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

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 :-)

Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story

Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story

Some time ago, I pointed out that certain mobile apps developed by pharmaceutical companies for use by physicians lack adequate disclaimers. Specifically, I was concerned about the software used in these apps that perform calculations to generate data to aid in medical diagnoses. A Psoriasis/PASI app by Janssen Pharmaceutica is an example (see "FDA Promises Still More Guidance! This Time It's Mobile. Janssen's Psoriasis iPhone App May Need It"). I pointed out that this app does NOT include any information about the clinical validity of the PASI calculator nor does it warn the user not to depend on the accuracy of the data.

Today, I found out about AFib Educator 2.0 developed by Sanofi-Aventis (I seemed to have missed 1.0!). The app is intended to be an "interactive way for healthcare providers to illustrate atrial fibrillation and its pharmacologic management for patients and families" (see review on iMedicalApps blog). The "pharmacologic management" is not what you may think; that is, there is no mention of any AFib drug either by trade name or generic name. The app only mentions that "there are treatments available."

Let's look at the disclaimers for these two apps (click the image for an enlarged view):

On the left is the disclaimer for Sanofi's AFib Educator 2.0 and on the right is the disclaimer for Janssen's PAS calculator (updated since I last reviewed the app).

Both disclaimers mention that the app is "not a substitute for medical advice/professional medical care". But only the AFib disclaimer mentions that "Persons using the data within for medical purposes should not rely solely on the accuracy of the data herein." It also mentions that data might be updated periodically -- meaning, I suppose, corrections or more accurate data.

Why doesn't Janssen's Psoriasis/PASI app, which is MUCH more data driven (it calculates a PASI score!), include a similar warning? Obviously, I think it should include that warning.

But more importantly, Janssen's app should include information about the source of the equation it uses to calculate PASI. As I pointed out previously (op cit), there is some difference of medical opinion regarding how PASI should be calculated and which formula should be used by healthcare professionals.

Obviously, ANY healthcare professional can download and use the PASI app. You don't have to be a dermatologist who may be more familiar with PASI calculations than is a general practitioner. In fact, you don't have to be a physician at all! That's fine, but the audience should be made more aware of what's operating "behind" the app to generate the PASI scores.

Be Aware of What's Behind the App
What's going on "behind the app" is a hot topic these days. Recently, major news outlets have reported that there is software running in the background on virtually all smart mobile devices that record every keystroke, supposedly merely to "monitor performance" (see "Is Your Smartphone Tracking Your Keystrokes, Texts and Location?" and the YouTube Video embedded at the end of this post).

It's interesting that part of Janssen's NEW disclaimer HINTS that data are being collected when people use its Psoriasis/PASI app (see screen shot below).

Janssen claims that it is monitoring clicks for performance purposes. However, since it is possible to collect and record ALL keystrokes, there is the possibility that data other than icon clicks are being collected by Janssen. I'll have to see if Trevor Eckhart -- who made the video below -- will take a look at exactly what data the Janssen apps records.