April 23, 2009 in Nation/World

FDA expands availability of Plan B pill

Agency to allow 17-year-olds to buy morning-after pill without prescription
Ricardo Alonso-Zaldivar Associated Press
 

The morning-after pill

Name: Plan B.

Manufacturer: A subsidiary of Teva Pharmaceuticals Inc.

Use: If taken within 72 hours of unprotected sex, it can lower the risk of pregnancy by up to 89 percent.

What it is: A high dose of a drug found in many regular birth-control pills.

What it isn’t: It’s not the same as the abortion pill RU-486. Plan B prevents ovulation or fertilization of an egg; it also may prevent the egg from implanting into the uterus, though recent research suggests that’s unlikely. It has no effect on women who already are pregnant.

What else it isn’t: Everyday contraception. It’s not intended for routine use.

Who can buy it: Starting soon, women 17 and older can buy it without a prescription. Currently, they must be 18 for nonprescription sale. Anyone younger still requires a prescription.

Side effects: Some nausea, dizziness, breast tenderness atemporary menstrual changes.

Associated Press

WASHINGTON – Seventeen-year-olds will be able to buy the “morning-after” emergency contraceptive without a doctor’s prescription, a decision that conservatives denounced as a blow to parental supervision of teens but that women’s groups said represents sound science.

The Food and Drug Administration said Wednesday it would accept, not appeal, a federal judge’s order that lifts Bush administration restrictions limiting over-the-counter sales of “Plan B” to women 18 and older. U.S. District Judge Edward Korman ruled last month in a lawsuit filed in New York that President George W. Bush’s appointees let politics, not science, drive their decision to restrict over-the-counter access.

Women’s groups said the FDA’s action was long overdue, since the agency’s own medical reviewers had initially recommended that the contraceptive be made available without any age restrictions.

Korman ordered the FDA to let 17-year-olds get the birth control pills. He also directed the agency to evaluate clinical data to determine whether all age restrictions should be lifted.

The FDA’s latest action does not mean that Plan B will be immediately available to 17-year-olds. The manufacturer must first submit a request.

“It’s a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science,” said Nancy Northup, president of the Center for Reproductive Rights, which filed the lawsuit.

Conservatives said politics drove the decision.

“Parents should be furious at the FDA’s complete disregard of parental rights and the safety of minors,” said Wendy Wright, president of Concerned Women for America.

Plan B is emergency contraception that contains a high dose of birth control drugs and will not interfere with an established pregnancy. It works by preventing ovulation or fertilization. In medical terms, pregnancy begins when a fertilized egg attaches itself to the wall of the uterus.

If taken within 72 hours of unprotected sex, it can reduce a woman’s chances of pregnancy by as much as 89 percent.

Critics of the contraceptive say Plan B is the equivalent of an abortion pill because it can prevent a fertilized egg from attaching to the uterus. Recent research suggests that’s possible but not likely.

The battle over access to Plan B has dragged on for the better part of a decade, through the terms of three FDA commissioners. Among many in the medical community, it came to symbolize the decline of science at the agency because top FDA managers refused to go along with the recommendations of scientific staff and outside advisers that the drug be made available with no age restrictions.

© Copyright 2009 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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