This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill." The Plan B morning-after pill is moving over-the-counter, a decision announced by the Food and Drug Administration just days before a court-imposed deadline. On April 30, 2013, the FDA lowered to 15 the age at which girls and women can buy the emergency contraceptive without a prescription ? and said it no longer has to be kept behind pharmacy counters. Instead, the pill can sit on drugstore shelves just like condoms, but that buyers would have to prove their age at the cash register. (AP Photo/Teva Women's Health)
This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill." The Plan B morning-after pill is moving over-the-counter, a decision announced by the Food and Drug Administration just days before a court-imposed deadline. On April 30, 2013, the FDA lowered to 15 the age at which girls and women can buy the emergency contraceptive without a prescription ? and said it no longer has to be kept behind pharmacy counters. Instead, the pill can sit on drugstore shelves just like condoms, but that buyers would have to prove their age at the cash register. (AP Photo/Teva Women's Health)
WASHINGTON (AP) ? The Obama administration's decision to appeal a court order lifting age limits on purchasers of the morning-after pill set off a storm of criticism from reproductive rights groups, who denounced it as politically motivated and a step backward for women's health.
"We are profoundly disappointed. This appeal takes away the promise of all women having timely access to emergency contraception," Susannah Baruch, Interim President & CEO of the Reproductive Health Technologies Project, said in a statement late Wednesday.
"It is especially troubling in light of the Food and Drug Administration's move yesterday to continue age restrictions and ID requirements, despite a court order to make emergency contraception accessible for women of all ages. Both announcements, particularly in tandem, highlight the administration's corner-cutting on women's health," Baruch said. "It's a sad day for women's health when politics prevails."
The FDA on Tuesday had lowered the age at which people can buy the Plan B One-Step morning-after pill without a prescription to 15 ? younger than the current limit of 17 ? and decided that the pill could be sold on drugstore shelves near the condoms, instead of locked behind pharmacy counters. It appeared to be a stab at compromise that just made both sides angrier.
After the appeal was announced late Wednesday, Terry O'Neill, president of the National Organization for Women, said, "The prevention of unwanted pregnancy, particularly in adolescents, should not be obstructed by politicians." She called it a "step backwards for women's health."
Last week, O'Neill noted, President Barack Obama was applauded when he addressed members of Planned Parenthood and spoke of the organization's "core principle" that women should be allowed to make their own decisions about their health.
"President Obama should practice what he preaches," O'Neill said.
In appealing the ruling Wednesday, the administration recommitted itself to a position Obama took during his re-election campaign that younger teens shouldn't have unabated access to emergency contraceptives, despite the insistence by physicians groups and much of his Democratic base that the pill should be readily available.
The Justice Department's appeal responded to an order by U.S. District Judge Edward Korman in New York that would allow girls and women of any age to buy not only Plan B but its cheaper generic competition as easily as they can buy aspirin. Korman gave the FDA 30 days to comply, and the Monday deadline was approaching fast.
In its filing, the Justice Department said that Korman exceeded his authority and that his decision should be suspended while that appeal is under way, meaning only Plan B One-Step would appear on drugstore shelves until the case is finally settled. If Korman's order isn't suspended during the appeals process, the result would be "substantial market confusion, harming FDA's and the public's interest" as drugstores receive conflicting orders about who's allowed to buy what, the Justice Department concluded.
Reluctant to get drawn into a messy second-term spat over social issues, White House officials insisted Wednesday that both the FDA and the Justice Department were acting independently of the White House in deciding how to proceed. But the decision to appeal was certain to irk abortion-rights advocates who say they can't understand why a Democratic president is siding with social conservatives in favor of limiting women's reproductive choices.
Current and former White House aides said Obama's approach to the issue has been heavily influenced by his experience as the father of two school-age daughters. Obama and Health and Human Services Secretary Kathleen Sebelius have also questioned whether there's enough data available to show the morning-after pill is safe and appropriate for younger girls, even though physicians groups insist that it is.
Rather than take matters into his own hands, the Justice Department argued to the 2nd U.S. Circuit Court of Appeals that Korman should have ordered the FDA to reconsider its options for regulating emergency contraception. The court cannot overturn the rules and processes that federal agencies must follow "by instead mandating a particular substantive outcome," the appeal states.
The FDA actually had been poised to lift all age limits and let Plan B sell over the counter in late 2011, when Sebelius overruled her own scientists. Sebelius said some girls as young as 11 were physically capable of bearing children but shouldn't be able to buy the pregnancy-preventing pill on their own.
Sebelius' move was unprecedented, and Korman had blasted it as election-year politics ? meaning he was overruling not just a government agency but a Cabinet secretary.
More than a year later, neither side in the contraception debate was happy with the FDA's surprise twist, which many perceived as an attempt to find a palatable middle ground between imposing an age limit of 17 and imposing no limit at all.
Any over-the-counter access marks a long-awaited change, but it's not enough, said Dr. Cora Breuner of the American Academy of Pediatrics, which supports nonprescription sale of the morning-after pill for all ages.
"We still have the major issue, which is our teen pregnancy rate is still too high," Breuner said.
Even though few young girls likely would use Plan B, which costs about $50 for a single pill, "we know that it is safe for those under 15," she said.
Most 17- to 19-year-olds are sexually active, and 30 percent of 15- and 16-year-olds have had sex, according to a study published last month by the journal Pediatrics. Sex is much rarer among younger teens. Likewise, older teens have a higher pregnancy rate, but that study also counted more than 110,000 pregnancies among 15- and 16-year-olds in 2008 alone.
Social conservatives were outraged by the FDA's move to lower the age limits for Plan B ? as well as the possibility that Korman's ruling might take effect and lift age restrictions altogether.
"This decision undermines the right of parents to make important health decisions for their young daughters," said Anna Higgins of the Family Research Council.
If a woman already is pregnant, the morning-after pill has no effect. It prevents ovulation or fertilization of an egg. According to the medical definition, pregnancy doesn't begin until a fertilized egg implants itself into the wall of the uterus. Still, some critics say Plan B is the equivalent of an abortion pill because it may also be able to prevent a fertilized egg from attaching to the uterus, a contention that many scientists ? and Korman, in his ruling ? said has been discredited.
___
Associated Press writer Pete Yost contributed to this report.
Associated PressDana Vollmer Ryan Dempster Phelps NBC Olympics Live Olympic medal count Medal Count 2012 London 2012 Fencing
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.