Building a Case, AdComm Preparation, Part 2

Last week, after a talk I gave on the subject, I put up a posting Building a Case, AdComm Preparation, Part 1, where I talked about some of the reasons why communications is almost as important of a factor in AdComm preparation as the data and science.  There is a sweet spot between good data and good communications that is the place where any sponsor ought to be aiming.  Today, let’s look a little more at some of the mechanics of good prep.

First off with regard to the presentation itself – as with any communications challenge – it is best not to approach it on a piecemeal basis.  Before getting to the individual sections of a presentation – the need for the compound, the safety, the efficacy, etc., it is a good idea to sit down and develop the overall narrative first.  If you were going to write it as a story, what would you have to say?  This master document then is the master messaging document and works to ensure that the individual components hang together to be able to tell a convincing story.  A piecemeal approach can work, but there is also a chance that it can result in a presentation that is halting and at times, even inconsistent.  The overarching narrative provides a master messaging document from which the individual presentations can flow and relate to one another.

But before you even get to the presentation, there is the issue of messaging and organization around the issues one faces.  So prior to developing the narrative around those issues, one must begin to catalog and prioritize the issues.  That work primarily is done in two areas:  research into the history of the committee and the drug class and a good, hard look at the candidate compound itself.

The committee research is comprised of several components.  First look at the history of the committee going back for a few years.  Note that in part 1, I mentioned that I recently databased each committee – the number of meetings, the number of recommendations for approval, etc.  That is a start.  Many people like to track the voting patterns of individual members, and in addition, it is important to go through the transcripts provided on the committee site and assess current sitting members for their hot button issues or recurrent themes or concerns.  Particular attention is paid to compounds that have the same or similar indications.

The other part in looking at the history of the committee is to look at each committee member up close.  What is their expertise and research history that could shed light on the types of questions they may ask?  What professional societies figure in importantly, or third party organizations?  Looking at the committee as a whole, is there expertise that might be missing with regard to the compound and therefore signals a possibility that FDA would bring in a consultant for the meeting?  Who might that consultant be?  In addition, a media analysis of the committee is important.  How have media covered this committee in the past – are there “go-to” spokespeople among the committee members who important members of the media seek out for comment after a meeting?  Who are the likely third parties who will be sought after for comment?

With this outward assessment going on, it is also important to look inward.  Every candidate compound is different and everyone has warts.  A fresh set of eyes – those of someone unburdened by an investment of time and effort in the compound or its success – can be very helpful in cataloging the issues that the particular compound has which may be of concern.  Data, efficacy, design of clinical trials, recruitment of clinical trials, makeup of clinical trials, special populations, outliers… all issues to be assessed.  Here the messaging must be built around each of those issues, taking into account a number of angles for questioning.

A strong master narrative, an environmental research effort and an inward assessment area all key components to get you into the sweet spot.  In Part 3, we will look at a few more issues regarding the meeting itself.

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Reflections on 8 years of Blogging – Eye on FDA Starts a 9th Year

Hello.  Eight years ago yesterday – February 9, 2006 – I began this blog with my first posting.  Since then, I have published 1250 more postings.

Though it seems like only yesterday, 2006 was a very different time:

  • George W. Bush was President of the United States.
  • There was no FDA Commissioner at the time – Lester C. Crawford had left FDA in September 2005 and Andrew C. Von Eschenbach would not come in until December 2006.
  • FDA approved 22 new molecular entities that year.
  • People were getting nervous about Avian flu.
  • Google bought YouTube.
  • Facebook was two years old and in September 2006, it was opened up to anyone over 13 years of age who had an email address.
  • MySpace was a top web site.
  • Twitter would not exist for another month.

Certainly Pharma wasn’t engaged in social media – nor were many other companies. Journalists, with the exception of some bloggers, weren’t there either.

Back then, professional blogs were kind of scarce.  Blogging was considered the realm of teenagers keeping diaries online, or sensationalists spreading gossip, to a large degree.  A colleague of mine began writing a blog that had intelligent musings on what was going on – with a regular Friday posting called This Week in Jewish Baseball.  I thought to myself, “Hey, I could do that – only write about the area in which I work professionally…”  I was – and am – fortunate enough to work for a company that saw the wisdom in that.  And so I began writing about the regulation of the marketplace for medicines and the actions of the agency that regulates one-fourth of our economy.

Since then, I have tried to cover the stuff that is important related to the developments that affect not only those who communicate about the pharmaceutical market place, but patients who are consumers in that marketplace.  There have been a few basic driving tenets along the way – I have always wanted to give readers useful information – things that would make them look smart and resources that would help them make important decisions.  I have always wanted to call attention to things that, while important, might have their strategic implications overlooked because we are so busy in our daily lives. Sometimes, the blog has given me a little room to provide personal insight, particularly about my time working in the HIV/AIDS epidemic.  And from time to time even, there has even been news – such as when FDA provided its first insight into the regulation of social media in a podcast in March, 2009.

Certainly times have changed.  Advisory committees activities used to be reported on by reporters who attended meetings and wrote about them in their publications.  Today tweets from those watching the proceedings tell the story.  Patients have not only become e-patients, but one-fourth of the people using the FDA website are doing so from a mobile device.  The pharma industry has scores of Twitter feeds, Facebook pages, YouTube channels, Pinterest accounts and presence on Google+.  Even FDA has 13 Twitter feeds that it manages.  All of this has had profound ramifications and implications for the communications around medicines and how we use them.  It has been nothing short of fascinating to see communications so changed in such a short span of time.

Eight years is a long time and a lot has happened and yet amazingly, I have not aged at all.

There are about 3300 subscribers to the blog – divided about half and half between people who subscribe by RSS feed and people who subscribe by email.  You are mostly FDA beat writers, people who work in pharma and folks in other communications firms who work with industry, as well as patient organizations.  The Eye on FDA Twitter feed has over 10,500 followers.  I want to thank everyone for reading and watching and sticking around.  And I look forward to talking about more in the years to come.

Thanks everyone.

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Weekly Roundup 2.7.14

Well, it has been one long winter.  I have the February blues and I am blaming that fact on my being a bit tardy with the Weekly Roundup here.  While I love a good snow fall, the fact is that here in Washington, we aren’t even getting much snow.  We get forecasts like “ice pellets” and things like that.  No lovely vistas of snowscapes.  There has also been a handy amount of dark ice.  Good times.  But just to cheer us all up, here is a nice close up of Marky the Cow.  She is growing up so fast…

And also to cheer you up, here is a bit of what happened this week:

  • FDA Launches Campaign to Reduce Youth Tobacco Use – The agency acted this week to reduce the number of people in the next generation of smokers by launching a campaign called “The Real Cost” directed to young people ages 12-17.  The agency said that it was the first of several campaigns that would be launched over time.  FDA says that it is using a comprehensive, multimedia approach with compelling facts and vivid imagery designed to change beliefs and behaviors over time, using several social media platforms.  The campaign will be evaluated to measure its effectiveness over time and is designed to target subcategories of the audience including multicultural youth, rural youth and LGBT kids.  You can view the ads on the FDA’s YouTube channel and visit the campaign web site here.
  • FDA Update Requirements on Infant FormulaFDA issued an interim final rule to further safeguard the health of infants being fed infant formula.  One of the interesting facts from the FDA’s press release on the issuance of this rule was that the agency cited the fact that despite the recommendation that mothers breastfeed their babies “only 75 percent of infants in the United States start out being breast fed” – and actually I was surprised to know it was that high.  In any case, this interim rule amends the agency’s quality control procedures, notification and record and reporting requirements for manufacturers.  The agency will be accepting comments on the interim final rule for a 45 day period.

That’s it for me – like February, today’s posting is short.  Have a good weekend everyone and know that we only have a month from Monday for Daylight Savings!

Photo courtesty of Anne Becker.

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Building a Case – AdComm Preparation, Part 1

Today I am giving a talk here in Washington about preparation for advisory committees. Over the years, I have had occasion to attend more meetings of FDA Advisory Committees than I care to think about, often with the purpose of helping a company on their own approach to an FDA Advisory Committee meeting – sometimes on product approval, sometimes regarding a policy issue.  I thought it might be worthwhile to cover a little bit of what I will be talking about today.

First of all, of course my remarks are aimed at the non-clinical aspects of AdComm preparation.  To prepare for this task, I began assembling a data base – no surprise to those who know me.  I went back to 2009 and profiled every Advisory Committee meeting regarding a drug, tracking the committee, the date, whether it was held jointly with another committee, whether it was a meeting to consider an approval or whether it was a meeting regarding an issue of policy, the company, the compound, the indication and whether or not there was a definitive positive vote.  As of now, the data is pretty raw, meaning I haven’t had the chance to go through and ensure that all of the entries are correct.  Nor did I look at every angle the way I would like to – for instance, what is the track record of individual companies – so the numbers I will have today will not be final. But I did find that of the over 200 meetings held since 2009, roughly just over half of those that considered approvals had positive votes (again without the benefit of the yet to come review of the entries).

When I broke it down by committee, one can see that some committees, like Oncology and Endocrinology, have been very busy – but the positive vote rate varied considerably between the two.  Without going into the specifics of the numbers (until I have had a chance to check the entries), it does indicate that it is important to know your committee and to glean the best practices from the positive outcomes that were related to that committee – they can provide a blue print for a new sponsor in that treatment category.

Let’s turn away from those numbers to content and delivery.

There is a sweet spot in AdComm preparation to be realized at the intersection of having really good data with having really good communications and delivery.  Can you get a positive outcome with good data and bad communications?  Yes, you probably can.  Can you get a positive outcome with bad data and really good communications.  No, you probably cannot.  Still, the place where you are best off is within the sweet spot of good data and good comms.

Why?  The content of this meeting echoes on long after everyone leaves the room.  It is important to remember that the AdComm is where branding for the product takes its first breath.  It is here that the public is really being introduced to the compound for the first time – all the more reason why communications place an important role.  That is the focus on the first part of the talk.

When it comes to fashioning the actual presentation, the presenters have more at hand than the task of conveying a simple presentation – they need to build a convincing case on the need for the compound, and that there is a favorable risk/benefit ratio.  On this front, it is a great pitfall to get lost in the weeds, without thinking about the entirety of the case being made.

In the end, while most people treat this as a scientific meeting – and it is – it is also important to look at it like an adversarial proceeding.  There is a judge (the Chair), there is a jury (the AdComm), media cover it (FDA beat reporters and trades), there is a prosecutor (FDA reviewers) and the sponsor is the defense.  Witnesses may show up as special experts or speakers at the Open Public Comment period.  That said, it is important that you be able to present your evidence-based best case.  In part 2, more on that topic.

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Upcoming AdComms by Subject Matter

The Advisory Committee calendar put up by FDA is very useful, but lists the upcoming meetings chronologically by date and by their named committee.  I thought it might be helpful every so often to provide an overview of upcoming AdComm meetings by topic instead so that one can readily discern where there is likely to be news.  So here is my first effort, notable perhaps for the fact that there is little action related to new drug approval.





  • New Indication for Test – The Microbiology Devices Panel will meet to discuss the premarket approval application for a new indication as a first line primary cervical screening test for the cobas Human Papillomavirus (HPV) Test, sponsored by Roche Molecular Systems, on March 12.


  • Flu Strains – The Vaccines and Related Biological Products Committee will meet to hear an overview of a research program in the Laborary of Respiratory Viral Diseases, CBER and then will discuss and make recommendations on the selection of strains to be included in the flu virus vaccine for the 2014-2015 season on February 28.


  • PreMarket Application for new lens - Meeting of Ophthalmic Devises Panel to discuss application from Starr Surgical Company for Visian Toric Implantable Collamer Lens (TICL) for new lens for the treatment of addressing myopic astigmatism in adults 21-45, February 14.



  • PreMarket Application for new deviceMeeting of the Anesthesiology and Respiratory Therapy Devices Panel to consider application for Inspire Medical Systems’ Inspire II Upper Airway Stimulator to be a permanently implanted device to treat moderate to severe sleep apnea in patients not effectively being managed with continuous positive airway pressure devices, February 20.

In addition  to this, I have begun a data base on Advisory Committees held since 2009 that will profile a number of characteristics, including outcomes.  More on that later.

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