LOL FDA

I don't think this has ever happened before.  I was
reading an
article about the organizational chart at the href="http://www.fda.gov/" rel="tag">FDA
and I laughed out
loud.  







Unfortunately it was not a good "monkey-on-a-goat" LOL moment; rather,
it was a "WTF-sounds-like-Bush" kind of LOL.



The chart is from this article: href="http://content.nejm.org/cgi/content/full/357/10/960">Sidelining
Safety — The FDA's Inadequate Response to the IOM,
by Sheila Weiss Smith, Ph.D, in the latest NEJM (Volume 357:960-963).
 (It's open-access.)



I've written about this at length before ( href="http://scienceblogs.com/corpuscallosum/2007/04/things_that_affect_you_pdufa_a.php">1
href="http://scienceblogs.com/corpuscallosum/2007/04/things_that_affect_you_pdufa_a_1.php">2
href="http://scienceblogs.com/corpuscallosum/2007/04/things_that_affect_you_pdufa_a_2.php">3).
 Bascially, the problem is that all of the safety experts at
the FDA are ina divsion sererate from the division that approves drugs.
 And all the regulatory authority is in the division that
approves drugs.  So the safety people have no regulatory
authority.  



The FDA commissioned the rel="tag">Institute of Medicine to prepare a
report with recommendations for improving safety...
 

They got href="http://www.nap.edu/catalog.php?record_id=11750#toc">the
report, and promptly ignored the most important
recommendations.  Naturally, two of the most important
recommendations were to: more closely integrate the safety and approval
people, and to give the safety people some regulatory authority.
 Their response, as described by Smith:

In response to an IOM recommendation that
scientists with expertise in pharmacoepidemiology or public health be
included as regular members of all scientific advisory committees, the
agency has proposed that it include such expertise "when safety issues
are an important component of the issues before the Committee."

That is when I laughed.  It is such a classic Bush
Administration line.  We'll include the safety experts when
safety is important.  



Well, when is safety not important?
 Indeed, that is what Smith wrote in her next few sentences:

But safety should always be on the agenda.
Such expertise is critical for evaluating and interpreting often sparse
safety data at the time of drug approval, for evaluating proposed
postmarketing studies, and for assessing risk-management action plans.
The FDA's response once again highlights the low priority it assigns to
its responsibility for arbitrating drug safety.

This is just incredible.  They commission a bunch of really
smart people, who work really hard to come up with really good
recommendations.  So far, so good.  Then they just
ignore the whole thing.

Recognizing the pervasiveness of this
marginalization [of the safety experts] at the agency, the IOM
recommended that DHHS appoint an external management advisory board to
help find ways of transforming the agency's culture. The FDA responded,
instead, with a series of internal initiatives, pilot studies, and
further evaluations that leave safety experts working largely in
isolation, with limited resources and outdated technology.

Here at SceinceBlogs, we often are critical of the government for
suppressing, distorting, and misusing science.  But now
they've gone one step further: now they just ignore it.