is doing rather well. It should be pointed out that JNJ's YouTube Health Channel includes 302 videos. In all, the total upload views for JNJ's videos is 2,170,352.
JNJ Health Channel's Rob Halper, Director, Video Communication at Johnson & Johnson, is a "Friend" of Janssen-Cilag's Living with ADHD. "Great channel! Terrific contribution to You Tube," said Rob. BTW, Rob Halpert is one of the people nominated (by me) to receive the coveted Pharmaguy Social Media Pioneer Award (see the announcement below).
The Pharmaguy Social Media Pioneer Awards
We might be tempted to give Janssen-Cilag a reward for launching "ADHD: A day in the life" social networking campaign. But instead of having awards for specific pharma social media sites or campaigns, why not give awards to the pioneers who have lead the way? We can learn more from how these pioneers overcame the obstacles to launch social media projects or promote social media than from the end result – even if the end result is flawed. People tend to live much longer than their creations and pharma social media pioneers are no exception. They may move on to new positions and spread their influence far and wide.
Who is @garymonk, for example? I want to know more about this person. How did he get to be in charge of the Janssen-Cilag YouTube ADHD channel? What are the issues he had to deal with? Etc.
That is what the Pharmaguy Social Media Pioneer Award is all about. Let's discover the pioneers and hear their stories. Please use this online form to nominate candidates. The introduction explains the rules for nominating candidates and you can also vote on a dozen or so candidates that I have already chosen.
P.S. I found out who @garymonk is. He is Gary Monk, a Product Manager (Marketing) at Janssen Cilag and, according to his LinkedIn profile, he has already won a few awards such as: The "2009 PM Society Digital Awards - Triple Award Winner (1) Best overall promotional solution (2) Best Integrated Campaign (3) Best Edetail." Nevertheless, I added his name to the nominees for the Pharmaguy Social Media Pioneer Award.
