FDA's Morning-After Pill Shift Stirs Debate

April 22, 2009— -- For Susan Wood, Wednesday's announcement by the U.S. Food and Drug Administration may have offered a degree of vindication that has been nearly four years in the making.

In August 2005, Wood -- formerly the assistant FDA commissioner for women's health and director of the Office of Women's Health -- resigned from her post over a decision by the agency to further delay over-the-counter access to the Plan B contraceptive, also known as the morning after pill.

One year later, the FDA approved the over-the-counter sale of the pill to women 18 and older without a prescription.

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On Wednesday, the agency announced a full reversal of its prior reticence with regard to Plan B -- extending the contraceptive's over-the-counter status to 17-year-old women as well.

"It's a start," Wood said. "It is not the be-all and end-all. It's one more step in the right direction."

The move on Plan B had been widely anticipated since last month, when a U.S. District Court rejected a Food and Drug Administration decision to limit over-the-counter access to the emergency contraceptive to women 18 and older -- and further stipulated that the FDA act within 30 days to extend over-the-counter access to the pill to 17 year olds.

While the FDA originally did not move on the issue of whether the pill should be available prescription-free to 17-year-olds, it appears that it will not contest the court's order.

"The government will not appeal this decision," the FDA said in a brief statement issued Wednesday afternoon. "In accordance with the court's order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."

But where Wood and other proponents of expanded over-the-counter access to Plan B saw a positive step, opponents used the announcement as an opportunity to air their concerns over increased availability of the pill.

"This decision is driven by politics, not by what is [good for] minors," said Wendy Wright, president of the conservative public policy group Concerned Women for America. "Now the FDA is making the drug available to minors, without parental consent. Parents should be furious with the FDA."

Plan B Pill Decision Stirs Up Lingering Debate

The pill at the center of the debate, officially known as levonorgestrel, contains a high dose of birth control drugs. Taken within 72 hours of unprotected sex or a contraceptive failure, the drug can prevent a fertilized egg from attaching to the wall of the uterus.

While religious conservatives have likened Plan B to an abortion pill for this reason, those who support its wider availability are quick to point out the differences between the morning after pill and RU-486, a pill which induces a chemical abortion of an established pregnancy.

Wright is not the first to allude to the politics behind the issue; indeed, supporters of wider availability of Plan B have maintained for years that the FDA decisions on the matter have been driven more by politics than by research.

"Today's announcement by the FDA is a strong statement to American women that their health comes before politics," said Planned Parenthood president Cecile Richards in a statement. "And that's the way it should be. This decision is commonsense policy that will help reduce the number of unintended pregnancies and protect the health and safety of all women."

Stacie Geller, director of the National Center of Excellence in Women's Health at the University of Illinois College of Medicine in Chicago and author of a 2007 review paper on emergency contraception, is another supporter of wider Plan B availability. At the time of last month's court decision, she said that there was no evidence to suggest that the drugs were in any way dangerous to women younger than 18.

"There is nothing in the studies to suggest that women less than 18 years old had any different reaction, side effects or reproductive outcomes that were any different from those women 18 [and older]," she said. "The political agenda of the right always attacks the young and the poor first; they are the most vulnerable and have the hardest time organizing and fighting back."

Opponents to Plan B Availability Register Moral Objections

Nancy Northup, president of the Center for Reproductive Rights, further noted in a statement released Wednesday that the development is a victory for science.

"We are pleased that the FDA is taking the necessary steps to comply with the court's order. It's a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science," Northup's statement reads. "It's time the FDA restores confidence in its ability to safeguard the public health and put medical science first."

But along with the debate over the science has come a debate over the propriety of allowing women younger than 18 to take Plan B. It is this facet of the debate that has split pharmacists -- some of whom have registered their moral objection to offering the pills in the first place.

But Diana Zuckerman, president of the National Research Center for Women and Families, said that the primary issue at play has always been one of safety.

"The issue all along has been the safety of this product and at what age can a girl or woman make an appropriate choice," she said. "Seventeen seems like a reasonable compromise. Certainly it should prevent unwanted pregnancies, which is very important."

Zuckerman added that the morning after pill may also be a tool to prevent pregnancies from rape in teenage girls.

Wood agreed that the pill would be a boon to many women in this age group.

"For 17-year-old women, it will make a great deal of difference," she said, adding that she believes there should be no age restriction on the pill.

"No one should be blocked from it," she said. "There are a lot of over-the-counter drugs with much more serious safety issues, this is not breaking any new ground."

Wright disagreed.

"A minor girl can't get her ears pierced, in many states can't go to a tanning booth without her parents' permission," she said. "And yet, now the FDA is making this drug available to 17-year-olds and there will be pressure to make it available to [girls] even younger, to 17."

Change Will Not Happen Right Away

Not surprisingly, TEVA Pharmaceuticals -- the maker of Plan B -- applauded the decision.

"We support the FDA's decision to expand OTC access for Plan B to consumers 17 and older," TEVA's statement read. "The company believes that timely access to Plan B is extremely important, as the sooner Plan B is taken the more effective it is. We will continue to work closely with FDA to ensure that all provisions of this decision are met."

Plan B Policy Change Could Take Months to Implement

But the shift in policy could take as long as 10 months to take effect.

The first step will involve the FDA officially informing TEVA that it has permission to start marketing and selling Plan B to 17-year-olds over the counter. The company then will have to submit for a label change approval.

The FDA has said that the change will not take the entire 10 months, but spokespeople were not able to say how soon the new policy would take effect.