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Women and girls of all ages will soon be able to purchase the Plan B One-Step emergency contraceptive pill without a prescription now that the federal government has dropped its legal challenge to making it more easily accessible to minors.
On June 10, the Food and Drug Administration announced that it would comply with a federal court order to make levonorgestrel-containing emergency contraceptives available as an over-the-counter product without restrictions based on age or point of sale.
Recently, the FDA approved Plan B One-Step for sale without a prescription for young women aged 15-16 years, provided they can verify their age. With the court battle over, the FDA has asked the Plan B One-Step manufacturer to submit a supplemental drug application to make the drug available OTC to all ages. "Once the FDA receives that supplemental application, the FDA intends to approve it promptly," according to an agency statement.
Nancy Northup, president and CEO of the Center for Reproductive Rights called the government’s reversal on Plan B One-Step a "significant step forward." But she said the FDA also needs to approve less-expensive, generic versions of the drug for over-the-counter sale.
"We are pleased that women should soon be able to buy Plan B One-Step without the arbitrary restrictions that kept it locked behind the pharmacy counter when they needed it most urgently," Ms. Northup said in a statement. "But we will continue to fight for fair treatment for women who want and need more affordable options."
The Obama administration has been criticized by many physicians and reproductive rights organizations over its decision to block minors’ OTC access to emergency contraception. The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine all recently voiced their opposition to the government’s ongoing court battle.
On Twitter @MaryEllenNY
Women and girls of all ages will soon be able to purchase the Plan B One-Step emergency contraceptive pill without a prescription now that the federal government has dropped its legal challenge to making it more easily accessible to minors.
On June 10, the Food and Drug Administration announced that it would comply with a federal court order to make levonorgestrel-containing emergency contraceptives available as an over-the-counter product without restrictions based on age or point of sale.
Recently, the FDA approved Plan B One-Step for sale without a prescription for young women aged 15-16 years, provided they can verify their age. With the court battle over, the FDA has asked the Plan B One-Step manufacturer to submit a supplemental drug application to make the drug available OTC to all ages. "Once the FDA receives that supplemental application, the FDA intends to approve it promptly," according to an agency statement.
Nancy Northup, president and CEO of the Center for Reproductive Rights called the government’s reversal on Plan B One-Step a "significant step forward." But she said the FDA also needs to approve less-expensive, generic versions of the drug for over-the-counter sale.
"We are pleased that women should soon be able to buy Plan B One-Step without the arbitrary restrictions that kept it locked behind the pharmacy counter when they needed it most urgently," Ms. Northup said in a statement. "But we will continue to fight for fair treatment for women who want and need more affordable options."
The Obama administration has been criticized by many physicians and reproductive rights organizations over its decision to block minors’ OTC access to emergency contraception. The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine all recently voiced their opposition to the government’s ongoing court battle.
On Twitter @MaryEllenNY
Women and girls of all ages will soon be able to purchase the Plan B One-Step emergency contraceptive pill without a prescription now that the federal government has dropped its legal challenge to making it more easily accessible to minors.
On June 10, the Food and Drug Administration announced that it would comply with a federal court order to make levonorgestrel-containing emergency contraceptives available as an over-the-counter product without restrictions based on age or point of sale.
Recently, the FDA approved Plan B One-Step for sale without a prescription for young women aged 15-16 years, provided they can verify their age. With the court battle over, the FDA has asked the Plan B One-Step manufacturer to submit a supplemental drug application to make the drug available OTC to all ages. "Once the FDA receives that supplemental application, the FDA intends to approve it promptly," according to an agency statement.
Nancy Northup, president and CEO of the Center for Reproductive Rights called the government’s reversal on Plan B One-Step a "significant step forward." But she said the FDA also needs to approve less-expensive, generic versions of the drug for over-the-counter sale.
"We are pleased that women should soon be able to buy Plan B One-Step without the arbitrary restrictions that kept it locked behind the pharmacy counter when they needed it most urgently," Ms. Northup said in a statement. "But we will continue to fight for fair treatment for women who want and need more affordable options."
The Obama administration has been criticized by many physicians and reproductive rights organizations over its decision to block minors’ OTC access to emergency contraception. The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine all recently voiced their opposition to the government’s ongoing court battle.
On Twitter @MaryEllenNY
