Tuesday, September 23, 2014

Don't Follow FDA Guidance on Use of Google Adword Site Links

In case you haven't realized it yet, the FDA is not very well-versed in the intricacies of new media, which may be why it took the agency so long to deliver guidelines for pharma's use of social media (see the PharmaGuy Social Media Timeline for details).

A good example of FDA's lack of digital expertise is its recommendation for the use of Google Adword site links. "Ad site links," says Google, "add value to your existing AdWords ads by providing additional links to specific, relevant content deeper within your site map."

FDA suggested that drug adwords -- even adwords for drugs with black box warnings -- can use site links to "convey the most serious risks associated with [the drug], including the boxed warning and additional warnings about fatal and life-threatening risks."

The guidance document includes this example of ad for the hypothetical drug Headhurtz:

FDA example of Google ad with site links. Numbers are FDA's counts of characters used/maximum characters allowed. Click on the image for an enlarged view.
"FDA would not intend to object to this sponsored link format," notes the Agency in its guidance document. Unfortunately, if a real drug ad followed this advice, the FDA might renege on its promise and "object."

Why is that?

Thursday, September 18, 2014

Are Patient Stories Becoming Anecdotal "Evidence" in Pharma Marketing Campaigns?

Social media and real patient stories are a "match made in heaven." Combine that with a celebrity spokesperson who is also a patient or a caretaker of a patient and you got gold!

That's how I see campaigns such as Shire's "Keep Momming," which was featured in the September 2014 issue of MM&M. According to the article (find it here), "The unbranded 'Keep Momming' campaign has more of a straightforward educational thrust: It seeks to help mothers better identify the symptoms of ADHD in young girls and to make them more cognizant of the inattentiveness aspects of ADHD (as opposed to the easier-to-spot hyperactivity ones)."

Shire, you may recall, markets Vyvanse, a drug indicated for the treatment of ADHD in children and in adults.

This campaign includes a celebrity spokesperson: actress, singer, and NFL wife, Holly Elizabeth Robinson Peete who says her daughter has ADHD. Her story is featured in a video on Shire's KeepMomming.com Website, the title of which is "Real Stories from Real Moms & Daughters."


In the video, Holly talks about her daughter's symptoms such as daydreaming, inability to focus on homework, "tears - a lot of tears," etc. The diagnosis "made things a lot easier" and "when you know better, you do better." She stops short of saying her daughter is now medicated, but presumably that's what "doing better" is all about.

Although I am a fan of using real patient stories, I am a little uncomfortable using this powerful technique for controversial medical conditions like ADHD.

Mad Men vs. Med Men: Brand vs. Patient

In the September 2014 issue of MM&M, I came across what these days is referred to as "content marketing," but what MM&M calls "ViewPoint." I'm referring to the piece -- you can't call it an article -- titled "Medical marketing needs mainstream Mad Men" written by John Barker (find it here). At least I'm pretty sure it's content marketing, because you can never be sure when it's labeled something else. More on that later in this post.

The premise of the piece can be summed up in the last sentence: "Going forward, staying competitive in the ACA marketplace may mean asking more Mad Men to be Med Men." That is, the pharmaceutical industry should hire agencies -- such as Barker, which is Barker's agency -- that "don't know the difference between the FDA and FDR. But they know branding."

Yeah, that's going to go over big with pharma brand teams, which these days are figuring out how to be more "patient-centric" while staying compliant with FDA regulations.

Barker's logic is that somehow the Affordable Care Act (ACA) is forcing pharma marketers to "shape authentic and trusting relationships with their customers, moving beyond traditional selling points to generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike."

Let's leave ACA out of this for now and just consider branding versus customer relationship, aka "patient-centricity."

Friday, September 12, 2014

The Pharma Social Media Pioneering Era is Over! Long Live the Pharma Mobile App Pioneer!

Today I will chairing CBI's Social Media Compliance Strategies and Benchmarking Summit in Philadelphia. In my opening comments I declared that the pharma social media pioneer era is over. Here's a draft of what I said: Welcome fellow “wonks” to CBI’s Social Media Compliance Strategies and Benchmarking Summit!

I say “wonks” because I assume most of you like Peter Pitts, our first speaker, relish the art of interpreting FDA rules, regulations, and guidances. I know I do!

But before we get to Peter and his wonky views, let me explain why I am wearing this shirt and hat. It’s to remind you that I am PharmaGuy, although it says John Mack on my badge.

For the past 4 or 5 years I have been recognizing pharma marketers who thought – and acted -- outside the “social media box” by handing out the PharmaGuy Social Pioneer Award, which is the shirt you see in the slide here. I wore that shirt at one of the first conferences – actually “unconferences” -- focused on pharma social media. It helped me stand out from the crowd and it’s a fitting symbol for how pharma social media pioneers stand out from the crowd.

This year, I will be making the FINAL presentation of the award.

Why final?

Friday, September 05, 2014

FDA Says Men Who Receive Drugs for "Low-T" Have 30% Increased Risk of Major Adverse Cardiovascular Events

As I reported back in February this year, Public Citizen urged the FDA to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. (see "Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling").

That petition may have lead to the FDA calling for an advisory panel meeting on Sept. 17 to discuss "two controversial issues regarding testosterone replacement therapy (TRT) that have important public health implications. The first issue is identification of the appropriate patient population for whom TRT should be indicated, and the second is the potential risk of major adverse cardiovascular events (or MACE, defined as non-fatal stroke, non-fatal myocardial infarction, and cardiovascular death) associated with TRT use" (see FDA's briefing document here).

More worrisome is the fact that only about one-half of men taking testosterone therapy had been diagnosed with hypogonadism, and 25% did not have evidence of having their testosterone concentrations tested prior to initiating therapy.

And more and more men are receiving prescriptions for so-called "Low-T" drugs such as Androgel. How many more?
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