"Plan B OK’d over counter for 15 and older" by Deborah Kotz | Globe Staff, May 01, 2013
Less than a month after a federal judge ordered the Food and Drug Administration to make emergency contraception available over-the-counter without any age restrictions, the agency said that it would allow one product to be offered on drugstore shelves — but only to those age 15 and over.
The agency said Plan B One-Step could be sold on shelves next to other family planning products such as condoms and pregnancy tests. Consumers will be required to show proof of age at the register....
The decision is “not intended to address the judge’s ruling,” the FDA said in a statement, but was in response to an application filed by Teva, the manufacturer of Plan B One-Step, before reproductive rights organizations filed the lawsuit that led to the New York judge’s ruling on April 5.
The judge gave the FDA 30 days to comply. The Department of Justice has until the end of this week to appeal the decision and is “still considering next steps in the litigation,” according to the FDA....
“Today, we welcome the FDA’s decision to provide extended and improved access to this important product, a significant milestone for women,” said Teva vice president Marty Berndt.
Women’s health advocates who initially cheered the judge’s ruling had a tepid response to the FDA’s decision....
“It’s a strange decision,” said Dr. Susan Wood, an associate professor of health policy at George Washington University School of Public Health. She resigned from the FDA in 2005 after the agency initially dragged its feet on allowing Plan B to be sold over-the-counter for adult women. “It offers improved access to some women with IDs but not to high school students, and it clearly isn’t what the judge directed,” she said....
Many of those under age 17 may not have a photo ID if they do not yet have a driver’s license....
The court case stemmed from the Obama administration’s decision to overrule the FDA in 2011, when it decided to allow the One-Step product to be available over-the-counter without age restrictions. After that, Teva amended its application in a compromise, seeking to have its product approved for use in girls age 15 and over.
The FDA said Teva submitted study data showing that women age 15 and older “understood that the product was not for routine use and would not protect them against sexually transmitted diseases” and could be used safely without a doctor’s supervision....
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Also see: Slow Saturday Specials: The Morning After
NEXT DAY UPDATE:
"Justice Department appeals ruling on access to morning-after pill" May 02, 2013
WASHINGTON — 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.
I no longer respect you.
The decision came a day after the Food and Drug Administration 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 the pill could be sold on drugstore shelves near the condoms, instead of locked behind pharmacy counters.
Related: Slow Saturday Special: Obama's Daughter Needs an Abortion
But he'll fight for you, ladies.
The only thing this president fights for is his political image.
With the appeal, the government is making clear that it is willing to ease access to emergency contraception only some — and not nearly as broadly as doctors’ groups and contraception advocates have urged....
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.
From the president who said science.... sigh.
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.
I'm kind of uncomfortable with the whole thing.
Sebelius’ move was unprecedented, and US District Judge Edward Korman of New York had blasted it as election-year politics — meaning he was overruling not just a government agency but a Cabinet secretary.
Only Repuglicans do that.
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UPDATES (think of them as check-ups):
"Obama backs effort to restrict sales of morning-after pill; Justice Dept. is appealing age elimination" by Julie Pace | Associated Press, May 03, 2013
MEXICO CITY — President Obama said Thursday that he was comfortable with his administration’s decision to allow over-the-counter purchases of a morning-after pill for anyone 15 and older....
Obama, speaking at a news conference while in Mexico, said the FDA’s decision was based on ‘‘solid scientific evidence.’’
What is still unclear is whether the administration will prevail in 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....
I warned you.
Last week, Terry O’Neill, president of the National Organization for Women, 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.
Well, he is a politician. He'd probably turn to sand if he did that.
In appealing the ruling Wednesday, the administration recommitted itself to a position Obama took during his reelection 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 US 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.
Any age?
In its filing, the Justice Department said Korman exceeded his authority and that his decision should be suspended while that appeal is underway, 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.
Since when has the FDA been concerned about the public?
Reluctant to get drawn into a 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.
Which one needs the abortion?
Obama and Health and Human Services Secretary Kathleen Sebelius have also questioned whether there is enough data available to show that the morning-after pill is safe and appropriate for younger girls, even though physicians groups insist that it is.
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Also see: Obama’s power grab threatens FDA
