overcoming pharma’s social media challenges
DESCRIPTION
I this presentation, I present pharma social media “milestones” or “firsts” that have paved the way for others to follow and identify the “Pioneers” who have helped the industry navigate through “uncharted” territory lacking regulatory guidance. I also review some “mistakes” made by both leaders and followers. Only those who learn from the mistakes of their competitors will move forward. Those who learn from their OWN mistakes will move forward fastest! Finally, I offer some ideas for “best practices” and “guiding principles” that may help pharma avoid regulatory actions.TRANSCRIPT
Thank you for invi.ng me speak at the Roche Digital Academy! Unfortunately, I will have to speak rapidly in English to get through all my slides in the alloAed .me, but I am sure you will get a copy of my slides – including my notes – to read at your leisure aDerward.
I this presenta.on, I will show you some pharma social media “milestones” or “firsts” that have paved the way for others to follow. I will iden.fy the “Pioneers” who have helped the industry navigate through “uncharted” territory lacking regulatory guidance. I will also show you some “mistakes” made by both leaders and followers. Only those who learn from thee mistakes of their compe.tors will move forward. Those who learn from their OWN mistakes will move forward fastest! Finally, I will present some ideas for “best prac.ces” and “guiding principles” that may help you avoid regulatory ac.ons.
The dic.onary defines "aficionado" as a “person who is very knowledgeable and enthusias.c about an ac.vity, subject, or pas.me.” I have been around for a quite some .me and have first-‐hand experience with government regulatory and voluntary industry codes of prac.ce. Studying digital pharma has been my “pas.me” for many years. But I don’t just study digital pharma, I document and try to INFLUENCE it, as you will see in the following slides.
FDA’s famous 14 leAers alerted pharma to the fact that the agency is now looking carefully at how the industry promotes its products via the Internet.
I pushed this issue in December 2006 when I blogged that “FDA should be taking a closer look at drug promo.on via the Internet.”
And the .ming of my 2009 April Fools’ joke was perfect – many pharma people were primed to believe the FDA actually came out with digital guidance and several were angry at me for playing such a cruel joke!
The 14 leAers took aim squarely at the so-‐called “one-‐click rule” which was not a rule at all – it was just what pharma people wanted to believe and were lead to believe by FDA’s inac.on prior to the 14 leAers. In fact, I warned the industry about the invalidity of this “rule” or “received wisdom” as far back as November, 2006, when I debated it at an industry conference. Alas, only someone outside the industry could see that the Emperor had no clothes!
I’d like to believe that my call for public hearings back in April 2009, mo.vated the FDA to act. Unfortunately, however, the hearings were has.ly organized and as a result, they did not include ALL stakeholders as I urged. Consumer advocates were missing and agencies and industry service providers dominated the speaker roster. Rela.ve to the 1996 hearing, few pharma companies made presenta.ons at the 2009 hearing. This shirt appeared in my presenta.on to the FDA at the November hearings! It was my way of predic.ng the outcome.
Congress put some language in in recent legisla.on that requires the FDA to issue social media guidance by July 2014. Does that mean the FDA will deliver? If not, it wouldn't be the first .me that a government agency missed deadlines imposed by Congress. I call this FDA's "Social Media Guidance Cliff.”
FDA Safety and Innova.on Act (FDASIA)-‐TRACK must include the deliverables with statutory dates, as well as other tasks required to implement the law.
To date, no “other tasks” for SM guidance have been entered in the database.
Why the delay? Perhaps the industry wants legally binding regula.ons, not guidance. Pfizer, for example, contends that FDA’s proposed social media guidance “raises First Amendment concerns.” Guidance, said Pfizer, is too vague and engenders “extensive [First Amendment] li.ga.on.”
Over the 2011 Christmas holidays, while most of us were s.ll on vaca.on, the FDA quietly issued without fanfare "Guidance for Industry Responding to Unsolicited Requests for Off-‐Label Informa.on About Prescrip.on Drugs and Medical Devices." Sec.on VI. of this guidance addresses responding to unsolicited requests on public forums such as the Internet. While this may not be the "social media" guidance many people were expec.ng, it does include guidelines for responding to unsolicited requests for off-‐label informa.on encountered through "emerging electronic media.” The primary take-‐away is that such requests NOT be handled by sales or marke.ng people and that responses should be via private channels not via open forums such as on Youtube, blogs, and TwiAer.
As soon as the FDA issued the public no.ce about the hearings and posted 19 ques.ons it was seeking to answer, I hosted a survey that asked my readers to respond to those same 19 ques.ons.
FDA asked “Open-‐Ended” ques.ons. My survey asked respondents to vote on specific op.ons as well as including comment boxes.
I submiAed the complete survey results to the FDA docket and summarized the results in my presenta.ons at the hearing. The following slides also summarize some results from that survey as well as comments submiAed to the docket by major pharma companies.
FDA asked “Open-‐Ended” ques.ons. My survey asked respondents to vote on specific op.ons as well as including open-‐comment boxes. Regarding accountability, the survey wanted to compare situa.ons where pharma paid for content, provided grants for independent content, or sponsored branded ads that targeted specific 3rd-‐party content.
Another survey I hosted asked slightly different ques.ons in an aAempt to define some “best prac.ces” regarding disclosures and accountability.
One “best prac.ce” that I’d like to see more companies prac.ce is a Public Social Media Policy that includes a no.ce of its transparency/disclosure and other policies rela.ng to social media. About two-‐thirds of survey respondents agree with me!
I know of only one company that has a public social media policy. That company is Roche.
Comments submiAed to the FDA docket by the drug industry allow us to learn more about what the industry considers to be best social media prac.ces and where it believes the regulatory boundaries are. Not all pharma companies, however, agree on defini.ons or where to draw the boundaries.
Back to my survey. How pharma corrects or allows misinforma.on to be posted on social media sites it controls is an important part of its social media policy that should be revealed to visitors of such sites. Nearly a majority of pharma respondents would not like to see FDA mandate that they correct misinforma.on about products on 3rd-‐party sites, although about one-‐fiDh think misinforma.on of real and imminent danger to the public health (to be determined by company) should be corrected.
One important 3rd-‐party site where misinforma.on about drugs may be found is Wikipedia. “If you want your customers to access informa.on about your products from the quality perspec.ve and in the simplest way, you have to deal with using Wikipedia,” said Dr. Bertalan Meskó (@Berci).
Berci, however, did not mean that pharma companies should secretly and selec.vely alter informa.on as in this example: In July of 2007, employees of AbboA Laboratories altered entries to Wikipedia to eliminate informa.on about a Mayo Clinic study that revealed that pa.ents taking the arthri.s drug Humira faced triple the risk of developing certain kinds of cancers and twice the risk of developing serious infec.ons. I hosted another survey asking respondents under what circumstances should pharma edit drug ar.cles on Wikipedia. Based on this. The best prac.ce is to appoint an “official” Wikipedia editor as recommended by Berci and ensure that editors reveal .es to companies. Although a substan.al minority of respondents feel that FDA should regulate pharma edits to Wikipedia drug ar.cles, in comments submiAed to the FDA docket, PhRMA suggested that manufacturers would welcome correc.ng misinforma.on about their products posted to 3rd-‐party sites such as
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According to my survey, the vast majority – 83% – of pharma respondents think it is impossible to adequately handle AEs from social media sources. “It's remarkable how very liAle we see that meets the criteria of an adverse event,” said one pharma respondent. The criteria referred to are these: an iden.fiable pa.ent, a specific medica.on, an iden.fiable reporter and a reac.on.
The “iden.fiable reporter” is the most difficult bit of “required” informa.on to obtain. “Many people use the Internet to share informa.on and remain anonymous when doing so, even if an email address or other personal (excluding a name) is provided,” noted PhRMA in its comments to the FDA. “Unless people opt-‐in to say they want their informa.on to be shared with pharmaceu.cal (or other) companies, these companies should not pursue contac.ng a person if an AE is reported. While not everyone understands that AEs can be reported directly to the FDA or a company, there needs to be more emphasis to consumers about how they should/can report AEs so that companies are not liable for what they "happen" to find online.” In light of all the emphasis US pharma companies place on “iden.fiable reporter,” it is interes.ng that ABPI (UK) advised its members that “AEs should be collected and documented, regardless of seriousness of event and whether or not there is an iden.fiable reporter” (see SLIDE # X).
Pharma companies had some sugges.ons for how FDA could help the industry deal with online adverse event reports.
Meanwhile, some companies are sexng the “Gold Standard” for managing online adverse event reports and deploying the necessary resources to make it possible.
The Associa.on of the Bri.sh Pharmaceu.cal Industry has also come out with specific guidelines for managing adverse events on pharma owned or sponsored Web sites. Interes.ngly, the guidelines ignore the “iden.fiable reporter” condi.on required by the FDA for an AE to be “reportable.” The Brits have also issued some guidance for using TwiAer to communicate with physicians, making correc.ons to Wikipedia – an issue discussed in a previous slide – and appropriate use of metadata.
You can find details by following the links given.
Despite the lack of FDA guidance, pharmaceu.cal marketers have come a long way in integra.ng social media into their overall marke.ng strategy. These are data from the Social Media Readiness survey tool I have been running since December, 2007. Over 300 marketers working for drug or device companies have taken the survey. The survey asks ques.ons to evaluate readiness in three categories: regulatory (e.g., aversion of risk), culture (e.g., sensi.vity to cri.cism), and personal experience. Scores are calculated. This compares scores prior to July, 2009, with scores aDerward. Not every pharma company, however, is at the same point in the adop.on curve. Some are more willing to take "risks," some are more savvy about applicable FDA regula.ons, and some are more knowledgeable about social media in general. Let’s see how Roche did.
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These results, of course, are based on a very small number of responses. It seems, however, that Roche employees feel that the company is savvy regarding the regulatory issues rela.ng to social media but lacks the type of culture required to be comfortable with making social media mistakes. If you have not taken the survey, please do. I can report back updated results aDerward.
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Let’s look at more detail regarding how pharma employees rate their companies’ readiness to deal with social media readiness issues. You can see that in the early period prior to July 2009, the majority of respondents thought their companies had a “very cau.ous” regulatory climate with only 24% saying the climate was “very aggressive.” Theses days, it seems from these results, pharma companies are seen as much less cau.ous and more aggressive.
I guess that is due to the lack of significant FDA “warning” leAers being sent that involve social media. In other words, the “received wisdom” is that pharma companies are nego.a.ng the social media regulatory challenges without specific guidance from the FDA.
Be careful though! The FDA hammer may fall again just as it did the day aDer April Fools’ Day in 2009.
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While pharma may be gexng more comfortable engaging in social media without FDA guidance, there has been some retrenchment in adop.ng social media for marke.ng.
For example, there are fewer pharma Facebook pages today than there were prior to August 15, 2011, when Facebook changed its policy on comments. ADer the change, which did not allow pharma companies to turn off comments to their Facebook pages, many companies just shut down their pages. "This new policy will alter our ability to consider the appropriateness of comments before they are posted which is important to us as a company in a highly regulated industry,” said McNeil Pediatrics when it shut down its ADHD Moms page.
An example of this was the shutdown of the Psoriasis Facebook page by Janssen Pharmaceu.cals. This page – launched in October, 2010 – was the first pharma Facebook page that published comments BEFORE reviewing but reserved the right to delete them aDerward. Janssen cited its inability to moderate posts made to the Psoriasis 360 wall, one-‐third of which "men.on[ed] a specific drug by name, or talk[ed] about the efficacy of a par.cular treatment is (or its side effects)." In such cases, Janssen had to ask for the post to be removed or to "pull" it. Perhaps this decision represents a lack of commitment aDer Alex Butler, former Janssen Digital Strategy and Social Media Manager, leD the company. Alex was the person responsible for Psoriasis 360. For his efforts, I awarded him the first ever Pharmaguy Social Media Pioneer award. Another example was the shutdown of the ADHD Moms Facebook page by McNeil Pediatrics. This was the first pharma Facebook page – launched in June, 2008.
"This new policy will alter our ability to consider the appropriateness of comments before they are posted which is important to us as a company in a highly regulated industry,” said McNeil.
There were examples of pharma-‐owned or sponsored open discussion boards even before Facebook became popular. GSK’s Ques.onEverything, which was launched in April, 2006, is an example. It allowed comments from consumers and posted them aDer review (“pre-‐modera.on”). This site is no longer available.
Pre-‐modera.on – where possible – may be the best prac.ce for pharma social media sites, including YouTube. However, these days, very few pharma companies allow any comments at all, which is a shame because that is the best way to build community and aAract more viewers
Of course, there is good reason why pharma companies fear comments on Facebook as this case demonstrates. However, this could have been prevented:
• Problem #1: No one at S-‐A was monitoring this site or seemed to be responsible for it.
• Problem #2: There was no policy in place for what cons.tutes acceptable comments and how comments would be moderated or deleted.
• Problem #3: There was no social media “crisis management plan” other than “remove all comments!”
Sanofi learned from its mistakes and even spoke about them in a public forum; i.e., my Pharma Marke.ng Talk show .tled: “What Sanofi-‐Aven.s Learned from Its FaceBook Experience & What the Experts Recommend It Do Now.” In that show I interviewed Dennis Urbaniak, VP U.S. Diabetes. Listen to the podcast: hAp://bit.ly/PMT098
The Sanofi US Diabetes team won the third (2012) Pharmagy Social Media Pioneer Award.
Even the biggest pharma company in the world can be humbled by Facebook backlash. In this case, it was Pfizer and the product is not regulated by the FDA. Nevertheless, it illustrates how important it is to pay aAen.on to what’s going on in the social media spaces that you own and to have a “crisis plan” in place.
The issue was this: Pfizer selec.vely deleted “nega.ve” comments in an aAempt to control the discussion.
What’s the lesson? You are NOT in control of the discussion on social media.
This is pharma’s major social media conundrum:
(1) pharma marketers are used to controlling the discussion (or not having a discussion at all), and
(2) pharma marketers are legally responsible for the content of the discussions on sites they own.
Although Pfizer got into trouble with comments on Facebook, it did not shrink from allowing comments on other social media sites like its “Get Old” community.
On June 18, 2012, Pfizer launched "Get Old," a mul.-‐year ini.a.ve supported by nearly a dozen advocacy organiza.ons.
Registered users can post links, videos, photos, or stories (including comments up to 1000 characters) to the site. You can even submit comments to other posts and "Like," tweet, or email comments. Every comment submiAed is reviewed before being uploaded -‐ a process that is completed within 48 hours. Pfizer says it has a social media “Playbook,” according to Ray Kerins, Pfizer’s former Vice President of Worldwide Communica.ons. “While I don't want to say it's proprietary,” said Kerins, “I also don't want to make too big of a deal about it because we call it common sense.”
In the U.S., of course, direct-‐to-‐consumer branded drug adver.sing is permissible, but is it always necessary? I cri.cized this tweet as “sleazy twiAer spam” because I did not follow this account to receive branded messages but to learn more about how the celebrity racecar driver Charlie Kimball coped with managing his diabetes while racing. Although the adver.sed product is part of the story, this tweet had no educa.onal value and was merely a “product placement” or “reminder” type of ad that PhRMA says should not be used – at least on TV. But if it’s not OK for TV, it should also not be OK for social media.
Anyway, Novo Nordisk par.cipated in open discussion about this and learned – I haven’t seen any other tweets like this since.
Listen to this Pharma Marke.ng Talk podcast: “Novo Nordisk's Race With Insulin Campaign: It's Not Just About TwiAer”
hAp://bit.ly/PMTalk087
Back in November, 2011, I asked “Will a Pharma Company Ever Host a Chat on TwiAer?” (hAp://bit.ly/Twchat). I answered my own ques.on with: “most pharma companies may never directly host or moderate TwiAer chats because they can control neither the audience nor the message.”
So, I was surprised when Astrazeneca hosted the first live TwiAer chat session on February 16, 2011.
Despite dire predic.ons of "PR failure," the chat was a great success and proof that a pharmaceu.cal company can indeed host meaningful TwiAer chats. There were a few aAempts by two or three "malcontents" to "hijack" the conversa.on. These people made the most tweets that included the #rxsave hash tag, but despite their aAempts to ask "the tough ques.ons" about off-‐label promo.on of drugs and Seroquel side effects, everyone completely ignored the hijackers and the conversa.on con.nued as if these people were not even there.
Tony Jewell (@tonyjewell), Senior Director of External Communica.ons at AstraZeneca US, received the 2nd Pharmaguy Social Media Pioneer award for his pioneering use of TwiAer.
It is one thing to host a TwiAer chat where you can control what is being posted by your representa.ve(s) as part of that chat. But it is quite another problem controlling unauthorized tweets made by employees without the knowledge of your MLR people as this case illustrates.
A “Global Social Media Policy” doesn’t mean much unless • It is publicly available so the company can be held accountable in a
transparent fashion, and • Employees are trained in the policy, which should include sanc.ons
such as dismissal for viola.on of the policy.
Having social media principles that guide how your employees use social media and interact with the public online is a good first step. But if they are to have any effect, employees must be TRAINED to understand how to apply the principles in the real world. And, as with privacy policies, the fact that employees receive this training should be stated in the outward-‐facing social media policy that the company publishes. These are just a few of my “half-‐baked” ideas pertaining to a public social media policy for pharmaceu.cal companies to adopt.
Roche is the only pharmaceu.cal company that has publicly disclosed its social media principles. Bravo!
In closing, I would like to emphasize that to implement a strategy for using social media as part of your marke.ng campaigns, it is important to have a plan. But what are the ac.on items for implemen.ng your plan? This survey asked respondents to indicate how important the following ac.on items are in implemen.ng a social media plan: • #1: Get everyone -‐ including marke.ng, regulatory people, corporate
communica.ons, C-‐level execs -‐ on board
• #2: Become a dialogue company -‐ learn how to listen and respond, not just push messages out
• #3: Have a sustained vision/goal • #4: Train people who will be interac.ng directly with consumers • Create a social media Tsar posi.on to oversee all the company's SM projects
to assure compliance with guidelines
• Develop a modera.on strategy • Develop guideposts, internal and external standard opera.ng procedures • Marshall necessary resources -‐ use the best tools available • Unblock corporate access to social media so employees can monitor and
use applica.ons such as Facebook while at work
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