Former FDA commissioner highlights women's history month

Susan F. Wood, former assistant FDA commissioner for women's health and director of the Office of Women’s Health, visited the College on Wednesday, March 7 to recount her decision to resign when her agency delayed the approval of Plan B, the “morning-after-pill,” for over-the-counter (OTC) status.

Beginning with a recap of the FDA’s history with women’s health, Wood detailed events that spanned from the beginning of the 20th century to present-day. She explored how the feminist movement in the United States has affected the FDA’s decisions regarding women’s health, explaining that the FDA has historically taken high regards for women’s health, reacting to research to determine whether or not a product is safe enough to be sold to the public.

She cited the FDA’s decisions not to approve thalidomide and to remove diethystibestrol from the market. The FDA felt that these pregnancy drugs did not have sufficient research backing them up and it was later found that they could cause serious complications.

“We should expect the FDA to carry out according to research,” Wood said.

However, Wood said, when top officials from the FDA delayed approval OTC status of Plan B in 2005, the decision was political.

Emphasizing that Plan B, which had been available by prescription since 1999, is not abortion, Wood explained how research defended the drug as a safe and effective method of preventing pregnancies if taken within 72 hours of failed contraception or unprotected sex. Additionally, an FDA expert advisory panel voted 23 to 4 in favor of the switch, she said. The controversy continued for several months in spite of the panel’s decision.

“This should have been a routine approval,” Wood said, adding that no other drug had ever been subject to so the same amount of scrutiny.

When OTC approval was delayed again in August of 2005, Wood resigned from her position. Although Wood said she is still loyal to the mission of the FDA, she decided she could not represent it after that.

“How was I going to defend this decision?” Wood asked. “There is no way to defend it, no way to explain it. I decided it was best to step aside.”

Since Wood’s resignation, Plan B was approved for OTC but only to individuals 18 and older. Though she says this is “real progress,” she continues to tour the country speaking in defense of the drug.

She urged the audience to, whatever their cause is, make themselves aware of what is going on around them.

“If you want to make a difference you have to engage in the conversation and learn what is happening.  I urge you to take those steps.”