From The San Francisco Gate, 4/18/04:
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/06/18/MNG7V78AGB1.DTL
Experts not behind reversal on Plan B
FDA bowed to politics, critics say
Marc Kaufman, Washington Post
Washington --
Just days before the Food and Drug Administration rejected an
application to make the emergency contraceptive Plan B available
without a prescription, top FDA scientists dismissed the reasoning
that was used to justify the rejection as unfounded, internal agency
documents reveal.
The documents, which contain the scientific conclusions of three
separate levels of FDA reviewers, show that the scientists disagreed
in particular with the contention that there was insufficient
information to assess how easier availability of the drug would affect
the sexual behavior of young teenagers.
That was the primary reason given for the FDA's dismissal of the
application as "non-approvable."
One top official wrote that by raising the issue of teenage use,
former Commissioner Mark McClellan and Center for Drug Evaluation and
Research acting director Steven Galson appeared to be introducing a
different standard for evaluating Plan B than the FDA had applied to
other contraceptives.
"The agency has not (previously) distinguished the safety and efficacy
of Plan B and other forms of hormonal contraception among different
ages of women of childbearing potential, and I am not aware of any
compelling scientific reason for such a distinction in this case,"
wrote John Jenkins, director of the FDA's Office of New Drugs, which
oversees all drug reviews for the agency.
When Galson announced the surprise rejection of Plan B on May 6, he
acknowledged that the FDA staff disagreed.
But there was no further explanation; the internal documents offer the
first look at the depth and breadth of the disagreement.
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Scientology tries to disrupt terrorist attacks relief efforts: http://www.cosvm.org/
"Easy everyone, it's just the chocolate milk talking." -- Miles Long
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