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EMERGENCY CONTRACEPTION
Emergency contraception (EC), also known as the morning after pill, is an FDA-approved form of contraception. EC is an extremely time-sensitive drug that is most effective if used within the first 12 to 24 hours following unprotected sex, birth control failure, or sexual assault. If women at risk of unintended pregnancy use it correctly and consistently, EC has great potential to reduce the need for abortion. EC is often confused with the abortion pill (RU-486/Mifepristone), but they are not the same thing. EC works to prevent a pregnancy, but it cannot terminate a pregnancy. EC is not effective once a pregnancy is established. While some pharmacists refuse to dispense birth control pills, EC has been the primary focus of pharmacist refusals.
There are currently three types of EC available at U.S. pharmacies:
All of these are available without a prescription to women age 17 and older. Girls who are 16 or younger still need a prescription for EC. Individuals seeking EC, regardless of age, will need to ask for it at a pharmacy counter. Visit www.not-2-late.com or call 1-888-NOT 2 LATE to find locations that offer over-the-counter EC or a list of providers who will write you a prescription if you are under 17.
Note: In March 2009, a federal district court ordered the FDA to reconsider whether to make emergency contraception available to women of all ages without a prescription, but it has not yet done so.
Factsheets for Consumers
Policy Factsheets
Process of Approving EC for Over-the-Counter Status
Process of Approving EC for Over-the-Counter Status
· July 28, 1999:The U.S. Food and Drug Administration (FDA) approves Plan B® emergency contraceptive as a prescription drug.
· April 16, 2003: The manufacturer of Plan B® files an application with the FDA to change its status from prescription-only to over-the-counter (OTC) for all ages.
· December 16, 2003: Two FDA advisory committees recommend in a vote of 23 to 4 that the proposed OTC switch for Plan B® be approved. FDA review staff also agree that Plan B® should be granted OTC status.
NWLC Supports Application of Plan B to Transition Emergency Contraception to an Over-the-Counter Drug (December 16, 2003)
· February 2004: The FDA postpones its decision on the Plan B® application for 90 days.
· May 6, 2004: The Acting Director of the Center for Drug Evaluation and Research overrides the approval recommendations and issues a “not approvable” letter.
NWLC is Outraged at FDA's Decision Not to Approve Emergency Contraception for Over the Counter Use (May 7, 2004)
· July 22, 2004: The manufacturer submits a revised “dual label status” proposal that would make Plan B® available without a prescription for women aged 16 and older and prescription-only for those 15 and younger.
· January 21, 2005: The FDA fails to issue a decision on the Plan B® application within the time required under the Prescription Drug User Fee Act.
· June 15, 2005: The Senate Health, Education, Labor and Pensions Committee votes on the nomination of Dr. Lestor Crawford to head the FDA. Senators Patty Murray and Hillary Clinton place a hold on the nomination, delaying consideration by the full Senate due to FDA’s failure to make any decision on Plan B®.
· July 15, 2005: Senators Murray and Clinton lift the “hold” on Crawford’s nomination in exchange for a promise that the FDA will act on the Plan B® application by September 1, 2005.
· August 26, 2005: The FDA submits the Plan B® “dual label” application to the administrative rulemaking process and opens a public comment period.
FDA Delay Decision On Over-The-Counter Distribution Of Emergency Contraception (August 26, 2005)
Summary of Responses to the FDA's Advance Notice of Proposed Rulemaking on Plan B (November 1, 2005)
NWLC Calls on FDA to Stop Stalling on Emergency Contraception Approval (November 1, 2005)
GAO Report Confirms FDA Put Politics Ahead of Women's Health (November 15, 2005)
· March 15, 2006: Acting Commissioner Andrew von Eschenbach is nominated to head the FDA. Senators Murray and Clinton announce they will block his confirmation vote until a decision is made on the Plan B® application.
· July 31, 2006: The FDA announces that no further rulemaking is needed and that it is proceeding with the evaluation.
· August 1, 2006: The Senate Health, Education, Labor and Pensions Committee holds a hearing for von Eschenbach. Senators renew their “hold” on confirmation until the FDA acts on Plan B®.
· August 8, 2006: The manufacturer meets with the FDA and subsequently resubmits an application.
· August 23-24, 2006: The FDA agrees to make Plan B® available without a prescription only to women 18 and older, requiring women 17 and younger to obtain a prescription, and restricts its purchase to clinics and pharmacy counters.
· March 23, 2009: A federal district court orders the FDA to make Plan B® available to 17 year-olds without a prescription, and to reconsider whether to make the drug available to women of all ages without a prescription.
· April 22, 2009: FDA announces it will not appeal the court ruling.
· July 10, 2009: Plan B® One-Step, a one-pill version of Plan B®, becomes available over-the-counter for women 17 and older; it is available by prescription for girls 16 and younger.
· August 28, 2009: Next Choice™, the generic version of Plan B, becomes available over-the-counter to women 17 and older; it is available by prescription for girls 16 and younger.
