Following the recent announcement from the Food and Drug Administration that they are postponing the decision on whether or not to grant over the counter approval of the drug Plan B, the FDA announced they are soliciting public opinion on how to regulate the controversial drug also known as the morning after pill. The agency is seeking to address a series of complex regulatory questions regarding how to make the drug available to women 17 years and older while keeping it prescription-only for those who are younger.

Volume 3, Number 9
October 5, 2005

Following the recent announcement from the Food and Drug Administration that they are postponing the decision on whether or not to grant over the counter approval of the drug Plan B, the FDA announced they are soliciting public opinion on how to regulate the controversial drug also known as the morning after pill. The agency is seeking to address a series of complex regulatory questions regarding how to make the drug available to women 17 years and older while keeping it prescription-only for those who are younger.

Plan B was approved for prescription use in 1999. It works similar to the normal birth control pill by preventing ovulation but also – if ovulation has already occurred – by preventing the living embryo from implanting in the uterus. After the FDA announced it was postponing whether or not to grant it over the counter approval, Susan Wood, the director of the FDA's office of women's health, generated controversy and media attention by announcing that she was resigning. "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," she said in an e-mail.

But Wendy Wright, executive vice president for Concerned Women for America, says the research tells a different story. Greater access to Plan B does nothing to reduce surgical abortions according to a recent report she coauthored, which presents the findings of several studies on the topic. One of the studies from Scotland reported that "in Glasgow, morning-after pill prescriptions increased 300 percent from 1992 to 1999. Yet, abortions did not decrease. In Lothian, where schools handed out condoms and sent pupils to clinics for morning-after pills, teenage pregnancies among 13 to 15-year-olds soared 10 percent in one year."

Research from the UK also revealed that over the counter access to Plan B "coincides with surges in STD rates. In areas where a limited program began in 1999 . . . chlamydia cases rose from 7,000 in 1999 to 10,000 cases in 2002. Gonorrhea cases climbed nearly 50 percent, to nearly 3,000 cases in 2002 . . . Abortions increased by nearly 6,000 in a one year period, jumping 3.2 percent in 2003 from 2002, with the largest leap among girls under the age of 16."

Wright also says making Plan B over the counter would create numerous problems especially with regard to keeping it out of the hands of minors. "The FDA has no mechanism for enforcing a regulation that prohibits sale to minors," she said.