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?").

"Shoe" Comic Strip Spoofs Pfizer's Chantix (unbranded) Side Effects

My Sunday newspaper comics section prominently features the "Shoe" comic strip on the front page. It's a favorite of mine. Today's Shoe spoofs the side effects of Rx drugs -- specifically a smoking-cessation drug. Although it doesn't mention any brand names, Chantix is the only non-nicotine drug approved by the FDA for smoking cessation currently available by prescription.

Here's the comic, which I pinned on my "Fun Pharma Images" Pinterest board:

Source: shoecomics.com via Pharma on Pinterest

According to the Shoe web site "The strip's namesake, Shoe, is based on legendary North Carolina journalist Jim Shumaker, Jeff MacNelly's first newspaper boss. P. Martin Shoemaker is a grouchy, cigar-smoking, newspaperbird with a tough side and an even tougher other side."

Even tough birds, it seems, can suffer drug side effects. Shoe mentions "chest pains, bad breath and a hacking cough" as his main side effects. This is funny in context of the quit smoking indication but Chantix has been linked to a much more serious side effect: suicide. For more on that see "Chantix May Be More Dangerous Than Smoking!" and the chart below:

Source: pharmamkting.blogspot.com via Pharma on Pinterest

Of course, Shoe may be taking some other drug such as a generic version of Zyban.

The question remains: would Shoe be better off smoking his cigars or taking a medication to quit?

I'm not a cigar smoker, but I wouldn't inhale cigar smoke if I were. But there's the secondary effects of inhaling the smoke that's released into the surrounding air by cigars.

In any case, Shoe would be a terrible boss to work for whether he quit smoking or not!

Is There a Doctor in the House? FDA Bad Ad Program is Designed for You. Not So Much for Me!

Two days ago, I sent an email to FDA's "Bad Ad" program (email addr: BadAd@fda.hhs.gov) to cite a Pfizer iPhone App as a "Bad Ad" (see "Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?" for background). For the record, here's a screen shot of the email I sent (click on it for an enlarged view):

A minute later, I received an acknowledgement email from the FDA that started with "Thank you for taking the time to alert us to potentially misleading promotion," but ended with "If you are not a healthcare provider, please refer to the OPDP website for instructions on how to submit a complaint, or call (301) 796-1200." I was confused, so I called the number and left a message.

Today, Olga Salis, OPDP Senior Project Manager, called me back to explain the Bad Ad complaint process. It appears that "healthcare professionals" (i.e., mostly physicians) can submit complaints about ads via email whereas ordinary citizens such as myself MUST use snail mail; i.e., send a physical letter to FDA/CDER/OPDP, 5901-B Ammendale Rd, Beltsville, MD 20705-1266. This distinction is not clear from the information provided on the Bad Ad page here.

It's OBVIOUS that the FDA does not want to be bothered or flooded by consumer complaints because it is not making it easy for consumers to submit complaints. Who knows if FDA would have done anything with my complaint had I not called. As it is, it may take OPDP THREE months to respond or take action on my complaint, "if it has merit."

NOTE: FDA receives complaints from three sources: Healthcare Professionals (HCPs), Consumers, and "representatives of regulated industry" (ie, pharma companies ratting out their competitors). The "pharma" group of complaints was the most credible -- 58% of those complaints were deemed worthy for "comprehensive review," whereas 46% of HCP complaints and only 21% of consumer complaints made the cut (see figure below and also here):

Source: pharmamkting.blogspot.com via Pharma on Pinterest

I will followup with a written letter sent to OPDP. However, I encourage any healthcare professional reading this blog to download the Pfizer iPhone app in question and if you agree with me that it is worthy of a "bad ad" complaint to the FDA, then all you have to do is send an email to BadAd@fda.hhs.gov. Easy for you, not so  much for me :-(

Online Physician Communities Hold Promise, But Do They Deliver?

Doctors 2.0 and Pharma Marketing News is currently running the "Exploring the Doctor 2.0" survey (find it here), which asks respondents about the impact of New Technologies on healthcare, a subject that is right now being discussed by the "Online Health Care Professional Communities" panel at the Doctors 2.0 & You Conference in Paris, France.

I will be reviewing in more details the results of this survey in the upcoming issue of Pharma Marketing News, but will give you a glimpse of the results of the first question, which asked respondents to rate the importance internet tools and services in improving healthcare. The results are shown in the following chart:

Source: Uploaded by user via Pharma on Pinterest

Over 80% of respondents (N=54) said that online professional communities were very useful or essential tools for improving healthcare. Close behind that were mobile apps for professionals and patients. The chart shows a comparison between EU (yellow line) and North American (red line) respondents.

However, According to a QuantiaMD and Care Continuum Alliance 4,033-clinician study, 28% of clinicians access online physician communities. “A notable 92% of physicians are interested in interacting with colleagues in online professional networks to learn from experts and peers, discuss clinical issues and share practice management challenges. However, more than 70% of physicians say patient privacy issues would hold them back from using these networks, and two-thirds are worried about liability issues. Lack of time and issues with compensation are also areas of concern.” Chart:

Source: pharmamkting.blogspot.com via Pharma on Pinterest

Note: N=4032 for all responses except physician communities, which only includes respondents with no prior QuantiaMD connection (N=854). Source: QuantiaResearch www.quantiamd.com

For more about this discrepancy (highly rated importance of physician communities and actual low use of them by physicians) see "Physician Participation in Peer-to-Peer Social Media Sites: Why Is It Less Than Expected?" Use discount code 'P2Pfree' to get it free.

Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?

I just learned that Pfizer has developed an iPhone/iPad app that promotes LIPITOR, the drug company's off-patent lipid-lowering drug. The app is "Recipes 2 Go." It is the first pharmaceutical app that I know of that promotes a prescription drug.

Here's what the promo screen on iTunes looks like (click on it for an enlarged view):

The description -- shown here in its entirety -- mentions LIPITOR and the FDA-approved indication, which is managing high cholesterol.

Is This an FDA-regulated Drug Ad?
My question: Does this iTunes page qualify as an prescription drug ad that must comply with FDA regulations regarding fair balance (ie, Important Safety Information or ISI)? If it does qualify, then it violates FDA regulations because the page does not include ANY fair balance or a link to the full prescribing information.

Did Pfizer submit this page to FDA for regulatory review? Did it submit the page to its own MLR (medical/legal/regulatory) people?

I downloaded the app to my iPhone and found the side effect/fair balance information plus a link to the "full prescribing" information on the very bottom of the "About Us" screen. Here's what the screen looks like:

Only when you scroll down to the next screen do you see the notice "Scroll down to see Important Safety Information," which appears about 14 screens further down! Whew! That's a lot of scrolling!

The multi-page End-User Agreement (dated April 20, 2012)  should be read carefully. For one thing, it states that "NO STATEMENTS MADE IN THIS SOFTWARE HAVE BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION."

To which I say, Why Not? The FDA should definitely take a look at this app and decide if it complies with regulations.

Because this app does not present the ISI where it can easily be found (and not at all on the iTunes promo page), I gave it only a single star rating on iTunes :-)

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.