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 :-)
John,
ReplyDeleteThis 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!
Rich,
DeleteThanks 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 :-(
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:
ReplyDeletehttp://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
Jane,
DeleteThanks 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,
ReplyDeleteThank you for covering this! I am having trouble locating it in the store now. Has it been taken off already?? If not, would you mind posting a link?
Thank you!
Alex
Yes, it appears to have been pulled after my post was published. :-)
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