In 2003, Barr Laboratories applied to the FDA for over-the-counter status on a drug that had previously been sold in the United States with a prescription. The special advisory committee appointed to review the bid was clearly impressed with the safety of the drug in question, commenting, “This might be the safest drug [the FDA has] ever reviewed.” They voted unanimously to approve the application. But the FDA, in an unprecedented move, chose to delay its decision an unprecedented three times – most recently this past August, with the deferral ominously tagged “indefinite.” Why has the FDA moved to delay granting over the counter status to a drug widely recognized as being “safer than aspirin”? Because the drug in question is Plan B, also known as “emergency contraception” or “the morning after pill,” and the FDA is under enormous political pressure from the current administration to keep it under wraps. There are widespread misconceptions about Plan B that cause unwarranted concern among both politicians and the general public. Some worry that Plan B can end an established pregnancy, confusing Plan B with RU-486, the “abortion pill”; they are not the same. Other pro-life groups worry that Plan B interferes with implantation by thinning the uterine lining, making it more difficult for a fertilized egg to implant. This is not the case, according to a study published in Biomedicine in May of this year. Joe DeCook, MD, retired OB/GYN and vice president of the American Association of Pro-Life Obstetricians and Gynecologists clarifies: “The post fertilization effect was purely a speculation that became truth by repetition.” Many worry that the drug will affect sexual behaviors or contraceptive use. But a study out this past January on the effect of emergency contraception on sexual behaviors including contraceptive use, published in the Journal of the American Medical Association this past January, found “there were no differences in patterns of contraceptive or condom use or sexual behaviors by study group.” Not to mention that EC is over the counter in 38 countries, including Canada, the UK, Australia, Israel, Sweden, France, the Netherlands, and South Africa. Plan B is also available without a prescription in 7 states – Alaska, California, Hawaii, Maine, New Mexico, and Washington. Recently, the Massachusetts legislature voted to allow Plan B sales over the counter, which will come into effect as soon as the state Health Department draws up pharmacy guidelines regulating the sale of the drug. (Although the Health Department reports to Governor Mitt Romney, who unsuccessfully tried to veto this particular bill, so it’s likely that this project will be put on hold indefinitely). What can you do? If you’re interested in learning more, Professor Gloria Weinstein of BU’s Chemistry Department will give a talk on the Science of Emergency Contraception tonight (Tuesday, Oct 18th) at Morse Auditorium at 7:15pm. Additionally, this Saturday (the 22nd) BU’s VOX: Voices for Choice group will be holding a Live Action Camp, an awareness project focused on Emergency Contraception. (Email [email protected] for more information). The FDA has also offered an opportunity for concerned citizens to voice their opinions on this issue at their website, fda.gov. Approximately 3 million unintended pregnancies occur every year in the United States alone. Women’s health experts estimate that over-the-counter emergency contraception has the power to halve that number, and prevent hundreds of thousands of abortions annually. Isn’t that something we can all get behind?

Natalie Doran [email protected] (978) 846-1011 CAS 2006