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prochoice_marylandA federal district court overturned Friday the Obama administration’s ban against women under 17 purchasing over-the-counter emergency contraception without a prescription.
Describing the restriction as “a strong showing of bad faith and improper political influence” Judge Edward Korman of the District Court of Eastern New York directed the Food and Drug Administration to lift it within 30 days.
“The decisions of the Secretary with respect to Plan B One-Step…were arbitrary, capricious, and unreasonable,” Judge Korman wrote, directing the FDA to “Make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days.”
A spokeswoman at the FDA said Friday the agency had no comment, citing the ongoing legal case. A spokeswoman at the Justice Department said agency officials were “reviewing the opinion.”
White House press secretary Jay Carney said that President Obama supported Health and Human Secretary Kathleen Sebelius’ 2011 decision to reject a request to allow teenage girls and women to buy Plan B over-the-counter in drugstores and pharmacies.
“He supports that decision today,” Carny said, adding that Obama believes it is a “common-sense approach.”
In doing so, she overruled the FDA, which was set to rule that the morning-after pill be made available to all women, with no prescription necessary.
Women’s health groups quickly derided the decision as political, and blocking access to a safe medication. The Center for Reproductive Rights filed this lawsuit within days of Sebelius’s announcement.
Right now, Plan B is available to teenagers under 17 by prescription, while older women must request it from a pharmacist.
Plan B has, for over a decade now, seen a number of setbacks and obstacles in obtaining federal approvals. Multiple administration officials have resigned over the issue and, because of all the infighting, there is now a complicated web of regulations around the contraceptives.
The FDA first approved Plan B as a prescription emergency contraceptive in 1999. In 2003, its manufacturer asked the FDA to make the drug available over the counter. The FDA rejected that request, citing a lack of data on how the drug effected young teenagers.
In 2005, two FDA officials resigned when the FDA announced plans to indefinitely postpone any further review of bringing Plan B out from behind the counter. Within a year though, the agency decided it would allow women over 18 to purchase the drug without a prescription, although they would still need to request it from the pharmacist.
Women’s health and medical groups quickly praised the ruling.
“Science has finally prevailed over politics, to the benefit of millions of women across the United States,” Nancy Northup, president of the Center for Reproductive Rights, told reporters Friday. “Today’s court order has swept away all the FDA’s stalling, all the interference, and all the political gamesmanship. No longer will women who need emergency contraception have to clear all manner of hurdles to get it.”
Cora Collette Breuner, a pediatric professor at the University of Washington and a doctor at Seattle Children’s Hospital, said that despite Friday’s ruling, more work remains — especially in making sure the pills remain affordable to all women.
“While we’ve won this battle, we still also need to win the war,” Breuner said. “I also really worry that companies might increase the cost, thus making yet another barrier that is thrown up so that adolescents under 17 still can’t get it because it costs too much.”
She said she hopes that state Medicaid programs continue to pay for the contraceptives, even after they begin to be sold over the counter.
“They fund many over-the-counter medications,” she said. “So I don’t think it’s a complete done deal that it’s not covered, just because it’s over-the-counter, for our patients that don’t have the financial means to pay for it.”
Read the full decision here.
Describing the restriction as “a strong showing of bad faith and improper political influence” Judge Edward Korman of the District Court of Eastern New York directed the Food and Drug Administration to lift it within 30 days.
“The decisions of the Secretary with respect to Plan B One-Step…were arbitrary, capricious, and unreasonable,” Judge Korman wrote, directing the FDA to “Make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days.”
A spokeswoman at the FDA said Friday the agency had no comment, citing the ongoing legal case. A spokeswoman at the Justice Department said agency officials were “reviewing the opinion.”
White House press secretary Jay Carney said that President Obama supported Health and Human Secretary Kathleen Sebelius’ 2011 decision to reject a request to allow teenage girls and women to buy Plan B over-the-counter in drugstores and pharmacies.
“He supports that decision today,” Carny said, adding that Obama believes it is a “common-sense approach.”
In doing so, she overruled the FDA, which was set to rule that the morning-after pill be made available to all women, with no prescription necessary.
Women’s health groups quickly derided the decision as political, and blocking access to a safe medication. The Center for Reproductive Rights filed this lawsuit within days of Sebelius’s announcement.
Right now, Plan B is available to teenagers under 17 by prescription, while older women must request it from a pharmacist.
Plan B has, for over a decade now, seen a number of setbacks and obstacles in obtaining federal approvals. Multiple administration officials have resigned over the issue and, because of all the infighting, there is now a complicated web of regulations around the contraceptives.
The FDA first approved Plan B as a prescription emergency contraceptive in 1999. In 2003, its manufacturer asked the FDA to make the drug available over the counter. The FDA rejected that request, citing a lack of data on how the drug effected young teenagers.
In 2005, two FDA officials resigned when the FDA announced plans to indefinitely postpone any further review of bringing Plan B out from behind the counter. Within a year though, the agency decided it would allow women over 18 to purchase the drug without a prescription, although they would still need to request it from the pharmacist.
Women’s health and medical groups quickly praised the ruling.
“Science has finally prevailed over politics, to the benefit of millions of women across the United States,” Nancy Northup, president of the Center for Reproductive Rights, told reporters Friday. “Today’s court order has swept away all the FDA’s stalling, all the interference, and all the political gamesmanship. No longer will women who need emergency contraception have to clear all manner of hurdles to get it.”
Cora Collette Breuner, a pediatric professor at the University of Washington and a doctor at Seattle Children’s Hospital, said that despite Friday’s ruling, more work remains — especially in making sure the pills remain affordable to all women.
“While we’ve won this battle, we still also need to win the war,” Breuner said. “I also really worry that companies might increase the cost, thus making yet another barrier that is thrown up so that adolescents under 17 still can’t get it because it costs too much.”
She said she hopes that state Medicaid programs continue to pay for the contraceptives, even after they begin to be sold over the counter.
“They fund many over-the-counter medications,” she said. “So I don’t think it’s a complete done deal that it’s not covered, just because it’s over-the-counter, for our patients that don’t have the financial means to pay for it.”
Read the full decision here.
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