FDA's Answer to ePharma Marketing Guidelines: "circles and arrows and a paragraph on the back"

Today, Mark Senak (Eye For FDA) posted a podcast interview with Dr. Jean Ah Kang, Special Assistant to Tom Abrams at DDMAC in charge of Web 2.0 policy development (see "A Conversation with FDA/DDMAC About Pharma, Social Media and Web 2.0").

This was the second time in one week that the FDA had the "bully pulpit" and the ears of ePharma marketers. The first was at CBI's eMarketing conference in Princeton, NJ, where Sanjay Koyani, Director of FDA Web Communications, gave a keynote presentation, which will be summarized in the March issue of Pharma Marketing News.

On both occasions pharma eMarketers had their ears perked up to hear what the agency had to say about regulation of pharmaceutical marketing on the Web and especially on social networking sites.

On both occasions, we were disappointed.

Regarding the keynote presentation, ePharma Pioneer Club member Jonathan Richman had this to say: "It was the FDA showing all the great things that social media can do (which everyone in attendance knew already), but completely ignored the elephant in the room, which was the question: How can we do it and not get into trouble?"

Mark Senak also was rebuffed in his attempts to get some actionable information out of Dr. Ah Kang. "There was no expectation, of course, that the FDA was going to issue a guidance in the context of a podcast," said Senak, "but it did seem important to start getting some definition to the environment where there has largely been only speculation."

Mark posed a scenario to Dr. Ah Kang that I thought was odd. It addressed what Mark said was "the real fear among many companies that if they generate and post original materials that they may later be changed by others." I've never heard that one before and it's a trivial concern compared to pharma's fear of adverse reporting obligations.

Dr. Ah Kang spent the last 4-5 minutes going over the details for submission of ALL promotions -- including Web ones -- produced by pharma for so-called "pre-approval" -- actually, "advisory comments" -- by the FDA. She said: Go to the FDA website, look over the org chart, find the right division, the right "docket," the reviewer responsible for the docket, click on the submission information link, and make sure to put together the package as indicated. Be sure to include a cover letter, all your promotional materials, annotate the materials (ie, with "circles and arrows and a paragraph on the back of each one"), include references. highlight and annotate those references (more circles and arrows and paragraphs), include a PI, etc. Got a problem? Call the FDA's main number!

But whatever you do, don't leave your name on an envelope in the bottom of that half-ton pile!

FDA Widgets: How About One for Adverse Event Reporting?

Fabio Gratton is at it again! He has started a poll, which asks "To all pharma marketers: A universal FDA Adverse Event widget required by all pharma websites (brand, disease, social) would be effective?"

I assume he is following up on the "Tit-for-Tat Tithe" idea and that the widget he is proposing would allow visitors to pharma websites to easily report adverse events DIRECTLY to the FDA. This would lift the burden from pharmaceutical companies to track, investigate and report the adverse events themselves and free them up to focus on using social media sites for marketing purposes.

Sounds like a good idea. What do you think? Take Fabio's poll here.

Meanwhile, here are a few widgets developed by third parties that push out FDA information on drug safety topics. They are not interactive in the sense that you can enter information into them.

Tit-for-Tat Tithe on Pharma Marketing. How It Can Work.

A few weeks ago, Fabio Gratton, Co-founder nd Chief Innovation Officer at Ignite Health and ePharma Pioneer Club™ member, was a guest on my Pharma Marketing Talk live streaming audio/chat show where he enlightened us about "How To Measure Social Network Communications Success" (see PMT Show #69).

During that interview, Fabio threw out a half-baked idea idea intended to help pharmaceutical companies effectively use social media networks by limiting the regulatory risks in exchange for setting aside 10% of their resources (online ad spend? total marketing? profits?) to promote general health and well being.

The regulatory risk most often cited by the drug company regualtory people is the uncertainty about investigating and reporting adverse events (AEs) their companies receive through comments on social media sites (see "Report from CBI's eMarketing Forum: Taking on the AE Boogey Man").

Gratton says there should be guidelines to encourage pharma to focus more of its time on the general well-being of patients without worrying about AEs. "If pharma companies do this (focus more of its time on the general well-being of patients), regulatory agencies should cut them some slack with regard to the use of social media, according to Gratton." What the nature of this "slack" should be remains an open question (see my idea at the end of this post).

To get a discussion going on this, I asked respondents to the recent "How to Earn Back the Public's Trust Survey" if they thought this was a good idea. I also asked them to submit comments. I will report the full results in the upcoming March 2009 issue of Pharma Marketing News. If you are not already a subscriber, you may want to subscribe now and get this issue delivered free as soon as it's published.

Here's a preview of what I learned. As the pie chart below demonstrates, the idea has some traction, although most people understandably wanted to learn more about the details.


None of the healthcare professionals HCPs) and consumers who responded to the survey thought this was a great idea. About 40% of HCPs thought it was a terrible idea. Keep in mind that there are not enough data to expand these results to the general population. Look upon this as an ad-hoc focus group.

Some comments, however, were of interest:

'Without fear of penalty' is the equivalence of how do we hear about adverse events without being held responsible for doing nothing. The bottom line is that 'doing the right thing' may result in lower profits and that is unpalatable. Regulatory agencies cut too much slack as it is.
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Patients are the center of this industry and we should want to open channels of communication wherever possible. Some of the benefits of this communication include better informed patients, patients more eager to enter therapy, more awareness around clinical trials (and other non-prescribed therapies), and patients who are pre-qualified seeking treatment options. This list can go on!
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Given the industry's history of marketing and the consequences of DTC, CME, etc., I am skeptical. However, anything that improves patient management and promotes compliance and better outcomes is to be encouraged.
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What is meant by "focus more time on the general well-being of patients"? The industry spends hundreds of millions of dollars each year to discover new and more effective therapies, fund extensive disease state awareness efforts, donate charitable contributions to therapeutic co-pay foundations, support of patient advocacy programs and patient assistance programs, and so on. A lack of transparency and bad marketing practices by some has been the detriment to all... not just a lack of good will to patients. Additionally, regulatory agencies always regulate a few steps behind technology. General web advertising guidance came years after the advent of web advertising. "Good will" will not change regulatory opinion. A responsible approach to using new technology will. We sit back and wait for the guidance, when in reality we should be (in a sense) writing the guidance by demonstrating a responsible approach to educating our customers using new technology.
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Post marketing Pharmacosurvalience (sic) could be enhanced by the use of social media. It is in the industry’s best interest to open up the channels and see and hear what is really happening in the marketplace. It could prevent drug recalls by getting out in front of problems that were not encountered during the clinical trials prior to launch.

I have refrained from identifying who made these comments and whether or not they were pharma respondents. I will provide more comments and details in the upcoming Pharma Marketing News article.

Several people doubted that the FDA would ever publish guidance for pharmaceutical use of the Internet 1.0 let alone the 2.0, social networking version of the Internet. "Regulatory agencies always regulate a few steps behind technology," said one survey respondent.

But the answer lies within the pharmaceutical industry itself. If it has an interest in getting clearer guidelines for social media marketing, it should petition the FDA to respond. The industry has brought pressure on the FDA before -- ie, to publish guidelines on the distribution of off-label information to physicians.

The FDA could take a small step and define the industry's responsibility to report adverse events (AEs) they come across on web sites -- including social media sites -- under their control. It's not really a technology issue. That guidance could simply be something like "No self-reported AEs on social media sites need to be reported by pharma on Form 2253 under the following conditions..." Under a "tit-for-tat tithe" program, the conditions define a "safe harbor" available to pharma companies who commit to spending 10% of their marketing budgets to non-branded disease awareness programs approved by an independent 3rd party.

I'm interested in other ideas, if you have any.

Rooster and Friends Win Pharm Exec Ad Stars Award

Forgive me, but I just could NOT pass this up!

In the March 2009 issue of Pharmaceutical Executive (PE) magazine, I found this image -- sans my added text -- showing the Saatchi & Saatchi Consumer Health + Wellness ad team that won a prestigious (I guess) 2009 "ad stars" award given them by the Pharm Exec staff.

PE identifies the two guys in the photo as (from left) Andrew Curtis, copywriter and Jay Marrotte, art director. The rooster, aka "cock," was not identified, although PE did claim that the rooster was "specially trained to stay up at night."

When the "Silence Your Rooster" ad first appeared on TV, I noted that most of the rooster vignettes used in the commercial were "politically incorrect": men worried about sports, cars, and creative outlets whereas women worried about vacuum cleaners and hair dryers (see "Introducing the Politically Incorrect AmbienCR Rooster"). I suspected that there were more male than female masterminds responsible for these creative vignettes. Now that I see these two guys, my hunch has been verified!

P.S. Come on guys... Tell me that I am not the only one who thought "Two guys, one cock" when shown this photo!

What's the Cause of the Drug Industry's Bad Reputation?

Thanks to everyone who responded to the "How to Earn Back the Public's Trust Survey" that Pharma Marketing News hosted online between February 4 and March 14.

I've gotten some great insights from respondents and will report the full results in the upcoming March 2009 issue in a few days. If you are not already a subscriber, you may want to subscribe now and get this issue delivered free as soon as it's published.

Meanwhile, I'll whet your appetite by presenting a few highlights from the survey here. Specifically, I'll focus on why respondents believe the industry's reputation is so bad.

This all started when I quoted Ray Kerins, Pfizer's global PR chief, who said "How in the hell do we have such a bad reputation?"

His answer: The media is the main culprit because it reports mostly bad news about the industry and not the good that it does. His solution: Engage the media more pro-actively and tell them the good the industry does. I've heard a lot of pharma executives say the same thing. In fact, the common belief among pharma PR people is that it takes 6 positive stories to counteract 1 negative story.

The "Media as culprit" argument seems to be more popular among pharma respondents and their agency allies than among healthcare professionals (HCPs) and the general public. Pharma respondents also believe the the industry has not done enough to educate the public about the benefits it provides.

However, the two most-often cited reasons among all respondents were the high cost of drugs and the lack of transparency when it comes to reporting negative clinical data.

I was a bit surprised that "profits" were not cited more often as the cause of the industry's bad reputation.

All in all, the survey indicates a bit of a disconnect between the industry and its customers -- HCPs and patients. I suppose this is to be expected.

The next question is, how can the industry improve it's reputation and earn back the trust of its customers? The survey included several suggestions, including the following:

1. The drug industry should freeze or lower prescription drug prices for everyone.
   
2. It should not lower prices across the board, but it should help by re-imbursing all or part of co-payments made by people with prescription drug coverage.
   
3. It should greatly expand its patient assistance programs to cover more people (eg, the unemployed).
4. It should be much more transparent in reporting clinical trial results.
   
5. It should do more to promote comparative studies to prove the efficacy of prescription drugs.
   
6. It should support Medicare's right to negotiate prices under Part D.
   
7. It should ramp up its PR effort (eg, pay much more attention to the media by "engaging" and "educating" them).

Unfortunately, the survey is now closed, but if you have any suggestions that you wish to contribute and to be cited in the article, please post them as comments to this post. You can remain anonymous or identify yourself -- your choice (I wouldn't want anyone to be fired because they made an honest comment to a blog!).