Monday, July 21, 2014

FDA's Ten Commandments

Remember FDA's Social Media Webinar?

It was supposed to answer all our questions about the two recent social media guidances issued by the FDA.

There were technical difficulties and when participants could actually gain access and hear what was being said, they were surprised that the FDA presenters were simply reading the guidance documents verbatim.

"The #FDASM webinar, a haiku: Reading verbatim. Good use of my precious time? I'm not sure it is," tweeted @whendanieltalks.

This reminded me of Moses reading the ten commandments to the Israelites, who afterward agreed to obey those laws. Whether or not the pharma industry will obey the current drafts of FDA's "ten commandments" remains to be seen. Personally, I think the industry wants to send Moses, er, Abrams, back up the mountain.

If FDA actually had ten commandments, these might be them:

Thursday, July 17, 2014

Do Marketing Buzzwords Affect Pharma's Reputation Among Patients & Physicians?

Consultant and strategist Andrew Spong, PhD, former scholar and currently STweM‘s managing director, recently tweeted:

"Building trust is far from impossible for #pharma. Abstaining from digital conferences is a great start."

The tweet linked to a 2013 anti-pharma marketing screed posted on STweM titled "For pharma, the era of multi-channel marketing, closed loop marketing, sales force effectiveness, and market access is over"

I assume Spong singled out "digital conferences" because these buzzwords are frequently heard at such conferences.

It's a year later and the industry has "abstained" from using a couple of these buzzwords, at least within topics presented at industry conferences. "Multi-Channel Marketing" and "market access" are still frequently-used terms, but "sales force effectiveness" and "closed-loop marketing" are hardly to be heard nowadays at industry conferences.

Today, you will hear buzzwords like "Engagement" and "Centricity" as in "Patient Engagement" and "Patient Centricity."

So, it seems that pharma marketers have moved on and/or heard and obeyed Spong when he said:

"The era in which pharma could expect to be able to speak of ‘multi-channel marketing’, ‘closed loop marketing’, ‘sales force effectiveness’, or ‘market access’ without being called out as to their relevance, coherence, or appropriateness [with reference to the needs, interests, and concerns of the industry's patient, healthcare professional, and payer audiences] is over. As a consequence, pharma needs to get over them, too."

Now that pharma is using more customer-friendly terminology, is it any less "interested in its customers as bars on a chart, sales targets and data points than as people with individual needs?"; i.e., were these new terms introduced just for appearances in order to bolster pharma's reputation?

Tuesday, July 15, 2014

Total CME Revenue is Up, But Pharma Support is Down (Again) in 2013

The Accreditation Council for Continuing Medical Education (ACCME) 2013 Annual Report is out. Here's the data regarding total CME income and breakdown according to source of income. Note: the data analyzed in this post include income received by BOTH ACCME-Accredited and ACCME-recognized State-Accredited CME providers.

Click on chart for enlarged view.
Let's look more closely at the numbers for pharma support.

Friday, July 11, 2014

FDA's Social Media Guidance Webinar: A Third Guidance Needed for Mobile Devices?

Yesterday, the FDA hosted a public webinar to "further" the Agency's "communications with stakeholders, media and the public" about recently-published social media guidelines.

Unfortunately, I did not learn of this until it was too late -- registration to attend was closed. So, I urged those attending to live tweet during the webinar using the #fdasm hashtag.

If you read those tweets, you'll soon discover three things:

First, there were so many technical difficulties, the whole thing seemed to be heading for an epic #FAIL. Eventually, however, people were able to hear what was being said.

Second, when participants could actually gain access and hear what was being said, they were surprised that the FDA was simply reading the guidance documents verbatim.
"The #FDASM webinar, a haiku: Reading verbatim. Good use of my precious time? I'm not sure it is," tweeted @whendanieltalks.
This reminded me of Moses reading the ten commandments to the Israelites, who afterward agreed to obey those laws. Whether or not the pharma industry will obey the current drafts of FDA's "ten commandments" remains to be seen. Personally, I think the industry wants to send Moses back up the mountain.

The third thing people discovered was that, for a while, it seemed there would be no time for questions. But I guess a few were allowed and answered.

So, what was the main takeaways?

Tuesday, July 08, 2014

Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised?

At the end of June, the FDA sent a Notice of Violation (NOV) letter to Dr. C (you can find his name in the letter), Director, Regulatory Affairs Advertising and Promotion at Gilead Sciences, citing a sponsored link on Google for VIREAD (you can find the letter here).

Here's the ad in question:


Unless Dr. C (he has a PharmD degree) has been hiding under a "regulatory rock" since 2009, it's difficult to imagine that he would have approved such an ad. Because as WE all know, FDA views such ads, which include the drug brand name AND indication but no fair balance safety information, as violative of the FD&C Act.

Anyone, such as Dr. C, who is a regulatory authority -- he's worked in a regulatory capacity for several pharma companies since 2004 -- should be aware of FDA's "received precedent" on this type of ad (i.e, 14 warning letters issued in April 2009).

VIREAD is associated with serious risks and includes a black box warning. To advertise such a drug without providing any mention of such risk is unconscionable.

But there are even more serious problems with this ad, that, IMHO, should get Dr. C in hot water with Gilead's CEO!

Wednesday, July 02, 2014

Another Idea for Creating FDA-Compliant Promotional Tweets: Put the Carriage Before the Horse

In previous posts, I discussed a few different techniques that pharma marketers could use to create Rx branded promotional tweets that satisfy recently-published FDA guidelines.

One such idea was to attach an image of the required important safety information (ISI) to the promotional tweet (see "A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance").

I polled readers about this and a majority of readers who took my poll said, yes, it's possible that such a tweet would satisfy FDA guidance requirements:


In discussions with the Twitter "pharma team," however, I learned that on small-screen mobile devices -- e.g., smartphones -- which are very often used to send and view tweets via the Twitter app, these images are too small to be readable.

There are other problems when viewing such tweets on smartphones.