Rodale's Study Cites My Estimate Regarding DTC Ad Spending; I'm Flattered, But...

My friend Richard Meyer over at World of DTC Marketing Blog posted some key findings and charts from the 2012 Rodale DTC Study (see "A new era for DTC marketing").

There's a lot of interesting data in that study, but I will focus on one chart that documents DTC (direct to consumer) ad spending by the pharmaceutical industry from 1997 through 2012. Here is the chart:

I noticed that the "DTC Ad Spend" data (top line) looked familiar. Sure enough, when I searched through my Pinterest "Charts & Data" board, I found a chart that I created back in April 2012 (see "Lipitor Holds Key to DTC Ad Spending in 2012"; the chart is shown below):

All the numbers regarding DTC Ad Spending are the same in the two charts. In other words, Rodale copied my data to the "penny," but did not credit me as the source. In fact, Rodale did not cite any third party as the source!

OK, I didn't get credit. Big deal. I'm not complaining because I didn't get my 15 minutes of fame. The problem is that my original post did cite the source of my data and the last two columns (for 2011 and 2012) were estimates based on a few assumptions. Here's what I said:

"This chart actually plots measured media data (excluding Internet display and search advertising) through 2010 from AdAge, which got the data from TNS Health. I calculated the 2011 total based on the 1% decrease reported by Nielsen (sorry, I don't have TNS data for 2011).  

"The final bar of the chart is my estimate for 2012, which is based on the premise that DTC ad spending for Lipitor will be less than half of what it was in 2011."

So, thank you Rodale for repeating my estimated data for 2011 and 2012, but you should have included the above information about how those estimates were calculated!

P.S. BTW, it is possible -- but not probable -- that my estimates were right on and the Rodale chart is based 100% on new data from AdAge/TNS/Nielsen.

Is Online Pharma Promotion ROI Scalable?

Yesterday, at the 6th Annual Digital Pharma East conference here in Philadelphia, I met many "old" friends including Bill Drummy, CEO of HeartBeat Ideas.

Drummy's presentation had a long and complicated title -- "Outsize Results on Modest Budgets: Think You Can't Afford World-Class Marketing on Your Limited Budget? Think Again" -- but his message was simple: the ROI of online promotion is an order of magnitude greater than the "typical" 2:1 ROI for non-digital channel promotion.

"With digital you can get way more bang for your buck," said Drummy, "so you HAVE to think of the digital channel. If you have a real insight about your target, use really bold creative, and use a lot of precision targeting and pay-for-performance techniques, you can get dramatically higher and better results."

Drummy then said that ROI for digital ranges from 4:1 on the low end to high double digits on the high end. He's seen digital ROIs of about 29:1 in "a number of different cases." That's return on investment measured by increased sales, not surrogate key performance indicators like ad impressions, clicks and Facebook likes, etc.

Drummy didn't go into too much detail about how these ROI are measured, but he did show a blinded digital promotion case study (paid search and online display) where the ROI was about 5:1 (it was 13:1 for just paid search). The spend on that promotion was $32,000, I believe.

My question is this: Is this scalable to the point where digital promotion gives you a significant bump in sales?

A 5:1 ROI on a spend of $32,000 translates into $160,000 in additional sales. This is a small number as far as Rx sales go. A TV ad campaign spend of $100 million at 2:1 ROI results in $200 million in additional sales -- now we're talking about a real bump. At 5:1 ROI, how much money would you need to spend on search/display ads to realize a bump of $200 million? You would have to spend $40 million! I contend that it is impossible to spend that amount of money in one year on paid search and display advertising. And, if it was possible, would the ROI still be greater than the traditional, non-online ROI of 2:1?

If Drummy knows of a case to disprove this, I'd like to hear about it.

To be fair, Drummy was talking to companies with LIMITED budgets for promotion. In that case, there are probably limited sales opportunities as well. Therefore, putting your limited promotion budget into digital makes sense.

Drummy showed some examples of what he considered online campaigns that had "bold creative." I'll have more to say about this is a later post; right now, I have to get ready to have a chat with BI's John Pugh over coffee and bagels!

Rich Meyer: We Don't Need No Stinkin' Fair Balance! The One-Click Rule Revisited.

My friend Rich Meyer over at DTC Marketing Blog wrote an inflammatory-sounding post titled "Time to eliminate fair balance on DTC ads." With a title like that, this post is sure to be read by a lot of pharma marketing pundits.

But Meyer is not talking about TV or print drug ads directed at consumers. He specifically is referring to online direct-to-consumer (DTC) advertising:

"...fair balance online and in search makes no sense. Patients are not going to see an online ad or search copy without doing more research and the FDA needs to acknowledge this by revising guidelines."

Recall that in DTC advertising, fair balance refers to the presentation of accurate and fair assessment of the risks as well as the benefits of the drug (more here).

"DDMAC needs to come into the 21 century and provide guidelines that are realistic on how patients make healthcare decisions," says Meyer. "Too many online drug ads provide little in the way of benefits because there is so much fair balance. Does DDMAC and the FDA really believe that someone is going to see an ad for a prescription drug and ask their doctor about it without doing more research?"

It sounds like Meyer is urging the FDA to re-instate the "one-click rule," which the agency shot down in those famous 14 NOV letters in April, 2009. That would mean reversing itself and losing face. But wait! DDMAC no longer exists! It was reorganized as the Office of Prescription Drug Promotion (OPDP)! OPDP can reverse the old DDMAC (Division of Drug Marketing, Advertising and Communications) ruling on the one-click rule and the FDA won't lose face! Brilliant!

BTW, Meyer isn't alone in wishing the return of the one-click rule; see "Pharma Prefers '1-Click Rule' for Presenting Fair Balance in Social Media & Other Internet-based Rx Ads" and "Merck Says FDA Should Approve the 'One-Click Rule'".

Did Pharma Online Ad Spending Increase 50% in First Half of 2012?

"Entertainment, automotive, pharmaceutical and healthcare were the fastest growing vertical sectors for online advertising in the first half of the year, according to a new report from the Interactive Advertising Bureau" (IAB) reports ClickZ (here). The report (get it here) utilizes data and information reported directly to PwC by companies generating online / mobile advertising revenues, and publicly available corporate data. The following figure shows the online ad formats tracked and how much was spent on each in the first half of 2012 compared to the first half of 2011. Overall online ad spending was $17.0 billion in the first hlaf of 2012 compared to $14.9 billion in the first half of 2011 (a 14% increase).

Search accounted for 48% of the online ad spend and display-related advertising accounted for 33% (Display-related advertising includes Display/Banner Ads, Rich Media, Digital Video, and Sponsorship).

Here's the data comparing the total online ad spending by major industry category:

Online ad spending by "Pharma & Healthcare" increased by 50% (from 4% of the total to 6% of the total). Keep in mind that not all of this is specifically spending by the Rx drug industry because the category includes "pharmaceutical products, facilities, services, researchers, and biological products. Also comprises establishments providing healthcare and social assistance for individuals as well as personal care, toiletries, and cosmetic products."

6% of $17.0 billion is $1.02 billion. That could pan out to be more than $2 billion for the entire year -- again, not all of that will be spent by the Rx drug industry.

eMarketer has predicted that online ad spending by the health industry in 2012 will be $1.58 billion (see "Bogus Predictions of Pharma Industry Online Ad Spending"), which is significantly different than the IAB guesstimate 0f $2.04 billion based on the data for the first 6 months.

Why the difference? It could be that eMarketer is measuring something different. However, its 2011 number of $1.28 billion is virtually the same as what IAB said the healthcare industry spent online in 2011 (4% of $31.7 billion equals $1.27 billion).

$1.58 billion, $2.04 billion -- whatever. Pharma's share of that ad spend is probably 50% or $0.8 to $1.0 billion. Taking out the 48% attributed to search, we get $0.38 to $0.48 billion spent on other types of online advertising. This compares to about $4 billion pharma spends on all direct-to-consumer (DTC) advertising -- a number that does not include the online spending of any sort. In other words, online ad spending by pharma is still insignificant compared to offline ad spending.

Lilly Overtakes Pfizer as Biggest DTC Advertising Spender!

According to cegedim Strategic Data, Lilly overtook Pfizer in total direct-to-consumer (DTC) spending in April, 2012. The chart below shows the top 10 DTC spenders between July 2011 and April 2012.

Pfizer spent nearly $900 million in DTC advertising in 2011. $220 million of that was for Lipitor. I predicted that Lipitor would hold the "Key to DTC Ad Spending in 2012" (see here) and this chart proves it.

Lilly's Cymbalta and Cialis were the #2 and #3 highest in DTC ad spending in 2011. It looks like they will be #1 and #2 in 2012.

"The Crowd is My Only Drug," Says GSK Olympics Anti-Doping DTC Ad Campaign

GlaxoSmithKline (GSK) will raise awareness of its role in anti-doping measures at the London 2012 Olympic Games as part of its first consumer-facing corporate campaign in the UK (see here).

Advertisements will appear across a range of media, including television, and outdoor advertising space, commencing July 23. One TV ad is currently available on Youtube:



Obviously, when the athlete star of this video is quoted as saying "The Crowd is My Only Drug," he means illegal drugs that some athletes may use to boost performance, not the drugs sold be GSK for legitimate use. But I wonder if social media "crowds" -- as in "Wisdom of the Crowd" -- can replace some Rx drugs for some people? I'm thinking about GSK drugs such as diet pill Alli and diabetes drug Avandia, both of which have been problems for GSK (see here and here).

JNJ Attempts YouTube Humor to Promote a DTC Advertising Goal

The goal of every direct-to-consumer (DTC) ad is to get people to visit their doctors and ask about the advertised Rx drug. But are these ads effective?

The drug industry often defends DTC ads, claiming they ARE effective in achieving this goal. Some studies, however, seem to indicate that once people visit their physicians, they do not ask for the advertised drug (read, for example, "Advertisers Don't Know How DTC Works. Say wha?").

But the ads may not even be effective in driving people to see their physicians. Maybe that's why Johnson and Johnson (JNJ) recently promoted a YouTube video it uploaded more that two years ago called "The Appointment." It's an non-branded attempt to use humor. JNJ's corporate Twitter account (@JNJComm) recently posted this tweet:

"Afraid to visit the doctor? Don't be! Watch 'The Appointment' for medicinal laughter - and important info > http://t.co/0PQanPNF @JNJVideo"

On the YouTube page, JNJ introduces the video: "Many people are wary of making a doctors visit. In The Appointment, some extreme humor works to make several important points about why you should visit your doctor and most importantly things you should not be afraid to understand and ask. Enjoy and no, there really isnt a needle that big!"

Here's the video:




A few people do not think the video is funny. One commenter (yes, JNJ accepts comments on its YouTube channel) said:

"I'm not one to start a YouTube spitting contest - I'm just saying that this seems to be a bit (not massively!) insensitive to both the clinicians and the patients who are trying to treat each other better. Your ultimate message in the vid is perfect - it just strikes me as missing the mark in its opening approach."

One commenter even said it was "misguided":

"Wow. I'm sure you meant it to be funny, but I have to say, this is the worst-conceived pitch I've ever seen for being an empowered patient. In addition to the patient looking like something of a simpleton, to me it charicatures doctors in the worst possible way too.. I'm sure y'all meant well, but wow, this is misguided."

To which JNJ replied:

"I understand and respect your point of view. It was supposed to be a lighthearted reminder to those who might not be practicing preventive care. You are already an informed, empowered patient who has dealt with, and become educated about, a life threatening disease. Although it uses caricutures of doctors and patients, the video is aimed at those who might have misconceptions or fears about visiting their doctors for annual check ups and other routine care."

What do you think?

Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads "artificially enhance consumers' perceptions of the product's quality" while also resulting in an "unbalanced or misleading impression of the product's safety." To test whether or not this is true, the FDA will soon start yet another study focused on Rx print ads: "Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions" (see Federal Register Notice archived here).

[I recently posted about another planned FDA study to determine if disease awareness information in branded ads confuses consumers. See FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"]

The history of this study is long and mysterious. I first blogged about it 2006; read "FDA, Coupons, and Sleep Aid DTC Ads." Shortly after that the Federal Register notice regarding the study was "yanked" (see "FDA Backs Down on Coupon Study"). Also, the Advertising Age and Wall Street Journal articles cited in those posts can no longer be found in the archives.

In September, 2011, however, the proposed study re-emerged in the Federal Register (here). Whatever happened between 2006 and 2011 is anybody's guess, but I assume that the Bush era FDA leaders axed the proposed study when they learned of it. By September, 2011, these people were on the way out and the door was open again to propose the study anew.

Anyhoo, I want to focus here on comments that PhRMA made in response to the proposal. Alexander Gaffney (@AlecGaffney), Health wonk and writer of news for @RAPSorg, summarized the general attitude of PhRMA (see "US Regulators Move Ahead With Planned Study on DTC Marketing"):

In its statement to FDA, PhRMA wrote it was “concerned that the study, as currently envisioned, will not yield information that is relevant to FDA’s regulatory responsibilities to ensure that DTC advertising is truthful, accurate and balanced.”

“Although the study may provide interesting information about the effect of promotional offers on consumer attitudes toward a brand,” explained PhRMA, “it likely will provide little information on whether promotional offers create or contribute to false or misleading advertising, particularly under real-world circumstances or whether additional regulatory requirements are warranted.”

PhRMA: The Physician is the Decider
I dug a little deeper into PhRMA comments (here) and was surprised to learn that PhRMA's position is that "it is the physician, not the patient (my emphasis), who ultimately must decide whether the benefits of the advertised drug outweigh its risks for any particular patient." Thus, says PhRMA, "the risks of 'misperceptions' ... should be even lower [PhRMA's emphasis] for prescription drugs than for experience goods [i.e., a product or service where product characteristics, such as quality or price are difficult to observe in advance, but these characteristics can be ascertained upon consumption] because any potential misperception, of necessity, will be quickly corrected prior to use through consultation with the patient's treating physician."

This is a very paternalistic POV in this day and age of social media and patient empowerment. Actually, it is the old "learned intermediary" defense that the drug industry often raises (in the past, less so these days) to shield itself from blame when things go wrong.

FDA must respond to comments submitted, but I couldn't find a direct response to PhRMA's comments cited above. I did find, however, the following comments and FDA's response that addressed the issue of the patient-physician relationship generally:

(Comment 22) Two comments mentioned that the study does not assess how consumer perceptions of product risks and benefits are translated into a discussion with their health care provider. One comment stated that because these products can only be purchased after a discussion with a health care provider, the study be redesigned so that consumer perceptions are measured after a discussion with a health care provider.

(Response) We concur that this study does not address behaviors, such as how ad perceptions are translated into a discussion with a health care provider. As noted previously, one purpose of DTC advertising is to motivate consumers to engage in a discussion with their health care provider about health concerns. Another purpose, supported by research findings (Refs. 20 and 21), is to increase awareness of available treatments. DTC advertising does not exist solely in the confines of a doctor's office; rather, DTC advertising targets consumers outside of a doctor's office, with the goal of prompting consumers to ask their physicians about the product. In deciding whether or not to discuss a particular product with their health care provider, consumers presumably are engaging in some sort of judgment about the product being promoted. Therefore, clear communication of risks and benefits is needed for consumers before a consultation with a physician, and it is valid to measure these impressions.

AZ Posts "Reminder Drug Ad" to Its Corporate Blog

Last week I reported that AstraZeneca (AZ) posted an ad for CRESTOR on its "AZ Health Connections" corporate blog (see "AstraZeneca's Timely CRESTOR Branded Blog Post: Did It Violate Its Own Policy?"). The post included the indication for CRESTOR and also the "Important Safety Information" (ISI) that is required by the FDA whenever a drug company talks about a brand and its approved indication.

I wrote about that only because it was the first time -- to my knowledge -- that a pharma corporate blog promoted a branded product and I wondered if such posts violated AZ's own posting policies (turns out that it may or may not depending upon what you mean by "may" -- see the post for details).

Today, I noticed an AZ Health Connections blog post that talked about another AZ drug - ARIMIDEX, which is approved for "adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer."

This time, however, the post (find it here; see screen capture above) did NOT mention the approved indication. It is, by FDA definition, a "reminder ad." According to the Pharma Marketing Network Glossary:

Reminder advertisements are identified as an exemption to the advertisement regulations, including provisions to provide a brief summary. Reminder advertisements " . . . call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product. . . . and, optionally, information . . . containing no representation or suggestion relating to the advertised drug product." Reminder advertisements cannot make a representation about the product or suggest a use for the product.

The AZ Health Connections post does "call attention to the name of the drug," but it also directs readers to ARIMIDEX Direct, which is a program that "allows eligible patients to receive ARIMIDEX delivered to their homes for $40 a month, including shipping and handling." Sounds like a good deal, although I did not investigate what the eligibility requirements were.

AZ deserves credit for reaching out to the online community to learn more about how it can make its drugs more accessible. Recall that AZ was the first pharma company to host a Twitter chat "to raise awareness about helping patients save money through prescription savings programs" (see "OMG! AstraZeneca Hosts Twitter Chat & World Does NOT End!").

PhRMA "forbids" Reminder Ads, But Not on Internet!
AZ's post raises some interesting questions regarding the promotion of Rx drugs on the Internet that neither the FDA nor the pharma industry has addressed. For example, PhRMA's "Guiding Principles for Direct-to-Consumer Advertising" (here) prohibit reminder ads on TV but NOT on the Internet:

Principle #10: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." [Alos see "Reminder Ads - Pharma's Dodo?"]

AZ, I believe, is a signatory to these voluntary guidelines. Since these guidelines only apply to TV advertising, AZ is not in violation. It's still the "wild west" on the Internet with regard to reminder ads; i.e., It's perfectly fine to run "reminder ads" on the Internet. This is usually the case when pharma companies buy Adwords (paid search ads) from Google, especially after the FDA came down on Adwords that included the indication with the brand name.

Another interesting issue is how pharma companies can manipulate "natural" (aka "organic") Google search results to display what is essentially a branded product ad that includes the brand name and indication, but no ISI.

Search Google for "arimidex" as I just did and you will find this:

The #4 (or #3, depending on how you count) search result leads you to the home page of the www.arimidex.com Web site. Note that the search result looks like an ad with copy that mentions the indication of the drug: "Learn about IN YOUR CORNER, an online breast cancer support resource for women with early breast cancer and the people who care about them."

How did that copy get there? Simple, AZ included the following "meta tags" in the "header" of the HTML code that generates the home page:

Google mindlessly reads the META NAME tag to display the description of the site in the search result. The information contained in that tag, of course, was written by AZ with the full realization that a Google search will include it in the search result. From there, it is only necessary to ensure that the site gets good placement in the natural results list and BINGO! You've got a branded "ad" that mentions the drug name and the indication WITHOUT the required ISI.

P.S. The Arimidex search result shown above may actually be what's called "paid inclusion," which refers to a sponsored "organic" search result (see, for example, "Paid Inclusion: Too Hot for Pharma Marketing?").

Shire Seeks to Maintain YouTube "Loophole" in FDA's Draft Guidelines for TV Ads

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., submission of static storyboards for video ads), FDA estimates that "approximately 2 hours on average would be needed per submission, including the time it takes to prepare, assemble, and copy the necessary information." Compared to that, the creation of "final filmed" versions of TV ads is indeed a significant burden on sponsors. However, since FDA's new guidelines are specifically aimed at products with significant safety concerns, it "behooves" the drug industry to carry that "burden" in the interest of patient safety, IMHO.

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.

PhRMA Demands that FDA "Cabin" Its Discretion to Regulate DTC Ads

In a 20-page comment submitted to the FDA on May 14, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA), advised the FDA to "proceed cautiously and in a manner that fully protects the free speech rights of advertisers and patients" with regard to the agency's recent Draft Guidance for Industry on Direct-to-Consumer (DTC) Television Advertisements."

Recall that the Food and Drug Administration Amendments Act of 2007 (FDAAA) gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement" (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

In its comments, PhRMA uses the word "cabin" as a verb, as in "clearly defined standards that cabin the reviewing official's 'unbridled discretion'" and "objective standards to cabin FDA's discretion."

Why does PhRMA want to banish FDA to a "cabin" in the woods as far it's discretion to pre-review DTC ads is concerned?

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, which is cited several times in PhRMA's comments. For example, PhRMA reminded the FDA (as if that was necessary) that the Supreme Court "recently affirmed that '[s]peech in aid of pharmaceutical marketing .... is a form of expression protected by the Free Speech Clause of the First Amendment.' Thus," says PhRMA, "when the FDA restricts the speech of pharmaceutical manufacturers and other regulated entities, the restrictions are subject to scrutiny under the First Amendment."

But the Supreme Court Court is not likely to scrutinize "informal guidance," which is not legally binding. Therefore, PhRMA is pushing the FDA to issue regulations, which carry the weight of law. "Regulations that unduly burden truthful, non-misleading commercial speech about a lawful product," says PhRMA, "hinder consumer choice ... and rarely survive constitutional scrutiny."

Of course, FDA wants to prevent "misleading" drug ads from being aired. Right now, however, it can only cite ads as "misleading" AFTER they have already been aired.

I'm not going to delve into the legal arguments that PhRMA puts forth. You can read them yourself here. I just find it interesting that the drug industry is pushing FDA to stop issuing non-binding guidances in this case as well as in the case of social media (see "WLF & Pfizer Ask Court to Block FDA Guidance on Social Media"). I also like how PhRMA uses "cabin" as a verb, hence the cabin image that accompanies this post.

Hat Tip to @AlecGaffney for alerting me to the publication of PhRMA's comments in the Federal Register, where "occasionally interesting reading [is] to be had."

As Pharma Spends More on Digital, External Digital Agencies Receive Poor Ratings from Marketing Executives

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).

Janssen Uses Digital Storytelling, Animation to "Bring Prescription Medicine Labeling to Life." But Not iPhone or iPad Life!

Have you ever seen those animated stories any one can create using a service called "Xtranormal?" According to the web site, "Xtranormal helps you create amazing interactive stories with a few clicks and a little imagination."

The following funny animation about medication adherence was created using Xtranormal Movie Maker by HealthPrize, a company that markets a drug adherence program that was featured Pharma Marketing News (read "HealthPrize Teams Up with RealAge to Improve Adherence"¹; use discount code hprze).



Basically, you create a script, choose characters, scenery, gestures, etc. and  "Ta-da! You're instantly an animator, poet, pundit, educator or comic. Couldn't be easier," says Xtranormal.


Janssen Therapeutics -- a division of Janssen Products, LP, which is part of Janssen Pharmaceuticals, which in turn is a Johnson and Johnson company -- is currently "piloting" a series of animations that remind me of Xtranormal scripted animations like the one above. The script for the Janssen pilot, however, comes from the patient information sheet that accompanies the prescription medicine PREZISTA® (darunavir), which is used in the treatment of HIV.

To enhance patients’ access to and use of this information, Janssen launched this pilot program -- called The PREZISTA Zone (here) -- designed to "transform the experience of exploring this information online through digital storytelling and animation."

Features include the story of Jacob, a man who has just been diagnosed with a "chronic disease" (ie, HIV infection), told through a series of seven animated clips that help illustrate sections of the Patient Information (read more about this here).

Unfortunately, showing you the animations embedded in this blog post is problematic because they were created with Adobe Flash. If you have a flash-enabled browser, you'll be able to view the "trailer" video created by Janssen. I have embedded that bit of flash code below. If, however, you are viewing the mobile version of this blog on your iPhone or iPad (two of the leading mobile devices used by physicians and by patients like Jacob), you won't be able to see the "trailer." You also won't be able to view any of the animations over on the PREZISTA Zone web site.




You can see why these animations remind me of "movies" created with Xtranormal.

The following screen shot shows Jacob's physician explaining the side effects of PREZISTA to Jacob using what might be an iPad (probably would be in the real world).

Too bad Jacob's physician can't show Jacob the relevant PREZISTA Zone animation. She could be attending other patients while Jacob watched the animation and then answered any questions he may have had when she returned. That would have improved her practice. But she has to go through the list of side effects just as if she were reading them from the patient information sheet. That's what it sounds like when watching this animation, which reminds me of how the characters sound in the Healthprize animation.

Of course, Jacob has a smartphone (most likely an iPhone), which he is seen using in the following frame where he is talking to his sister about how to store PREZISTA:

“As a physician, I know from experience that people tend to learn in different ways, and that can pose different kinds of challenges for patients trying to educate themselves about their medications,” said Bryan Baugh, MD, Medical Director at Janssen Therapeutics. “We designed The PREZISTA Zone to meet a variety of personal preferences for learning and interacting with online information.

Too bad Jacob cannot "learn and interact" with The PREZISTA Zone via his iPhone!

¹Healthprize is an advertising client of Pharma Marketing News but I have not been paid to mention Healthprize in this blog post.

Lipitor Holds Key to DTC Ad Spending in 2012

As reported by Nielsen, direct-to-consumer (DTC) advertising spending by the pharmaceutical industry was down by 1% compared to 2010. I used that bit of information to update my chart of DTC spending trend over the years (see below).

This chart actually plots measured media data (excluding Internet display and search advertising) through 2010 from AdAge, which got the data from TNS Health. I calculated the 2011 total based on the 1% decrease reported by Nielsen (sorry, I don't have TNS data for 2011).

The final bar of the chart is my estimate for 2012, which is based on the premise that DTC ad spending for Lipitor will be less than half of what it was in 2011. Of course, Lipitor is now available in generic form, so we would expect Pfizer to spend less on its advertising. However, for the first 6 months or so in 2012, Pfizer will continue to spend money on advertising its $4 co-pay coupon for branded Lipitor. But after that, I expect spending to drop precipitously.

I did a little exercise to predict that DTC spending in 2012 will be down by over 3% compared to 2011 solely due to the drop in Lipitor advertising. Here's how I came up with that estimate.

First, let's look at the TOP 20 brands by DTC spending in 2011 (this chart is based on Nielsen data that I found in the April 2012 issue of MM&M):

In 2011, Pfizer spent $220 million on Lipitor DTC advertising according to Nielsen. That compares to $272 million in 2010 (a 20% decrease). So, right away, we know that Lipitor DTC spending is dropping although it still represents 5.5% of the total spend in 2011 (it was 6.3% in 2010).

Based on what I said above and a poll of readers (see here), I estimate that Pfizer will spend less than $100 million (ie, $90 million) on Lipitor DTC in 2012. If we assume everything else remains the same, that decrease of $130 million represents a 3.3% decrease in overall DTC spending!

Of course, not everything else will "remain the same." Other drugs may come on the market that may be have substantial DTC advertising budgets. But I don't think that is likely -- more and more drugs in the TOP 20 list will be coming off patent.

In any case, this is just a little thought exercise that demonstrates how much a SINGLE drug can impact the overall DTC spending trend. Not only that, but a single drug company -- Pfizer -- accounts for nearly one-quarter (22.3%) of the total (see chart below)! Seven of the TOP 20 drugs are marketed by Pfizer.

One of the TOP 20 advertised Pfizer drugs is VIAGRA. Currently, it appears that Pfizer is focusing on the counterfeit Viagra problem to bring in web visitors to viagra.com (see display ad on left).

Another TOP 20 advertised Pfizer drug is ENBREL. Pfizer & Amgen spent nearly $100 million on Enbrel DTC advertising in 2011 (compared to $71 million in 2010). And this number does NOT include what the Amgen/Pfizer has paid Phil Mickelson to be the Enbrel celebrity spokesperson (see "Amgen Blows Its Marketing Budget on Phil Mickelson Campaign" for more on that). On TV, Mickelson promotes Enbrel for the treatment of his psoriatic arthritis. According to the MM&M article cited above, psoriatic arthritis afflicts "around one in 20 of the 2% of Americans who suffer from psoriasis." That works out to be 375,000 people (1 in 20 of 7.5 million).

Approximately 63 cents out of every DTC ad dollar goes to TV. So, Pfizer/Amgen spend about $63 million to reach 375,000 people via TV ads! It seems a bit exorbitant to spend so much for broadcasting versus a more targeted approach. Anyway, that's the crazy world of Pharma DTC advertising! Go figure.

A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon

If you think waiting over two years for FDA to issue guidelines it promised for regulation of "Promotion of Prescription Drug Products Using Social Media Tools," then you should take a look at the following timeline and weep.

This timeline documents the major steps in FDA's process of developing guidance for direct to consumer television (DTC) and radio ads; ie, "standards that would be considered in determining whether the major statement in direct-to-consumer television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner":

• 1 November 2005: FDA convenes a 2-day public hearing to discuss the issue (see "FDA DTC Hearings: Snippets from Day 1" and "DTC Pros and Cons Presented at Public Hearing"). Sound familiar?


• 21 August 2007: FDA announces it will conduct a study of "consumer evaluations of variations in communicating risk information in direct-to-consumer (DTC) prescription drug broadcast advertisements." It opens a 90-day period to submit comments regarding this study. This study used the latest cognitive science technique called Affect Misattribution Procedure (AMP), in which participants are asked not to judge the TV ads' imagery directly, but to judge whether or not a Chinese character shown to them afterward is positive or negative. I suggested FDA NOT use Chinese characters because that would be discriminatory, but they did not listen to me (see "FDA at a Mall Near You: The Manchurian Connection"). With regard to social media guidelines, the FDA has also announced it will do some studies before issuing guidance (see "FDA's Proposed Web Study Will Further Delay Social Media Guidelines"). Deja vu all over again!


• 29 March 2010: FDA finally publishes the draft guidance, more than 4 years after the public hearing (see Federal register ref: 75 FR 15376). FDA was goosed along by an act of Congress: the Food and Drug Administration Amendments Act of 2007 (FDAAA), which required that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA was forced into RULEMAKING mode rather than GUIDANCE mode, which is how the pharma industry wants the agency to approach the regulation social media drug promotion as well (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").


• June 2011: FDA published an executive summary of a study of the methodology of the AMP study cited above entitled "A Supplementary Test of Distraction in DTC Advertising Using an Implicit Measure, The Affect Misattribution Procedure" (find it here). Maybe FDA read my comments after all!


• 27 January 2012: FDA announced that it added a document to the docket for the proposed rulemaking concerning a study entitled: "Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements" (Distraction Study; see Docket No. FDA–2009–N–0582). This document reopened the comment period (extending the deadline to February 27, 2012) for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards. Way back during the public hearing in 2005 I was unimpressed by research claiming that TV drug ads were designed to "distract" viewers from reading the fair balance (see op cit and "Ruth Day and the Bees Repeat Performance at House DTC Hearing" for an update on that).


• 23 March 2012: FDA reopens the comment period for a second time "in response to a request for more time to submit comments to the Agency." The new comment period will expire on April 9, 2012. According to the FDA, the "Pharmaceutical Research and Manufacturers of America (PhRMA) submitted a letter dated February 20, 2012, requesting an additional 15 days for interested persons to comment. FDA believes that an additional 15 days to comment on the Distraction Study as it relates to the proposed standards is appropriate."

What strikes me are the similarities between the evolution of these DTC guidelines/rules and the long-awaited social media guidelines.

First, there are the delaying studies and studies of studies. It's well-known that if you wish to halt progress, do a study.

Second, I sense that the drug industry pushed the FDA into RULEMAKING rather than issuing guidelines although it took an act of Congress to do that in this case. The drug industry may use the courts in the case of social media (another example of how an "activist" judiciary can work both sides of the aisle).

If it takes the FDA SEVEN or more years to complete this process for TV ads, I imagine it will take them 10 years to finalize guidance or rules (whatever!) for regulation of the use of social media for drug promotion. While TV has more or less stagnated during the seven years since 2005, social media will look completely different by the time those 10 years are up in 2019!

Pharma DTC TV Advertising Is a Joke. Seriously.

No wonder CBS refused to run the following "Stoogesta" ad during the NCAA basketball tournament. According to Deadline, network execs were concerned because the spoof, which promotes the forthcoming “The Three Stooges” movie, makes "light of prescription drug ads."

I've seen some pretty funny spoofs of drug DTC ads in my time (eg, see "ADHD Boy"), but this is the best I have ever seen. It convinced me to visit my movie theater & ask for an Rx of silly!



I imagine that pharmaceutical advertisers sent a clear message to CBS that they did NOT find the spoof funny. Rx drugs, after all, are serious and should not be made "light of."

However, it's not the drugs that are being spoofed. It is the drug advertisers who have rolled out the same formulaic DTC TV ads for years and years. Even kids think most of these ads are a joke.

Will the formula ever change? I don't think so. Here's why.

One of the funniest lines in the spoof is "Three in 6 billion people are afflicted by Stoogation (?), a disorder that causes the brain to ricochet and bounce..." That's just slightly more outrageous than some claims made in real drug ads about the prevalence of some "disease" you never heard of before.

I've commented on the topic of DTC ads making outrageous disease prevalence claims before (see "Disease Awareness or 'Disease Mongering'?", for example). In many cases, it is absolutely necessary for drug ads to make such claims to justify the millions of dollars spent on mass media TV ads to reach the "three in 6 billion" people who may suffer from the condition advertised.

So, the tradition of "making light of drug ads" will live on as long as advertising agencies and TV networks rake in millions of dollars to air ads that would be better off targeted to the truly appropriate audience.

BTW, the NCAA basketball tournament audience is PERFECT for the Stoogesta ad! But the ad that was chosen to run in its place is totally wrong; that ad spoofs Christianity! Where's the religious right when you need them?

Medical Device Marketing Don't Need No Stinkin' ROI!

"Standards for devices exist, they just don't make sense," industry critic Dr. Diana Zuckerman, president of the National Research Center for Women & Families, said in a Consumer Reports release (also read this CBS report "Investigation: Most medical devices implanted in patients without testing"; see video below).

"An investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following areas of concern:

• Medical devices often aren’t tested before they come on the market. “What they’re doing is conducting clinical trials on the American public,” says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a specialty catheter, cleared without testing, that malfunctioned during a procedure to treat an abnormal heartbeat.
• There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices. “A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” Zuckerman says. “Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.”
• Without major changes in the system, there’s not much that patients can do to protect themselves.

According to Consumer Reports, the majority of medical implants are not tested to make sure they are safe. Most of the time device manufacturers only need to pay the Food and Drug Administration (FDA) a fee of about $4,000 with minimal testing in order to get approval for marketing. Compared to drug approval, this is a walk in the park.

In fact, sometimes device manufacturers bypass this minimal approval process altogether as did Johnson and Johnson's Ethicon unit (see "J&J Marketed Medical Device Without FDA Approval").

Not only is the approval of medical devices by FDA more lax than the process used to approve drugs, medical device marketing is worlds apart from Rx drug marketing as I learned from a presentation made by a Medtronic marketing VP. The presentation focused on a case study of a marketing campaign for the Prestige Cervical Disc.

That case study showed that out of an estimated 5 million spine surgery candidates (patients) in the US, Medtronic only needed to capture 125 of them to break even on a very successful marketing campaign that reached 6.2 million local TV viewers, 80.5 million radio (especially satellite radio) listeners, 4 million print readers, and 73 million Internet browsers. (Get more details about that case study by downloading this Pharma Marketing News article: "Medical Device Marketing: Worlds Apart from Rx Drug Marketing"; use discount code 'DEV444' BEFORE April 15, 2012 to get it FREE!).

While drug advertisers would sweat and moan over whether such a campaign would have a positive ROI (return on investment), medical device marketers don't need to worry about no stinkin' ROI because of such low numbers of conversions required AND also because very little resources need to go into premarket testing in order to get FDA approval.



Although the FDA has met most of its goals for fast-track medical device approvals, it's taking substantially longer to issue decisions on devices than it used to, concluded a report from the Government Accountability Office (GAO). The GAO said:

"FDA has begun to take steps to address GAO’s 2009 recommendation about high-risk devices that are allowed to enter the U.S. market through the less stringent 510(k) process, but progress has been limited. High-risk devices include those which are implantable or life sustaining. In 2009, GAO recommended that FDA expeditiously take steps to issue regulations for the device types classified as high risk that are currently allowed to enter the market via the 510(k) process. Since then, FDA has set strategic goals to address these device types, but has issued a final rule regarding the classification of only one device type. As of April 1, 2011, FDA’s action on the 26 remaining types of high-risk devices was incomplete. Thus, these types of devices—such as automated external defibrillators and implantable hip joints—can still enter the U.S. market through the less stringent 510(k) process. GAO found that, since its report was issued in January 2009, FDA has cleared at least 67 510(k) submissions that fall within these high-risk device types. FDA has taken some additional steps to enhance premarket device safety since GAO’s 2009 report was issued—for example, it commissioned the Institute of Medicine to conduct an independent review of the premarket review process—but it is too early to tell whether any forthcoming changes will enhance public health."

To get a copy of the GAO report, see the end of this post: "FDA Taking Longer to Approve Medical Devices, Says GAO"

A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement." The notice of issuance of "Draft Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program" was published today in the Federal register (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

Before I get to the "loophole," here's a summary of the guidance.

Up until now, the FDA allowed the VOLUNTARY submission of TV ads for review prior to airing, but did not require it. The draft guidance details which type of TV ads REQUIRE approval prior to "dissemination," how long it will take FDA to review these ads and get back to the sponsor (45 days), and what the sponsor can do if the FDA does NOT meet the 45-day deadline. Of course, it also mentions CRIMINAL and CIVIL MONETARY penalties that may be sought by the FDA for violations.

Which Ads Will Require "Pre-dissemination" Review?
The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the following categories:

• Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug 
• Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act) 
• Category 3: All TV ads for Schedule II controlled substances 
• Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling 
• Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter  
• Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision

"Specifically, these categories allow the Agency to review and provide comments on TV ads for prescription drugs with particularly serious risks," says the FDA

Regarding the 45-Day Review Period, FDA says:

"Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments. However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations."

That is, if the FDA misses its deadline, the situation reverts back to what is the current practice -- air the commercial and perhaps suffer the consequences, which could be nothing more than a warning letter, but may also require the sponsor to air a correction.

What Exactly Will the FDA Review?
In the past, FDA has primarily reviewed TV Ad storyboards, which are graphical representations of key scenes in the ad with dialog included. Storyboards are blueprints for production and are created BEFORE any video production has begun. Now, however, FDA requires a video of the TV ad to be submitted to fulfill the submission requirements. Only after the video is submitted will the 45-day review clock start running.

"FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review package without a final recorded version of the ad, but once the final recorded version is produced, it will need to be submitted to the Agency for pre-dissemination review."

After writing this, I had short Twitter conversation with Alexander Gaffney (@AlecGaffney), health wonk and writer of news for @RAPSorg & Regulatory Focus. Regarding FDA's requirement to review videos and not just storyboards, Alec said the guidance would likely cuts down on "poor marketing" spending, which I interpreted to mean "pushing the envelope" spending. In the past, pharma marketers could submit a storyboard (cheap) and run the ad without waiting for comments from the FDA. The ad could push the regulatory envelope and run its course on TV before the FDA could issue a warning letter. I commented on this previously. Read "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?"

The "Loophole"
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.

The bright line between TV and online video is getting more blurry every day. I currently am able to watch Youtube videos on my TV via Apple TV. Of course, it is not the same as regular TV ads that I can skip over thanks to my new cable box that allows me to record programs and play them back later. And I may be the only person that would actively search out drug TV ads published on YouTube!

Would a pharma company want to do this? Maybe, if it does not violate the "letter" of the law; ie, is not classified as "dissemination." That would let the company off the hook for violating the law, but FDA could still cite the YouTube version as violative (ie, as it does right now). A violative YouTube version of the video could result in an FDA warning letter, which probably would be issued months after the ad was first uploaded.

Just my thoughts and a comment that I think the FDA should consider when developing its FINAL guidance.

Charlie Kimball - Novo's Branded Spokesperson - Makes Expensive TV DTC Debut

Charlie Kimball, the Indy racecar driver spokesperson for Novo Nordisk's NovoLog Flexpen, which is used to treat Type 1 diabetes, made his debut as star of his first direct-to-consumer (DTC) TV ad. Not only does the ad feature Novo's product, it also promotes Kimball's Indy team Chip Ganassi Racing. A win-win!

I saw the commercial on the CBS evening News last night. Kimball did a great job.

I couldn't find a version of the commercial on the Internet, but I DID find a video titled "Charlie Kimball and Novo Nordisk" in which Kimball discusses how the commercial was made. One thing that the video demonstrates is why pharma spends so much money on broadcast (ie, TV) DTC. It's not just the loads of money spent on buying airtime on the major networks. It is also the cost of producing the commercial itself. This is what Kimball discusses in the video (embedded below).

Kimball is amazed by all the people involved such as director, assistant director, key grip, not to mention the production crew's four trucks, two motor homes, and catering trailer. All together, 50 people were involved said Kimball.

In the past, Kimball had only been tweeting (see, for example, "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!" - the #3 Google search result for "sleazy tweet"!) and making personal appearances, which is more of a PR effort than a marketing effort. My guess is that PR costs much less than marketing and employs fewer people compared to marketing's BIG item productions such as TV ads.

So, thank you Charlie and Novo Nordisk for helping America solve it's unemployment problem!