February 21, 2024

Opill: The FDA approved the first over-the-counter birth control pill in the US. What will happen next?



CNN

The oral contraceptive Opill has been approved by the US Food and Drug Administration for over-the-counter use, making it the first non-prescription birth control pill in the United States, but it will be months before it is available.

The pill is expected to hit shelves in early 2024. The American College of Obstetricians and Gynecologists called it “a critical advance in reproductive health care accessibility.”

“Access barriers are one reason for inconsistent use or lack of contraceptive use,” ACOG said in a. statement after its approval. “Allowing individuals to access birth control at their local pharmacy or drugstore will remove some barriers, such as taking time off for an appointment, paying an office visit copay, or navigating sometimes confusing prescription refill protocols.”

Here’s what you need to know about the difference between Opill and other forms of oral contraception, how much it will cost and what challenges we may face.

Opill is a “mini-pill” that uses progestin, a synthetic form of the hormone progesterone, and does not contain estrogen. The typical combination birth control pill, the most commonly used form of oral contraception, uses both hormones to prevent pregnancy.

The FDA approved the 0.075-milligram norgestrel tablet for prescription use in 1973. Opill is about 98% effective if taken as directed, at the same time each day, according to the FDA.

Opill is not an emergency contraceptive or abortion medication.

A number of similar “mini-pills” are also available with a prescription, but Opill is the only oral contraceptive approved for purchase without a prescription.

Most progestin-only birth control works by creating thick cervical mucus that makes it difficult for sperm to enter the uterus and fertilize an egg, according to ACOG. In some cases, progestin stops ovulation from occurring; however, about 40% of women who take “mini-pills” will continue to ovulate.

Dr. Carolyn Westhoff, who specializes in obstetrics and gynecology at Columbia University, said progestin-only pills are as effective as combination pills when used as directed.

“Progestin alone is sufficient for contraceptive efficacy. Supplementing with estrogen helps with more regular bleeding and can also improve the effectiveness of progesterone. Adding estrogen has some benefits, but it is not essential for contraceptive effectiveness,” she said.

Opill can also be seen as a medical tool, not only to prevent pregnancy, said Dr. Kristyn Brandi, ob/gyn in New Jersey and chair of the Board of Directors of Physicians for Reproductive Health.

“People use birth control for things outside of preventing pregnancy like [polycystic ovary syndrome], treating heavy periods, painful periods,” she said. “There are a lot of uses outside of birth control that people will also benefit from if they can get it over the counter.”

There is no age limit to buy Opill.

This could have a big impact on teenagers and young adults who might not otherwise have the resources to access birth control, according to Brandi.

“Teenagers face so many barriers to accessing reproductive health care, like birth control, that many of them never make an appointment to receive that care,” Brandi said.

Dr. Anne-Marie Amies Oelschlager, chair of the ACOG Clinical Consensus Committee on Gynecology, said Opill can be a good short-term alternative for someone with limited resources.

“If someone is waiting to get into a health care provider but needs birth control right away, they can start Opill until they can see a provider and discuss all the contraceptive options available,” she said.

Brandi believes Opill’s approval can help bring peace of mind to marginalized groups.

“There are many reasons why people don’t want to engage with the health care system but still want to [birth control] for their own well-being,” she noted, such as racism or transphobia in medicine.

Amies Oelschlager said in a statement that oral contraceptives containing estrogen may cause side effects such as headache, nausea, and breast tenderness.

Opill may have similar side effects, including “irregular bleeding, headache, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating,” according to the FDA.

However, Amies Oelschlager said, “Progestin-only methods are safer for people with migraine headaches, uncontrolled blood pressure, and those at high risk of blood clots.”

Opil costs and insurance cover

The cost of Opill is one of the biggest unknowns after its over-the-counter approval, and it’s unclear whether the contraceptive will be covered by insurance.

“I think the short answer is, we don’t know yet,” said Dr. Jennifer Robinson, assistant professor of complex family planning in the Department of Obstetrics and Gynecology at Johns Hopkins University.

“When [emergency contraception] Plan B went over the counter, there was a lot of concern that its over the counter status would change the insurance plan’s willingness to pay for it,” she said.

Today, Plan B is often covered by insurance even though it is available over the counter.

“I think there’s a good chance that insurers will still pay for Opill even though there are similar products available for prescription,” Robinson said.

Frederique Welgryn, Perrigo’s global vice president for women’s health, said last week that the company is “committed to making sure Opill is affordable and accessible to people who need it.” The suggested retail price will be announced in the coming months, she said.

Last month, President Joe Biden released executive order directing the secretaries of the Treasury, Labor, and Health and Human Services to “consider new actions to improve access to affordable over-the-counter contraception.”

“These actions may include convening pharmacies, employers and insurers to discuss opportunities to expand access to affordable over-the-counter contraception; identify promising practices for OTC contraceptive coverage at no cost to patients; and provide guidance to support seamless coverage of over-the-counter contraception,” reads a White House fact sheet about the orders.

The Affordable Care Act requires coverage of “contraceptive methods and counseling for all women, as prescribed by a health care provider,” according to healthcare.gov. It is unclear, however, whether the ACA will cover non-prescription contraception such as Opill.

Opill’s low cost and easy access could help combat the high number of unintended pregnancies in the United States, experts say. Almost half (46%) of the 6.1 million pregnancies in the nation each year are unintended, according to the FDA.

Some experts fear legal challenges to Opill’s approval following the US Supreme Court’s Dobbs decision and a district judge’s ruling this year challenging the FDA’s approval of the abortion drug mifepristone.

“I think the outcome of the mifepristone case could have implications for the approval of Opill or any drug approval,” Robinson said. “[Could] does this allow someone who disagrees with the use of the medication to challenge every drug approved by the FDA?”

But some experts are optimistic that Opill’s over-the-counter approval will change how contraception is viewed over time.

“My hope is that as we become more normal, a lot of people have sex, and they don’t always want to get pregnant. … That’s a normal part of human behavior,” Robinson said. “My hope is that this will become normal and not unusual in any way.”

CNN’s Meg Tirrell contributed to this report.

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