The FDA is Finished
READ MORE: 2006, Investigations
The FDA is here to protect us and to ensure, among other things, safe
drugs.

http://www.huffingtonpost.com/dr-peter-rost/the-fda-is-finished_b_21827.html

This is a tough task, a task which will often result in criticism.

And when the FDA is caught red handed making decisions that have
nothing to do with science, and everything to do with politics and
religion, the trust in the FDA effectively ends.

The FDA, as we know it, is finished, and here's why:

It was just revealed that two key Food and Drug Administration
officials recently testified that former FDA Commissioner Lester
Crawford took them out of the agency's normal drug approval process,
in order for him to personally block over-the-counter sales of an
important early pregnancy contraceptive or "morning-after pill."

We're talking about Crawford's decision in August 2005 to block
nonprescription sales of Plan B even though the key agency officials
wanted to approve them.

And who's behind this decision? The usual suspects. Conservative
groups and religious fundamentalists have lobbied the FDA and the
White House against nonprescription Plan B sales.

Religious fanatics argue that Plan B causes abortions, although the
scientific truth is that the drug, when it's taken within 72 hours of
unprotected sex, simply prevents pregnancy.

According to transcripts of the depositions, Dr. Steven Galson,
director of the FDA's drug evaluation center, and Dr. Janet Woodcock,
deputy operations commissioner, Crawford removed them from involvement
in the agency's decision on Plan B.

Galson, who testified he was unhappy with the FDA's Plan B process,
said: "What happened around that time frame is that Dr. Crawford, who
was the acting commissioner then, told me that he was concerned about
where we were heading because he knew that I was heading towards this
recommendation [approval], and he told me that he was going to make
the decision on what to do with the application."

He, he. Sounds different than when Galson motivated FDA's rejection of
Barr's application for Plan B non-prescription sales earlier, in May
2004.

On May 6, 2004, Galson wrote in a memo: "Some staff have expressed the
concern that this decision is based on non-medical implications of
teen sexual behavior, or judgments about the propriety of this
activity. These issues are beyond the scope of our drug approval
process, and I have not considered them in this decision."

Right. The truth doesn't always get out, but sometimes it does.

So, in August 2005, Crawford blocked Plan B and said the FDA needed
more time to consider a revised application from Barr to allow Plan B
sales without a prescription to women 16 and older but with a
prescription to girls 15 and under.

Dr. Susan F. Wood, the FDA's top women's health officer, then resigned
in protest over Crawford's handling of this matter.

The end of the saga is that the drug is still not approved without a
prescription and Dr. Crawford the former, eminent FDA czar, is now
under investigation himself.

The criminal investigation of Dr. Crawford by a federal grand jury
over accusations of financial improprieties and false statements to
Congress, was revealed only a month ago. Dr. Crawford resigned in
September 2005, less than three months after the Senate confirmed him
as the permanent FDA commissioner, a position which he had held on an
"acting" basis for a couple of years. He said then that it was time
for someone else to lead the agency.

Yep, criminal charges can do that to you. Time to move on.

Question is when the clowns who are messing with our healthcare system
and approval of vital drugs will be charged with their crimes.