An over-the-counter birth control pill is being sought for approval by the FDA. The pill is called a mini pill because it only contains progestin. It would be the first oral contraceptive in the US without a prescription.
A coalition of advocates, researchers and health care providers have helped lay the groundwork and build support for regulatory approval of over-the-counter pill options in the US.
The application for approval was submitted in the wake of the overturn of Wade, but the work began more than a decade ago. CynthiaHarper is a professor of OB/Gyn and reproductive sciences at the University of California, San Francisco.
According to a survey, nearly 30% of women of childbearing age have a problem obtaining a birth control prescription or refill. Lack of insurance is one of the reasons. The American College of Obstetricians and Gynecologists, which has about 60,000 members, says there are barriers to contraception and access. She says that seeing a doctor and filling prescriptions can be difficult to navigate. She says that she takes time off work, gets child care, and drives.
Over-the-counter contraceptives have been supported by ACOG. The American Medical Association supports the cause. Birth control is safe to offer over the counter and doesn't need a prescription according to the data.
She says that Mexico and many other countries in Latin America and Europe have opened up access to oral contraceptives by allowing the pills to be sold over the counter. Over-the-counter birth control has shown us that it works. HRA Pharma was granted a license to sell a contraceptive pill in the UK.
The birth control pill is called O pill. It has a lower risk of blood clot than other birth control pills because it does not contain the hormone estrogen.
It may be easier to get over-the-counter approval if you have a lower risk profile. The first over-the-counter pill in the US would be the progesterone-only pill.
The combined pill has more space for error than the progesterone-only pill. You don't have as much room to miss a pill or mistime your pill because of that. According to the U.K.'s National Health Service, the efficacy with typical use goes down to less than 100 percent. Villavicencio says that it's still very effective.
In order to get over-the-counter approval in the United States, HRA pharma has to meet a lot of criteria. It needs to show that individuals can screen themselves to determine if the pill is right for them. The daily contraceptive pill can be taken without a doctor's explanation, if the company shows that. The pharmaceutical company has to prove that through their data and research. She says that the coalition helped build evidence over the last 10 years. The pills are safe and effective and people should be able to follow the instructions.
In March, a group of lawmakers, including the co-chairs of the Pro-Choice Caucus in the House of Representatives, sent a letter to the FDA urging the agency to review applications for over-the-counter birth control pills without delay. Legislators said that the health care system creates barriers to access. People of color, immigrants, LGBTQ+ people, low-income individuals, young people, and people in rural communities are disproportionately affected by these barriers. The FDA has an important role to play in helping people with their reproductive health, according to the lawmakers.
The FDA's review process is expected to take about 10 months.
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