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Response to Some Comments
In response to a few of the comments that have come in we have added a new section to the “About This Blog” page. On that page you will now find a description of the Task Force’s Actions and Membership. We will also provide a webcast of the Public Meeting on the 24th. The link to the webcast will provided here in a separate post as well as on the Task Force website. The webcast will also be available for viewing online after the public meeting.
If you have any other suggestions on how we can improve this blog and make it more useful please let us know.
Thank you and we look forward to your input and participation.
FDA Transparency Task Force
Transparency is indeed a good thing. However we seem to be moving in the wrong direction, as of late. FDA approval dates are passed, often without any comment. If a comment is made stating an extension timeframe (see HEB), then often that timeframe is simply missed as well.
Clearly we do not expect any leaking of sensitive information, but transparency should include transparency for missed approval dates, and accuracy for extensions to those dates.
It really is not that hard to manage. Please assure the public at large that the FDA is run in a professional and competent manner, and start meeting approval dates, or clarifying extensions to those dates in a timely fashion.
Thanks
I can’t tell you how disappointing it is that the redesign of the website could not maintain information at the same web addresses. Not only are most – or even all – of my links obsolete without being redirected, but some pages of important information are altogether missing. For example, the FDA A-Z index has dropped subjects such as Employee Directory. Not very “transparent”!
The Washington Post interview of Margaret Hamburg is all over the medical blogs. It would be nice to provide the link to it (http://www.washingtonpost.com/wp-dyn/content/article/2009/06/17/AR2009061700595.html) on the FDA Home page, or at least on this blog. Dr. Hamburg had something to say about the Transparency Task Force, too: “We’ve changed our posture to one that is more aggressive and forward leaning,” Hamburg said. At her direction, Sharfstein is chairing an internal task force to recommend ways to release more information about FDA decisions and policies. The agency has long been criticized for keeping private information about drugs or devices under study, even when the products are linked to serious health problems or deaths.”
Other news items of interest. Is tobacco regulation authority as bad for the agency as this post suggests http://www.gooznews.com/node/2959#comments? German regulators found out that Pfizer was deliberately withholding data on its antidepressant reboxetine (http://www.fiercepharma.com/story/germans-accuse-pfizer-sitting-data/2009-06-16?utm_medium=rss&utm_source=rss&cmp-id=OTC-RSS-FP0). Kudos to the FDA for not approving reboxetine in 2001 because of the lack of efficacy!
Dr. Hamburg had something to say about the Transparency Task Force, too: “We’ve changed our posture to one that is more aggressive and forward leaning,” Hamburg said. At her direction, Sharfstein is chairing an internal task force to recommend ways to release more information about FDA decisions and policies. The agency has long been criticized for keeping private information about drugs or devices under study, even when the products are linked to serious health problems or deaths.”
I just hope that you will have a consistency in everything you do.
I heard a while back that Dr. Sharfstein left FDA. I’d just like to thank him for the work he did to further FDA transparency. Is Afia gone now also?
Is FDA planning on continuing this blog? Is it to serve more of a public relations and announcement purpose? Are you still interested in hearing general ideas and concerns from the American public? A lot has been on my mind lately regarding FDA, but I am hesitant to post as those ideas don’t fit neatly into any recent blog post categories. It would be nice to have an open-ended “Tell us what is on your mind” post.
The Agency is still committed to the Transparency Initiative, and we hope that the blog will increase the dialogue between the Agency and stakeholders. We are always looking for new ways to increase transparency and to improve FDA Basics and the blog. We appreciate your recommendation and will discuss it with the Task Force.
I see that there’s also a will to improve whatever is being done…
Was the info that Phizer lied regarding info on antidepressants used to sandbox them and aid with the birth defects issue.