FDA Official Resigns Because Contraceptive
Decision was Political
Washington Post
FDA Official Quits Over Delay on Plan B
Women's Health Chief Says Commissioner's Decision on Contraceptive Was
Political
By Marc Kaufman
Washington Post Staff Writer
Thursday, September 1, 2005; Page A08
The top Food and Drug Administration official in charge of women's health
issues resigned yesterday in protest against the agency's decision to further
delay a final ruling on whether the "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 M. Crawford's announcement 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
overruled," she wrote in an e-mail to her staff and FDA colleagues.
Crawford said last week that unresolved regulatory issues made it impossible
to approve expanded use of the emergency contraceptive. Wood said the decision
was widely seen in the FDA as political.
"Many colleagues have made it known that they are deeply concerned about the
direction of the agency," she said in an interview.
Wood also said other FDA officials who are typically involved in important
matters were kept in the dark about the contraceptive, called Plan B, until
Crawford announced his decision, which she believed was made at higher levels
in the administration. Wood said that when she asked a colleague in the
commissioner's office when the decision would be made, the answer was, "We're
still awaiting a decision from above; it hasn't come down yet."
In a statement, the FDA said Wood's resignation "is unfortunate as we work
toward solving the complex policy and regulatory issues related to Plan B. . .
. The FDA is committed to protecting and advancing women's health, and under
Susan Wood's leadership, the agency has made significant strides."
Before coming to the FDA in 2000 in a civil service position, 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 secretary and
assistant secretary for health. She has also worked as a research scientist
specializing in the biochemistry of smell at Johns Hopkins University.
Her FDA job description was to "be a champion for women's health."
The Plan B issue has become an emotional one both for advocates who believe
that the contraceptive will reduce the number of unwanted pregnancies and
abortions, and for opponents who believe that it will encourage teenage
promiscuity and that, in some cases, its mode of action constitutes
abortion.
The FDA and mainstream medical associations say Plan B, which is generally
effective in preventing pregnancy if taken within 72 hours of a contraceptive
failure or unprotected sex, prevents a pregnancy rather than ends one.
Religious conservatives and some members of Congress say that pregnancy
begins with the fertilizing of the egg. They argue that anything that harms the
resulting embryo amounts to abortion. Although Plan B generally works by
preventing fertilization, researchers believe that in some cases it might keep
a fertilized egg from implanting in the uterus.
Wendy Wright, policy director for Concerned Women for America and a critic
of easier access to Plan B, welcomed Wood's resignation.
"Thank goodness there is now one less political activist at the FDA who puts
radical feminist ideology above women's health," she wrote in a statement. "Now
that Susan Wood has some free time on her hands, she can look at the studies
from countries that have made the morning-after pill available without a
prescription. She'll find it creates a public health hazard, with no decrease
in pregnancies, no decrease in abortion, but a substantial increase in sexually
transmitted diseases."
Plan B has been available as a prescription-only drug since 1999, and
distributor Barr Laboratories Inc. applied in 2003 for permission to sell it
over the counter. An FDA expert advisory panel voted 23 to 4 in favor of the
switch, which agency staff members believe would significantly cut the number
of abortions and unintended pregnancies.
The FDA rejected the application last year, however, saying it did not have
enough information about the possible consequences on teenagers younger than
16. At the suggestion of FDA officials, Barr Labs filed a new application that
would allow over-the-counter sales for women 17 and older and prescription-only
sales for those younger than 17. Crawford said Friday that the proposed
division by age poses "unique" regulatory problems that cannot be resolved
without a formal rule-making, which could take years.
Crawford also said FDA scientists and executives had concluded that the drug
could be safely sold over the counter.
Many supporters of the Plan B application -- including Sens. Hillary Rodham
Clinton (D-N.Y.) and Patty Murray (D-Wash.) -- accused Crawford of making a
political decision that ignored science and public health. The two senators
were especially angry at Crawford's ruling because they had lifted a hold on
his pending nomination based on promises, relayed by HHS Secretary Mike
Leavitt, that the Plan B issue would be resolved by Sept. 1.
Clinton and Murray have accused the administration of breaking its promise,
but Leavitt has disagreed. "The commitment was they would act," he told Reuters
on Monday. "Sometimes action isn't always yes and no. Sometimes it requires
additional thought."
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