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Finally. Individuals Speak Out Pro & Con (Mostly Con) About Online Pharma Marketing

December 11, 2009

The comments are dribbling in to FDA regarding whether or how it should regulate the use of the Internet by drug companies for promotion of its products. Either that, or www.regulations.gov, which is collecting the comments here, has a growing…

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Transcripts of FDA’s November 2009 Public Hearing on Social Media Available

December 8, 2009

You can find the transcripts here:

  • Day 1 (November 12, 2009): PDF File, 507 pages
  • Day 2 (November 13, 2009): PDF File, 517 pages

 Enjoy!

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Dear FDA: Where Are the Public Comments Regarding Regulation of Internet, Docket FDA-2009-N-0441?

December 2, 2009

A public service message from FDA Intern:

Not only does FDA Intern want to know where all the comments are, I want to know also! It’s been over 2 months since the FDA called for comments and three weeks since the public…

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FDA Social Media Guidelines Best Done in Baby Steps

November 14, 2009

In his closing remarks at yesterday’s public hearing on FDA regulation of social media, Tom Abrams, Director of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), said “what we have heard is it’s a different medium.”

As far as I…

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FDA Social Media Hearing Day 1: My Key Takeaways

November 13, 2009

In my presentation before the FDA at yesterday’s public hearing, I made some specific suggestions, including the use of an FDA-designated hash tag to be included in each branded Tweet posted by pharmaceutical companies. If each product was assigned a…

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I’m Off to FDA Hearing: Here’s What I Plan to Show (PPTs) and Tell (Transcripts)

November 11, 2009

I am scheduled to make two presentations at the November 12 - 13 FDA public hearing on the use of social media for Rx (and device) promotion:

Presentation #1: Accountability, Fulfilling Regulatory Requirements, and
Posting Corrective Information
Date: November 12, 2009
Time: 9:30…

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FDA Panelists at the Upcoming Social Media Public Hearing

November 10, 2009

Only the following 13 FDA panel members will be able to ask questions during this week’s public hearing on the use of social media by the pharmaceutical industry:

  • Thomas W. Abrams - Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) -…
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PhRMA Proposes FDA-Approved Use of Universal Safety Symbol for Branded Tweets & SE Ads

November 9, 2009

In a telephone news briefing, PhRMA proposed an “FDA-Approved Use of Universal Safety Symbol” that could be used in branded/sponsored ad links (eg, Adwords) and Twitter posts (see image below).

PhRMA says in its slide presentation (see here):

  • Universal safety symbol (FDA…
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FDA Public Hearing: Not Deja Vu All Over Again?

November 5, 2009

At eyeforpharma’s eCommunication & Online Marketing Summit, the audience had a lot of questions about the upcoming FDA public hearing. At one point, the discussion turned to the nature of the speakers for this hearing versus the 1996 hearing. I…

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My FDA Social Media Hearing Presentations

November 5, 2009

As you no doubt know, FDA is hosting a public hearing on pharma’s use of social media for Rx drug (and device) promotion next week (see here). I will be making two presentations at that meeting (see speaker schedule here):

  • 9:30-9:45…
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