FDA Approves Two New Birth Control Methods Amid Mixed Reactions

The Food and Drug Administration (FDA) recently approved two new forms of birth control, sparking mixed reactions. Women’s health advocates celebrated the approval of a new vaginal ring that can prevent pregnancy for up to a year. However, some raised concerns about the approval of a mobile phone app, Natural Cycles, which tracks body temperature and menstrual cycles to help women avoid pregnancy through “fertility awareness.”

While the new vaginal ring, Annovera, received praise for its extended usage, critics questioned the effectiveness of the Natural Cycles app. Reports from Sweden indicated that at least 36 women became pregnant despite using the app to track their cycles. Critics fear that the FDA’s approval might lead some women to believe fertility awareness methods, such as tracking ovulation and avoiding unprotected sex, are as effective as other highly reliable birth control options like intrauterine devices (IUDs). While natural methods can be effective, they often require close daily monitoring.

Unplanned pregnancies remain a significant issue in the United States. A study in the New England Journal of Medicine revealed that 45 percent of the 6.1 million pregnancies in 2011 were unplanned, a slight improvement from 51 percent in 2008, but still higher than in many other industrialized countries.

The FDA has approved nearly two dozen contraceptive methods, including the pill, patches, IUDs, and implants. These methods are covered by insurance, meaning women do not pay out-of-pocket.

The new vaginal ring, Annovera, prevents pregnancy by releasing hormones that stop ovulation. It is inserted for three weeks, then removed for seven days before being reinserted. It can be used for up to one year. However, it won’t be available until late 2019, and its price has not yet been disclosed.

The Natural Cycles app, which costs about $80 per year, requires users to take their temperature at the same time every morning and track their menstrual cycle. The app signals when ovulation occurs, suggesting women avoid unprotected sex during this time.

Both methods require more active participation than an IUD, which can remain effective for five to 10 years after insertion with no further action needed. Despite this, some health experts fear that the FDA’s approval might mislead women into thinking that fertility awareness methods are equally reliable.

Dr. Christopher Zahn, vice president of practice activities for the American College of Obstetricians and Gynecologists, emphasized the importance of counseling. He noted that women should be informed about the effectiveness of different birth control methods, as some may interpret the FDA’s approval as an endorsement of the app’s effectiveness.

On the other hand, Dr. Gillian Dean, senior director of medical services at Planned Parenthood, welcomed the new methods. “More options are always better,” she said, emphasizing that a variety of contraceptive choices increases the chances that women will find one that suits their needs. Dean pointed out that the right contraceptive method depends on factors such as reproductive plans, menstrual cycle, number of sexual partners, and how crucial it is to avoid pregnancy.

Highly effective methods like IUDs and hormonal implants have a failure rate of less than 1 percent, making them among the most reliable options. In contrast, the pill, patch, and vaginal ring are about 91 percent effective. Fertility awareness methods, however, have a failure rate of about 24 percent, according to the Centers for Disease Control and Prevention (CDC). This statistic, however, often refers to older methods like the rhythm method, which relies on a calendar to predict ovulation, rather than newer biometric methods that track body temperature, cervical mucus, or urinary hormones.

Recent studies indicate that the Natural Cycles app has a pregnancy rate of 9.8 percent, though an FDA study reported a lower rate of 6.5 percent. According to Chelsea Polis, a senior research scientist at the Guttmacher Institute, around 3 percent of women use fertility awareness-based methods either alone or alongside other forms of birth control, and their numbers are increasing.

Polis sees the FDA’s approval of the app as a positive step, noting that it provides a clear regulatory path to evaluate these methods. She expressed relief that the FDA is carefully reviewing such contraceptive methods and their claims.