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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Weekly Roundup 1.31.14

It will be groundhog day this coming week.  I know I will be watching to see what is predicted because I, for one, am done with the cold nature of this surly winter.  Dog walks have been painful.  Cars everywhere are covered in salt.  And of course my biggest beef with winter – the days are short and there is no quality time on the front porch.  In fact, there is no time on the front porch.  I am sure many of you will be watching too.  Let’s keep our fingers crossed.

In the meantime, it was a busy week for me and I did not get any postings up, for which I am sorry.  I will endeavor next week to be more fruitful.  Meanwhile, here is a little bit of what I thought I’d pass along from this week:

  • First OPDP Letter of 2014 Posted – The first, and right now only, regulatory action letter from the Office of Prescription Drug Promotion was posted (technically last week, it appears, but only noticed by me this week).  It was for a sales sheet and OPDP’s letter cited several issues with the promotional language.  If you represent a product that is not intended for pregnant women, this is a letter you may want to check out to see how to avoid being dinged by the agency for broadening the patient population indicated in the label.
  • FDA Issues Rule to Prevent Food Safety Risks During Transportation – The seventh and final major proposed rule to be announced under the Food Safety Modernization Act (FSMA) was issued this week by FDA that would require certain shippers, receivers and carriers transporting food by motor or rail to meet specific criteria for sanitary transportation.  An example provided in the press release would be that shippers would inspect a vehicle for cleanliness prior to loading food that is not completely enclosed in a container – for example, fresh produce in vented boxes.  This rule does not cover shippers who have less than $500,000 in annual sales.  Three public meetings are scheduled around the country to discuss the proposed rule and the public comment period runs through May 31.
  • Preparing for Advisory Committee – In case you are interested, I will be presenting next week at the CBI conference – the 5th Annual Effective Preparation for FDA Advisory Committee Meetings on February 6 here in Washington, D.C.  I will be presenting on non-clinical aspects of preparation – so please say hi if you are there.  I will be covering panel intelligence and issues mapping as well as various aspects of pre-approval communications.

That’s it for me after this cold week.  Stay warm and be well and have a good and restful weekend.  Groundhog, do your stuff!

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Weekly Roundup – 1.24.14

Many regular readers might remember last September when I was able to share the news that a friend had named a new born calf after me – Marky! Well, Marky is growing up and here she is – pictured behind this fine young man in front – showing off her beautiful cow eyes.

It is hard to believe that January is almost over and that we are all still trying to get used to writing 2014 instead of 2013.  Actually, truth be told, I am still in the 1990s.  But as the rest of the world moves on, here is a bit of what happened this week:

  • FDA Issues New Guidance on Dear Healthcare Provider Letters – This week the agency announced the availability of a new guidance entitled “Dear Health Care Provider Letters: n Improving Communication of Important Safety Information” meant to provide recommendations on the content and format of these missives to convey important information about a drug or to set about correcting misinformation.  Contained in it are recommendations on when to issue a letter, the types of information in it and organization and format information. Interestingly, this is issued in the same week FDA postponed a Risk Communications Advisory Committee meeting that had been scheduled to identify the impact and reach of topics of interest to consumers that had been scheduled for February 3 and 4.
  • Advisory Committee Portal Launched - FDA launched a new online, interactive portal that allows for electronic submissions for persons interested in sitting on one of the agency’s 33 advisory committees.   The portal provides a paperless means of applying and applications will be uniform and streamlined.  The announcement states that nominations may be made by professional societies, industry and consumer groups and other interested persons.  Coincident with the launch of the portal, the agency also made available conflict of interest guidelines.
  • FDA Bars Specific Ranbaxy Facility from Producing Drugs for U.S. Market – FDA announced that it was extending the scope of an existing consent decree with Ranbaxy Laboratories to cover pharmaceutical ingredients from a Toansa, India facility which would prohibit the distribution, manufacture, exportation or provision of API to American companies following an inspection of the facility on January 11 of this year where numerous violations were said to have been found.

Yee hah – let’s get on with the weekend.  Marky (the cow) and me (Marky the person) wish you a very good one.

Photo courtesy of Anne Becker.

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Looking Back Down the Road – What Have We Learned from FDA on Regulation of Digital Media?

So last week there was a lot of interest and commentary on the issuance of a draft guidance by FDA that provided some insight into how the agency is regulating promotional speech and social media platforms.  It seemed like a good time to produce a recap on where we are – and where we aren’t – with respect to social media.

  • March 2009 – It’s the Not the Medium, It is the Message – In April 2009, representatives from the Office of Prescription Drug Promotion (OPDP), then called the Division for Drug Marketing, Advertising and Communication (DDMAC) sat down with me to do a podcast to provide their thinking into how promotional speech would be regulated on these new platforms.  At the time, the thinking seemed to be that existing regulatory guidance was sufficient – that if you couldn’t say it in print or broadcast, you couldn’t say it in social media.  In short, the attitude was – it is not the medium, it is the message.  While that sounded simple and direct, in fact, the very nature of the Internet and social media platforms raised very specific questions that were unique to digital media – which quickly became apparent the following month.
  • April 2009 – The 14 Untitled Letters and the One Click RuleIn a seeming contradiction to “It’s Not the Medium, It is the Message” message FDA then issued 14 untitled letters to companies primarily for a failure to include risk information in banner ads on the Internet.  Banner ads had been a widespread practice in the world of prescription product promotion because of belief in the “one-click rule” – meaning that if risk information were one click away from copy that mentioned a product name and indication, then it was permissible.  Turns out the “one-click rule” was not a rule at all.  The takeaway however was clear – FDA laid out its first “guidance” on the Internet and social media by enunciating the tenet that when you have a drug name and indication present in promotional language, the risk information cannot be anywhere else but in the same place and cannot be incorporated by reference or included by link.  The FDA action resulted in a New York Times Headline – “FDA Rules on Drug Ads Sow Confusion as Applied to Web”.
  • September 2009 – FDA Announces Public Meeting on Internet and Social MediaApparently upon reflection FDA came to realize it is not just the message, it is the medium after all that begs some unique regulatory questions and announces in the Federal Register that it will hold a two-day meeting on the “Promotion of Food and Drug Association-Regulated Medical Products Using the Internet and Social Media Tools” to be held in Washington, D.C. (ironically in a room without a WiFi connection).
  • November 2009 – Two Day Public Workshop – FDA holds a two day meeting that had full attendance and participation by many pharmaceutical companies.  The meeting was patterned to answer a series of questions:  (1) For what online communications are manufacturers, packers, or distributors accountable? (2) How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, post marketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)? (3) What parameters should apply to the posting of corrective information on Web sites controlled by third parties? (4) When is the use of links appropriate? and finally (5) Questions specific to Internet adverse event reporting.  The docket for this topic was open to receive comments through February 2010.
  • July 2010 – Agency Issues an Untitled Letter Involving Facebook – In what has been the only regulatory action involving social media as a medium, OPDP issued an untitled letter regarding a Facebook share function based in part on the fact that the share function conveyed the drug name and indication without the risk information – again another version of the “one-click” rule – not really providing any new insight into the parameters discussed at the November 2009 meeting, but reinforcing the principle that wherever goeth the name and indication also must goeth the risk information.
  • December 2011 – FDA Issues Draft Guidance that Mentions Social Media – After a long, long period of silence, FDA finally issued a draft guidance that mentioned social media in its context, prompting some to believe this was the long-awaited social media guidance.  Rather, it was a guidance entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” which included what to do if the request came via digital media platforms, but provided little insight into FDA’s actual outlook on any of the questions raised during the 2009 public meeting.
  • Also in December 2012 – An Interesting Non-OPDP Warning Letter - FDA sent a Warning Letter to a manufacturer of an animal drug product that involved a social media communication. In this case, among other things that concerned FDA, the manufacturer “liked” a posting on their Facebook page that carried a claim by a third party, indicating a human had taken the product and experienced satisfactory results.  This perhaps indicates that a “like” – as an endorsement of the content that would be violative if the manufacturer had said it and one could extrapolate from this that a “re-tweet” of a comment that would contain a violative claim would also be an issue for FDA.
  • January 2013 – Another Non-OPDP FDA Warning Letter May Tell Us Something About Search - In the context of a letter citing other violations, one thing FDA noted in this non-OPDP Warning Letter was that by typing in specific medical conditions into the search engine on the site, the results included products which were not approved for the treatment of that condition.  ”In addition, typing the word ‘cancer’ or ‘diabetes’ into your product search field located on your website brings up your products… implying your products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases.”  This at least raises some questions about optimization issues.
  • January 2014 – FDA Issues a Draft Guidance on Post-Marketing Submissions Involving Social Media - It is perhaps telling that FDA issued a guidance about how to do post-marketing promotional submissions involving social media without ever having issued any guidance about use of social media, but that is what happened.  Here FDA gave the most insight it has ever given on the topic.  As mentioned last week, it was perhaps most notable for what it seemed to indicate regarding third party sites and third party commentary on a company owned site.

By staging the 2009 hearing, as it did, with specific questions being asked in a specific order FDA lent the altogether reasonable impression that the agency would answer these questions in the same order the form of a guidance document. That has not happened. Instead, we are getting puzzle bits to place back into the construct of the discussion.

If you go back to the questions, one can see that these events tell us some of the answers – from use of links to how third party material is regarded.  We will hopefully see more about correcting material of third parties, more on the appropriate use of links, about optimization – something not contemplated in the hearing – and more direct guideline as to how the agency is regulating these rapidly evolving media.  After four years, we are informed, but not fully.

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