{"id":6686,"date":"2011-02-07T14:54:00","date_gmt":"2011-02-07T14:54:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/questions-for-ddmac-director-thomas\/"},"modified":"2019-02-21T01:21:10","modified_gmt":"2019-02-21T01:21:10","slug":"questions-for-ddmac-director-thomas","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/questions-for-ddmac-director-thomas\/","title":{"rendered":"Questions I Intend to Ask DDMAC Director Thomas Abrams at the ePharma Summit"},"content":{"rendered":"

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<\/b> that begins today in New York City (see here<\/a>), 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.<\/p>\n

Of course, as I mentioned in a previous post (“11.5 Things I’d Like to Learn at ePharma Summit<\/a>“), 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?<\/p>\n

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.<\/p>\n

The third slide describes the FDA’s guidance sausage-making process (shown below; click for enlarged view):<\/p>\n

<\/a><\/div>\n

\nAgain, 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 We are somewhere in the “Prepare a draft guidance document and vet through internal clearance process” stage; ie, the sausage is jammed in the machine.<\/p>\n

Here’s what I hope to ask Tom Abrams at the Summit (if he allows questions from the audience):<\/p>\n

“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:<\/p>\n