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June 16, 2009

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Brad


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

Ellen C

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"!

TSC

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."

TSC

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!

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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

Posted by: Brad | June 17, 2009 at 12:02 PM

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"!

Posted by: Ellen C | June 17, 2009 at 06:09 PM

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."

Posted by: TSC | June 20, 2009 at 08:50 PM

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!

Posted by: TSC | June 20, 2009 at 09:25 PM