For three years, drugmaker Barr has asked to sell the emergency contraceptive Plan B without a prescription. And now the Food and Drug Administration says it's willing to consider a compromise.
FDA officials are considering an unusual split status for Plan B. Those 18 or older could buy the drug over the counter. Anyone younger than 18 would still need a prescription. Barr is requesting that the drug be sold to those older than 16.
Sens. Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) call the FDA's announcement "more smoke and mirrors." The senators earlier pledged to block any nomination of a new FDA chief until the agency made a decision — yes or no — on the status of Plan B.
Here, a look at the science and debate over Plan B:
Q: How does the drug work?
The drug consists of two high doses of the hormone progestin — the most common ingredient in regular birth control pills. If taken within 72 hours of unprotected sex, it reduces the odds of getting pregnant by 89 percent. The chances of getting pregnant are even lower if Plan B is taken sooner.(See sidebar for more on how the drug works, and how it differs from the abortion pill RU-486.)
Plan B is now available by prescription. Why do supporters want it sold over the counter?
Plan B is most effective if taken within the first three days after unprotected sex. Some women's health groups, such as the National Organization for Women and the Reproductive Health Technologies Project, argue that most unprotected intercourse happens on the weekend, when it's hard to reach a doctor to ask for a prescription. If Plan B were available without a prescription, say supporters, women could obtain and take the drug sooner, making it more effective.
What are the objections to making Plan B available over the counter?
The FDA originally said no to Barr Pharmaceuticals' request in 2004, citing in part concern over young teens using the drug without a doctor's supervision. Opponents of the drug also say that easier availability could encourage teens to have sex and might increase the spread of sexually transmitted diseases.
Some anti-abortion groups also debate how Plan B works. They say it could act to prevent implantation of a fertilized egg, thus making it, in their view, a drug that causes abortion rather than a contraceptive.
Supporters counter that making the product more widely available could greatly reduce the risk of unintended pregnancy and the need for abortion.
Aren't there ways around the last-minute rush to get a prescription?
Through collaborative agreements between individual physicians and pharmacists, women can get Plan B without a visit to a health care provider in nine states: Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont and Washington.
The Association of Reproductive Health Professionals' Web site Not-2-Late.com also lists brands of regular birth control that can be used as emergency contraception. ARHP, along with the American Medical Association, recommends that doctors write advance prescriptions for women so they'll have the drug when they need it.
What's the status of emergency contraception in other countries?
At least 41 countries sell emergency contraception without a prescription, according to Lisa Wynn of Princeton's Office of Population Research. Some countries do have age requirements, such as Great Britain, where emergency contraception is available without a prescription only for those 16 and older.
Other countries where emergency contraception is available without a prescription include Aruba, Australia, Belgium, Benin, Burkina Faso, Cameroon, Canada, China, Congo, Denmark, Estonia, Finland, France, French Polynesia, Gabon, Ghana, Greece, Guinea-Conakry, Iceland, Israel, Jamaica, Latvia, Luxembourg, Mali, Mauritania, Mauritius, New Zealand, Niger, Portugal, Senegal, Slovakia, South Africa, Sri Lanka, Switzerland, Togo and Tunisia.
What are the side effects and risks of Plan B?
Side effects are similar to those of regular birth control pills: nausea, vomiting, cramping, fatigue, headache, dizziness, breast tenderness and menstrual changes. The AHRP says "most women can safely use emergency contraceptive pills, even if they cannot use birth control pills as their regular method of birth control."
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