Archive for the ‘FDA’ Category

Pharma and biotech sales (and training) leaders, take note: the FDA is actively training doctors to sniff out your transgressions and turn you in.

The FDA has recently launched an e-learning course in order to educate the medical community on misleading drug promotions.

From the FDA’s press release: The FDA’s Office of Prescription Drug Promotion announced Monday the launch, with MedScape, of the e-learning course, which offers continuing education credits for healthcare professionals. The course is part of Bad Ad, a program designed in 2010 to raise awareness about misleading and untruthful drug ads. It’s aimed at healthcare professionals, but anyone can take it, the agency said. The office has developed several case studies based on warning letters the FDA has sent to drug companies, representing common problems.

You can launch the course here (anyone, in fact, can go through it). The screen shot below shows the structure of the course:

FDA course menu

Of particular interest is Module 5, where actors representing sales reps engage in questionable promotional practices to demonstrate violative sales tactics. This should be examined carefully by every commercial biopharma organization.

FDA Rep ecourse

Hat tip to Corey Nahman for the heads-up.

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If you’ve followed my writing and speaking over the years, you know I’ve been a big proponent of social media as a vehicle for communications, network-building, and new business approaches. And I absolutely believe – more than ever – in the power and utility of digital networked communications

I was among the first in the pharma universe to begin blogging and tweeting pharma/healthcare topics. The first time I used Twitter at an industry conference, I wondered if I might be discovered and tossed out!

In fact, I even put together the first published list of pharma folks and companies active in social media – which, at the time, was a pretty small group! That number has since grown considerably, which is a very good thing.

As the industry has evolved, however, I can’t help but ask the question – is it time to give up on the idea of commercial prescription pharma interactively participating in the open, public social media space using current platforms? (please note the careful choice of words before having a knee-jerk reaction).

I’m not giving an answer – I’m asking a question. Here are the streams of thought feeding into this inquiry:

1. The FDA has shown zero readiness to give guidance about the use of on-line media in pharma communications. They are ready, however, to send warning letters about perceived violations in an ad-hoc fashion. This seriously inhibits pharma companies from getting involved. Regulatory fear does not go along well with open, public discussion.

2. The nature of current social media approaches and tools demands real-time interactive response and dialogue, out in the wilds of digital space. Pharma does not and cannot communicate that way.

  • Facebook demands interactivity and informal 2-way communication. Pharma companies are forced to come up with all kinds of work-arounds to make Facebook something other than it is, in order to participate. It’s like trying to enter a canoe into a speedboat race.
  • Twitter demands short bursts of communication. Pharma communications (prescription brands) demand fair balance, context, long explanation, disclaimers, and all kinds of monitoring/reporting. Would a congressman reading a speech from a teleprompter fit nicely at a cocktail party?
  • LinkedIn is all about the individual professional. Nice platform for recruiting, even in pharma. But my experience with pharma folks (I have years of it) on LinkedIn is that interactivity is almost nil. Pharma professionals live and work in an atmosphere of non-openness. You can sow seed on a gravel driveway, but don’t expect much of a harvest.
  • YouTube is one place where pharma companies can participate on a social platform, as long as you strip it down to, essentially, one-way broadcast and storytelling. It’s not social, but it is media.

3. Pharma companies tend to rotate commercial professionals (sales, training, marketing, etc.) through their job roles every 1-3 years. This means a constant default to short-term thinking. However, successful involvement in public social platforms demands long-term commitment and readiness to innovate. As soon as a little bit of expertise begins to accumulate, it’s time to move on to the next rung up the ladder (personally, I think that this, and the bondage of short-term quarterly profit reporting, are the two biggest hidden killers of pharma companies making true inroads in social networking).

4. Social media is moving rapidly to point-to-point on-demand mobile communications (including real-time UGC of all sorts, location data, commerce, and fragmented data streams). Pharma is all about centralized, one-way, controlled communications. Black, meet white.

We could go on, but the point is this: Public, interactive, real-time social media platforms and commercial pharma communications simply don’t mesh well. At all. And I don’t see that changing any time soon. Stuff you can easily say about other industries really isn’t going to translate well to pharma (as much as I like Chris Brogan, he’s out of his league on this post).

Is that a death knell for social media usage across all areas of pharma? Not at all. Non-branded communications can occur on existing public platforms, albeit often with a good dose of restrictions and care. Non-public networks (private communities) are a fruitful area of valuable involvement. Private, internal social networks (Yammer and the like) are potentially hugely useful apps for digital networked communications. One-way storytelling, while not fully social, can still add value, even in the public sphere (if done very carefully). Mobile apps that provide information or services are great – though again, they are using social-ish platforms in a less-than-fully-social fashion.

Also, the maturation of a platform like Google Plus could lead to more controlled communications to distinct, defined groups – and that is where the future could well be brighter.

Commercial, prescription pharma communications happen within thickly-walled gardens. The open, public social web is anything but that – and it’s not going to change for the pharma industry. Current platforms make it very difficult to marry the two. The future may well lie in walled social gardens, but existing approaches are still maturing through the wild west stage. Maybe we should expend less concern about “getting on Facebook” or Twitter, and architecting a social strategy that fits the industry – rather than trying to fit this square industry peg into a round, shape-shifting hole.

What do you think? Agree or disagree? Add your comment!


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After numerous delays attempting to issue guidance documents regarding pharmaceutical social media, the FDA’s DDMAC division has finally thrown in the towel and decided to outsource the task.

“Look, the pharma companies all use outsourced services, right?” stated N. T. Ropee, Divisional Director and Acting Adjunct Associate Abrogator of Responsive Guidance Production. “They have CROs (Contract Research Organizations), CSOs (Contract Sales Organizations) – so why shouldn’t we use a CGO (Contract Guidance Organization)?

“We figure they’ll get some smart people in a room and hammer this thing out in about 3 weeks. That’s the FDA goal: timeliness and efficiency!”

Pharmaceutical marketing executives were initially ecstatic, but enthusiasm rapidly cooled as Ropee began to explain the process of selecting a CGO for the project.

“First, we have to do a feasibility study to analyze the potential for a needs assessment, after which we’ll require a full market landscape analysis to narrow down the potential suppliers according to specifications not yet developed by the Directorate of the Division of Specification Development, which will then be followed by a pre-publication analysis of possible public commentary paths seeking input on potential information-gathering procedures, including a full re-analysis of the unpublished data from the incomplete guidance not published in the ’90s about the Internet, which will be followed by – don’t hold me to any time frames now – a review of all current, past, and future…”

It’s business as usual. Happy first day of April!


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I really probably shouldn’t write, or publish, this post.

You’re not supposed to write stuff up when you’re really infuriated.

I’m going to publish it anyway.

Today, at the ePharma Summit conference, we had the much-anticipated talk by Thomas Abrams, Director of DDMAC/FDA. Tom seems like a nice enough guy and this rant isn’t about him personally. We’d probably enjoy a nice talk over a Samuel Adams Winter Ale. It’s about the monstrosity we were subjected to – an overview of the no-decision-making process of this watchdog of American health, the FDA.

If you’re trying to keep up with social media, it’s like racing with speed skaters. What we were subjected to, for 45 minutes, was a description of a Zamboni. Now with bigger brakes!

DDMAC has ostensibly been on the verge, after many months of deep ponderings, of giving some BASIC guidance to the pharma industry about the use of social media in public communications. Turns out nothing of the sort is imminent. In fact, after today’s overview, I’ve sketched out what I believe must be the (simplified) version of the FDA no-decision-making process:

I am now convinced that the industry cannot count on helpful, pro-active, useful, timely guidance from DDMAC. If I’m not mistaken, FDA never even came out with guidance about the web 1.0 Internet. And now our digitally-networked world is evolving even faster (ironically, FDA is making pretty good use of social media tools – for themselves). Social media does not move at a glacial pace – it’s a sprint. Whatever comes out of this mill in 10 years or so will be about as helpful as guidance about the proper use of a FAX machine.

I’m sure there are some very fine people in the FDA, and when abstracted from the bureaucratic tangle that now engulfs what they do in relation to pharma, there are some noble goals about protecting patient health, etc., etc. But when the only deliverable is a process of considering a process to arrive at a decision-making process about reviewing possible preliminary guidance that may or may not be relevant by the time it sees the light of day, well, I’m sorry, but that has nothing to do with human health. It does, however, have everything to do with opportunity cost – the years and man-hours wasted only hold back the ability of industry and patients to get at useful ways to communicate. That’s what makes me so frustrated. The very folks charged with making sure that the right folks get the right message about the right medicines are prescribing beta-blockers when we need eyeglasses.

More research is not a result. It’s an excuse.

Now, let me temper my rant with this fact: short-sighted dolts in the pharma industry who continue to violate pretty straightforward practices about on-label and accurate marketing are bringing all this on themselves. When will we get more courageous leadership in the pharma industry that sees beyond next quarter’s numbers; that values ethics and integrity above maximized profit? When will we see the Golden Rule instead of the Gold-in Rule? I’m all for fair competition, sales, and profit – this is a business marketplace. And a good number of the folks within pharma are seeking to do things right (I know and work with many of them). But the regulatory tangle we are subjected to today is, at least in part, because of jerks who incentivize jerks to cheat the system.

People inside pharma companies cannot speak this bluntly in a public setting, but I’m an outside voice. I have a mind and a conscience and (hopefully) a few remaining shreds of common sense, and it’s time to just tell it like it is. This industry is in serious need of culture change. And so, evidently, is its watchdog. But maybe that’s a premature conclusion. It needs further study. I’d better hold a public hearing and bring in some experts for more advice…and please, just FAX in your comments.

I’ll post them on my Zamboni for public comment.


UPDATE: forgot about this year-end spoof I did – now it looks downright prophetic!

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One of this week’s major news items in the world of pharma is the less-than-enthusiastic response of an FDA panel to Boehringer-Ingelheim’s experimental “sexual desire for women” pill, flibanserin.

I believe the quest for a “female Viagra” (an inaccurate parallel, by the way) is fundamentally misguided. Here’s why:

There’s a big difference between sexual function and sexual desire. Viagra does something that a pill can, in fact, do – impacts a physiological process. Erectile dysfunction is, in some cases, a medical problem that can be addressed with a medical solution.

But sex is not purely physical. And sexual desire is not some abstraction or isolated function that can be fixed by some sort of medical booster.

Yes, our bodies age and the physiological aspects of libido may be impacted. I’m not denying that. But can any pill really deal with the many elements that make up sexual desire, including:

– a loving relationship

– a climate of trust and freedom

– confidence and a sense of self-esteem

– personal attractiveness (and attracted-to-ness) on multiple levels

– hormonal fluctuations/levels

– physical function that allows fulfilling intercourse

And, in fact, are we even addressing the right question anyway with these proposed treatments? Should our focus be on creating/boosting a physiological desire for sex, or on making better relationships? Physiological aspects are a component of sexual desire…but are we going to keep medicalizing some things that are, to a large extent, simply part of a normal aging process?

I realize that there’s no money to be made by drug companies on the latter, but frankly, I’m forced to conclude that the whole exercise is a futile pursuit of profit at the expense of a healthier focus on the better relationships that will lead to better sex.

A pill is not a substitute for the genuine work of nurturing one’s mate so that a steady desire to please and be one with each other is a natural outgrowth. Viagra can make some things grow that forgot how. But I seriously doubt that any female Viagra will grow something as multi-faceted as sexual desire. Let’s go about curing real diseases.


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Had a great time last week at the SPBT conference. Planning to get out a summary post later this week…


Big news for Novartis: FDA panel unanimously recommends approval for oral MS drug – A Food and Drug Administration panel has unanimously backed the safety and effectiveness of Novartis’  multiple sclerosis treatment fingolimod. The panel voted 25-0 in support of fingolimod’s “substantial evidence of effectiveness” in treating patients with relapsing remitting multiple sclerosis. That makes it likely the drug will be the first oral MS treatment to gain FDA approval, beating Merck, Sanofi  and Teva – all of which are developing their own oral MS drugs – to the punchmore

Glaxo cuts 700 more sales/marketing positions – A Glaxo spokeswoman said 700 sales and marketing staffers (and related support staff) have taken buyout offers in recent months, while others’ jobs are being cut. She declined to give a total figure, but said the cuts are affecting “a variety of different positions in the U.S. pharma commercial staff.”more

Uncomfortable links being investigated – ARB high blood pressure drugs/cancer; Daiichi‘s Benicar and heart disease; troubling new data on GSK‘s Avandia and heart disease.

A “pill mill” in Kansas and multiple fatalities from the “lollipop of death.”


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Fresh from the tube this weekend: the first ever DTC commercial for medical devices?


This may just be the most hideous website “designed” by man. Do not click with any consumables in your mouth…


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