FDA's New Drug Safety Initiative

[elisa]

For anyone who is interested in FDA's actions....
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http://www.fda.gov/cder/drugSafety.htm
FDA is launching a new program to make drug safety information available to you in an easily accessible format. Because patients are taking a more active role in their healthcare, we want to make safety information available about the medicines they are using. We believe that patients, their healthcare professionals, and other consumers will find the information we are providing useful in their prescribing and treatment decisions.

Our Drug Safety Initiative has the following components:

* Drug safety information located together in a new web location
* Drug specific information for healthcare professionals, patients, and other consumers
* Other consumer education
* Draft Guidance: FDA’s “Drug Watch” for Emerging Drug Safety Information [PDF] [Word] [html]
* Manual of Policies and Procedures (MaPP): Drug Safety Oversight Board (DSB)
* Questions and Answers on FDA's New Drug Safety Initiative [PDF] [Word] [html]
* Secretary Leavitt's February 2005 Press Release

[scotty]

Looks nice, but isn't this what they're supposed to be doing????

FDA’s “Drug Watch” for Emerging Drug Safety Information

And yet they have the "adverse drug reaction reporting" that they totally dismiss as anecdotal.

I'm bitter, but until we see a change at the top of the FDA this is all window dressing.

Thanks for finding this Elisa!

[rdjanis]

Originally Posted by scotty

Looks nice, but isn't this what they're supposed to be doing????

This is exactly what I thought when reading this.

[elisa]

Originally Posted by scotty

Looks nice, but isn't this what they're supposed to be doing????

FDA’s “Drug Watch” for Emerging Drug Safety Information

And yet they have the "adverse drug reaction reporting" that they totally dismiss as anecdotal.

I'm bitter, but until we see a change at the top of the FDA this is all window dressing.

Scotty, at least the FDA in publishing this article would HAVE to be accountable to the public, wouldn't you say? Ofcourse, I agree with you that the TOP has to be changed......that's THE MOST important issue.

[scotty]

The accountability has been there the whole time. But they are in the unique position of evaluating the data however they choose. If they say that the drug is OK, then its OK! When a problem arises after the approval they cover their butts with "We weren't given all the facts!".Until all the facts are mandated nothing will change. All these changes remain voluntary. ie internet publication of clinical trials, adverse drug reaction reporting etc.. So true data is skewed by lack of participation in the process.

[elisa]

As always Scotty, you're right on!!