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April 23, 2009

FDA To Allow Morning After Pill For 17-Year-Olds

In a decision denounced by conservatives as an affront to parental rights, the U.S. Food and Drug Administration (FDA) said Wednesday it would accept, not appeal, a federal judge's order to lift restrictions put in place under former president George W. Bush that permitted over-the-counter sales of the "morning after" pill only to women 18 and older.

Women's groups praised the FDA's decision, which would allow seventeen-year-olds to purchase the "Plan B" pills over-the-counter.

"Plan B" is emergency contraception containing a high dose of birth control drugs that prevent ovulation or fertilization. If taken within 72 hours of unprotected sex, the pill can reduce a woman's chances of pregnancy by up to 89 percent.

In a ruling last month in response to a lawsuit filed in New York, U.S. District Judge Edward Korman said that President George W. Bush's appointees let politics, rather than science, dictate their decision to limit over-the-counter access to the pills.

Supporters of expanded access to Plan B called the FDA's decision long overdue, particularly since the agency's own medical reviewers had originally recommended the contraceptive be made available without any age restrictions.

Korman ordered the agency to permit 17-year-olds get the birth control pills, and directed it to analyze clinical data to assess whether all age restrictions should be lifted.

However, the FDA's latest move does not mean that Plan B will be immediately available to 17-year-olds, since the pills' manufacturer must first submit a formal request.

"It's a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science," Nancy Northup, president of the Center for Reproductive Rights, which filed the New York lawsuit, told the Associated Press.

Conservative groups said the FDA's action was driven by politics.

"Parents should be furious at the FDA's complete disregard of parental rights and the safety of minors," an AP report quoted Wendy Wright, president of Concerned Women for America, as saying.

Plan B critics say the pills are the equivalent of an abortion because they can prevent a fertilized egg from attaching to the uterus. In medical terms, pregnancy begins when a fertilized egg attaches itself to the uterine wall.

However, research suggests that while that is possible, it is not likely.

The battle over access to Plan B has continued for nearly 10 years through the terms of three FDA commissioners.  

The controversy has come to symbolize the decline of science among many in the medical community and at the FDA because top managers refused to side with recommendations of scientific staff and outside advisers who recommended the drug be made available without age restrictions.

"The FDA got caught up in a saga, it got caught up in a drama," Susan Wood, who served as the FDA's top women's health official, told the AP.

Wood resigned in 2005 over delays in issuing a decision.

"This issue served as a clear example of the agency being taken off track, and it highlighted the problems FDA was facing in many other areas."

The Plan B treatment, which consists of two pills made by a subsidiary of Teva Pharmaceutical Industries, sells for $35 to $60. Currently, women seeking to purchase Plan B must ask for it at the pharmacy counter and show proper identification that includes their date of birth.

The drug does not prevent sexually transmitted diseases.

Supporters of broader access have claimed the pills are safe and effective in preventing unwanted pregnancies, and could help reduce the number of abortions.

However, opponents argue that it would encourage promiscuity and could ultimately be used by criminals running prostitution rings and sexual predators.

Scores of organizations petitioned the FDA early in the Bush administration to allow sales of Plan B without a prescription. 

But court documents show the issue became quickly politicized.

In 2003, a panel of independent advisers voted 23-4 in favor of recommending over-the-counter sales without age restrictions. 

But FDA officials nevertheless told their subordinates that no approval could be issued, and that a decision would be made at a higher level within the government "“ something considered unusual since the agency typically has the last word on drug decisions.

Korman said that members of the FDA staff were told the White House was involved in the decision on Plan B.

But according to court papers, the government said politics played no role.

The Center for Reproductive Rights and other organizations sued in federal court in 2005 to force an FDA decision.  The agency decided the following year to allow Plan B to be sold without a prescription to adults only.   But the debate continued over access for teens.

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