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. ...
Thứ Sáu, 3 tháng 5, 2013
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)
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.
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.
Thứ Tư, 1 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.
___
Associated Press writer Pete Yost contributed to this report.
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. ...
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.
___
Associated Press writer Pete Yost contributed to this report.
Thứ Sáu, 5 tháng 4, 2013
U.S. judge widens 'morning-after' pill access for young girls
NEW YORK (Reuters) - A federal judge on Friday ordered the Food and Drug Administration to make the "morning-after" emergency contraception pill available to girls of all ages without a prescription.
The ruling by U.S. District Judge Edward Korman in Brooklyn, New York, comes in a lawsuit brought by reproductive-rights groups, which had sought to remove age and other restrictions on emergency contraception.
(Reporting by Jessica Dye; Editing by Martha Graybow; Editing by Gerald E. McCormick)
Judge making morning-after pill available to all
WASHINGTON (AP) — The morning-after pill might become as easy to buy as aspirin.
In a scathing rebuke accusing the Obama administration of letting election-year politics trump science, a federal judge ruled Friday that women of any age should be able to buy emergency contraception without a doctor's prescription.
Today, women can do that only if they prove at the pharmacy that they're 17 or older; everyone else must see a doctor first. U.S. District Judge Edward Korman of New York blasted the government's decision on age limits as "arbitrary, capricious and unreasonable," and ordered an end to the restrictions within 30 days.
The Justice Department was evaluating whether to appeal, and spokeswoman Allison Price said there would be a prompt decision.
President Barack Obama had supported the 2011 decision setting age limits, and White House spokesman Jay Carney said Friday the president hasn't changed his position. "He believes it was the right common-sense approach to this issue," Carney said.
If the court order stands, Plan B One-Step and its generic versions could move from behind pharmacy counters out to drugstore shelves — ending a decade-plus struggle by women's groups for easier access to these pills, which can prevent pregnancy if taken soon enough after unprotected sex.
Saying the sales restrictions can make it hard for women of any age to buy the pills, Korman described the administration's decision, in the year before the 2012 presidential and congressional elections, as "politically motivated, scientifically unjustified and contrary to agency precedent."
Women's health specialists hailed the ruling.
"It has been clear for a long time that the medical and scientific community think this should be fully over the counter and is safe for women of all ages to use," said Dr. Susan Wood, who resigned as FDA's women's health chief in 2005 to protest Bush administration foot-dragging over Plan B.
Half the nation's pregnancies every year are unintended. Doctors' groups say more access to morning-after pills — by putting them near the condoms and spermicides so people can learn about them and buy them quickly — could cut those numbers. They see little risk in overuse, as the pills cost $40 to $50 apiece.
"The fact that it's over the counter does not make people have sex," said Dr. Angela Diaz, director of New York's Mount Sinai Adolescent Health Center. "Sixty percent of young people are sexually active by 12th grade, and the more tools we have to help them be responsible, the better."
Social conservatives criticized the ruling.
"There is a real danger that Plan B may be given to young girls, under coercion or without their consent," said Anna Higgins of the Family Research Council. "The involvement of parents and medical professionals acts as a safeguard for these young girls. However, today's ruling removes these common-sense protections."
Deirdre McQuade, spokeswoman for the U.S. Conference of Catholic Bishops, said: "Plan B does not prevent or treat any disease, but makes young adolescent girls more available to sexual predators. The court's action undermines parents' ability to protect their daughters from such exploitation and from the adverse effects of the drug itself."
The morning-after pill contains a higher dose of the female progestin hormone than is in regular birth control pills. Taking it within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent. But it works best within the first 24 hours.
If a woman already is pregnant, the 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.
The Food and Drug Administration actually was preparing to allow over-the-counter sale of Plan B One-Step with no age limits in late 2011 when Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled her own scientists. Sebelius said some girls as young as 11 are physically capable of bearing children but shouldn't be able to buy the pregnancy-preventing pill on their own.
The federal judge dismissed that argument.
"This case is not about the potential misuse of Plan B by 11-year-olds," said Korman, who called the pills safe for girls but said the number using them "is likely to be minuscule" as less than 3 percent of girls under age 13 are sexually active.
He cited the Administrative Procedure Act as granting a judge the authority to set aside an agency's rulings "if they are 'arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law.'"
Korman said regulation requires that when the FDA allows nonprescription drug sales, "the standards are the same for aspirin and for contraceptives" — and he ultimately determined that the government violated those standards in the case of Plan B.
"The decision that the agency was forced to make, contrary to its own policies and judgment, is not entitled to any deference," Korman concluded. "Indeed, it is hardly clear that the secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable."
It was the judge's latest ruling in a lawsuit filed by the Center for Reproductive Rights and dating back to 2005 that pushed for unfettered over-the-counter access to Plan B.
Korman didn't spare the FDA from criticism, citing "a strong showing of bad faith and improper political influence" going back to the Bush administration, when the center filed a citizen's petition to try to get the agency to act. That was followed by the lawsuit.
"More than twelve years have passed since the citizen petition was filed and eight years since this lawsuit commenced," Korman wrote in a decision dated Thursday and released Friday. "The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster."
The judge said the FDA decided after 11 months, 47,000 public comments and hundreds of thousands, if not millions, of dollars spent, that it did not need rulemaking on the subject.
"The plaintiffs should not be forced to endure, nor should the agency's misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction," he wrote.
Four years ago, Korman was highly critical of the Bush administration's initial handling of the issue when he ordered the FDA to let 17-year-olds obtain the medication, instead of setting the age at 18. At the time, he accused the government of letting "political considerations, delays and implausible justifications for decision-making" cloud the approval process.
__
Neumeister reported from New York. Associated Press writer Ricardo Alonso-Zaldivar contributed to this report.