May 11, 2013 |
In yet another scathing critique of government health officials, a federal judge refused Friday to stay his order making emergency contraceptives available to consumers of all ages without a prescription. Calling government efforts to restrict the sale of drugs such as Plan B "frivolous and taken for the purpose of delay," U.S. District Judge Edward R. Korman of New York wrote that the medications would be available to all unless the 2nd Circuit Court of Appeals ruled otherwise by noon Eastern time on Monday.
May 5, 2013
Re "Birth control ruling appealed," May 2 It is fitting that the online version of this article on the Obama administration's appeal of an order to remove the age limit on Plan B emergency contraception appears on The Times' Science Now blog. As a pediatrician who has done extensive research on emergency contraception and young women, we need science now. Science must be the basis for these decisions, not politics. Medical opinion is solidly united that this medication is safe for women of all ages, and research shows women know when and how to take it. There is simply no scientific reason to fight Plan B going over-the-counter for all women, and the new age limit will create restrictions for all women in need of Plan B. This is politics trumping science again, and it's bad medicine.
May 2, 2013 |
MEXICO CITY -- President Obama says he's “very comfortable” with a Food and Drug Administration ruling that maintains age restrictions on females who can buy the so-called morning after pill without a prescription. The rule announced this week prohibits girls younger than 15 from buying the drug, known as Plan B, over the counter. The decision was made by the FDA and Secretary of Health and Human Services Kathleen Sebelius, Obama said, pushing back against women's groups that have suggested the White House has interjected its political concern about a touchy subject into the rule process.
April 30, 2013 |
The U.S. Food and Drug Administration announced Tuesday that it has approved the sale of the emergency contraceptive pill, Plan B One-Step, without a prescription for females ages 15 and older. The action comes roughly three weeks after a federal magistrate harshly criticized government regulators for their handling of the drug's approval process, calling their actions "politically motivated and scientifically unjustified. " FDA officials said Tuesday that their decision was based on a pending, amended application submitted by the drug's manufacturer, Teva Womens' Health Inc. It was not, they said, intended to address a recent court order that the FDA make the drug available, over-the-counter, to all customers without age restrictions.
April 6, 2013 |
Science trumped politics, but politics may still present problems for teens trying to purchase emergency contraception. “A lot of stuff is going to happen over the next 30 days,” said Dr. Cora Breuner, a pediatric medicine specialist at the University of Washington. Breuner was reacting to a judge's decision Friday to overturn age restrictions on access to emergency contraception. U.S. District Judge Edward Korman called those restrictions by the Food and Drug Administration “politically motivated and scientifically unjustified.” He ruled that levonorgestrel-based contraceptives such as Plan B One-Step and Next Choice should be available over the counter to all customers within 30 days.
April 5, 2013 |
A federal court judge has ordered the U.S. Food and Drug Administration to lift controversial restrictions on the so-called morning-after pill, saying females of all ages should have unimpeded access to emergency birth control. In a ruling released Thursday, U.S. District Court Judge Edward Korman directed the FDA to make levonorgestrel-based contraceptives available over the counter, and without a prescription. The ruling overturns a 2011 decision by Health and Human Services Secretary Kathleen Sebelius requiring that girls under age 17 obtain a prescription for the Plan B One-Step contraceptive or its equivalents In his strongly worded ruling, Korman called Sebelius' decision “politically motivated, scientifically unjustified and contrary to agency precedent.” No serious health risks have been associated with the drug's use among adults and children, Korman wrote, and even the FDA acknowledged that the drug's “safety and efficacy in the pediatric population have been established.” The ruling comes in response to a lawsuit filed by the Center for Reproductive Rights, which argued that restrictions placed on the drug imposed unreasonable delays for women of all ages.