WASHINGTON (ABP) — The federal Food and Drug Administration has declined permission for over-the-counter sales of an emergency contraceptive — despite recommendations for approval from its own staff and an expert panel.
The agency acknowledged May 6 that it had sent a letter announcing the decision to Barr Laboratories, the New Jersey-based firm that sells the so-called “Plan B” drug. The drug is already available by prescription. However, the company and others had argued that making the drug available over the counter would help reduce unwanted pregnancies and abortions, because it is most effective within 24 hours of sexual intercourse.
The drug is essentially a higher-than-normal dose of a hormone commonly found in birth-control pills. Unlike with other “morning-after” pills, such as RU-486, most medical experts do not consider Plan B to be an abortifacient, or an agent that causes the death of a fertilized embryo.
However, many anti-abortion groups opposed the drug's approval because it can prevent implantation of a fertilized egg in a woman's uterus, which they say amounts to abortion. They also have argued that the drug could have negative effects on some users' health, making ectopic pregnancies more likely.
As justification for the denial, FDA officials cited concerns about the lack of information on the drug's effect on pubescent and teenaged girls. In a study conducted as part of the approval process, only 29 of 585 patients who took Plan B were under the age of 16.
But abortion-rights supporters and others suggested President Bush's re-election hopes influenced the decision by the Food and Drug Administration.
“Women's health should not be held hostage to election-year politics and pandering to anti-choice extremists,” Massachusetts Sen. John Kerry, the presumptive Democratic presidential nominee, said in a campaign statement. “In this White House, politics trumps sound science every time. The Bush administration is clearly more interested in appealing to its electoral base than it is in protecting women's health.”
The Kerry campaign and other groups pointed out that the FDA's own professional staff had recommended approval of the drug for over-the-counter sales. Most recently, an FDA expert advisory panel on over-the-counter drugs voted 23-4 to recommend Plan B for non-prescription sales.
Anti-abortion groups, meanwhile, welcomed the FDA decision. In a May 6 press release, Tony Perkins, president of the conservative Family Research Council, applauded the FDA “for putting the safety of American women and girls above the wishes of the pro-abortion lobby.”
In his daily e-mail newsletter to supporters the next day, Perkins said their calls and e-mail communications to the FDA “made a huge difference in the outcome of this story.” Perkins also said the “battle has been waging for months, with pro-abortion groups once again putting their abortion-on-demand ideology ahead of women's health — something they say they care so much about.”
Perkins accused the medical advisory panel that voted to recommend the drug's approval of being “stacked.”
The battle may not be over. The FDA letter to Barr Laboratories noted ways the drug could gain approval for over-the-counter status in the future. They included the pharmaceutical firm re-applying with a plan to make the drug available freely to women ages 16 and over and only by prescription for younger women.
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