This summer, for the first time in U.S. history, women will be able to access birth control pills without a prescription.
The Food and Drug Administration is weighing the benefits of approving a type of over-the-counter birth control that’s been in use since the 1970s called Opill, a progestin-only pill that prevents unwanted pregnancies in about 94 percent of cases.
HRA Pharma on Tuesday presented real-world evidence showing that the vast majority of eligible people took the pill correctly with no negative consequences and followed instructions without the help of a medical professional, a concern FDA officials had about allowing it to go OTC. to make.
The pill maker also reported that teens and those with less understanding of their health and the healthcare system were able to stick to their daily medication regimen, a strong sign that the populations most vulnerable to unplanned pregnancies would be well protected.
The debate over prescription-free birth control has been going on for years, but reached a boiling point last year after the Supreme Court’s landmark decision to revoke the federal guarantee on abortion that was established 50 years ago.
HRA Pharma, now owned by Perrigo, approved the first-ever birth control pill that women could buy without a prescription. A French drugmaker’s request leads to a major decision for the Food and Drug Administration amid the political ramifications of the recent Supreme Court decision overturning Roe v Wade
Access to mifepristone, one of two pills in a drug-induced abortion regimen, has become a fixture in the culture wars dictated by far-right conservative ideology.
Although birth control is entirely different from mifepristone, it has been dragged into the fight over abortion ever since the Supreme Court judge wrote that the court should “rethink” several precedents related to the right to privacy, including the legality of birth control.
Approval of Opill for over-the-counter use would increase birth control options for more than 19 million women living in parts of the US without reasonable access to a health center that offers the full range of contraceptive methods.
About three dozen medical organizations, including the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians, have been advocating for an over-the-counter birth control pill for years.
Opill, also known as the minipill, has been safe to use for about five decades, but the US has been an outlier when it comes to making the pills available without a doctor’s prescription.
Opill only contains progestin, unlike many oral contraceptives that contain both progestin and estrogen.
This is the appeal of the minipill. Since it does not contain estrogen, which increases the risk of blood clotting by a multiple, the progestogen-only pills are seen as having a lower risk.
The modus operandi is to thicken the mucus in the cervix, making it difficult for sperm to enter the uterus and fertilize an egg.
Progestogen-only pills do not prevent ovulation as well as combined birth control pills. Therefore, their effectiveness is slightly lower.
The FDA’s Advisory Committee on Nonprescription Drugs and the Advisory Committee on Reproductive and Urological Drugs had two primary concerns about designating Opill for over-the-counter use.
The first concern was obesity, which has become more common over time. The number of states where at least 35 percent of residents are obese has nearly doubled since 2018. Currently, about four in ten Americans are medically considered overweight. In 1960 it was almost 13 percent.
Agency officials said: ‘While the original clinical trials for norgestrel tablets [mini-pill] not presenting data based on weight or BMI, the prevalence of adult obesity in the United States has changed dramatically since the original clinical trials were conducted more than 50 years ago.”
‘The extent to which efficacy of [Opill] is reduced in overweight or obese individuals (who collectively now represent about 60% of the US reproductive age population…) remains unknown,” they added.
The morning-after pill, also known as Plan B, appears to be slightly less effective in women with a body mass index above 30.
According to HRA Pharma’s review of a dozen different studies, a high BMI did not reduce the minipill’s effectiveness.
FDA officials also worried that making the pill available without a prescription would remove the ability for doctors to explain to patients the importance of taking the pill within the same three-hour time frame daily, increasing the risk of missed doses or accidental doubling of the pill increases. doses.
HRA Pharma addressed the concern in a comprehensive study called ACCESS, which mimicked an OTC environment to see if people were able to self-screen and take Opill properly. The study found that 93 percent of people taking the minipill did so on a schedule every day.