FDLI Conference Part 4 - The Final Day

With the best of intentions, I set out to live blog from the FDLI Conference.  While Day 1 did not afford me an electrical outlet or a dynamic laptop battery, the second day I successfully planted myself next to an electrical outlet.  Then my cell phone rang and my morning was consumed by an emergency.  So it goes...

That necessitated my missing out on the morning breakout session that had a panel with both company and FDA representation to discuss DTC and compliance.  However, I did get back in to hear a panel discuss "The New Transparency".  Of most interest was the discussion of ghost writing.  Ghost writing is not new and has been around for a long time.  Certainly when we see an opinion piece in the newspaper by a Senator or Chief Executive Officer or Chairman of the Board, you can bet the farm that the piece was written for them.  So why is it more egregious when a scientific article is authored by one person and signed onto by another.  Have you ever seen the CV's of FDA Advisory Committee members.  Some of them have lists of academic article publications that go on for pages and pages, making them more prolific than Joyce Carol Oates.  Does anyone think they actually wrote all of those articles sitting at their computer as I sit now typing away at the kitchen table while having my morning coffee?  Ghost writing is the elephant in the room I think, and it is not confined to one journal or one medical society or one pharmaceutical company.  The real question when a company is involved is whether or not an article penned by a company (or written by someone paid by the company at their  behest) and given to a doctor to sign on to is two-fold.  One - does that make it a promotional piece rather than a scientific article?  I would think yes.  And two - should there be disclosure?  Again, yes.  Ghostwriting is not illegal, but the continued practice will almost certainly make it so at some point in the future.  It is a good example of one of those things that it would be easy for the industry to self-police and the failure to do so will result not only in some possible future legislation, but another public relations black eye.

During lunch I was able to sit with Tom Abrams, Director of DDMAC.  We were able to further explore my question posed the day before to Dr. Woodcock - given the long lead time for the development of a guidance on social media, and the fast evolution of new media (e.g., Google Wave) and the valuable role social media tools could play in protecting public health - what can the FDA do between now and the time a Guidance comes out to inform stakeholders about their direction and thinking.  Tom appreciates the fact that the situation has moved quickly and the agency seems to understand that it is behind the curve and needs to catch up.  His response was that if companies want to engage a particular tactic that they should include it in the marketing tools they put forward for FDA approval - in his words - "put it in a proposal" and get input.  He reiterated that the agency is anxious to get all points of view at the public meeting.  As of this writing, the link to Regulations.gov where you can sign up for the meeting is still not working.  FDA is working on it.  If you follow me on Twitter, I'll be tweeting when it does go up.

Again, the most valuable session of the day was the final session.  This one involved a panel made up of CDER, CBER, CDRH and CVM leaders who assembled solely to answer questions that had been written over the past few days.  This was emceed by a very capable and entertaining Wayne Pines from APCO.  Perennial questions were asked - such as how the FDA decides between a Warning Letter and an Untitled Letter.  Tom Abrams stated that the criteria include:  an assessment of how egregious the violation is and how likely an important matter of public health is being affected; the scope and dissemination of the communication; and whether or not it is an example of repeat behavior on the part of the company.  In response to a question that put forth the fact that some companies merely regard warning letters as a slap on the wrist, he highly discouraged that point of view, citing recent legal actions as a result of companies not taking the warnings seriously enough.  Perhaps of most interest involved the review of regulatory action letters by FDA's counsel.  Many understood from remarks made by Commissioner Hamburg at an August 6 meeting of FDLI that, in the interest of speeding up the process by which regulatory action letters get out, that the agency would dispense with this practice.  Apparently that is not so.  While untitled letters from CDER and CBER will not be reviewed, Warning Letters still will be sent for legal review.  

Change is certainly occurring at FDA, it is safe to say and the new leadership is re-molding the agency.  But it is not easy, workable clay and for those who have been waiting a long time for change, we will have to remember each day -  this is going to be a process, not an event.  

Comments

[Arnold I. Friede]

With respect, I think that who initially writes a draft of a scientific article is not dispositive of whether it is scientific speech protected by the First Amendment or fully regulable commercial speech subject to all of the rules governing advertising and promotion. There is a substantially more nuanced First Amendment analysis that needs to be evaluated in determining whether FDA can exercise regulatory jurisdiction over a scientific article on the sole and exclusive basis that the article was originally drafted by someone working for or on behalf of a commercial enterprise. After all, newspapers are written by paid writers. That does not make everything in the newspaper advertising. Accordingly, you may wish to advise your readers that this is not an open and shut case as your comment suggests. Otherwise, you may find yourself cited in a government brief as supporting FDA’s jurisdiction in every circumstance of the kind you identify.

ARNIE FRIEDE
Arnie@FriedeFDALaw.com

[Senak]

Arnie - point well taken. I think I was perhaps too enthusiastically
conveying what I thought was the FDA point of view and wasn't clear on that.
M

On Wed, Sep 23, 2009 at 9:41 AM, wrote: