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Medical Forum / Diseases and Disorders / Diabetes / March 2006

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Follow up drug studies not conducted

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Susan - 06 Mar 2006 15:00 GMT
These are the studies that are supposed to give us a truer picture of a
drug's safety once a large population is using it.

Susan

http://abcnews.go.com/Health/wireStory?id=1684277

"WASHINGTON Mar 3, 2006 (AP)— Drug companies have yet to even begin
nearly two in three of the follow-up studies they agreed to undertake
once their medicines were on the market, according to a government tally
released Friday.

Often the drugs received expedited approval from federal regulators on
condition that the studies be carried out.

The Food and Drug Administration said in an annual report that, as of
Sept. 30, 65 percent of the 1,231 so-called "post-marketing" drug
studies that companies had pledged to carry out were still pending. "

Susan
Michael - 06 Mar 2006 15:53 GMT
My first reaction was that FDA should stonewall approvals until
companies get their backlogs cleared.

But, then I had a thought:  who says /any/ of these are supposed to be
completed?  The article doesn't say how late, if at all, any of these
post-marketing studies are.  Maybe none of them are due to be completed
until 2008.

OTOH, if I know congress and FDA, there's probably /no/ time limit on
these studies.

> x-no-archive: yes
>
[quoted text clipped - 18 lines]
>
> Susan
Susan - 06 Mar 2006 16:01 GMT
> My first reaction was that FDA should stonewall approvals until
> companies get their backlogs cleared.

That's what they were supposed to be doing all along.

> But, then I had a thought:  who says /any/ of these are supposed to be
> completed?  The article doesn't say how late, if at all, any of these
[quoted text clipped - 3 lines]
> OTOH, if I know congress and FDA, there's probably /no/ time limit on
> these studies.

So you're saying that the FDA is not performing it's most important
function in safeguarding consumers against potentially dangerous drugs.

Susan
 
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