FDA Approves: Plan B To Be Dispensed Over The Counter; Critics Come Out Swinging
WASHINGTON (CBSNewYork) — Controversy is coming to a pharmacy near you.
The Food and Drug Administration announced Tuesday it has approved making the Plan B morning-after pill available over the counter. But purchasers have to be at least 15 to buy it, and will have to provide proof of age at the cash register.
Plan B-One Step will now include a label reading “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified,” CBS News reported.
The decision was reached in regard to an amended application submitted by Teva Women’s Health Inc., CBS News reported. The company had initially sought approval to market Plan B One-Step to all females of reproductive age, but changed its initial appeal for approval for those 15 and older.
“This decision is a step in the right direction for increased access to a product that is a safe and effective method of preventing unintended pregnancies,” U.S. Sen. Patty Murray (D-Wash.) said in a statement to CBS News. “It’s also a decision that moves us closer to these critical availability decisions being based on science, not politics. Plan B is an essential part of a woman’s basic health care and I will continue to push for more information from FDA and HHS on the practical application of this policy while also working to ensure that access is based on science, safety, and efficacy.”
Earlier this month, a federal judge ruled the morning-after pill should be available without age restrictions, and gave the FDA 30 days to act.
Brooklyn U.S. District Judge Edward Korman on April 5 ruled the pregnancy-preventing pill must be made available to people of all ages without a prescription, calling an age requirement “arbitrary, capricious, and unreasonable.”
Judge Korman wrote that extensive research shows the pill is safe, and said the decision to require a prescription was political.
Plan B One-Step, also known as the “morning-after pill,” is a form of emergency contraception that can reduce the chance of pregnancy after a person has engaged in unprotected sex, meaning they did not use another form of birth control or their chosen method did not work, CBS News explained.
There are currently three types of emergency contraception available for sale in the U.S.: Plan B One-Step, Plan B, and Ella. Plan B is a two-pill system that requires a prescription for those who are under 17. Ella also requires a prescription, regardless of age.
Plan B-One Step does not stop pregnancy if a woman is already pregnant, nor has any scientific evidence shown that it will harm a fetus that already exists. The single-dose pill works best if taken within three days after sexual intercourse, CBS News explained.
Planned Parenthood touted the benefits for women of all ages, saying: “This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy.”
However, 20-year-old Julie Onorato of Staten Island told CBS 2′s Derricke Dennis there are potential risks and complications, especially for uninformed teens.
“Kids will be kids, they’re young, they don’t understand what they’re getting involved in, and without parental guidance a lot of bad things can end up happening,” Onorato said.
Laura Timoney with the advocacy group New York City Parents Union is among many opposed to a newly approved application by the FDA for the emergency contraception to be made available to 15-year-olds, and not the current age of 17 without a prescription.
“I think it’s crazy to be quite honest,” Timoney said. “I don’t think that there’s been any research that points to 15 being the age that girls should be getting contraception.”
Separate from the new FDA decision is a pending federal case that could eliminate any and all restrictions on the morning-after pill, regardless of age. The government has not said what it’s next move will be, CBS 2′s Dennis reported
For now, Plan B could be available to teens as young as 15, this summer.
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