Federal regulators have approved the first over-the-counter hormonal birth control pill, which means American women and girls will be able to buy contraceptive medication from the same aisle as aspirin and eyedrops without any medical oversight.
The Food and Drug Administration (FDA) said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales.
Ireland-based Perrigo did not announce a price for its birth control pill. Over-the-counter medicines are generally much cheaper than prescriptions, but they typically aren’t covered by insurance. Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government.
Other approved formulations and dosages of other oral contraceptives will remain available by prescription only, the FDA said in a press release.
They cite safety concerns about potential medical complications. Second, they say it puts girls and women at risk of being controlled by abusers.
Reacting to the FDA’s approval of Opill as an over-the-counter contraceptive on Thursday, Students for Life of America President Kristan Hawkins called sexual exploiters “the big winner with this decision.”
“Who knew that sex abusers had such a powerful lobby at the FDA, which has abandoned all medical ethics by making it easier for criminals to cover up their sexual abuse and statutory rape crimes,” Hawkins said in a statement to CBN News.”Sexual exploiters are the big winner with this decision, while young girls lose the protection of informed consent along with any adult engagement on all the risks they may be facing.”
“This policy change won’t even be effective when it comes to reducing pregnancies, as even the Planned Parenthood-founded Guttmacher Institute reports that more than half of women getting an abortion used birth control the month they became pregnant. The false confidence and poor understanding of how the pills function over time makes young and naïve women vulnerable,” Hawkins continued.
“Where is President Obama when you need him?,” she added, alluding to then-President Barack Obama’s opposition in 2011 to making the morning-after birth control pill available over the counter.
As the Associated Press reported at the time, Obama said that “it was just common sense to keep girls under the age of 17 from being able to buy a morning-after contraceptive pill off a drugstore shelf.
Citing his own two daughters, he said: ‘I think most parents would probably feel the same way.'”
No Relation to Current Legal Battle Over Mifepristone
The FDA’s decision has no relation to the ongoing court battles over the abortion pill mifepristone.
As CBN News reported in April, the U.S. Supreme Court is allowing full access to the mifepristone abortion pill, at least for now. The high court has halted lower court rulings that had temporarily restricted access to the drug mifepristone while the case works its way through the appeals system.
The federal courts are considering whether the FDA violated federal guidelines when it rushed approval of the drug two decades ago.
In its internal review published in May, the FDA noted that some women in Perrigo’s study had trouble understanding the drug’s labeling information. In particular, the instructions warn that women with a history of breast cancer should not take the pill because it could spur tumor growth. And women who have unusual vaginal bleeding are instructed to talk to a doctor first because it could indicate a medical problem.
Common side effects of the pill include bleeding, headaches, dizziness, nausea, and cramps, according to the FDA. The label also cautions that certain drugs can interfere with Opill’s effectiveness, including medications for seizures, HIV, and hypertension.
Perrigo submitted years of research to the FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.