Snapshot » FDA

Allergan Settles Charges It Went Too Far Marketing Botox

Betsy — Thu, 02 Sep 2010 09:29:27 +0000

Judge Refuses to Block Generic Lovenox

Betsy — Thu, 26 Aug 2010 10:35:51 +0000

Making the Case for Public Relations

Betsy — Fri, 06 Nov 2009 14:11:05 +0000

Sunday I fly to San Diego for PRSA’s Annual Conference themed “Delivering Value.” I’m expecting to bring back data, examples and measurement tools to help me help my clients convey the critical business necessity of communications as budgeting begins for 2010. I promise to share the good stuff here for those of you who aren’t going. My expectations are high because, a month ago, PRSA launched a campaign to raise awareness of PR’s value called “The Business Case for Public Relations.” The campaign already includes a library of resources. You can read more about it here.

In my own session, on Monday, with Impactiviti blogger Steve Woodruff, we will talk about ways that healthcare communicators can work with their Legal and Regulatory departments to (1) integrate social media outreach into the communications mix and (2) move forward responsibly while waiting for the FDA to issue social media guidelines. Do you have lessons learned on how to show PR’s business value to management that you can share, below? What has worked for you? What hasn’t?

Product Expertise

theadmin — Thu, 01 Oct 2009 17:38:19 +0000

Context:

FDA Cardiology Advisory Committee to review blood-thinner Fragmin for quality of life indication in terminal cancer patients

Challenge:

Higher mortality rates in Fragmin study arm viewed negatively by FDA

Solution:

Advised Pfizer team how to clarify the misunderstanding and revised the proposal flow

Results:

Unanimous approvable recommendation by the FDA Committee for the new indication

What do the FDA and google have in common? They are making changes that will impact your company’s communications

Betsy — Thu, 01 Oct 2009 11:14:49 +0000

So much is happening in social media that will impact pharmaceutical PR and marketing that it is hard to know where to begin in this first post.

The FDA has called for a much-needed public hearing on social media and the internet. The hearing is scheduled for November 12 and 13, with registration closing on October 9. The FDA will accept written and electronic comments through February 28, 2010. This is an important opportunity for healthcare communicators to have input into new regulatory policy that will impact their ability to manage their organization’s reputation in the digital world. For valuable commentary on the opportunities and challenges posed by this hearing, read Shwen Gwee’s take on Med 2.0. Mark Senak makes excellent suggestions on what industry communicators can do to prepare effective comments, and provides a link to the announcement on the Federal Register, at his blog Eye On FDA.

The other potentially big news right now — certainly a potentially big headache – is google’s SideWiki. Be prepared: anyone can use the SideWiki to post their uncensored comments right next to your web site. Some commentators I have read say the SideWiki is too geeky and too difficult to upload to get much pick up. I disagree, having just uploaded it this morning, very easily. The big issue here is, can a company be held responsible for discussions on or next to its site over which it has no control? For some thoughtful takes on this new development, read Steve Woodruff’s post on Impactivi and Fard Johnson’s post on Walking the Path.

Let me know if this was interesting or helpful to you. Also, please feel free to let me know what social media topics you would like to see covered here.