Women's Health Chief Quits Food and Drug Administration Over Delays on "Morning After" Pill
September 1, 2005
Amid widening protest over the Food and Drug Administration's decision to delay a ruling on whether the "morning after" contraceptive can be sold without a prescription, the head of the agency's women's health office resigned yesterday. "I can no longer serve ... when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," wrote Susan F. Wood, a biologist who held the title of assistant commissioner.
Proponents of Barr Laboratories' Plan B say that making it easily available will help prevent unwanted pregnancies and reduce abortions. But opponents fear that it will encourage promiscuity, and they compare it to an abortion drug -- a position that is counter to the FDA's.
On Friday, FDA Commissioner Lester M. Crawford announced that even though Plan B is safe, proposed restrictions on teen girls' access to it have raised legal issues that must be examined in a process that could take months, or longer.
Plan B was approved by FDA as a prescription drug in 1999, but efforts to make it available over-the-counter have been stymied. Last year, FDA overruled an advisory panel recommendation and decided Plan B would remain a prescription drug. The agency invited Barr to reapply after submitting additional data, and the company requested that the contraceptive be made available to women over age 16; younger girls would need a prescription. According to an FDA fact sheet, Plan B works "like other birth-control pills to prevent pregnancy."
In a one-paragraph statement, FDA called Wood's resignation "unfortunate." The agency said regulators had made "significant strides" under her leadership in protecting and furthering women's health.
Los Angeles Times
09.01.2005; Ricardo Alonso-Zaldivar
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.