Kathleen Sebelius, secretary of the Department of Health and Human Services (HHS), rejected Wednesday (Dec. 7) a recommendation by the Food and Drug Administration (FDA) that would have enabled even young teenagers and preteens to buy a drug with abortion-producing potential as easily as hair spray and cough drops. The move by an Obama administration official known as a strong supporter of abortion rights surprised both pro-choice and pro-life advocates.
Her action means the "morning-after" pill known as Plan B One-step will continue to require a prescription for girls less than 17 years of age. Women 17 and older still will not need a prescription, but they also will continue to need to request the drug from pharmacists, who stock it behind their counters.
The same restrictions apply to Plan B, which is a drug requiring a two-step process.
Both versions of Plan B are referred to as "emergency contraception," a term used interchangeably with the "morning-after" pill. While both work to restrict ovulation in a woman or prevent fertilization, it is their back-up mechanism that draws particular opposition from pro-lifers. Acting after fertilization, the drug can block implantation of a tiny embryo in the uterine wall, thereby causing an abortion, pro-life advocates point out.
FDA Commissioner Margaret Hamburg said in a Dec. 7 statement she believed Plan B One-step should be approved for non-prescription sale but had received a memo from Sebelius saying she did not agree with Hamburg's decision. The Center for Drug Evaluation and Research, which makes recommendations to the FDA, decided the drug was safe and effective for younger females and could be used properly by them, an assessment with which Hamburg said she agreed.
In her statement the same day, Sebelius said she did not believe the evidence provided by the pill's manufacturer, Teva Women's Health Inc., demonstrated that girls as young as 11 would be able to understand Plan B One-step's label and use the drug properly. About 10 percent of girls are able to reproduce at 11.1 years of age, Sebelius said.
"If the application is approved, the product would be available, without a prescription or other point-of-sale restrictions, even to the youngest girls of reproductive age," Sebelius wrote in her memo to Hamburg.
"Based on my review, I have concluded that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages," she said.
Had Sebelius not overruled the FDA, pro-life and pro-family advocates would have strongly protested what would have been another move making it easier to obtain the "morning-after" pill. The FDA, which approved the two-step Plan B for sale by prescription in 1999, has twice since liberalized its requirements. The agency authorized the non-prescription sale of the drug to women 18 and older in 2006. It lowered the age for non-prescription sale to 17 after it chose not to challenge a judge's ruling in 2009.
Foes of the approval and expanded sale of the "morning-after" pill have expressed concern not only that it will result in the deaths of many unborn babies but open girls and women up to potential harm from unsupervised doses of hormones. In addition, they have said it would undermine parental oversight and set minors up for exploitation by adult sexual predators.
They commended Sebelius' decision.
"I applaud Secretary Sebelius for her wisdom in protecting girls 16 and under from the unprescribed usage of Plan B One-step," said Richard Land, president of the Southern Baptist Ethics & Religious Liberty Commission. "If this had gone on the open shelves, we would have begun to see young girls appearing in emergency rooms hemorrhaging.
"This is a dangerous drug without a doctor's supervision, and I certainly think we have an obligation to protect girls from using this drug without being under the supervision of a physician," Land said. "This is a very wise and prudent decision from the secretary of Health and Human Services."
"The average age of a girl who is sexually trafficked in the U.S. is 13 to 14," Monahan said. "There is a real danger that Plan B could be given to young women, especially sexually abused minors, under coercion or without their consent. Interaction with medical professionals is a major screening and defense mechanism for victims of sexual abuse."
Monahan also said, "Women of all ages have the right to know how this drug may act in their bodies and on their newly developing babies."
Abortion rights advocates expressed strong disapproval.
"We expected this kind of action from the Bush administration, so it's doubly disheartening and unacceptable that this administration chose to follow this path," said Nancy Keenan, NARAL Pro-choice America's president.
The Planned Parenthood Federation of America, the country's leading abortion provider, "is extremely disappointed" with Sebelius' action, a spokeswoman said.
The "morning-after" pill, which is also marketed under the brand Next Choice, is basically a heavier dose of birth control pills. Under the regimen for Plan B and Next Choice, a woman takes a pill within 72 hours of sexual intercourse and another dose 12 hours later. Plan B One-step can be taken in a single dose within 72 hours.
The FDA approved Next Choice and Plan B One-step for marketing in 2009. Next Choice is available only by prescription.
Tom Strode is Washington bureau chief for Baptist Press.
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