Lilly Overtakes Pfizer as Biggest DTC Advertising Spender!

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

"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

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?

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

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

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

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

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

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!

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

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

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.

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!

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

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 - 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!

Reminder Ads OK in EU But Not in US. Huh?

Reminder Ads OK in EU But Not in US. Huh?

The Geneva-based International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) expanded its practice code to cover all interactions with health-care professionals, medical institutions and patient organizations, including a ban on doctors from receiving payments to attend conferences (see "Big Bad Pharma, Bribery and the New EU Industry Code").

According to the above cited source (WSJ's "Corruption Currents" blog) this was a bit like closing the barn door after the cows have left:

"This comes at a time when the association’s members are trying to drum up business in developing countries, some of which have state-run health systems. Employees of such systems, including doctors and nurses, can be considered foreign officials under the U.S. Foreign Corrupt Practices Act, a 1977 law that bars bribing foreign officials for business purposes.

"To that end, the Securities and Exchange Commission and the Justice Department are in the midst of a sweep of the industry. In April 2011, Johnson & Johnson agreed to pay $70 million to resolve violations, and The Wall Street Journal reported in November 2011 that Pfizer Inc. will pay more than $60 million when its settlement gets finalized.

"Both companies, the Journal reported, ratted on their competitors.

"Those competitors included AstraZeneca, Merck & Co., Bristol-Myers Squibb Co., GlaxoSmithKline PLC and others that have disclosed investigations for possible FCPA breaches. Eli Lilly & Co. was in advanced talks in April 2011 with the Justice Department, and the company said Feb. 24 in its annual results it’s at the same level with the SEC.

"Letters of inquiry to several of the companies, dating back more than a year, laid out several types of of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals."

Any way, I decided to download the new "IFPMA Code of Practice" to see if there was anything interesting or actually new (you can find it attached to the post here). The code is intended to cover "interactions with healthcare professionals, medical institutions and patient organizations, and the promotion of pharmaceutical products."

This section popped out at me:

5.2 Reminder Advertisements

A “reminder” advertisement is defined as a short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product. For “reminder” advertisements, “abbreviated prescribing information” referred to in Article 5.1 above may be omitted. 

The "abbreviated prescribing information" include "an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications, precautions, and side-effects."

In other words, it is perfectly OK to promote drugs to healthcare professionals and patient organizations using reminder ads that do not include safety information. Note: these ads must be print ads in professional publications because no such ads would be allowed on mass media such as TV, which reaches consumer audiences. Promotions  of Rx drugs to consumers is not allowed in the EU, reminder ads included.

The U.S. pharma industry does not have a "practice code" for advertising or "marketing" to healthcare professionals, medical institutions and patient organizations. It does, however, have "Guiding Principles" for direct-to-consumer (DTC) advertising, published by PhRMA (the U.S. industry trade association) in December, 2008. Principle 13 states "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." I.e., NO REMINDER ADS!

Of course, PhRMA's principles leave open the door for running DTC PRINT ads, although I haven't seen many of these in the consumer publications I read. The exception is BOTOX, marketed by Allergan, which has NOT signed on to PhRMA's principles (see "PhRMA Intern vs. BOTOX!").

So, why does the IFPMA Code of Practice specifically carve out an allowance for "reminder ads?" Is that a technique often used in the EU to win over the hearts and minds of healthcare professionals? I don't get it.

The Coming Pharma Digital Depression Caused by Facebook

The Coming Pharma Digital Depression Caused by Facebook

P&G Discovers It's "Free" to Advertise on Facebook!

That's the gist of an article written by Jim Edwards over at Business Insider - Advertising (read the article here).

Of course, advertising on Facebook is not really free, but it's pretty darn close when compared to TV. According to the article, "P&G said it would lay off 1,600 staffers, including marketers, as part of a cost-cutting exercise."

Interestingly, P&G CEO Robert McDonald had some interesting comments about the cost-effectiveness of digital advertising, including:

"I believe that over time, we will see the increase in the cost of advertising moderate. There are just so many different media available today and we're quickly moving more and more of our businesses into digital. And in that space, there are lots of different avenues available. In the digital space, with things like Facebook and Google and others, we find that the return on investment of the advertising, when properly designed, when the big idea is there, can be much more efficient."

If a packaged goods company like P&G is "moderating" its cost of advertising by shifting to digital and laying off marketers, then the pharmaceutical industry can't be far behind. A "recession" in pharma digital marketing is even more likely considering the well-known "patent cliff" that's currently in progress; ie, blockbuster drugs with a combined $170 billion in annual sales will go off-patent by 2015. That means even less mass media advertising and more digital advertising.

But "more digital advertising" does not mean that much more money will be spent in the digital arena. That's because of social media, where it's virtually free to advertise!

Today, I will present a webinar on this topic as part of a BrightTalk "Digital Marketing & Pharma Summit" series of webcasts. The title of my presentation is "The Coming Pharma Patent Cliff and 'Recession' in Digital Spending."

According to BrightTalk's Quoc-Thai Dang, "At this summit, we'll be exploring the realities of how Pharma is spending it's budgets on digital. Experts will critically evaluate the impact of social media and mobile marketing, and if this has had an impact on their business."

My webinar will be at 10:00 AM this morning (January 31, 2012). You can go here to attend live or listen afterward or use the widget below.

I admit that my ideas are only half-baked and invite your comments.

Despite Increase in DTC Ad Spending, WebMD Suffers

Despite Increase in DTC Ad Spending, WebMD Suffers

2011 is shaping up to be a good year for pharma direct-to-consumer (DTC) advertising -- that is, broadcast advertising, NOT Internet advertising.

According to Nielsen data prepared for DTC Perspectives Magazine, total pharma DTC ad spending -- excluding Internet advertising -- increased 3.2% for the first 3 quarters of 2011 vs. the same period in 2010 ($3.045 billion in Q1-Q3 2011 vs. $2.951 in Q1-Q3 2010).

A chart of the top 25 or so drugs promoted in Q1-Q3 2011 in shown below (click on the chart for an enlarged view).

This is good news for TV, which raked in 64% of the broadcast DTC ad dollars during that period and magazines, which raked in 30%. Newspapers and radio shared the scraps left over.

What about Internet DTC spending?

Recall that in October I reported that a representative of Google said "pharma needs to leverage the Internet" and that "pharma was not considered a key client by Google because of pharma's low spend" (see "Double Dip in DTC Ad Spend!").

Of course, Google is concerned primarily with search advertising, which is often said to represent about 40% of the industry's total online advertising spending. But what about online display ads, which are major sources of income for health portal sites such as WebMD?

The Wall Street Journal reported that WebMD's Chief Executive Wayne T. Gattinella resigned, and the health-website operator "called off a search for a buyer as it braces for weaker financial results this year. A key issue, the company said, is pharmaceutical companies holding back on spending as they deal with expiring drug patents." (see "Dip in Drug Ad Spending Leads to WebMD Woes").

Predicting the Future of the Drug Industry: 2012 and Beyond

Predicting the Future of the Drug Industry: 2012 and Beyond

It's time to revisit a survey I ran a couple of years ago that attempted to predict future healthcare market scenarios that would impact the drug industry. The survey asks respondents how likely it is for certain events or conditions to unfold in the next 5 to 8 years (ie, 2012 to 2019).




You can take the survey here. But before you do that, let's review the first-round of results (ie, responses collected from 2 December 2009 through 8 January 2010). Events since then may have made some of the following scenarios more or less likely. You tell me.

The scenarios -- with my updated comments included in brackets [] -- that are included in the survey are as follows (see the chart afterward for the first-round results):

1. New follow-on biologics legislation in the U.S. will increase competition from generic equivalents and eventually decrease brand profits. [I think the legislation is still bogged down and when finalized may not have much impact within the time frame specified.]
2. Broadcast (ie, TV) Direct-to-Consumer (DTC) drug promotion will be banned or sharply curtailed by law in the U.S. [This may have been a big issue back in the day, but it doesn't seem to be center stage right now.]
3. The European Union will finally allow Direct-to-Consumer (DTC) advertising to its citizens. [The European Commission, the executive arm of the EU, recently ruled that pharma companies would not be allowed to disseminate information about drugs and their indications beyond a narrow set of circumstances. For the details, see, "In Rejecting Proposal, EU Dashes Drugmakers’ Hopes of Having a Voice"]
4. Internet-based drug promotion (including search engine marketing) will overtake TV-based DTC in the U.S. in terms of dollars spent. [There's still time for this to happen. I'm guessing that right now only about 5% (maybe 10% if you include search advertising) of pharma's DTC advertising budget is spent on Internet advertising whereas TV accounts for over 50% of the budget. See "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"]
5. Due to decreasing effectiveness of traditional physician detailing and rise of non-personal detailing, the role of traditional sales representative will become obsolete. [I'm surprised that over 50% of respondents think this is likely to happen before 2020 (see chart below). Perhaps a sign is the recent closing of Pharmaceutical Representative Magazine (see here). Also read this article: "Consequences of eDetailing Technology".]
6. New healthcare reform legislation will dramatically increase the sales of drugs in the U.S.
7. Extensive outcomes data available to payers and comparative effectiveness research will force the industry much further down the path of pay-for-performance (ie, adopt a more flexible approach to pricing). [For background in this, read the article "A Case for Supporting Comparative Effectiveness Research".]
8. Patients will become even more influential and empowered in making healthcare decisions as they are forced to pay a larger share of costs and/or have access to health information from a variety of sources. [For more background on this, read the article "The Empowered Patient: What It Means for Pharma Marketers".]
9. Despite lack of innovative new drugs and/or generic competition, sales of brand drugs worldwide will show a sharp increase due to increased demand in emerging markets (eg, China). [See the following articles: "Getting Market Research Right in Emerging Markets", "Getting Market Research Right in the Middle East", and "Getting Market Research Right in India & China".]
10. More efficient targeting of drugs and marketing to specific patient populations will greatly increase effectiveness and decrease side effects of drugs. [See, for example, "New Big Pharma Economies of Scale: Less Patients Needed to Reach Blockbuster Sales". At least one targeted therapy (I can't recall which), however, recently failed and that may cast a shadow on progress in this area.]
11. Social media marketing will become a significant part (>10%) of the pharmaceutical marketing mix. [Hmmm... A lot of people seem to believe this is likely (see chart), but FDA's delay in issuing guidance may have dampened the outlook for pharma use of social media.]
12. The next BIG opportunity for targeted marketing to patients and physicians is mobile apps on "smart phones." [To prepare for this, I recommend you read the article "Everything You Need to Know About Mobile Platforms". Take the survey and you will get a discount code that allows you to get this at no charge.]
13. Pharmaceutical and biotech companies will continue to increase their outsourcing of clinical trials and related drug development. Outsourcing will account for more than 50% of R&D spending by 2019.

The following chart summarizes first-round (prior to January 2010) survey results. Please take the survey now and help me get a more current view of what may be dow the road.