Hiển thị các bài đăng có nhãn morningafter. Hiển thị tất cả bài đăng
Hiển thị các bài đăng có nhãn morningafter. Hiển thị tất cả bài đăng

Thứ Sáu, 3 tháng 5, 2013

Justice Department appeals morning-after case

WASHINGTON (AP) — The Obama administration on Wednesday appealed a federal judge's order to lift all age limits on who can buy morning-after birth control pills without a prescription.

The decision came a day after the Food and Drug Administration had lowered the age that 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.

With the appeal, the government is making clear that it's willing to ease access to emergency contraception only a certain amount — not nearly as broadly as doctors' groups and contraception advocates have urged.

The order by U.S. District Judge Edward Korman of New York 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 Wednesday's filing, the Justice Department said 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.

"We are deeply disappointed that just days after President Obama proclaimed his commitment to women's reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions," said Nancy Northup, president of the Center for Reproductive Rights, which filed the lawsuit that prompted Korman's ruling.

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 Health and Human Services Secretary Kathleen 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.

Whatever happens in court, moving the morning-after pill over the counter, even if limited to buyers 15 or older, marks a big societal shift in the long battle over women's reproductive rights. But in the volatile debate, both sides were unhappy with FDA's surprise twist.

On Wednesday, doctors' groups including the American College of Obstetricians and Gynecologists urged the Obama administration not to let the FDA action be the last word, and to follow Korman's lead.

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.

Contraception advocates see a double standard. No one is carded when buying a condom, but under the FDA's decision they would have to prove their age when buying a pill to prevent pregnancy if that condom breaks.

"This isn't a compromise. This is wrong," said Cynthia Pearson of the National Women's Health Network.

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.

Obama aides bristled at the suggestion that the FDA decision was an attempt at political compromise, insisting the FDA merely responded to an application filed by Plan B's manufacturer which sought the 15 age limit and over-the-counter sales.

At the same time, Carney signaled that a policy allowing 15-year-olds to buy the pill off the shelf would be more palatable to Obama than the prospect of 11-year-olds having unfettered access. Pointing to Obama's comments in support of Sebelius back in 2011, Carney said, "he referred to younger girls, and I believe so did Secretary Sebelius."

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.

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Associated Press writer Pete Yost contributed to this report.


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Obama comfortable with FDA decision to let 15-year-olds buy morning-after pill

By Steve Holland

MEXICO CITY (Reuters) - President Barack Obama said on Thursday he is comfortable with a U.S. government agency's decision to allow over-the-counter purchases of a morning-after pill for anyone 15 and older.

Some critics have complained girls that young should not be allowed to purchase the pills without a doctor's approval. But Obama told a news conference in Mexico City that the decision was based on "solid scientific evidence."

The U.S. Food and Drug Administration on Wednesday appealed a court order directing the agency to make morning-after emergency contraception pills available without a prescription to all girls of reproductive age.

Lawyers with the Justice Department filed the appeal with the 2nd U.S. Circuit Court of Appeals in New York, according to court documents.

The appeal is the latest foray in the years-long legal battle over the pill known as "Plan B," a drug that has also sparked political and religious clashes. If taken up to 120 hours after unprotected sex, it is designed to prevent pregnancy.

The government is seeking to overturn U.S. District Judge Edward Korman's ruling from April 5 that required the FDA to make the emergency contraception available over-the-counter to women of all ages within 30 days.

Obama said it was not his decision to make, that it was up to the FDA and his Health and Human Services secretary, Kathleen Sebelius, to decide.

"The rule that's been put forward by the FDA, Secretary Sebelius has reviewed, she's comfortable with. I'm comfortable with it," he said.

(Editing by Lisa Shumaker)


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Obama OK with morning-after pill sales at age 15

MEXICO CITY (AP) — President Barack Obama said Thursday he was comfortable with his administration's decision to allow over-the-counter purchases of a morning-after pill for anyone 15 and older.

The Food and Drug Administration 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. The FDA decided that the pill could be sold on drugstore shelves near condoms, instead of locked behind pharmacy counters.

Obama, speaking at a news conference while in Mexico, said the FDA's decision was based on "solid scientific evidence."

What's still unclear is whether the administration will prevail on its appeal of a court order that would lift all age limits on purchasers of the pill.

That decision to appeal 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."

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, 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.

In its filing, the Justice Department said 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 stated.

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 writers Lauran Neergaard, Josh Lederman and Pete Yost in Washington contributed to this report.


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Thứ Tư, 1 tháng 5, 2013

Justice Dept to appeal morning-after case

May 1 (Reuters) - Post position for Saturday's 139th Kentucky Derby at Churchill Downs after Wednesday's draw (listed as barrier, HORSE, jockey, trainer) 1. BLACK ONYX, Joe Bravo, Kelly Breen 2. OXBOW, Gary Stevens, D. Wayne Lukas 3. REVOLUTIONARY, Calvin Borel, Todd Pletcher 4. GOLDEN SOUL, Robby Albarado, Dallas Stewart 5. NORMANDY INVASION, Javier Castellano, Chad Brown 6. MYLUTE, Rosie Napravnik, Tom Amoss 7. GIANT FINISH, Jose Espinoza, Tony Dutrow 8. GOLDENCENTS, Kevin Krigger, Doug O'Neill 9. OVERANALYZE, Rafael Bejarano, Todd Pletcher 10. PALACE MALICE, Mike Smith, Todd Pletcher 11. ...


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