Monday, February 07, 2011

Questions I Intend to Ask DDMAC Director Thomas Abrams at the ePharma Summit

I've noticed that FDA's DDMAC Director Thomas Abrams has been making presentations at several recent drug industry conferences. At the 10th Annual ePharma Summit that begins today in New York City (see here), Abrams presentation is titled: "Regulation and Oversight of Prescription Drug Promotion: Update from DDMAC," which is similar to presentations he's made at other conferences.

Of course, as I mentioned in a previous post ("11.5 Things I'd Like to Learn at ePharma Summit"), most attendees of the ePharma Summit are looking for updates on FDA's guidelines for use of the Internet and social media by pharmaceutical companies; ie, Where are they? When are they? What are they?

From a preview of Abrams' Powerpoint presentation, it appears that he will have very little to say in answer to these questions. Only 3 out of 46 slides concern social media guidelines. Two slides merely summarize what we already know: how many people made presentations at the November 15, 2009 public hearing and how many comments FDA received to the public docket.

The third slide describes the FDA's guidance sausage-making process (shown below; click for enlarged view):


Again, nothing new: Abrams, for example, has said before that FDA will issue "multiple guidances." We are somewhere in the "Prepare a draft guidance document and vet through internal clearance process" stage; ie, the sausage is jammed in the machine.

Here's what I hope to ask Tom Abrams at the Summit (if he allows questions from the audience):

"Tom -- I hope I can call you 'Tom'; I've seen you at so many of these conferences that I feel we should be friends on Facebook or Twitter if not in real life, but I can't find you on these social networks, so maybe I should stick to Mr. Abrams: What's holding up the process of releasing SM guidance? For example:
  • "Has President Obama's recent executive order for government agencies to review all regulations old and new to determine if they hinder economic growth thrown a monkey wrench into FDA's 'Social Media Guidance Process'? That is, is the FDA's guidance process slowed down because of this extra internal review that is required?
"Any comments at all about this issue that might be affecting the FDA's guidance process will be appreciated."

BTW, look for me wearing a special shirt, which may or may not be this one:

3 comments:

  1. Anonymous6:46 PM

    John--FYI you can attempt to Friend Tom here: http://www.facebook.com/#!/profile.php?id=569144406

    ReplyDelete
  2. Anonymous10:59 PM

    You are so lost when it comes to FDA. Why do conferences invite you to speak?

    ReplyDelete