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Generic emergency contraception: age restriction to remain in place Generic emergency contraception: age restriction to remain in place
(2 months later)
Americans' unrestricted access to emergency contraception is facing a new challenge after the Food and Drug Administration ruled that generic versions of the drug will still be subject to an earlier age restriction that was struck down by a federal judge in April.Americans' unrestricted access to emergency contraception is facing a new challenge after the Food and Drug Administration ruled that generic versions of the drug will still be subject to an earlier age restriction that was struck down by a federal judge in April.
Until April 2016, Teva Pharmaceuticals Plan B One-Step will be the only type of emergency contraception available to women of any age without a prescription, the FDA announced on Monday. Generic versions of the pill will still be available for sale, but they will be subject to age restrictions.Until April 2016, Teva Pharmaceuticals Plan B One-Step will be the only type of emergency contraception available to women of any age without a prescription, the FDA announced on Monday. Generic versions of the pill will still be available for sale, but they will be subject to age restrictions.
This means people under age 17 will only be able to buy generic versions of the time-sensitive drug with a prescription. Plan B One-Step costs about $50; the generic versions cost between $35 and $40.This means people under age 17 will only be able to buy generic versions of the time-sensitive drug with a prescription. Plan B One-Step costs about $50; the generic versions cost between $35 and $40.
A federal judge ruled in April that the pill should be made available over the counter to women of all ages in the US, but faced an appeal from the US government in a bid to stall the action from taking place.A federal judge ruled in April that the pill should be made available over the counter to women of all ages in the US, but faced an appeal from the US government in a bid to stall the action from taking place.
Andrea Costello, a senior staff attorney at the Partnership for Civil Justice who represented plaintiffs in the case, said that the FDA's decision is "an unjustified reward to a drug company".Andrea Costello, a senior staff attorney at the Partnership for Civil Justice who represented plaintiffs in the case, said that the FDA's decision is "an unjustified reward to a drug company".
"The administration is basically saying only those women who can afford to pay the monopoly price that Teva is going to demand have access to the morning-after pill," Costello said."The administration is basically saying only those women who can afford to pay the monopoly price that Teva is going to demand have access to the morning-after pill," Costello said.
Manufactures of generic versions of emergency contraception can apply to sell their version without the prescription, but would have to wait until the Teva agreement ends in 2016.Manufactures of generic versions of emergency contraception can apply to sell their version without the prescription, but would have to wait until the Teva agreement ends in 2016.
"If women cannot afford this drug, it is not truly accessible and that is the battle that's going on right now," Costello said."If women cannot afford this drug, it is not truly accessible and that is the battle that's going on right now," Costello said.
The FDA said the decision was made because Teva Pharmaceuticals had provided the only research data that shows it is safe for people under age 17 to use the drug without a prescription.The FDA said the decision was made because Teva Pharmaceuticals had provided the only research data that shows it is safe for people under age 17 to use the drug without a prescription.
Medical groups have advocated for unrestricted access to emergency contraception. In the April court order to allow unrestricted access to emergency contraception, US federal district court judge Edward Korman wrote:Medical groups have advocated for unrestricted access to emergency contraception. In the April court order to allow unrestricted access to emergency contraception, US federal district court judge Edward Korman wrote:
I do not dwell on this aspect of the prejudice suffered by the population of the youngest adolescents, although it should not be ignored, because the number of these adolescents who actually use levonorgestrel-based emergency contraceptives is miniscule, and they have been invoked in the debate over access to these contraceptives mostly as a red herring to justify the continued burdens suffered by older women who seek access to the drug.I do not dwell on this aspect of the prejudice suffered by the population of the youngest adolescents, although it should not be ignored, because the number of these adolescents who actually use levonorgestrel-based emergency contraceptives is miniscule, and they have been invoked in the debate over access to these contraceptives mostly as a red herring to justify the continued burdens suffered by older women who seek access to the drug.
The decision followed a more than decade-long battle that pitted the FDA and White House against people who support reproductive rights and prominent physicians groups, and occasionally each other.The decision followed a more than decade-long battle that pitted the FDA and White House against people who support reproductive rights and prominent physicians groups, and occasionally each other.
The FDA said in a December 2011 memo that "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential".The FDA said in a December 2011 memo that "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential".
The Obama administration relented in June, giving up a fight that opposed recommendations made by scientists, government health agencies and groups including the American Medical Association, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics have recommended unrestricted access to emergency contraceptives.The Obama administration relented in June, giving up a fight that opposed recommendations made by scientists, government health agencies and groups including the American Medical Association, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics have recommended unrestricted access to emergency contraceptives.
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