Women’s health experts applaud push for OTC birth control pills

GRAND RAPIDS, Mich. (WOOD) – HRA Pharma made headlines this week after filing a landmark application with the Federal Drug Administration – seeking permission to sell an over-the-counter birth control pill. It’s a decision that has a lot of support from women’s health experts.

The drug, known as Opill, was first approved by the FDA in 1973 for use as a prescription drug — the same year the Supreme Court cemented abortion rights in Roe v. Wade. Now, weeks after the SCOTUS decision in Dobbs v. Jackson, the same remedy is at the center of the birth control debate.

HRA Pharma is a subsidiary of Perrigo, a pharmaceutical company now headquartered in Grand Rapids. HRA Pharma acquired the rights to Opill from Pfizer in 2014 and has spent seven years conducting studies on to present its case to the FDAindicating that the drug is safe enough to be sold without a prescription.

Company officials called the application a groundbreaking moment for reproductive equality.

“More than 60 years ago, prescription birth control pills in the US empowered women to plan if and when they wanted to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers,” Frederique Welgryn, chief strategic operations and innovation officer at HRA Pharma. said in an announcement.

Dr. Cheryl Wolfe, vice president and chief of Women’s Services at Spectrum Health, said over-the-counter birth control pills have been “a long time coming.”

“I think when you look at medications that are now over the counter that used to be prescription only, such as ibuprofen, acetaminophen or even many prenatal vitamins, why not birth control?” Wolfe told News 8. “Let’s help patients. Let’s remove that barrier to family planning.”

Perrigo opened its new Grand Rapids headquarters in June 2022. HRA Pharma, a subsidiary of Perrigo, has filed an application with the FDA seeking approval for Opill to be sold over the counter. If approved, it would be the first birth control pill sold over the counter in the United States. (WOOD TV8 file)

WHY THE WAIT?

So if birth control pills have been used safely for decades, why aren’t they available over the counter? There are many reasons.

First, any pharmaceutical manufacturer must demonstrate that consumers adequately understand the drug’s risks and use it safely without supervision. And secondly, birth control pills can cause problems with blood clotting. Side effects are extremely rare but can be fatal.

Most birth control pills contain two synthetic hormones: progestin and estrogen. Progestin prevents pregnancy by blocking sperm from entering the cervix. Estrogen is the main component that helps reduce cramps, regulates menstruation and forms lighter flows.

Dr. Cheryl Wolfe, VP and Chair of Women’s Services at Spectrum Health. (Health Spectrum Health)

Data from the FDA shows that for every 10,000 women who take pills with both hormones, three to nine will experience a blood clot. The data shows that most of these blood clots are caused by excess estrogen. Opill contains only progestin, which means that the risk of blood clots is even lower.

The other argument in favor of Opill is that pregnancy poses a higher risk of blood clots than birth control pills.

“The American College of Obstetricians and Gynecologists has been really pushing for over-the-counter contraception for a long time,” Wolfe said. “When you look at patients who have these debilitating challenges with their cycles, painful cycles, very heavy cycles, many times (Opill) may not be the first option that we give the patient, but it is an option. And the benefits far outweigh the risks.”

Wolfe says we have decades of evidence that Opill has been used safely for a variety of purposes.

“We call it a mini-pill. Some breastfed patients may have received it after giving birth. Patients who had a history of high blood pressure may have received it. Patients who have a history of migraine headaches may have taken this pill. So we’re very familiar with it,” Wolfe said.

While Wolfe supports the idea of ​​over-the-counter birth control pills, she still recommends that women talk to doctors or medical experts before starting or switching medications.

“At the end of the day, most patients taking birth control pills don’t want to get pregnant. So they want to make sure this is right for me,” Wolfe said. “Because this is going to be a new concept. This is going to be a cultural change. Now I don’t have to go to my provider to get this. prescription, but is this the right pill for me?”

Over-the-counter birth control pills are now available in many other countries, including many countries in Asia, Africa, South America and the United Kingdom.

The FDA will hold public meetings to evaluate HRA Pharma’s application before announcing a decision. The pharmaceutical company says they expect a decision to be announced early next year.

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