Emergency contraception (EC)-- also known as the “morning after pill,” is a form of contraception that can be used shortly after sexual intercourse to prevent unintended pregnancy. EC is designed to be used in cases of unprotected sex or possible birth control failure, such as a condom breaking, and not as a regular form of contraception.
Progestin-only pills Plan B® and its generic form Next Choice® are the only EC pills available in the U.S., originally approved in 1999 by the Food and Drug Administration (FDA), for use with a doctor’s prescription. Research suggests that Plan B® prevents pregnancy by delaying or inhibiting ovulation or fertilization, or inhibiting a fertilized egg from implanting in the uterus. Plan B® is more effective the sooner it is taken after unprotected sex. If taken within 24 hours of unprotected intercourse, the risk of pregnancy is reduced by 95 percent. When taken within 72 hours Plan B® reduces the risk of pregnancy by 89 percent ,. EC cannot terminate or negatively impact an established pregnancy and is not a form of medical abortion or RU-486. EC also does not protect women against sexually transmitted infections.
After the initial approval of EC by the FDA, the manufacturer petitioned the agency for permission to sell Plan B® over the counter (OTC) without a doctor’s prescription. The FDA decision-making process was highly charged for several years. EC proponents argued that EC availability over the counter would provide easier access for women to help them prevent unintended pregnancies in the event of a contraceptive failure or after a sexual assault, while opponents contested that EC was an abortifacient . In 2006, the FDA approved the decision to sell Plan B® over the counter for men and women ages 18 and older . In 2007 OTC age eligibility dropped to age 17. Women younger than 17 years of age, however, are required to have a prescription to obtain Plan B® or its generic equivalent .
Currently the FDA is in the process of reviewing and, if approved, introducing a new EC regimen, ulipristal acetate, marketed as Ella® or EllaOne® in many European countries where it has been approved for efficacy and safety. Ella® is an anti-progestin pill regimen shown to prevent pregnancy after unprotected intercourse or contraceptive failure by delaying or inhibiting ovulation. The difference in effectiveness from Plan B® is that the window of time when Ella® is efficacious in preventing pregnancy is longer, up to 5 days after intercourse. Should Ella® be approved to be sold in the U.S., a prescription would be required for consumers of all ages.
Despite the establishment of EC as an OTC product that is widely available in most pharmacies, issues of EC access and availability persist and continue to stir polarizing debates, including EC’s high costs to those who want to obtain EC without a doctor’s prescription, lack of insurance coverage, structural barriers for women younger than 17 years of age to obtain EC (e.g. transportation, cost, privacy, lack of knowledge on where to obtain EC), and the role of pharmacists and other providers in providing the drug when they object to it for moral or religious reasons . The cost of EC varies by pharmacy and while certain family planning clinics provide EC at no cost, women without a prescription who want to obtain EC from a pharmacy may have to pay between $20-50 for a single dose.
- What has been the impact of EC since it was approved by the FDA?
- What state and local policies are currently in place to affect women’s access to EC?
- What are the major areas of disagreement about access to EC?
- Why would EC be confused with RU-486? What approaches could address this confusion?
- What policies are in place at the federal, state, and local levels to help assure that women who have been sexually assaulted have access to EC? What challenges do providers face?
Acknowledgements: Tina H. Park, Usha Ranji, and Alina Salganicoff of the Kaiser Family Foundation.
Updated: June 2010