FDA to Consider Making Emergency Contraception Available Over-the-Counter

Maybe you forgot to use your diaphragm. Maybe the condom broke. Maybe you didn't plan to have sex last night. Whatever the reason, these accidents happen all the time, which makes it important for you to know about emergency contraception.

Emergency Contraception (EC) is a concentrated form of birth control that, when taken within 72 hours of unprotected sex, reduces the risk of pregnancy by 89 percent by preventing ovulation, fertilization, or implantation. In February, 1997, the Federal Drug Administration approved EC as safe and effective, and today there are two FDA approved products available with a doctor's prescription, Preven and Plan B. It is important to know that EC works before a woman becomes pregnant and that EC does not affect women who may already be pregnant. Contrary to circulating myths, EC cannot cause abortion and should not be confused with abortion pills like RU-486.

Because EC is available now only with a prescription, to get it, you have to go to a clinic or gynecologist. However, the FDA is considering making Plan B available over-the counter without a prescription. This means that a safe precaution against pregnancy would be available on the shelves of your local pharmacy. Easier access to this pill could prevent up to 1.7 million unplanned pregnancies and thousands of abortions each year.

Making Plan B available over-the counter sounds logical, right? Especially because the drug meets all of the FDA's requirements for over-the counter sales and is already sold in pharmacies in five states. So why hasn't the pill already been made available for you? There are people who oppose easy access to Plan B because they think it will decrease responsible sexual behavior.

What do you think the FDA should decide? Selling Plan B at drug stores would be safe, convenient, and confidential. But would the availability of the drug make you less likely to protect yourself when you're having sex? Tell us what you think by voting on our main page.

UPDATE - May 2004

The Food and Drug Administration recently decided against making emergency contraception available without a prescription. Although a scientific and medical advisory committee had voted 23-4 to make the pill more readily available, the acting head of the FDA rejected the measure.

Ultimately, Dr. Steven Galson, the temporary director for drug evaluation and research, decided there wasn’t enough evidence to determine that teens could safely use the pills without guidance from a doctor or medical professional. Emergency contraception, sometimes known as the “morning after pill,” can prevent pregnancy if taken within 120 hours after having unprotected sex, although the sooner the pills are taken, the more effective they are.

Although the FDA’s decision is a set back for sensible men and women of all ages, Barr Laboratories- who applied for over-the-counter status for their emergency contraception pill, Plan B- has been given a chance to conduct research that could overturn the decision. Because the FDA is concerned about the potential risks of easier access to Plan B for teenagers, Barr Laboratories proposed making Plan B available only to women over 16 without a prescription, while continuing to require a prescription for younger users. The FDA will reconsider the prescription status of emergency contraception in another year if Barr Laboratories can provide more information about their proposal or more substantial data about the safety of emergency contraception use for teenagers.

Now is the time to contact your legislators and let them know what you think about emergency contraception. The government, specifically the FDA, is making decisions that ultimately affect your body. Speak up and let them know this is an issue that concerns you. For more information on how to reach your legislators to talk about emergency contraception, visit www.advocatesforyouth.org or www.backupyourbirthcontrol.org.

UPDATE - March 2005

Nearly six months after Barr Laboratories' resubmission of their application for over-the-counter sale of Plan B emergency contraceptive for approval, the FDA announced a delay on their pending decision on January 21, 2005. The FDA initially denied approval for over-the-counter status for Plan B in May 2004 based on a claim that there was not enough evidence concerning EC use among adolescents less than 16 years of age. In response Barr Laboratories adjusted their application (in July 2004) to suggest over the counter sale of Plan B Emergency Contraceptive to adolescents 16 years of age and older. Youths under 16 years of age would still need a prescription from a doctor for EC.

There is also the underlying concern that women will come to depend on EC as their main form of contraceptive and lower the use of other long term contraceptive methods (i.e. condoms, birth control pills). Recent studies have determined, based on sexual activity among adolescents and young adults, that the availability of EC did not have an effect on sexual behavior and contraceptive use. A study conducted by the University of California determined that among a group of young women between the ages of 15 to 24, greater access to EC, when compared to groups that had lower access to EC, did not promote a change in sexual activity. Adolescents with easier access to EC were not more likely to have unprotected sex than those who did not have the same type of availability to EC.

Studies have demonstrated that the presumption that greater availability of EC will promote unprotected sex is a misconception. Despite the growing evidence supporting the advantages of over-the-counter sale of EC, the FDA has yet to make a decision. In light of the FDA's delay on a decision, Barr Laboratories has issued an adjustment of their request; raising the age from 16 to 17 and older for over-the-counter sale of Plan B. Whether this new adjustment combined with recent studies will change the FDA's prior decision is yet to be known.

Although the FDA has not set a date for their final decision, you can stay updated on this issues by visiting:

www.kaisernetwork.org
www.fda.gov
www.plannedparenthood.org