Pharma Marketing Blog

Oh Snap! I wasted $3.40 sending my complaint to th...

2012-05-29T14:23:19.342-05:00

Oh Snap! I wasted $3.40 sending my complaint to the FDA via Certified Mail! Now they really are going to think I'm a nut!

curiously that app is no longer available in the a...

2012-05-29T14:15:52.219-05:00

curiously that app is no longer available in the app store, could it have been a consequence of your posts, if so, who needs Bad Ads??? (says a physician...)

Thanks for pointing that out. It should read "...

2012-05-29T14:14:41.394-05:00

Thanks for pointing that out. It should read "ARIMIDEX Direct." I guess the programers have not caught up with the PR and marketing folk who have coined the new name, which is BRANDED as opposed to "IN YOUR CORNER," which is not. AZ seems to be focused on increasing their drugs' brand awareness in the social media realm.

odd that that metatag points to InYourCorner, as t...

2012-05-29T14:03:17.557-05:00

odd that that metatag points to InYourCorner, as that is no longer a live website, wonder if AZ just forgot to update the metadata

Jane, Thanks for your comment. The timing of the...

2012-05-26T08:37:49.696-05:00

Jane,

Thanks for your comment.

The timing of the app's launch is even more curious given the fact that Pfizer announced a couple of weeks ago that it is suspending its promotion of Lipitor (see http://pharmamkting.blogspot.com/2012/05/pfizer-throws-in-lipitor-marketing.html).

I suspect that this app was under development for many months and its launch may have been delayed as often happens with software development. In any case, the money was spent, so you might as well release the app no matter what you have said about discontinuing other traditional promotions.

Obviously, the app is really geared to getting people to sign up for the $4 co-pay card, which, I believe, Pfizer is committed to support at least until the end of the year even though it hasn't helped sales much so far (see http://pharmamkting.blogspot.com/2012/05/pfizers-lipitor-co-pay-cardpbm-discount.html).

John, thanks for covering the regulatory aspect of...

2012-05-26T08:13:30.962-05:00

John, thanks for covering the regulatory aspect of the Pfizer app. My take focused on the timing of the app's launch, one week before Lipitor goes generic en masse. Your readers may be interested in that analysis in Health Populi here:

http://healthpopuli.com/2012/05/23/statins-food-and-a-mobile-app-pfizer-and-eating-well-partner-up-as-generic-lipitor-hits-the-market/

Thanks for staying on the FDA's case! JSK

Lol I couldn't even read that looooooong vanit...

2012-05-24T11:08:00.995-05:00

Lol I couldn't even read that looooooong vanity post. I skimmed it looking for something a bout latisse, but NOTHING.

sure are. Vioxx Dorothy Hammel ads were a big hit....

2012-05-23T22:00:35.989-05:00

sure are. Vioxx Dorothy Hammel ads were a big hit. Lanier the plaintiff lawyer stopped his opening every 15 minutes to play a commercial after saying "listen for the warning." Opps no warning. Company response was we gave them to the FDA and they approved them. tort lawsuits and not FDA regulations are the main barrier to lies misrepresentations and other illegal activities. FDA penalties including multi-billion dollar settlements are a joke.

Rich, Thanks for your comments. I have a call in ...

2012-05-23T15:39:30.411-05:00

Rich,

Thanks for your comments. I have a call in to FDA's BAdAd program (I also sent them this blog post). It seems that with regard to the BadAd program, FDA is primarily interested in hearing from physicians. So, if you know a physician who may want to submit this to the BadAd program, here's where they can find out more information about doing that: http://1.usa.gov/BadAdprog or call 301-796-1200. They haven't called me back :-(

Preeti, Thank you for your comments. Did you see ...

2012-05-23T15:30:50.686-05:00

Preeti,

Thank you for your comments. Did you see my later post about Shire's comments to the FDA? Shire asked FDA to clarify whether or not "dissemination" includes running videos on sites like YouTube. I guess they see it as a loophole if and only if they never plan to run the same video as a TV ad. Of course, FDA could cite that video as violative, but it would not be reviewed as a TV ad requiring pre-aproval.

Pharmaceutical companies know that posting on You ...

2012-05-23T15:02:58.585-05:00

Pharmaceutical companies know that posting on You Tube would constitute “dissemination” under the current regulations. So I do not see any “You Tube Loophole.” If a company was to take such approach they are exposing the company to further risk of FDA refusing to provide pre review comments on an already in use advertisement or subjecting the ad to an enforcement action.
I have not read all the comments that have been submitted to the Docket, but the solution may be quite simple: ask OPDP to turn around their review of the video of the TV ad in 5 days. From my experience, industry would benefit in the end. OPDP has worked hard to provide clarity industry has been asking for. Are we throwing out the baby with the bathwater?

John, This is great Blog post. Thank you for unc...

2012-05-23T14:58:55.741-05:00

John,

This is great Blog post. Thank you for uncovering this.

I think this could very well be considered an advertisement. The first sentence of the description mentions the indication and the second paragraph lists the brand (also elsewhere in the description. So the FDA could consider the description an advertisement. The Apple app store listing certainly does not have any fair balance or link to the full prescribing information. The questions that arise from this are: 1) will the FDA review this?, 2) is it a violation?

As for the app itself, it contains a lot more information. I think this is maybe the first app that has required that I actively agree to a End-user agreement. There is safety information on the "my favorites" section with a link to the Patient Prescribing Information (PPI). However on the iPad app I downloaded, it did not work the first time I clicked on it. A second try got it to open what appears to be a PDF document - try reading that on an iPhone for anyone over 45 y/o. The about us page also lists safety information and has the same link to the PPI. In the iPad landscape orientation it was on the fourth screen and the link to the PPI was at the very bottom.

There is no guarantee that this would pass FDA review if in fact they review it and some time. I have seen other apps and mobile optimized websites or "webapps" that contain pop up safety information or that maintain a scrolling text box at the top of the window with important safety information.

I think the outcome will be important learnings for Pharma companies and their agencies that develop mHealth initiatives and health applications. I hope that you will keep us updated on any developments.

It will be interesting to follow this story -stay tuned!

David, Thanks for your comment. Are DTC TV ads ci...

2012-05-23T10:11:16.459-05:00

David,

Thanks for your comment. Are DTC TV ads cited as evidence of drug safety in many tort cases?

The FDA has maybe 10 folks to check ALL marketing ...

2012-05-23T09:30:30.644-05:00

The FDA has maybe 10 folks to check ALL marketing 2253 submissions. I don't think they have ever stopped any ad until it went live & some competitor complained.

The companies use the submission to claim to juries that the FDA "approved" the ad. The main purpose of this regulation is as part of a tort defense. FDA should stop acting like it does something it never does. Let the free market and the courts decide.

phrma's comments are not posted in the Federal...

2012-05-22T13:00:44.466-05:00

phrma's comments are not posted in the Federal Register.... DUHHHHHHHHHHHH

Nice post, John. It's a brave new world. As wi...

2012-05-18T13:48:41.147-05:00

Nice post, John. It's a brave new world. As with everything, you learn best by doing.

I'm not sure where to reply, what box, because...

2012-05-18T10:45:32.692-05:00

I'm not sure where to reply, what box, because I don't tweet, blog . . . am thoroughly content to email and telephone and talk . . . but this subject disturbs me about Type II Diabetes, Victoza, and Paula Deen. My father had this type of diabetes and managed it beautifully with my mother's guidance of eating the right foods and managing his lifestyle to accommodate that, no drugs involved. I just heard Paula Deen on the news last night saying that she still eats whatever she wants, just fewer times a week and lighter portions. This is great if you're on a diet program, but managing diabetes is not a diet program. You don't just eat less with fewer fats and sugars, take the drug, and go about your business. Most of the time individuals with Type II Diabetes do not require insulin, only careful management, and life is still rich and full. I read the SPRY insert in our newspaper and there was Paula telling about how to manage her diabetes with some substitutes of ingredients and eating less; and then a half page underneath her article and a full page on the next page dominated the space, promoting the drug Victoza. Never have I seen such a blatant sell out of integrity, probably prompted by a worry that the diabetic condition would drastically cut the "feel-good-food" empire so bountifully built up by Paula and her family and that this affiliation would be a wise, lucrative connection to make (took three years evidently to seal the deal)should that happen. Paula is cheerful and lively and has a winning Southern way, but she is also, evidently, a hard-core business woman. Not exactly a healthy combination for those swayed by her food sense and potentially led as well into an unnecessary, potentially dangerous, drug world. Thanks for listening....Shirley J

Looks like these Big Pharma's really good in a...

2012-05-18T04:14:35.593-05:00

Looks like these Big Pharma's really good in advertisement. Now they are questioning that exercise and healthy diet are enough to lower cholesterol. What about their products? Why don't they tell statins side effects? they should if they really care.

Altay, Thanks for your comment. While the post ...

2012-05-16T09:00:26.483-05:00

Altay,

Thanks for your comment.

While the post does conform to FDA regulations as far as I know, it seemed a bit opportunistic and out-of-place on a corporate blog focused on broader issues of interest to AZ. If every corporate communications channel becomes just another channel to promote specific products, it diminished the value of that channel for the intended audience. This post, IMHO, strays from the blog's stated goal: "We will be talking about a range of topics including breaking news, corporate social responsibility, healthcare reform, and more." Of course, "more" opens the door to anything, but a reasonable reader would not expect "more" to include product promotions.

Also, dedicating the MAJORITY of a post titled "New CDC data shows drop in number of adults with high cholesterol" to the promotion of CRESTOR seems to belie what the title promised to deliver.

It's a timely post that includes the compulsor...

2012-05-16T08:22:01.430-05:00

It's a timely post that includes the compulsory regulatory info in proper context. They've linked to the PI per time-worn (in internet years, you know...) industry practice, you'll notice.

AZ have demonstrated that pharma can engage in social media when appropriate moderation is in place.
Well done to the AZ team and well spotted John.

A

PS I hope this activity supports your business case, Tony.

I just read your email and noted that this is NOT ...

2012-05-13T18:19:27.600-05:00

I just read your email and noted that this is NOT the first time a product brandname was mentioned in the AZ blog.

Tony, Thanks for your comment. My post may be mor...

2012-05-13T18:12:08.628-05:00

Tony,

Thanks for your comment. My post may be more about the timeliness of this post than abut whether it is consistent with your policy. Cirrect me if I am wrong: Is this the first time an AZ drug brandname and indication were mentioned in this blog?

John - This post - as with all of our posts, Twee...

2012-05-13T15:45:53.588-05:00

John -

This post - as with all of our posts, Tweets and Facebook items that mention disease states or AstraZeneca medicines - was reviewed and approved by our regulatory team. It is in line with our policies ("may not" and "will not" are two very different things).

We do review comments to ensure we do not run afoul of regulatory concerns, while also routing adverse event reports to the appropriate channel.

Feel free to contact me when you're curious about these things. I'd be happy to provide our perspective.

Tony Jewell, AstraZeneca

I agree with the other two replies that it is the ...

2012-05-10T16:16:09.700-05:00

I agree with the other two replies that it is the parents responsibility to teach and monitor what their kids eat. That's pretty straight forward and to the point.

But the real issue is actually educating and informing the parents on what is healthy. The marketing efforts of the food industry are great at making things look or sounds healthy when the product is actual very low quality. (Example: No-Fat Yogurts are filled with extra amounts of sugar. Market the healthy aspect, then give the customer unhealthy food)

In conversations I've had, people generally think that the government's "My Pyramid" is un-attainable and they want a pill (diet pill) to Make them lose weight.

Parents trying to teach their kids to eat healthy is like the blind leading the blind. Parents need to know how to eat better and actually do it. Until then Type 2 Diabetes will never stop increasing in this country.

In some ways, both are the same. Big Pharma indust...

2012-05-10T15:15:10.043-05:00

In some ways, both are the same. Big Pharma industry has talked about the acquisition of smaller companies almost as a way of outsourcing their R&D. Increasingly, the good ideas are coming from smaller companies, which Big Pharma in turn buys up as the ideas get closer to market.