Senior FDA Official Steps Down Over Announcement to Stall Plan B OTC Approval

Director of FDA's Office of Women's Health Resigns Over Agency's Refusal to

Approve Plan B OTC

Aug 31, 2005, 01:00 ET from Reproductive Health Technologies Project

    WASHINGTON, Aug. 31 /PRNewswire/ -- American women lost an advocate for
 women's health and scientific integrity as Susan F. Wood, Ph.D., Assistant
 Commissioner for Women's Health and Director, Office of Women's Health
 announced her resignation today.
     Wood's resignation comes after the FDA again refused to approve Plan B for
 over-the-counter use last week.  Despite saying that it completed its review
 of this application, as amended, and concluding that the available scientific
 data are sufficient to support the safe use of Plan B as an over-the-counter
 product, the FDA said it would begin another regulatory process, thereby
 delaying the decision indefinitely.  The FDA plans to hold a new 60-day public
 comment period -- with no clear criteria or explicit timetable for a final
     Ms. Wood sent the following correspondence today to her colleagues and
 women's health advocates:
     "Dear Friends and Colleagues,
     I regret to tell you that I am leaving the FDA, and will no longer be
 serving as the Assistant Commissioner for Women's Health and Director of the
 FDA Office of Women's Health.  The recent decision announced by the
 Commissioner about emergency contraception, which continues to limit women's
 access to a product that would reduce unintended pregnancies and reduce
 abortions is contrary to my core commitment to improving and advancing women's
 health.  I have spent the last 15 years working to ensure that science informs
 good health policy decisions.  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.  I therefore have submitted my
 resignation effective today.
     I will greatly miss working with such an outstanding group of scientists,
 clinicians and support staff.  FDA's staff is of the highest caliber and it
 has been a privilege to work with you all.  I hope to have future
 opportunities to work with you in a different capacity."
     For press availability for Susan Wood please contact: Chrissy Faessen at

SOURCE Reproductive Health Technologies Project