According to a website announcement, the US Food and Drug Administration (FDA) said it will go ahead and allow 17 year old girls to get the morning after pill levonorgestrel (Plan B) over the counter once the drug manufacturer has successfully applied for a license.
According to the Washington Times, last month in a New York law court, US district judge Edward Korman ruled that the Bush administration had allowed politics to dictate to science in making the decision only to restrict over the counter access to the morning after pill to women aged 18 and above.
In his ruling Korman told the court that the FDA must allow 17 year olds to have over the counter access (ie without a prescription) to the drug, and also to evaluate whether there should be any age restriction at all.
On its website, the FDA said the government will not be appealing against the ruling.
The Bush administration delayed the decision for three years, and then in 2006, it allowed over the counter sales to women aged 18 and over while still requiring 17 year olds to show a prescription, said a report by Reuters news agency.
The FDA wants the drug manufacturer, Barr Pharmaceuticals Inc, now part of Teva Pharmaceutical Industries Ltd, to submit more data about the drug’s safety and effectiveness among younger users, Diana Zuckerman, head of the National Research Center for Women & Families, told Reuters. This means it could be as long as 10 months before the younger users will be able to buy the drug over the counter.
However, according to Teva, the sales of Plan B have more than doubled since it became available over the counter, said Reuters.
The morning after pill is designed to stop a woman becoming pregnant as long as she takes it within 24 hours of having sexual intercourse. Plan B, which comes as two pills, has a more concentrated dose of progestin than the contraceptive pill.
The announcement has been met with a mixed reaction.
The move has been welcomed by women’s rights groups, who think it will result in fewer unwanted pregnancies and abortions and thereby help women protect their health: they also want the restrictions to be be lifted even further.
Nancy Northup, president of the Center for Reproductive Rights, the group that took the government to court in 2005, said it was time that the “FDA restores confidence in its ability to safeguard the public health and put medical science first,” and that the move was “a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science.”
However, conservative groups say they are against any non-prescription access to morning after pills because it can lead to promiscuity, especially when minors can get hold of it without their parents knowing about it. Also, because it uses the same ingredients as the contraceptive pill, they say it will result in worse health for women because of higher risk of blood clots, heart attacks and strokes.
President of Concerned Women for America, Wendy Wright, said the FDA should have challenged the court ruling and that parents should be “furious at the FDA’s complete disregard for parental rights and the safety of minors”, reported the Washington Times.
Sources: FDA, Reuters, Washington Times.
Written by: Catharine Paddock, PhD