Topline
Birth control without a prescription could be reality for American women soon as the Food and Drug Administration will consider the country’s first request for a birth control pill available over the counter next week, a significant move as birth control access has been threatened since the overturning of Roe v. Wade and reproductive rights have become a main political issue.
This illustration provided by Perrigo in May, 2023, depicts proposed packaging for the company’s … [+]
Key Facts
If the FDA were to approve it, pharmaceutical company Perrigo’s Opill, which was approved for prescription use in the U.S. about 30 years ago, would be the first contraceptive pill available in stores or online without a needed prescription; the decision would only apply to this pill, not other birth control pill brands.
In an initial review of the pill released Friday, AP reported that the FDA raised some concerns about the studies, including problems with data reliability, questions about if women would correctly opt out of taking it if they had other medical conditions and signs that some participants had trouble with the instructions for the pill.
The main study Perrigo presented to the FDA tracked almost 900 women who took the pill for up to six months, according to AP, and at least 92% of participants reported taking it daily and within a three-hour range, which is key to effectiveness.
The American Medical Association submitted comments to the FDA in support of making Opill available over the counter, saying the history of benefits “outweigh the limited risk.”
One of the reasons Opill is being considered for over-the-counter status is because it’s a progestin-only birth control pill, meaning unlike many others, it does not contain the hormone estrogen which comes with a higher risk of blood clots.
The FDA advisory committee that will make a non-binding recommendation on whether the benefits of moving the pill to over-the-counter status outweigh the risks will meet next Tuesday and Wednesday and a final decision is expected by the FDA later in the summer.
Although the overturning of Roe V. Wade doesn’t directly impact access to birth control, experts have speculated the decision could lead to more restrictions on reproductive health like limiting access to birth control, and CNN reported that just days after Roe was overturned they physicians were seeing “an increase in demand for different forms of contraception.”
Key Background
Perrigo first submitted the application for review last July, but research has been happening on the concept of over-the-counter birth control for 10 years. If this drug is approved, American women would join women in more than 100 countries who are able to get a birth control pill without a prescription. Forbes previously reported that before Perrigo even announced the application last year, upwards of 50 lawmakers asked the FDA to review any applications the agency receives for over-the-counter birth control “without delay,” saying the organization plays an important role in reducing barriers and giving people better control over their reproductive health.
Tangent
The review of the application comes at a time when reproductive rights are a hot-button issue in the U.S. and lawsuits are currently ongoing about the abortion pill mifepristone, which is completely unrelated to the contraceptive being proposed. Late last month, the Supreme Court announced it would continue to allow access to the drug that is the most common method of abortion and has been legal in the U.S. since 2000.
Surprising Fact
Perrigo estimates that 15 million U.S. women, which is about 20% of those who are at child-bearing age, either don’t use birth control or use a less effective method, including condoms.
Further Reading
FDA weighing 1st over-the-counter birth control pill (AP)
FDA considers whether a birth control pill could be sold over the counter (ABC News)
Birth Control Can Be Effective With Lower Dosage Of Hormones, Study Finds (Forbes)
FDA Considers Over-The-Counter Birth Control Pills Amid Sudden Fears Of Restrictions (Forbes)
Source: https://www.forbes.com/sites/mollybohannon/2023/05/05/fda-to-consider-the-first-request-for-over-the-counter-birth-control-pill/