By Richard Grossman MD | 22 June 2023
Last month the US Food and Drug Administration took a big step in reproductive health. An advisory panel voted unanimously to approve selling an oral contraceptive pill “Over The Counter” (OTC).
“The pill” has been available OTC in more than 100 countries without significant problems. Many organizations in the USA have recommended that it be available without a prescription. The list includes the AMA and American College of Obstetricians and Gynecologists, which sets the standards for my specialty.
In the USA there have been several ways women can get pills without an examination. Planned Parenthood prescribes pills to women with only a blood pressure check, if a screening health history didn’t turn up any problem. Women can receive pills from several online companies based on a screening questionnaire. And in more than half of US states, pharmacists can prescribe pills. However, with all of these methods of getting pills there are unnecessary steps and excess cost.
Free the Pill (FtP), a group that was established to move oral contraceptives to OTC status, has been working since 2004 with this as its goal. Although the recent decision is a victory for them, it is a triumph for the millions of people in the USA who don’t have insurance and don’t want to get pregnant.
We’re proud to have helped bring the oral contraceptive pill over the counter, achieving widespread media coverage for one of the biggest women’s health revolutions in decades. #DeliveringDifferently #HealthcareComms #OTC #ConsumerHealth pic.twitter.com/MQ9F2uCQXg
— The Difference Collective (@HelloDifference) June 23, 2022
Let’s look at some basics; there are 2 different types of birth control pills. Combined Oral Contraceptives (COCs), the most widely used category, contain two types of hormones—estrogen and progestin. Over the years the dosage of hormones has decreased, increasing safety and causing fewer side effects. The other pill formulation is the Progestin-Only Pill; POP or “minipill”. Each type has some advantages and some disadvantages. Both types are amazingly safe—especially when compared to the risks of pregnancy.
COCs provide excellent menstrual cycle control and high effectiveness (if taken consistently). Unfortunately, the estrogen in these pills increases the risk of blood clots in certain people. Older women, those who use tobacco or who are obese are at increased risk of potentially fatal clots. In fact, these people are at greater risk whether they use COCs or not, although the estrogen adds additional danger.
POPs, in use for years, are extra safe because they don’t increase the risk of blood clots significantly. They are so safe that the FDA advisory panel ruled that their only absolute contraindication is breast cancer. However, compared to COCs, they may have a slightly higher failure rate, and they often cause irregular bleeding. About 1/3 of women using POPs have regular periods, 1/3 have some irregularity and 1/3 have spotting or irregular bleeding. Fortunately, periods are usually lighter and less painful with the minipill. Women are encouraged to take the minipill at the same time of day, every day to increase effectiveness and decrease spotting.
One of the hurdles that FtP faced was to prepare, then test, patient information for an OTC pill. Since women will have access to oral contraceptives without an intervening healthcare professional, having good instructions was an important part of the FDA approval process. FtP has been able to develop patient information materials and test them; they were found to be very effective.
In a rare collaboration, FtP has worked in conjunction with a pharmaceutical company, HRA Pharma. They own the brand (Opill®) of minipill that was recommended for approval. What does the future hold? Both HRA and FtP are dedicated to getting approval for a COC to be available without a prescription. HRA has stated that they will set a price for Opill® that is affordable. However, don’t run out to your drugstore quite yet; it will be months before the FDA gives the green light and finally “The Pill” becomes available without prescription.
Federal regulators with the Food and Drug Administration should reject proposed over-the-counter use of the progestin-only “minipill” contraceptive, the U.S. bishops have said. https://t.co/lzgR4YpJOE
— Catholic News Agency (@cnalive) May 16, 2023
Reprinted with permission from the author.
Richard Grossman became concerned about overpopulation in high school and chose a medical path to work in the field. He practiced gynecology and obstetrics, including abortion care, for 40 years in Southwest Colorado. Now retired, he writes a monthly essay on aspects of human population. If you like his blog, www.population-matters.org, you can subscribe using the form at the bottom of the page.
Doctor Richard Grossman
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