More On: FDA
The Food and Drug Administration might finally let 'the pill' be sold over the counter, but there's a catch.
After the U.S. Supreme Court overturned Roe v. Wade last summer, HRA Pharma asked the FDA to change its birth control pills from ones that could only be bought with a prescription to ones that could be bought without a prescription.
The Food and Drug Administration (FDA) recently canceled a meeting of an advisory panel to talk about giving women over-the-counter access to a birth control pill that has only been available with a prescription since 1973. However, the drug maker still expects FDA approval by the middle of 2023.
If that happens, women in the United States will be able to get birth control pills without a prescription, just like women in most other countries.
But there is a catch: they will only be able to get one kind of birth control pill, a progestin-only pill, from one brand. Even though it might be safer than other birth control pills, it has some problems.
Estrogen and progesterone are two female hormones that are in regular birth control pills. Because it only has progesterone, the progestin-only drug is called "the mini-pill." Unlike regular birth control pills, the mini pill doesn't stop nursing mothers from making milk and is less likely to cause blood clots in women who smoke (venous thromboembolism, or VTE).
The mini pill, on the other hand, only works if women take it every day at the same time. If they take it more than three hours later, they have to use another method of birth control for the rest of the month and start the cycle over. If they miss a day, the same thing happens. If a woman forgets to take her regular birth control pill one day, she can take two pills the next day.
It is sexist of the FDA to limit women's over-the-counter options to only progestin pills and to only one progestin-only product. The agency probably doesn't trust women to figure out which birth control pill is best for them by weighing the risks and benefits of each one. Yet, a 2006 study of women in the Seattle area who were asked to evaluate birth control pills on their own found that they agreed with doctors 90% of the time. The other 10% said they were more cautious than the doctors.
The American College of Obstetrics and Gynecology has long supported all over-the-counter hormonal contraception, including estrogen/progesterone birth control pills. They say that the risk of VTE is small compared to the increased risk of VTE during pregnancy and the postpartum period.
The college also thinks that women who take birth control pills don't need an annual exam most of the time. Obstetrician-gynecologists make money by giving yearly exams, which makes the college's position even more interesting, since it goes against the financial interests of its own profession.
The American Medical Association and the American Academy of Family Physicians both back birth control pills that can be bought over the counter. In 2016, a survey of reproductive health care providers found that most of them liked birth control pills that could be bought without a prescription.
Research shows that over-the-counter birth control pills make people more likely to use them. One study compared oral contraceptives, which can be bought over the counter in El Paso/Ciudad Juarez, Mexico, just across the border from the United States. Researchers found that "users would be more likely to keep using if they got more pill packs and didn't have to get a prescription."
Ironically, the FDA lets kids buy aspirin and Tylenol in doses that could kill them without a prescription. But it keeps adult women from buying a safer product that doctors say they should be able to buy without having to go to the doctor, which is expensive and not necessary.
In 2006, the FDA made it possible for women 18 and older to buy the so-called "morning after pill" without a prescription. In 2013, the FDA said that women of any age could buy emergency contraception over the counter. "Plan B" is the name of the most well-known emergency method of birth control.
The FDA shouldn't make women wait until the middle of next year to start getting control over Plan A. All birth control pills, not just those with progestin, should be available over-the-counter to women of all ages.