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Plan B One-Step approved without restriction
In a huge win for women and choice, Plan B One-Step emergency contraception has been federally approved for over the counter sales without age restriction or need for a prescription. In 2009, Plan B became available to 17 year olds without a prescription, while requiring a prescription for those under 17.
Womenís health groups have been fighting a legal battle against the federal government for over a decade, to make emergency contraception easily accessible and affordable for all women, without restrictions.
After a continuous fight against lifting restrictions, the Obama administration conceded itís stance against it, dropping the appeal. U.S. District Court Judge Edward Korman approved the sale of the drug to anyone seeking to purchase it.
The FDA has said that once the maker of Plan B One-Step, Teva Pharmaceutical Industries Ltd., submits their application it will be approved quickly. Teva will also need time to re-package the emergency contraceptive, with an estimate for the product to hit store shelves sometime in July.
Plan B One-Step is emergency contraception that contains high levels of the hormone levonorgestrel, also found in lower doses in birth control pills. When taken within 72 hours (3 days) of unprotected sex it has an 89% success rate at preventing pregnancy, while taken within 24 hours the rate of success increases to 95%.
The side effects are minimal and similar to those of the birth control pill. After many extensive studies, there have been no serious complications or deaths with itís use. Research shows it to be safer than many over the counter medications, including aspirin.
Although the ruling is a giant victory for women, it is a ruling that only pertains to the brand Plan B One-Step. The one pill emergency contraceptive costs roughly $40 to $50, making it difficult for young teens and women of low income to afford. The ruling does not apply to the two pill versions, or generic brands of emergency contraception.
Judge Korman urged the FDA not to grant Teva Pharmaceutical Industries Ltd. exclusivity in the market saying in his 6 page ruling, "Market exclusivity means that no other manufacturer will be permitted to market its products over-the-counter for three years. "This confers a near-monopoly that will only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women."
The ruling brings light and hope to women, during a harsh political war on womenís reproductive health, and rights. It was the strength and voices of women all over the country, that made this victory possible. Donít stop now! Make your voices heard!!!
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