FDA Official Resigns
in Protest of
'Morning-After Pill'
Decision
By Marc Kaufman,
washingtonpost.com from the Web, August 31, 2005
Washington, DC -- The top Food
and Drug Administration official in charge of women's health issues resigned
today in protest against the agency's decision last week to further delay a
final ruling on the whether the emergency contraceptive "morning-after pill"
should be made more easily accessible.
Susan F. Wood, assistant FDA commissioner for women's health and director of the
Office of Women's Health, said she was leaving her position after five years
because Commissioner Lester Crawford's decision on Friday amounted to
unwarranted interference in agency decision-making.
"I can no longer serve as staff when scientific and clinical evidence, fully
evaluated and recommended for approval by the professional staff here, has been
overuled," she wrote in an e-mail to her staff and FDA colleagues.
She said that Crawford's position -- that unresolved regulatory issues made it
impossible to approve expanded use of the drug -- is "contrary to my core
commitment to improving and advancing women's health."
When the FDA rejected the first application last year to make the emergency
contraceptive Plan B available without a prescription, officials acknowledged
that the science staff had overwhelmingly favored the application. When
Crawford announced additional delays on Friday with a second application, he
again acknowledged that the staff and managers of the Center for Drug Evaluation
and Research had concluded that the drug was safe for over-the-counter use for
women over 17.
Crawford said, however, that the agency was wrestling with unresolved regulatory
issues regarding whether it could properly allow a drug to be sold as an
over-the-counter medication for most women, and by prescription-only for girls
under 17. He said the issue had to be addressed through a formal
rule-making process, which can be time-consuming.
Many supporters of the Plan B application -- including Sens. Hillary Clinton (D-N.Y.)
and Patty Murray (D-Wash.) -- accused Crawford of making a political decision
that ignored science and public health.
The Plan B issue has become an emotional one for advocates -- who believe it
will reduce the number of unwanted pregnancies and abortions -- and opponents
who believe that it will encourage teenage promiscuity and that in some cases
its mode of action constitutes abortion. Social and religious
conservatives flooded the White House with phone calls in the days before
Crawford's decision.
The FDA and mainstream medical associations consider that Plan B, which is
generally effective in preventing pregnancy if taken with 72 hours of a
contraceptive failure or unprotected sex, prevents a pregnancy rather than
ending one. Religious conservatives and some members of Congress disagree
and say that pregnancy begins with the fertilizing of the egg. They argue
that anything that harms the egg amounts to abortion. While Plan B
generally works by preventing fertilization, in some cases it can keep a
fertilized egg from implanting in the uterus.
Wood has been the senior official for women's affairs since 2000, and the
mission of her office is to "be a champion for women's health, both inside and
outside the agency."
Before coming to the FDA, Wood was the director for policy and program
development at the Department of Health and Human Services' Office on Women's
Health, where she led the development of policy for the office and recommended
initiatives for the assistant secretary for health and the secretary.
Before that, Wood worked on Capitol Hill for the Congressional Caucus for
Women's Issues, which is dedicated to advancing legislation that promotes legal,
economic, and health equity for women.
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