Weekly Roundup – 2.21.14

The snow has melted and the ground is soggy.  Looking at the ground there are daffodil tops poking out of the dirt and this morning on my dog walk, I spotted my first two crocus blooming purple.  The volume of birdsong has definitely increased.  And I find myself in moments where there is a quick mental break, with a wandering mind considering the scheduling and destinations of spring vacations.  Daylight savings is just 16 days away…

In the meantime, it looks like it was a fairly eventful week and here is a bit of what happened:

  • Supply Chain Pilot Program for Drugs Launched - In August 2013, FDA published a notice in the federal register seeking pharmaceutical company participation in a pilot program aimed at bolstering the security of the supply chain for drugs imported into the U.S.  The participating companies would agree to have in place a supply chain protocol validated by U.S. Customs-Trade Partnership Against Terrorism; a plan in place to quickly address potential problems; effective recall plans in place and maintenance of control over the drugs from time of manufacture through entry into the U.S.  Participants are permitted to have up to five drugs receive expedited priority import entry review.  You can see the thirteen companies that have been “pre-qualified” to participate in the FDA press release and there is a Web page on the FDA site devoted to the topic.
  • Another Orphan Product ApprovalThis week FDA approved Chelsea Therapeutics’ Northera for the treatment of neurogenic orthostatic hypertension which is a rare, chronic and debilitating condition often affecting people with Parkinson’s Disease.  People with the condition face a sudden drop in blood pressure upon standing.  The product was approved with a boxed warning and under FDA’s accelerated approval process.
  • FDA Looking to Overhaul OTC Monograph SystemFDA announced this week that it would be holding a public hearing on March 25-26 at the agency’s White Oak campus with an eye toward modernizing the process and regulatory framework for OTC Drug Review under the Monograph Process to make it more responsive.  The purpose of the hearing is to solicit opinions about how to better position the system in today’s environment.  The OTC Monograph system currently provides for the ability to categorically set standards for OTC products so that they do not have to get approval under the new drug approval process individually.  However this process put into place four decades ago is somewhat cumbersome.  FDA cites particular challenges including the fact that there are a large number of products marketed for which there is not a final monograph available.   FDA has set up a meeting information site on the Web site.  This will likely be the most important meeting regarding OTC drugs in many years.

That’s it for me this week.  The weekend feels like it was a long time in coming.  I plan to greet it with open arms.  Enjoy.

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Building a Case, FDA AdComm Prep – Part 3 (final)

In Part 1, we covered the need for good communications planning, in Part 2, a little bit about how to go about it and in Part 3, some thoughts about the day of your meeting.

You have developed your narrative and from it derived the individual components of the presentation on need, safety, efficacy and any other considerations.  You have looked at the warts – and asked the hard questions about the data and issues that relate to the risk/balance ratio – like the number needed to treat and the possible safety issues, the potential for a REMS program, how special populations might be affected, how the trials were conducted and recruited, the makeup of the clinical trials, etc.

Now you have chosen your presentation team.  It may be a combination of internal and external team members.  External consultants can be very useful and credible, particularly if they have a background associated with the drug approval process or connection with a major medical society related to the treatment area.  You establish “leads” for responses in key areas, with back up experts to be called upon for highly specific information.

The presentation team needs training not only in presentation technique, but in question response.  Speakers particularly need to be taught flagging and headlining as it related to providing the answer in a meaningful way; and need to be practiced and rehearsed on a range of questions.  In fact, the presentation team should be prepared not only with mock panels made up of outside experts to simulate the day of experience, but drilled frequently on the range of potential questions they will face.  And conduct as many mock panels as are necessary.

In addition, a sponsor must identify those people who will be responsible for speaking with the media and they must be media trained – not the same as presentation training. Which brings us to an important point.

The AdComm meeting is not just a scientific meeting about the approval of a compound – it is also where the baton gets handed off from the regulatory side of an organization to the marketing side.  The AdComm meeting is where the branding of the product draws its first breath – it is the public unveiling of the drug – warts and all, and therefore it is important that there be a coordination of communication between regulatory and marketing at this time.

A good deal of sponsor thought goes into the Open Public Comment (OPC) period of a meeting when third parties and patients can state a point of view.  Should a sponsor encourage third parties to participate?  Support and connections of sponsors for third parties need to be disclosed at the time.  Such connections have an impact.  Purely organic commentary is perhaps the most desirable.  However, in any case, OPC should be considered carefully.  No panel is interested in being condescended to or patronized during this part of the meeting.  The most useful kind of OPC participation occurs when those offering commentary are shedding real light on an issue – particularly the human face to the condition.  If the condition is one commonly understood by everyone, that is probably not necessary.  If, on the other hand, it is a condition that needs a human face, it can be quite useful.  I have seen good examples of this and bad.  Each must be assessed on a case by case basis.

Finally, from a media point of view, it is a good idea to understand the media environment for your day.  Are there other FDA AdComms meeting that day – unusual, but not unheard of – that could overshadow or blunt your coverage?  Are there hearings on the Hill that could do the same?  Look at the social media commentary from the last meeting in this space and develop your own social media listening approach to the meeting.

In the end, it is about data, data and data.  But good skills, good planning and even good luck still are factors not to be ignored.

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Weekly Roundup 2.14.14

Well, I am really tardy with this posting – the Weekly Roundup is not only late, it is real late.  Sorry, it was not Valentine’s Day festivities, nor was it a result of the snow storms – some of which left my herd grazing on snow.   It was just really busy and I was a bit stretched.  And I didn’t think in the end, anyone would truly mind.

But there were a few things of note, particularly this first item, so here it is, better late than never:

  • FDA Seeking Public Comment on DTC – The agency announced this week in the Federal Register that it would be seeking public comment on its research related to “Disclosure Regarding Additional Risks in DTC Prescription Drug Television Ads”.   The comment is on the collection of information, but in this notice FDA lays out its hypothesis about DTC ads as currently implemented with the “major statement” are too long thereby undermining patient comprehension.  In other words by being thorough and complete one is being boring and uncommunicative.  The ad warnings may be so long and involved that it does not penetrate with the audience.  On the other hand, how to get the information that is important into the ears and minds of patients?  How to solve the issue?  FDA is going to embark on a study with participants who have been diagnosed with one of three possible medical conditions who will view different versions of ads to assess risk comprehension.  Should be interesting.  You can see more about the study design in the Federal Register notice.
  • First Drug to Receive Rare Pediatric Disease Priority Review Voucher Approved - The agency announced approval of Vimizim to treat a rare congenital enzyme disorder called Morquio A syndrome.  The condition is caused by a deficiency in a particular enzyme which can lead to problems with bone development, growth and mobility and is so rare that the press release states that there are only 800 patients diagnosed in the United States.  The drug got priority review designation and prior to the approval there were no approved drug treatment options.
  • New Approval to Treat CLL - A new treatment for chronic lymphocytic leukemia called Imbruvica was approved under accelerated approval  to treat patients who have received at least one previous therapy.  In addition to being approved under accelerated approval, the new treatment was orphan-product designation.  According to the press release, CLL is a rare disease of the blood and bone marrow that gets increasingly worse over time and causes a gradual increase in white blood cells.

There (finally) is the Weekly Roundup for this week.  For those of you having a long weekend due to the holiday, I hope you have a good and restful one.

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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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