The U.S. District Court for the Eastern District of New York ordered the Food and Drug Administration to make the sale of an emergency contraceptive, Plan B, available to 17-year-olds without a prescription.
Currently, women 18 and over can get over-the-counter access to Plan B while those younger must have a prescription.
The FDA, as of Monday, Mar. 23, has 30 days to permit marketer Barr Pharmaceuticals to make the change; a move that U.S. District Judge Edward Korman claimed should have been done sooner, according to Larry Neumeister in the Mar. 23 Associated Press article "Judge Orders FDA to let 17-Year-Olds Plan B Morning Pill Without Prescription." Korman also accused the FDA of its unresolved issuance of the drug throughout the Bush Administration.
The court order was birthed from a lawsuit filed in 2005 by the Center for Reproductive Rights and others after the FDA denied a petition requesting that Plan B be available without a prescription to women of all ages.
Plan B: Emergency Contraception
Plan B, approved by the FDA in July 1999, is comprised of two progestin-only pills containing levonorgestrel, a more concentrated dosage of the same hormones used in regular birth control pills. Plan B was the first progestin-only pill approved in the United States for emergency contraception after unprotected sex, according to the Office of Population Research at Princeton University.
Plan B has been shown to reduce the risk of pregnancy by 89 percent if taken within 72 hours of unprotected sex, according to Plan B’s Web site. Plan B works in a similar way to birth control pills; preventing ovulation, fertilization and implantation of a fertilized egg in the uterus.
In 2006, the FDA allowed Plan B to be sold without a prescription to adults, but only by pharmacies that checked photo ID before selling the pills.
Plan B: Reactions to the Court Order
Wendy Wright, president of Concerned Women for America accused Korman of putting politics before facts in his decision to pressure the FDA.
“Minor girls need permission to go on a field trip, get a piercing, or in some states use a tanning booth. But now, by one judge’s order, girls will be encouraged to rely on an ineffective drug without medical oversight or parental involvement,” Wright said in her Mar. 27 reactionary statement, "Morning-After Pill Fails Test, But Judge Orders it for 17-year-olds."
Wright also claimed that making the morning-after pill more accessible has not resulted in fewer pregnancies or abortions, as advocates promised it would. She expressed concern of young women relying on Plan B as a regular form of birth control despite the drug never being tested for this type of use.
Debate also arises from the drug’s over-the-counter status. Before Plan B, the FDA has never classified a drug as over-the-counter when a lower dose of the same drug has required a prescription. National Organization for Women president Kim Gandy argues this is a good thing since the risk of unprotected sex is highest on weekends, a time when it is difficult to reach a doctor and obtain a prescription, according to her Dec. 16, 2003 "Statement in Support of Approval of Over-the-Counter Availability of Plan B Emergency Contraceptive."
The Association of Reproductive Health Professionals states in its May 2008 Position Statement on Contraception that since the FDA approved Plan B’s over-the-counter access to women over 18, sales have doubled “proving that eliminating barriers improve access.”
Until more research has been done about the long-term effects and pregnancy prevention of Plan B, debate about the accessibility of the drug will undoubtedly continue.
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