Health
plan b contraceptive gets FDA Green Light For Women 15 And Older
plan b contraceptive gets FDA Green Light For Women 15 And Older
Plan-B One Step morning-after contraceptive pill will now be more accessible to women and girls In the U.S. according to a ruling by the Food and Drug Administration (FDA).
The rule change compels pharmacies to remove the drug from behind the counter where the drug can be sold discretely to legal-age adults to over-the-counter aisles.
The FDA also lowered the minimum required age to 15 which means that girls will be allowed to purchase the contraceptive. Additionally, the FDA has ruled that parental consent is no longer required. The controversy is not likely to end anytime soon.
In early April, Judge Edward Korman of the US District Court of New York overturned President Obama’s 17-year-old age minimum age limit for the drug and ordered there to be no age limit whatsoever.
“The Department of Justice is considering next steps in the litigation,” the FDA said in a statement. “In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older.”
The matter brings to the forefront an interesting dichotomy where laws establish a legal age to consent to sex, but a US District court mandates no age limit for the use of the Plan-B contraceptive.
The FDA said the rule change they made was independent of what Judge Korman had ruled and was the result of a months-long study into the matter.
“While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy,” said President of Planned Parenthood Federation of America’s President Cecile Richards.
Women’s groups vowed to continue to fight so that there is no age limit required.
“The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a press release.
There are currently three emergency contraceptive drugs marketed in the United States – Plan B One-Step, Plan B, and ella. Plan B, available from generic manufacturers, uses two doses of levonorgestrel (.75 mg in each tablet), taken 12 hours apart, and requires a prescription for women under the age of 17. Ella (ulipristal) is a prescription-only product that prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected sexual intercourse. The approval of Teva’s application for Plan B One-Step does not affect the prescription status of these other drugs.
Many developed countries require a prescription for oral contraceptives, including Canada and most of Europe, but other countries sell the pill without a prescription even formally or informally.
On The Web:
Morning after pill OK for ages 15 and up
http://www.indianexpress.com/news/morning-after-pill-ok-for-ages-15-and-up/1110080/
FDA Approves Over-the-Counter Plan B for Women 15 and Older
http://abcnews.go.com/Health/fda-approves-counter-plan-women-15-older/story?id=19083495#.UYJ-r7Wshac
FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htm