Now What? I Thought Things Were Getting Better

I almost wrote about this yesterday: a pair of articles indicating that
the FDA is getting more serious about protecting people:



href="http://www.washingtonpost.com/wp-dyn/content/article/2007/01/30/AR2007013001496.html">FDA
Revamps Process for Safety of Drugs After Approval

href="http://www.washingtonpost.com/wp-dyn/content/article/2007/01/30/AR2007013001388.html">FDA
to Monitor Post-Market Drug Safety



The need to bolster post-marketing surveillance has long been a sore
spot with FDA-watchers.  It seemed that improvements were on the
way.  Plus, it appeared to be the case, that scientists who
expressed safety-related concerns would get a better chance to be heard.



But now we see this:

href="http://www.washingtonpost.com/wp-dyn/content/article/2007/01/31/AR2007013102015.html">Senators
Ask FDA to Keep Regional Labs

By Christopher Lee

Washington Post Staff Writer

Thursday, February 1, 2007; Page A07

The Food and Drug Administration should suspend plans to
close as many as nine of 13 laboratories that test the safety and
effectiveness of food, drugs, cosmetics and medical equipment, a
bipartisan group of senators said this week.



The network of labs, run by the agency's Office of Regulatory Affairs,
"could prove particularly vital in rapidly responding to public health
crises" during national emergencies, the lawmakers wrote Tuesday to FDA
Commissioner Andrew C. von Eschenbach...



...The FDA has not made public which labs it intends to shutter. Jeff
Ruch, executive director of the advocacy group, said FDA employees have
told his organization that the Cincinnati, Denver, Detroit, Kansas
City, Philadelphia, San Francisco and Seattle labs have been mentioned
as candidates for closure.



Among the duties of such labs is investigating food-borne illness such
as the recent outbreaks of E. coli in lettuce and spinach. Ruch said
closing labs would be a mistake at a time of heightened fears that
terrorists may try to tamper with drugs or the food supply.



"You compromise capability when you have laboratories removed from the
areas of need, such as large food-distribution centers or ports of
entry," he said...

So, with one hand, they plan to improve their policies and
procedures.  But with the other hand, they diminish the resources
available to implement those improvements.  Granted, no labs have
been closed yet, but it sure makes it hard to have faith in the
sincerity of the announcements that there will be improvements, when at
the same time, they are planning on downsizing.