Weave Social Media Into Your Marketing Strategy

As reported by @shwen via Twitter:

"Social Media has to be integrated into the fabric of your overall marketing strategy" - Sara Larsen (SAP) #iStrategy

Here's my visual interpretation of that:

Regarding Social Media Advice & Guidelines, PhRMA Will Follow FDA's "Lead"

Now that the British pharmaceutical industry has published its advice to members about using social media for drug promotion (see "Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma), the logical question to ask is "Should PhRMA (the US industry's trade group) follow ABPI's (the Association of the British Pharmaceutical Industry) lead and update its Direct-to-Consumer (DTC) Guidelines to cover drug promotion to consumers via the Internet and social media?" Although such advice and guidelines are voluntary and do not carry any legal weight, it would help the drug industry, which is not waiting for FDA guidance and is already doing quite a bit of promotion via social media.

When I asked PhRMA if it had any response to the Brit's published guidance and if PhRMA would follow ABPI's lead and update its DTC Principles to include "advice" on how to apply those principles online, I received this response from PhRMA attorney Jeff Francer (via Jeff Trewhitt, PhRMA's Media/Public Affairs spokesman):

"The Food and Drug Administration is taking the lead, and we're eagerly awaiting the guidance the agency is completing."

To which I responded:

"Ha Ha! I'm sure you guys know more about where FDA is going and when it will get there than I do!"

Whatever guidance the FDA may issue, it only will inform the drug industry how to stay within the LETTER of the law (ie, fda regulations). What's needed, IMHO, is some guidance on BEST PRACTICES that the industry should follow. Those best practices can go BEYOND the letter of the law.

PhRMA's voluntary DTC guidelines, for example, include principles that ban REMINDER drug ads (see definition here) on TV and Erectile Dysfunction ads on TV shows that children are likely to watch. Those principles go well BEYOND what the FDA requires.

Why not start thinking of social media principles that also go beyond what the FDA requires? That I believe is the role of voluntary guidelines and something appropriate for PhRMA to take the lead in developing.

Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster.

The Brits have won the race to issue social media guidance for the drug industry! (OK, it's NOT a race. Still, everyone says the EU regulators FOLLOW FDA's lead. Here's a case where the horse is following the cart!)

The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), just published "informal guidance" providing the drug industry advice on how to use online communications.

You can access the PMCPA "informal guidance" here.

While the US FDA (PhRMA too!) twiddles and delays, the British PMCPA tweets and delivers!

Most of the advice, however, is merely to follow the existing ABPI Code of Practice, which "applies irrespective of the method of communication." NOTE: In contrast to the British industry code, US PhRMA's DTC Guidelines specifically excludes online communications.

Regarding Twitter, PMCPA has this to say:

"If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code.

"Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine."

I interpret that to mean that Tweets such as the following from Boehringer Ingelheim (BI) may not pass muster with the Brits:

Back in October, 2009, I criticized tweets like this, which I thought violated FDA regulations (see "Boehringer's Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did"). So far, however, FDA has not issued any NOV letters to companies who post such tweets. Maybe BI is out of the FDA's jurisdiction because the tweet was meant for an EU audience and not a US audience? And since BI is not a British Pharmaceutical industry, it is not obligated to comply with the ABPI Code.

While many industry pundits fault the FDA for not issuing social media guidance in a timely fashion, no one has put any blame on PhRMA (the US industry equivalent of ABPI) for not issuing its own voluntary industry guidelines regarding Internet and social media pharmaceutical promotion. No one but me, of course (see, for example, "PhRMA Finalizes DTC Principles").

Amgen's Prolia Website Features Stories from "Typical" But Not "Actual" Women Like You

You've probably been seeing DTC TV ads for several different osteoporosis drugs these days. No longer does Sally Field dominate the airwaves hawking Genentech's Boniva. AMGEN's twice-per-year injectable Prolia, for example, is now competing with once-per-month injectable Boniva.

Unlike Boniva, however, Prolia does not have a celebrity spokeswoman. What it has are "Women Like You."

The Prolia website prominently displays the option titled "Stories from women like you." Below is a screen shot of that option showing Karen, 71, who talks about Prolia.

Unfortunately, neither Karen nor any of the other "women like you," is an actual patient. Their stories, AMGEN claims, are "examples of typical patients--not the experiences of actual patients." Maybe it's difficult to get real patient stories for a new drug. I've heard from posts on CafePharma that sales of Prolia suck big time because few GPs want to prescribe a new, unproven biologic that remains in the body for a whole year. Plus there are re-imbursement issues.

Karen tells her story AS IF she were a real patient and provides details of how she fractured her left wrist. "I should be glad it wasn't my right [wrist]," says Karen. "My doctor said, 'Karen, you didn't get a fracture from being clumsy. You got a fracture from weak bones.'"

[BTW, I love the new age music in the background!]

Karen mentions that she is doing "everything my doctor told me to do to strengthen my bones." At first -- within the first two minutes of the video -- she only mentions getting a "shot every six months," which she "likes" and says"works for me." Later on, Karen does mention calcium pills, exercise, etc.

While Karen doesn't mention specific side effects, some specific side effects do pop up in the video frame in mouse-sized type that is difficult to read -- especially, I imagine, for older women. The last 2 minutes of the video highlights the important safety information using a scrolling text screen and a voiceover.

Perhaps, over time AMGEN will collect stories from ACTUAL patients to replace Karen and other "not actual patients" on its website. Meanwhile, I remain queasy about actors portraying "typical" patients in drug ads. Has the FDA issued any guidelines regarding what constitutes a "typical patient" in drug ads? FDA has issued warning letters about actors whose dialogue overstates benefits or downplays risks, but I don't recall any letter that questioned whether or not the portrayal is "typical."

Suppose, instead of a typical patient, AMGEN had a video of a "typical" physician? Would the FDA (or AMA for that matter) rise up and challenge the concept of a typical physician?

It seems to me that allowing drug marketers to use actors to portray what is labeled a "typical patient" is worse than using actual patients who tell real stories stories, even if those stories are not typical. At least we can challenge the veracity of "real" stories versus "typical" stories.

PhRMA Statement on FDA Social Media Guidance Delay

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.

Here is our actual statement, released yesterday.

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!