Sanofi Says Proposed FDA DTC Guidelines Would Effectively Kill TV Drug Ads

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, arguing that recent "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads" (find it here) violates the Free Speech Clause of the First Amendment because pharmaceutical marketing is a form of free speech (see "PhRMA Demands that FDA 'Cabin' Its Discretion to Regulate DTC Ads").

Sanofi, on the other hand, in a comment submitted to FDA (see here) argues that "the process presented in the draft guidance would potentially require the sponsor [ie, Sanofi and other pharma companies] to cease the use of TV ads as a vehicle to educate consumers due to significant production challenges as a result of the draft proposed process."

The "process" that Sanofi is talking about is the requirement to submit a "final recorded version [of the ad] in its entirety." Sanofi is concerned that if the ad needs to be changed -- reshot and re-edited -- as a result of FDA pre-review, it be too costly and "resource intensive" for the sponsor.

Not all ads, however, will require FDA review before airing (see "Focus on Drug Safety Communication & TV DTC Advertising" for details) and it is not clear how much it would actually cost to redo the production to comply with FDA comments. Sanofi should have included some specific estimates of these costs and "resources" to bolster its case.

Sanofi offered a compromise. Instead of submitting a "final recorded version" of the TV ad "in its entirety," Sanofi suggests that sponsors submit an "annotated storyboard or animatic [animated?] version of the advertisement."

FDA already reviews storyboards submitted prior to ads being run. In at least one case, however, a violative ad was aired months after FDA had a storyboard in its possession. Only after the ad had run its course did the FDA issue a notice of violation (see "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?").

Sanofi also submitted a comment regarding FDA's requirement for "verification that a spokesperson who is represented as a real patient [in a TV ad] is indeed an actual patient." Sanofi asked that FDA clarify what type of verification would be needed. Would a "signed testimonial from an actual patient" be enough?

Snaofi may be planning to use more real patients in its TV ads as have other pharma companies (eg, Pfizer use of real patients in Chantix TV ads). I've documented one instance where Sanofi has used a real patient in a video ad on YouTube (see "Method Acting for Real Patients Who Play Themselves on Pharma YouTube Channels") but do not recall any TV ads for Sanofi products that used real patients.

Regardless of what verification FDA requires for TV ads, the guidelines only apply to TV ads and NOT to ads that run on YouTube. Hence, although these new guidelines may "kill" TV drug ads, they may be a boon for YouTube ads such as the Sanofi YouTube video mentioned above.

Pharma Celebrity Spokespersons: Unrepentant, Secretive, and (Expletive Deleted)!

I have documented the rise and fall of several pharma celebrity spokespeople (see, for example, this list) . This past week two such celebrities made the news: Paula Deen and Danica Patrick. These are two examples of celebrities with "baggage" that may hurt the image of their pharma company partners. Paula Deen's baggage concerns secrecy and her unrepentant recipes whereas Danica Patrick's baggage includes swimsuit and bikini pictures and colorful language. I just imagined Paula and Danica "switching" their baggage (ewww!).

Paula Deen continues to express no regrets about delaying her announcement that she has Type 2 diabetes for nearly three years until she secured a lucrative deal as "a paid pitch person for drug maker Novo Nordisk's new online program, Diabetes in a New Light, and for its pricy (sic) drug, Victoza, which she takes" (see USA Today article, "Paula Deen: no regrets"). She will continue to cook sugary, fattening meals as she always has done, declaring "I'm Southern by roots. I was taught (to cook) by my grandmother and nothing I can do would change that."

However, she said that "when she begins shooting new episodes of her show this spring, the recipes will offer something for everyone, including people who want healthier recipes."

Unfortunately, there will also be a delay before those new recipes are available because "filming and production schedules are set well in advance, it could take up to two years before those episodes are aired," notes the USA Today article.

Meanwhile, Deen remains silent about how much she is being compensated by Novo Nordisk to be a paid spokesperson, citing an excuse as American as her own "Savannah High Apple Pie" (see recipe, which includes at least 2 and a half cups sugar, one whole stick of butter, and 2 cups butter-flavored solid shortening (recommended: Crisco)):

"Yes, I am being compensated," she said Friday. "It's the way of the world. It's the American way. But I am taking a portion of that compensation and giving it back to the (American) Diabetes Association."

Deen would not reveal what portion of her compensation she would donate to the American Diabetes Association. That too is the "American" way?

To learn more about Novo's reasons for choosing Paula Deen as a spokesperson, I invite you to read the Pharma Marketing News article "Novo Nordisk Defends Choice of Paula Deen as Diabetes Spokesperson". You can download this article after taking a short survey that asks two short questions:

1. When it is proper to use paid celebrities - e.g., movie stars, TV personalities, sports figures - as spokespeople for drug brands?
2. Should pharmaceutical companies reveal how much they pay celebrities?

You can Take the Survey here and see the results to date afterward as well as getting a FREE copy of the article.

"Was das F**k!"

That's what Danica Patrick, spokesperson for Boehringer Ingelheim's DRIVE4COPD™ awareness campaign said after teammate Cole Whitt "nudged" her rear in the Drive4COPD 300 race this past Saturday. Actually, Danica spoke in English, but that is what I imagine Boehringer Ingelheim executives were saying when they heard about this latest news about their "bad girl" spokesperson.

"The (expletive) 88 hit me while we were in a big pack! What the (expletive)?" Patrick screamed. ESPN has the video and audio from her in-car radio (here).

"I don't think it's ever great when teammates come together," Patrick said. "So we'll have to figure out what happened and move forward." Patrick didn't complain, however, in the beginning of the race when another racer, Dale Earnhardt Jr., "pushed" her to the lead position at the beginning of the race. She dropped way behind after that and grazed the wall once on her own before the second incident occurred.

Coincidentally -- or maybe NOT! -- the DRIVE4COPD Web site (here) is undergoing a revision (see below). I entered my email address to be "notified when the new site is live." Will Danica still be there?

[UPDATE. 29 Feb 2012]
I was contacted by a Public Relations person at Boehringer Ingelheim Pharmaceuticals, Inc. who said:

"Just wanted to clarify an item in your recent post re pharma celebs. The DRIVE4COPD website has been "under construction" since December 28, 2011, as we work to revise it to reflect changes to the campaign going into its third year. Since 2010, Danica Patrick has helped drive education and awareness about COPD among NASCAR fans and has been a committed and passionate spokesperson for the cause due to her family’s personal connection to the disease. The status of the website has nothing to do with any specific recent events and is on track to be fully up and running by next month. "

Thanks for the update. I didn't really think one thing had anything to do with the other :-)

Social Media and Celebrities: A Winning Combination for Pharma Marketers

Attendees at yesterday's session of the Social Media for Pharma Conference were treated to two case studies that combined social media with celebrities.

The first was the "Kaleidoscope Case Study" (aka, "How To Extend The Value And Reach Of Your Organization’s Campaign To Increase Engagement And Program Results") presented by Jim Dayton (@JimDayton), Director of Emerging Media at InTouch Solutions.

According to the FaceBook "Kaleidoscope On Ice" fan page: “Kaleidoscope presented by sanofi-aventis” was a holiday entertainment variety special [presented on Thanksgiving Day, 2009] that featured Olympic skating champions and GRAMMY Award-winning music artists [as well as American Idol singers]. The show featured the historic return to the ice of the legendary Scott Hamilton and Dorothy Hamill who will skate to the music of fellow cancer survivor Olivia Newton-John. The event was in support of women who survived cancer.

This event was promoted in part via Twitter, a campaign that Dayton said was very successful based upon key performance measures -- followers, tweets, etc. Dayton noted that this success was based in part on the active tweeting of the event done by the celebrities who were not paid to tweet but who benefited form the self-promotion.

It's a shame that I did not hear about this event either via Twitter or otherwise. Or at least I don't remember it. Unfortunately for Sanofi, what I do remember is the incident of the woman cancer survivor who laid siege to sanofi-aventis VOICES Facebook Page (read this post: "Patient "Unadvocate" Lays Siege to sanofi-aventis VOICES Facebook Page. Where's S-A's Social Media VOICE?" and listen to this podcast: "What Sanofi-Aventis Learned from Its FaceBook Experience & What the Experts Recommend It Do Now").

The second social media/celebrity case study was "Race with Insulin" presented by Ambre Morley (@ambremorley), Associate Director of Product Communications and Lois Kotkoskie, Director of Promotional Review. Both work for Novo Nordisk. Morley and Kotkoskie made a good tag team, presenting some behind-the-scenes information about how the program was launched with careful regulatory oversight. Their presentation was entitled "How To Use Twitter To Deliver Measurable Results For Your Organization."

You might recall that Race with Insulin is also a campaign that combines a celebrity (racecare driver Charlie Kimball), social media, and real world events (listen to this podcast: "Novo Nordisk's Race With Insulin Campaign: It's Not Just About Twitter"). The twitter account (@racewithinsulin) is famous for being the first branded Twitter account and for posting the first branded tweet, which I labeled "sleazy Twitter spam (see here).

I tried to keep a low profile during both these presentations and did not raise the "fail" sides of these campaigns that I have blogged about in the past. Morley, however, incorporated my comments as part of her presentation to explain how to "Assess Your Promotional Challenges" and to answer the question "Does the reward outweigh the risk?"

During both these presentations, I wondered what was the tactic that actually brought the "rewards?" Was it the social media campaign or was it the celebrities? Could these overall campaigns have been successful without the celebrities? No way! Could they have been successful without the social media component, which most presenters said was just a tactic? Yes, definitely!

The day when real, non-celebrity patients are the celebrities in pharma social media campaigns is the day when pharma breaks away from the mold.

A point I made during Morley's presentation was that although @racewithinsulin has about 1000 followers, Novo Nordisk knows nothing about these followers other than what Morley gleaned from manually reviewing their Twitter profiles. I suggested that Novo Nordisk do what I do: ask followers to fill out a survey. Pharma marketers do this all the time on their web sites and via BRCs. Why don't they do it with their Twitter followers? Either they don't value their Twitter audience enough to learn more about it, or they do not have the resources to do anything with the information.

Inadequate resources was mentioned often at this conference. To move social media beyond merely being a promotional tactic to a strategy to learn more about consumers and patients, pharma has to devote more resouirces to the effort.