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Opill birth control pills

Courtesy of Perrigo Co.

FDA experts to consider first nonprescription birth control pill

May 8, 2023

Advisers to the Food and Drug Administration (FDA) are considering a proposal this week to allow some birth control pills to be sold without a prescription.

During May 9 and 10 meetings, FDA advisers will discuss nonprescription use of Opill from Perrigo Co. affiliate HRA Pharma. The progestin-only daily birth control pill consists of 0.075 milligrams of norgestrel. It was first approved by the FDA in 1973.

The FDA will be asking its advisers if they believe people would use the pills correctly without the help of a health care provider, especially adolescents, people with limited literacy and people using drugs that may interact with the birth control pills. They also will discuss whether they are confident people will avoid using Opill if they have a history of breast cancer or abnormal bleeding or are using other hormonal contraceptives.

AAP policy on contraception does not address over-the-counter birth control pills, and it is not weighing in on the proposal before the FDA. However, AAP leaders are calling on the FDA to consider safety and effectiveness data for adolescents when making a decision.

“The AAP definitely supports the rights of adolescents to access evidence-based, comprehensive reproductive health care,” said Elizabeth M. Alderman, M.D., FAAP, chair of the AAP Committee on Adolescence. “ … Abstinence is the way to prevent an unintended pregnancy, but if adolescents choose to have sex, we want to make sure they remain healthy and ... give them the tools to prevent the unintended pregnancy.”

Progestin-only pills are useful for young women who can’t take estrogen because of a medical condition or other medications they are taking. Progestin-only pills have few contraindications or drug interactions, according to Dr. Alderman, chief of the Division of Adolescent Medicine at The Children’s Hospital at Montefiore in the Bronx, N.Y.

About 30% of high school students have ever had sex, according to data from the 2021 Youth Risk Behavior Survey. About 33% used effective hormonal birth control the last time they had sex with an opposite sex partner, 52% used a condom and 10% used both.

Dr. Alderman said adolescents face numerous challenges to accessing birth control pills, including the need to see a doctor and obtain a prescription. This is difficult for those who don’t have a provider nearby, are unsure if they can access confidential care or may not want the pills covered by their parents’ insurance.

The birth rate for teens ages 15-19 years was 13.9 per 1,000 females in 2021, a record low, according to Centers for Disease Control and Prevention (CDC) data. Increases in both abstinence and birth control use likely played a role in the decline, the agency said.

Across all ages, data show about 45% of pregnancies are unintended. Access to birth control has taken on increased significance since the Supreme Court overturned Roe v. Wade and some states are enacting stricter limitations on abortion.

“While young people have long faced extensive barriers accessing this care, the Supreme Court’s recent decision to overturn Roe v. Wade makes it more urgent than ever that we remove barriers to evidence-based reproductive health care, including contraception,” then-AAP President Moira A. Szilagyi, M.D., Ph.D., FAAP, said in 2022. “… Reproductive health care is a key component of adolescent health, and it is important that we ensure young people are supported and have access to evidence-based care, like any other vital health care service.”

Regardless of what the FDA ultimately decides on nonprescription birth control pills, Dr. Alderman said the medical home remains an important place for pediatric health care providers to give adolescents nonjudgmental information about birth control options and protection from sexually transmitted infections.

“It doesn’t take us out of the equation,” she said.



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