Emergency Contraception 101 September 7, 2005

Emergency Contraception: What is It? Also known as Plan B or the Morning After Pill 2 high doses of estrogen/progestin pills – basically stronger oral contraceptives – taken 12 hours apart EC prevents the fertilization of an egg, the implantation of a fertilized egg, or causes the uterus to expel an implanted egg.

Is it an Abortion? IT CAN BE EC can cause abortions, even if providers claim they do not. Providers often define a pregnancy as implantation, not fertilization. Under this definition, when EC prevents a fertilized egg from implanting, it is not technically an abortion. However, life begins at fertilization.

Other Considerations The potential health effects of long-term use or misuse of EC EC is a high concentration of birth control, thus frequent use could result in the same side-effects experienced with birth control Playing with hormones can be tricky ground.

History of Emergency Contraception: Federal Confrontations 1997 – The Women’s Capital Corporation was formed to market Plan B to the U.S. and Canada July 1999 – Plan B gained FDA approval as a prescription drug. April 2003 – WCC pushed the FDA to make Plan B an over-the-counter drug. December, 2003—Barr Laboratories, the manufacturer of Plan B (EC), submitted an application to the FDA to legalize over-the-counter sale of EC to girls and women of all ages

History of Emergency Contraception: Federal Confrontations Feb – Barr Pharmaceuticals, Inc. buys out Women’s Capital Corporation to become the current developer. May 2004 – FDA rejects the request to make Plan B over-the- counter because not enough data supported the idea that young women could safely use the drug without the supervision of a doctor. Barr Laboratories revised its request to include an age limit, suggesting that EC be made available without a prescription to women 16 and older. The FDA was set to rule on the measure in January, 2005, but failed to. August 31, 2005—Susan Wood resigns from her position as chief of women's health at the Food and Drug Administration.

“The question we have been asked to address is whether Plan B should be available without a prescription on a pharmacy shelf, similar to the way other over-the-counter medicines like some cough syrups and allergy pills are sold, for women age 16 and older, and remain prescription-only for those under the age of 16.” FDA Commissioner Lester M. Crawford, August 26, 2005

“This was a personal decision for me and it was about what I could do inside the agency and the fact that I couldn't stand quietly as head of women's health while this decision, which is contrary to women's health, was made.” Susan Wood

Statewide Controversy August 4, 2005—Governor George Pataki of New York vetoed a bill that would provide over-the- counter EC, on grounds that it did not do enough to protect minors. The bill provided no limit on the number of pills that could be dispensed at one time. July, 2005—Governor Mitt Romney of Massachusetts vetoed similar legislation. Colorado Governor Bill Owen vetoed a bill that would have required information about emergency contraception to be present in all health care facilities. He reasoned that religious hospitals and care providers who are morally opposed to EC should not be forced to provide such information.

Legal Status of EC Plan B and Preven, 2 similar drugs, are available by prescription only FDA’s evaluation center has said that Plan B is safe to sell over the counter to women over 17, but the FDA has not yet approved this measure. They are opening the decision up to the public so that all interested parties can weigh in on the decision.

Emergency Contraception: What it is Not EC is NOT RU-486, or the Abortion Pill RU-486 is taken 5-7 weeks into pregnancy 3 clinician visits are required: Day 1, Day 3, and Day 14 for check-up RU-486 alters the placenta so that the fetus starves to death. A chemical called Prostaglandins then induces contractions that expel the fetus.

History of RU – Developed in France by Roussel-Uclaf, a French branch of the German company, Hoechst AG, formerly known as IG Farben. Sept – Approved for distribution and use in France. Oct – Roussel-Uclaf stopped distribution because of pro- life protesters in the U.S., France, and West Germany. (a few days later) Oct – The French Health Minister ordered RU-486 back on the market calling it “the moral property of women.” 1991 – Approved for distribution in Great Britain – Approved for distribution in Sweden.

US History with RU-486 The Bush (Sr.) administration placed RU-486 on an FDA list of items banned for importation to the U.S. The Clinton administration requested that the FDA reexamine the ban. May 1994 – Roussel-Uclaf gave the Population Council, a research institution, the rights to test the drug in the U.S. Since no U.S. company wanted to be connected to RU-486, the Population Council had to use a Chinese manufacturer. To market the drug in the U.S., the Population Council created a new company, called Danco. Sept – RU-486 gains FDA approval. Doctors may prescribe the drug if: 1. Doctors can tell how far along the pregnancy is. 2. The doctor must be near a hospital. 3. The doctor must be able to perform a surgical abortion if the pill doesn’t work.

Legal Status of RU-486 (Mifeprex) It is legal, but definitely prescription only FDA issued a public health advisory on July 22, 2005 stating that 4 known deaths have occurred from use of the drug Advisory also outlined the only approved regimen for taking the drug

EC On-Campus: The Student Health Center Examination including: Medical history form Informed consent form Pregnancy test if more than 28 days since last period Possibly a pelvic exam Check for vital signs Prescriptions Recommend a follow up gynecological exam

EC On-Campus: VOX’s EC Van National campaign to make EC more accessible Consultations/prescriptions ($27) from a registered nurse on board “All you need is an ID, check or cash, and the EC will be sent to you within 5 business days” “The van” stops by once a semester—be ready!

Bibliography “ Plan B Emergency Contraception: Still Waiting for the FDA” by Aaron Coles ec-otc.xml ec-otc.xml “Dismay over delay spurred FDA officer” by Alison Neumer Lara sep07,1, story?ctrack=1&cset=truehttp:// sep07,1, story?ctrack=1&cset=true "The Best Kept (ugly little) Secret in America“ by David C. Reardon, Ph.D. “Presidential Hopefuls Veto Emergency Contraception Despite FDA Support” “Pataki vetoes morning-after pill legislation” “Time for Plan B” by Grace Hood Baptists for Life: Life Dynamics.com: Planned Parenthood of Amarillo and the Texas Panhandle: Student Health Center: FDA: Clemson University: NARAL: VOX: Cavalier Daily: