FDA has received several comments from the pharmaceutical industry regarding the agency's "Draft Guidance for Industry Direct-to-Consumer Television Advertisements." In past posts I reviewed comments from PhRMA (the drug industry U.S. trade association) and Sanofi (see here and here). In this post, I report on comments made by Shire (find Shire's comments here).
Shire, like Sanofi, Novo Nordisk and Boehringer Ingelheim (BI), believes that submission of a final recorded version of a TV ad for FDA approval prior to being aired would be "burdensome." Shire specifically cites the optional two-step process FDA suggested; i.e., first submit an annotated storyboard and then a final recorded version of the ad. "This sequential two-submission process would double the time and resource burden on sponsors as well as the Agency," says Shire.
Serial OPDP Review Blues
BI also mentioned the "burden" of a two-step process in its comments to the FDA (find them here). But BI was referring to the need to resubmit a new version of the ad after receiving critical comments from the FDA concerning the first version submitted for review. "BIPI is concerned with the incremental time and cost that would be incurred by sponsors to routinely produce and submit multiple broadcasts for the purpose of OPDP [FDA's Office of Prescription Drug Promotion] pre-dissemination review," says BI. "BIPI is similarly concerned that the repeated submissions of storyboards to capture serial sets of OPDP suggestions (i.e., the submission of modified storyboards for advisory comments following integration of initial advisory comments) would greatly increase the time, if not the cost, of producing DTC broadcast ads." BI says that it "behooves sponsors to ensure storyboards submitted for advisory comments are representative of the final ad and to ensure that the Agency's comments are incorporated into the filmed version." In other words, BI suggests FDA just look at storyboards and trust that the sponsor will create a final "filmed" ad that is revised according to FDA comments.Shire, however, was the only pharma company to point out a "loophole" that I revealed on Pharma Marketing Blog in March (see "A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads"). In that post, I said:
"FDA does not define what exactly it means by 'dissemination.' Perhaps it has defined this term elsewhere in it regulatory archives, but I assume in this case it means airing the ad on mass market TV. Does that include uploading the video to YouTube? A drug company could upload a video of a pre-approved ad to YouTube at the same time that it submits the video to FDA for 'pre-dissemination' review. The video can then be embedded in the drug.com website or promoted via Twitter."Shire pointed out the same lack of clarity in its comments. "...there has been increasing availability and use of vehicles other than broadcast TV to present video advertising, such as on-demand viewing via the Internet," says Shire. "Shire recommends that FDA affirm that the scope of the guidance includes only DTC advertisements disseminated through broadcast television."
FDA and the drug industry continue to see no need to issue any mandatory or even voluntary guidelines specifically for drug promotion via the Internet. Shire points out, for example, that there already is an "advisory review process" that applies to video advertisements disseminated through "other viewing platforms' (i.e., the Internet). That process (see here) says "a sponsor may voluntarily submit advertisements to FDA for comment prior to publication."
However, if "dissemination" is defined according to Shire's rules, then it is possible for a drug company to run a video ad on YouTube months before it airs the same ad on TV without having to submit anything to the FDA for review -- the current "advisory review process" that Shire refers to is voluntary.
As part of that process (e.g., su read more..
Tuesday, 26 June 2012
Pharmaceutical Industry-Advisory Comments-Dissemination-Storyboards-Shire
Tuesday, 13 March 2012
Pharma Celebrity Spokespersons-American Diabetes Association-Boehringer Ingelheim
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:
- When it is proper to use paid celebrities - e.g., movie stars, TV personalities, sports figures - as spokespeople for drug brands?
- Should pharmaceutical companies reveal how much they pay celebrities?
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 read more..